Reviews on Recent Clinical Trials

Background and Objective Family caregivers of stroke patients suffer from a high caregiving burden that affects their quality of life. Telenursing can provide caregivers and patients with services at the lowest cost and full access. Therefore, the aim of this study was to investigate the impact of telenursing on the quality of life of caregivers of older stroke patients. Methods A total of 79 family caregivers of older stroke patients participated in this randomized clinical trial. The samples were selected from caregivers of older stroke patients admitted to a teaching hospital in Qazvin, Iran...

Background In older patients, prevention of acute respiratory tract infections (RTIs) is challenging. Experimental studies have consistently underlined an immune-potentiating effect of the bacterial lysates product OM85, on both cellular and humoral responses. Objective This work aimed to assess the potential efficacy of OM-85 for RTIs' prevention in older individuals. Methods This explorative longitudinal study included 24 patients aged 65 years or older recruited in the GeroCovid Observational Study- home and outpatient care cohort...

BACKGROUND: The increased prevalence of irritable bowel syndrome (IBS) among medical and nursing students is a global challenge. Unfortunately, data on the Italian medical and nurse student population are scarce. Therefore, this study was designed to assess the prevalence of IBS in this setting and to evaluate the demographic, university, Mediterranean diet adherence, and anxiety factors associated with its increased presence. OBJECTIVE: To assess the prevalence of IBS, anxiety levels, and adherence to the Mediterranean diet in medical and nursing university students...

BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) decreases the risk of local recurrence after surgery in patients with locally advanced rectal cancer (LARC) and metformin is constantly gaining scientific interest due to its potentially radiosensitizing effect. OBJECTIVE: This review article aims to better clarify the role of metformin as a radiosensitizer in patients with LARC undergoing neoadjuvant concurrent chemoradiotherapy. METHODS: We used the PubMed database to retrieve journal articles and the inclusion criteria were all human studies that illustrated the effective role of metformin in the neoadjuvant setting of locally advanced rectal cancer...

The battle against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) associated coronavirus disease 2019 (COVID-19) is continued worldwide by administering firsttime emergency authorized novel mRNA-based and conventional vector-antigen-based antiCOVID-19 vaccines to prevent further transmission of the virus as well as to reduce the severe respiratory complications of the infection in infected individuals. However; the emergence of numerous SARS-CoV-2 variants is of concern, and the identification of certain breakthrough and reinfection cases in vaccinated individuals as well as new cases soaring in some low-to-middle income countries (LMICs) and even in some resource-replete nations have raised concerns that only vaccine jabs would not be sufficient to control and vanquishing the pandemic...

BACKGROUND: Metastatic castrate-resistant prostate cancer (mCRPC) is a challenging disease, especially in heavily pretreated patients. Androgen pathway inhibitors have contributed to a notable improvement in the overall survival and quality of life in patients with mCRPC during the last decade. Still, a considerable percentage of patients are unable to draw benefits from this drug category and are deprived of a treatment that offers limited toxicity and preserves a good quality of life...

BACKGROUND: Human papillomavirus (HPV) is the most common sexually transmitted infection in the US.The first HPV vaccine was introduced in 2006. There are three different HPV vaccines that commonly target high-risk HPV types. OBJECTIVE: This study compares HPV vaccine efficacy based on alternative endpoints with the most recently available cervical cancer incidence data from the Surveillance, Epidemiology and End Results (SEER) program and SEER*Stat statistical software...

Adenomyosis lacks approved pharmacological treatment even after decades of its identification. We performed this study to review the status of clinical research on adenomyosis for finding an effective drug therapy and to identify the most common endpoints used in adenomyosis trials. A systematic search was performed in the PubMed and Clinicaltrials.gov registries to identify interventional trials for analysis without any time and language restrictions. Our search revealed that barely 15 drugs have been assessed for the management of adenomyosis from 2001 to 2021...

INTRODUCTION: Hypercapnic respiratory failure (HRF) is one of the most frequent reasons for intensive care unit (ICU) admissions. In this study, we aimed to investigate the risk factors for prolonged ICU stay in HRF patients for longer than 7, 10, and 15 days. METHODS: Impact of demographics, vitals at the admission, comorbid disease severity, respiratory parameters, admission diagnosis, noninvasive mechanical ventilation (NIV) application time and settings, arterial blood gas, and blood biochemistry results were analyzed in patients with HRF to investigate risk factors for longer ICU stay...

The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors...

Background We have recently confirmed that non-pain autonomic dysfunction symptoms occur in fibromyalgia and can be assessed with the 31-item Composite Autonomic Symptom Score (COMPASS 31) instrument. Fibromyalgia patients have been found to have higher scores than matched controls across all six domains of this instrument. Objectives To analyse the principal components of the autonomic COMPASS 31 domain scores in fibromyalgia patients to understand the fundamental dimensions of dysautonomia in this disorder...

BACKGROUND: Pituitary neurosurgery executed via the transsphenoidal endonasal approach is commonly performed for pituitary adenomas. Reasons for prolonged hospital stay include postoperative headache and protracted nausea with or without vomiting. Bilateral superficial trigeminal nerve blocks of the supra-orbital V1 and infra-orbital V2 (SION) nerves performed intra-operatively as a regional anesthetic adjunct to general anesthesia were hypothesized to decrease 6 hours postoperative morphine PCA (patient-controlled analgesia) use by patients...

INTRODUCTION: Due to the development of the academic field of prosthetics and orthotics (P&O) in recent years, scientific studies in this domain have increased. However, relevant published studies, especially randomized controlled trials (RCTs), are not always of acceptable quality. Therefore, this study aimed to evaluate the methodological and reporting quality of RCTs in the field of P&O in Iran to recognize existing shortcomings. METHODS: Six electronic databases, including PubMed, Scopus, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and the Physiotherapy Evidence Database, were searched from January 1, 2000, to July 15, 2022...

BACKGROUND: Anthracyclines can improve survival in many types of malignancies, but dose-dependent and irreversible results following the use of anthracyclines have been associated with cardiomyopathy. This meta-analysis aimed to compare the effects of prophylactic agents for preventing cardiotoxicity induced following anticancer agents. METHODS: In this meta-analysis, Scopus, Web of Science, and PubMed were surfed for articles published by December 30th, 2020. The keywords were angiotensin-converting enzyme inhibitor (ACEI), enalapril, captopril, angiotensin receptor blocker, beta blocker, metoprolol, bisoprolol, isoprolol, statin, valsartan, losartan, eplerenone, idarubicin, nebivolol, dihydromyricetin, ampelopsin, spironolactone, dexrazoxane, antioxidants, cardiotoxicity, n-acetyl-tryptamine, cancer, neoplasms, chemotherapy, anthracyclines, doxorubicin, daunorubicin, epirubicin, idarubicin, ejection fraction or a combination of them in the titles or abstracts...

OBJECTIVE: We evaluated polypharmacy and drug-drug interactions (DDIs) in hospitalized patients before and after using the SIMDA Computerized Medical Decision Support System (CMDSS). MATERIALS AND METHODS: We included the prescriptions of ≥18 years hospitalized patients in the Department. We developed and implemented the Hdc.DrApp Physician Order Entry System and the CMDSS SIMDA, which detects DDIs and signals dosage adjustment based on renal function. To evaluate the impact of the CMDSS, we made a comparison Before (Survey) / After (Intervention): Survey between Oct/22/2019, and Mar/21/2020, and Intervention between apr/4/2020 and sep/3/2020...

BACKGROUND: Current evidence appraisal concepts, such as the Assessment, Development and Evaluation (GRADE) approach and Cochrane's Risk of Bias (RoB) tool, rely on assumptions related to the classic problem of inductive reasoning and may suffer from insufficient inter-rater reliability. DISCUSSION: The Composite Quality Score (CQS) has emerged as a possible trial appraisal tool that does not rely on inductive assumptions and has been shown to be of potentially very high inter-rater reliability...

BACKGROUND: Matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPS) play a key role in the pathogenesis of osteoarthritis (OA). Recent research showed the involvement of some MMPs in COVID-19, but the results are limited and contradictory. OBJECTIVE: In this study, we investigated the levels of MMPs (MMP-1, MMP-2, MMP-3, MMP-8, MMP-9, MMP-10) and TIMP-1 in the plasma of patients with OA after recovery from COVID- 19. METHODS: The experiment involved patients aged 39 to 80 diagnosed with knee OA...

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Patients with severe traumatic brain injury (TBI) need to be admitted to intensive care (ICU) because they require invasive mechanical ventilation (IMV) due to reduced consciousness resulting in loss of protective airway reflexes, reduced ability to cough and altered breathing control. In addition, these patients can be complicated by pneumonia and acute distress syndrome (ARDS). IMV allows these patients to be sedated, decreasing intracranial pressure and ensuring an adequate oxygen delivery and tight control of arterial carbon dioxide tension...

BACKGROUND: Cerebral vasospasm is one of the frequent complications that can occur following subarachnoid hemorrhage (SAH). With new protocols in the management of SAH, the combined risk of death and long-term disability have been reduced by about 10% compared with the past. OBJECTIVE: This work aims to report the latest updates on the vasospasm developing after the SAH in patients in the ICU department. In this short review, we reviewed the latest scientific findings on the mechanisms of vasospasm, and in addition, we considered it necessary to review the literature to report the tools for early diagnosis of vasospasm and the best treatment strategies to prevent the negative outcome in patients admitted to ICU...