Some studies observed a benefit of Parkinson’s disease (PD) patients after treatment with safinamide in some non-motor symptoms (NMSs). The aim of this study was to analyze the effectiveness of safinamide on NMS burden in PD. SAFINONMOTOR (an open-la...
Depression is frequent in Parkinson’s disease (PD) patients, but the evidence for many antidepressant agents to treat it in PD is insufficient. The aim of the present prospective open-label single-arm study (VOPARK, an open-label study of the e...
Patients with Parkinson’s disease (PD) can improve some non-motor symptoms (NMS) after starting treatment with opicapone. The aim of this study was to analyze the effectiveness of opicapone on global NMS burden in PD. OPEN-PD (Opicapone Effecti...
The primary objective of this open-label, two chemotherapy arm, phase 4 study was to evaluate the safety and efficacy of newly developed recombinant granulocyte colony-stimulating factor (rG-CSF) used to prevent neutropenia-related complications in p...
Objective: This was an open-label pilot study to test the feasibility and preliminary efficacy of a wearable digital intervention developed to improve on-task behavior. This was an exploratory study to test for specificity of response on parent- and...
Monkeypox (mpox) is an acute exanthematous disease caused by the monkeypox virus (MPXV). Since May 2022, patients with mpox have been reported worldwide, mainly in Europe and the Americas. In Japan, LC16”KMB,” which is a smallpox vaccine...
Background: Agaro-oligosaccharides (AOS) have been shown to modulate the gut microbiota in in vitro and animal studies; however, human evidence remains scarce. Methods: Herein, we conducted a four-week open-label, single-arm, non-randomized pilot tri...
Autism spectrum disorder (ASD) is frequently associated with gastrointestinal symptoms, immune dysregulation, and altered microbiota-related signaling, supporting interest in microbiota-targeted interventions. This study evaluated adaptive functionin...
Background/Objectives: Parents of autistic children often face behavioral and participation challenges of their children, leading them to make accommodations to maintain a stable daily family routine. These family accommodations (FA) involve adapting...
Introduction: The general objective of this research is to improve the quality of colorectal cancer screening (CRC) by assessing, as an indicator of effectiveness, the ability of colonoscopy to detect more advanced adenomas in the exposed group than...
Prolonged grief disorder (PGD) affects approximately 10% of bereaved individuals and is now formally recognized in both the DSM-5-TR and ICD-11. Despite its prevalence, PGD often responds poorly to traditional therapeutic approaches. This manuscript...
Background: Cancer pain is highly prevalent, and existing treatments are often insufficient to provide adequate relief. Objectives: We assessed the long-term safety and efficacy of subcutaneous tetrodotoxin treatment in reducing the intensity of chro...
Migraine is a common disabling primary headache disorder with significant personal and socio-economic impacts. A combination of medication and non-pharmacological therapies is essential for migraine management. Outpatient multidisciplinary headache t...
Nitric oxide (NO) plays multiple roles in both normal and abnormal skin processes. Its deranging disbalance is involved in the pathogenesis of multiple dermatologic diseases such as acne vulgaris, pointing towards beneficial therapeutic directions. A...
Background: Placebo has been studied for many years and is ever-present in healthcare. In clinical practice, its use is limited by ethical issues raised by the deception entailed by its administration. Objective: To investigate whether, when given de...
The aim of this prospective open-label study was to treat disabling drooling in children with cerebral palsy (CP) with onabotulinumtoxin A (A/Ona, Botox®) into submandibular and parotid glands and find the lowest effective dosage and least invasive m...
(1) Background: Idiopathic or familial nasal hyperkeratosis (NHK) may be considered a cosmetic issue in its uncomplicated form. Nevertheless, the prevention of secondary lesions could be advised by proper management. (2) Methods: In this multicentre,...
Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, thes...
Dysphagia (difficulty swallowing) affects up to 13% of persons 65 years and older and 51% of older persons in nursing homes and can contribute to reduced adherence to oral medications. This was an exploratory, single-center, open-label, randomized, c...
(1) Background: Psoriatic Arthritis (PsA) is a painful disease of the joints and spine. Recent reports observed distinct enteric dysbiosis in PsA; intake of probiotic strains is considered to ameliorate enteric dysbiosis. If probiotics are effective...
Comparative pharmacodynamic (PD) analyses on different dosing schedules for cholecalciferol supplementation are limited. This was an open-label, randomized, parallel-group study involving 75 healthy individuals deficient in vitamin D (baseline 25OHD...
The benefits of probiotic supplementation to lactating mothers on human milk cytokines are inconclusive. Thus, we performed a comprehensive open-label pilot trial analysis of 27 human milk cytokines in lactating women with allergies (one to three mon...
Background: The aim of this study was to investigate the pharmacokinetic (PK) and safety profile of high-dose vitamin D supplementation, comparing different schedules (daily, weekly, or bi-weekly) in an otherwise healthy vitamin D-deficient populatio...
Obesity and high abdominal fat mass are risk factors for developing the chronic inflammatory skin disease psoriasis. They are associated with increased incidence, prevalence and severity of the disease. A positive effect of weight loss on psoriasis a...
Background and Objectives: Japan’s aging population faces growing challenges related to oral frailty, a condition characterized by the decline of oral function associated with physical and nutritional deterioration. Impaired oral function contr...
Background: An open-label, noncomparative study was conducted to assess the safety and efficacy of ciclopirox 8% nail lacquer topical solution in patients with type 2 diabetes mellitus. Methods: Forty-nine diabetic patients with distal subungual onyc...
Background and Objectives: Light therapy (LT) is used as an adjunctive treatment for sleep problems. This study evaluates the impact of LT on sleep quality and sleep-related parameters in patients with sleep disorders. Materials and Methods: We perfo...
The aim of this study (ClinicalTrials.gov registration NCT04666324) was to determine the effects of a nine-strain synbiotic and simethicone on the duration of crying and the gut inflammation marker calprotectin in colicky babies aged 3–6 weeks,...
28 January 2023
Background: Memory disorders are common among elder people, and nonclinical cognitive decline is commonly experienced with age. Preclinical investigations have explored the possible role of alpha-lipoic acid (ALA), a known antioxidant compound abunda...
Stress associated with veterinary visits represents a significant concern for cats, as well as a primary challenge for both caregivers and veterinary practitioners. Based on previous in vitro and in vivo studies on imepitoin, this pilot study was con...
Objectives: The present open-label multicenter pilot study sought to prospectively evaluate the efficacy and safety of rimegepant in treating migraine attacks. Methods: The primary endpoint was pain freedom at two hours post-dose, while the co-primar...
Background: Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aimed to evaluate the effect of a medical device gel based on adelmidrol + trans-traumatic acid in...
The aim of this single-center, open-label, randomized controlled study was to evaluate which formulation of vitamin D—between cholecalciferol and calcifediol—is most effective in the treatment of hypovitaminosis D in older adults. Demogra...
Introduction: Depression is the most common morbidity during pregnancy. Available first-line therapy options are limited and depressive disorders in pregnant women are often untreated, leading to negative effects on maternal and fetal health. Objecti...
Background/Objectives: Uremic pruritus and sleep disturbance commonly coexist in patients receiving maintenance hemodialysis. This analysis examined whether supplementation with Lactobacillus casei var. rhamnosus LCR35 was associated with changes in...
Ophthalmic tacrolimus compounded formulations are usually made from the commercial intravenous presentation, which contains ethanol as a solubilizer due to the low solubility of tacrolimus. The use of cyclodextrins is presented as an alternative to e...
Objective: The objective of this study was to evaluate the efficacy of a very-low-absorbable geraniol formulation, administered as a food supplement, in patients with irritable bowel syndrome (IBS) in a real-world setting in Italy. Methods: This open...
Background: Chronic inflammatory bowel diseases (IBDs), specifically Crohn’s disease and ulcerative colitis, present substantial clinical challenges characterized by a relapsing-remitting course. These conditions often lead to serious complicat...
25 November 2022
Background: Though Maytenus senegalensis is one of the medicinal plants widely used in traditional medicine to treat infectious and inflammatory diseases in Africa, there is a lack of safety data regarding its use. Therefore, the study aimed to assel...
Background and Objectives: Autism spectrum disorder (ASD) is a prevalent neurodevelopmental disorder with an increasing global incidence. Gut microbiota dysbiosis is believed to be playing a role in ASD pathogenesis. Fecal microbiota transplantation...
Objective: This study aimed to assess the bioequivalence of two oral methocarbamol formulations, as follows: the test (T) methocarbamol 1500 mg tablets and the reference (R) Robaxin® 500 mg tablets (3 tablets, total dose: 1500 mg) under fasting c...
Background: HIV and hepatitis B virus (HBV) coinfection has been associated with a higher risk of morbidity and mortality. HBV-active antiretroviral regimens have significantly improved the outcomes for coinfected people. Although bictegravir/emtrici...
This single-centre, open-label, randomised, parallel-group study assessed the acceptability, swallowability, palatability, and safety of film-coated, 3 mm diameter mini-tablets in children aged ≥2–<7 years. In total, 300 participants were...
The association between intravenous iron substitution therapy and hypophosphatemia was previously reported in patients with iron deficiency anemia. However, the extent of hypophosphatemia is thought to depend on the type of iron supplementation. We h...
Background: FN-1501, a potent inhibitor of receptor FMS-like tyrosine kinase 3 (FLT3) and CDK4/6, KIT, PDGFR, VEGFR2, ALK, and RET tyrosine kinase proteins, has demonstrated significant in vivo activity in various solid tumor and leukemia human xenog...
OnobotulintoxinA (OBT-A) is a treatment option for Chronic Migraine (CM). It works on central sensitization and pain but its mode of action is still unknown. To observe how OBT-A treatment works on single migraine attacks, this paper covers an over-6...
Background: A BMI > 25 is the most decisive, albeit modifiable, risk factor for knee osteoarthritis (KOA). This study aimed at assessing the efficacy of intra-articular injections of hybrid hyaluronic acid (HA) complexes (Sinovial® H-L) for the tr...
Background: As the microbiome plays an important role in instigating inflammation in ulcerative colitis (UC), strategies targeting the microbiome may offer an alternative therapeutic approach. The goal of the pilot trial was to evaluate the potential...
9 November 2021
In this single-arm pilot open-label study we examined the effect of a mindfulness-based intervention on reduction of headache frequency after 12 months in adolescents aged 12–18 with chronic or high-frequency migraine without aura. Adolescents were r...
The mechanism of premature ventricular complexes (PVC) occurring in the ventricular outflow tract (OT) is related to an intracellular calcium overload and delayed afterdepolarizations that lead to triggered activity. The guidelines recommend using be...
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