Reviews on recent clinical trials最新文献

Management of infections in heart transplant recipients is complex and crucial. In this population, there is a need for a better understanding of immunosuppressive trough levels (C0), infectious complications, and urinary tract infections (UTIs). The purpose of this review was to understand the association between immunosuppressive trough levels and UTIs after heart transplantation. A review of scientific literature (n= 100) was conducted based on the topic of interest by searching PUBMED.Gov (https://pubmed.ncbi.nlm.nih.gov/), Web of Science, and Scopus. The analysis of bacterial pulmonary infection required the occurrence of new or deteriorating pulmonary infiltrates and the development of organisms in cultures of sputum specimens. The diagnosis of UTIs was based on the result of related signs, pyuria, and a positive urine culture. The incidence of UTIs was reported as 0.07 episodes/1000 regarding heart transplantation days. An eightfold increase in the rate of rejection was noted in heart transplant recipients with higher variability in tacrolimus C0. There are associations between C0 of immunosuppressive drugs and clinical presentation of infection complications. Recipients with a low metabolism of immunosuppressive drugs are more susceptible to infectious complications. Attention to the biology of herpes viruses, Escherichia coli, Enterococcus spp., Pseudomonas aeruginosa, and Staphylococcus saprophyticus after heart transplantation are important, in which some of them are the most common pathogens responsible for UTIs. Pneumocystis and cytomegalovirus affect all transplant recipients. Pneumonia due to bacterial, viral, protozoa, and fungal infections, in addition to UTIs, are more specific reported types of infections in heart transplant recipients. Bacterial infections produced by extensively drug-resistant Enterobacteriaceae, vancomycin-resistant enterococci, and non-fermenting gramnegative bacteria were reported to increase after transplantation.

Background: It has been proposed that colchicine may have the potential to prevent cardiovascular and cerebrovascular dysfunctions.

Objective: This study evaluated the impact of colchicine on preventing recurrent stroke in patients with both ischemic stroke (IS) and atrial fibrillation (AF).

Methods: A randomized, double-blinded, placebo-controlled trial was conducted at Golestan Hospital (Ahvaz, Iran) over one year, involving IS patients with AF. Demographic and clinical data were collected from the participants, who were then assigned to either the intervention or placebo groups. The experimental group was administered colchicine at a dosage of 0.05 mg twice daily for one year, while the control group received a placebo at a comparable dosage over the same timeframe.

Results: In one year, 108 patients completed the study. There were 55 patients in the intervention group and 53 patients in the placebo group. During the second trimester of the trial, three patients in the colchicine group and 10 patients in the placebo group experienced recurrent strokes. Gastrointestinal issues were the most commonly reported complications (33 cases), followed by myalgia (8 patients). There were significant differences in the frequency of recurrent stroke and serum levels of C-reactive protein (CRP) between the colchicine and placebo groups (P < 0.05) after intervention.

Conclusion: In this study, colchicine was effective in reducing recurrent stroke and CRP levels in IS patients with AF compared to the control group. Further randomized controlled trials with larger sample sizes and extended durations are recommended to validate the results of this trial.

Aim: The aim of this study was to assess the role of seminal Malondialdehyde Acid (MDA) in the diagnosis of male infertility.

Background: Both male and female infertility is increasing all over the world.

Objective: The purpose of this study was to assess the impact of seminal MDA levels on various semen parameters of healthy fertile men and men with infertility, and to know the efficacy of seminal MDA in the diagnosis of male infertility.

Methods: This case-control study was carried out at the Department of Obstetrics and Gynaecology of a tertiary care center in rural Southern India over a period of two years. The study included 90 infertile men (≥21-50 years) having some pathology in semen reports as cases and 90 fertile men (having biological children) with normal semen reports as controls. Biochemical tests for MDA were performed using Human MDA Assay kits on 180 cryopreserved semen samples following the standard protocol. Results of seminal MDA levels were assessed among cases and controls and correlated with different semen parameters.

Results: The mean±SD age for cases was 30.10 ± 4.75 years, and for controls, it was 29.79 ± 5.08 years. Of all the cases, 44 (48.9%) had asthenozoospermia, 22 (24.4%) had oligoasthenozoospermia, 14(15.6%) had oligozoospermia, and 10 (11.1%) had azoospermia. A statistically substantial variance was observed in mean values of MDA (1.03 ± 0.31 mmol/mL vs. 0.60 ± 0.14 mmol/mL; p =0.001) between fertile men and men with abnormal semen reports. A negative association was observed between semen MDA levels with sperm motility, concentration, and normal morphology in 180 participants. The sensitivity of MDA for male infertility prediction was 86.67% at 76.67% specificity, 78.79% positive predictive value, and 78.79% negative predictive value.

Conclusion: MDA has been found to be a promising biomarker for predicting male infertility. However, large sample sizes and prospective cohort studies are required to further confirm its predictive accuracy across various populations.

Aim: The objective of this Multicentric Post-Marketing Surveillance (PMS) study was to evaluate the safety and tolerance of vitamin C and zinc tablets in the Indian population experiencing deficiencies of these nutrients. Furthermore, the study aimed to provide insights into physicians' prescription practices and characterise the patient population receiving the study medication.

Methods: This prospective observational study involved 358 participants from 8 study sites across India (including 2 government hospital sites), spanning a duration of approximately 12 weeks (3 months). The primary aim was to evaluate the safety and tolerability of zinc and ascorbic acid effervescent tablets for those who were deficient in zinc and vitamin C. Throughout the study period, adverse events were monitored and categorised by MedDRA Primary System Organ Class and Preferred Term. The analysis included evaluating the incidence, percentage, and correlation of adverse events with the treatment (safety population). Additionally, the frequencies of adverse drug reactions were examined across all enrolled patients. Vital signs and symptom-focused physical examinations were conducted during each visit in the safety population.

Results: Out of 358 (100%) patients, only 12 (3.35%) experienced minor symptoms in the study period. The majority of patients reported gastrointestinal disorders, i.e., two (0.6%) patients reported constipation and gastritis, respectively. Diarrhoea was reported by four (1.1%) patients. One (0.3%) patient reported gastrointestinal pain. Three (0.8%) patients reported vomiting. Diarrhoea was the most common symptom reported. All patients possess a mild intensity of adverse drug reactions in safety populations. The P-value is less than 0.05 (p-value < 0.05), and therefore there is a statistically significant relationship between the predictor variables and the response variable (i.e., the expected count of adverse drug reactions).

Conclusion: The fixed-dose combination of vitamin C and zinc effervescent tablets appears to be safe and tolerable for the treatment of vitamin C and zinc deficiencies in Indian patients. The favorable outcome underscores the mild nature of the adverse reactions and the right medical interventions and support.

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Background: Maternal position during delivery can affect the physiology of labour and the mechanics of childbirth.

Objective: The study aimed to evaluate the impact of an upright position during the first stage of labour on maternal outcomes.

Methods: This parallel group randomised control trial was conducted from April to June 2020 among 60 women (30 each in the experimental and control groups) admitted to the selected hospital in Punjab, India. Women who entered the active stage of labour naturally with a single live foetus in cephalic presentation, aged 18-45 years, and with normal body mass index were randomly assigned either to the experimental or control group using a concealed envelope method. Women in the experimental group were informed and encouraged to adopt the upright position, while those in the control group received the standard routine care during the first stage of labour. The effectiveness of upright positions during the first stage of labour was assessed in terms of duration of the first, second, and third stages of labour, mode of delivery, and perineal lacerations. Outcome assessors were blinded to the intervention. The differences in the groups were evaluated by mean, median, frequency, percentage, Chi-square, and t-test.

Results: The results of 60 women were analysed. Women in the experimental group experienced a significant reduction in the incidence of instrumental delivery (p =0.005), perineal laceration (p =0.001), and duration of the first stage (p =0.0001) and third stage (p =0.0001) of labour compared to those in the control group. No harm was reported across the study groups.

Conclusion: This study urges nurses and midwives to recommend the use of upright positions during the first stage of labour to reduce the duration of labour and incidence of perineal laceration among women.

Clinical trial registration number: CTRI/2022/04/041740.

Different levels of residual drugs can be monitored within a relatively safe range without causing harm to human health if the appropriate dosing methodology is considered and the drug withdrawal period is controlled during poultry and livestock raising. Antimicrobials are factors that can suppress the growth of microorganisms, and antibiotic residues in livestock farming have been considered as a potential cause of antimicrobial resistance in animals and humans. Antimicrobial drug resistance is associated with the capability of a microorganism to survive the inhibitory effects of the antimicrobial components. Antibiotic residue presence in chicken is a human health concern due to its negative effects on consumer health. Neglected aspects related to the application of veterinary drugs may threaten the safety of both humans and animals, as well as their environment. The detection of chemical contaminants is essential to ensure food quality. The most important antibiotic families used in veterinary medicines are β-lactams (penicillins and cephalosporins), tetracyclines, chloramphenicols, macrolides, spectinomycin, lincosamide, sulphonamides, nitrofuranes, nitroimidazoles, trimethoprim, polymyxins, quinolones, and macrocyclics (glycopeptides, ansamycins, and aminoglycosides). Antibiotic residue presence is the main contributor to the development of antibiotic resistance, which is considered a chief concern for both human and animal health worldwide. The incorrect application and misuse of antibiotics carry the risk of the presence of residues in the edible tissues of the chicken, which can cause allergies and toxicity in hypersensitive consumers. The enforcement of the regulation of food safety depends on efficacious monitoring of antimicrobial residues in the foodstuff. In this review, we have explored the rapid detection of drug residues in broilers.

Background: Microbial imbalance is thought to play a role in the pathogenesis of Diverticular Disease (DD).

Objective: We aimed to assess the efficacy of a symbiotic mixture (Prolactis GG Plus®) in the treatment of moderate to severe DD, scored according to the Diverticular Inflammation and Complication Assessment (DICA) classification.

Methods: A retrospective study was conducted enrolling the following patients: at the first diagnosis of DD; in whom DD was diagnosed with colonoscopy and scored according to DICA classification; treated with Prolactis GG Plus® two times/daily for 2 consecutive months; in whom the severity of the abdominal pain was scored with a 10-points visual-analogue scale (VAS) at baseline and the end of follow-up; in whom fecal calprotectin (FC) was assessed at baseline and the end of follow-up as μg/g.

Results: Twenty-four patients were identified (10 males, 14 females; 16 as DICA 2, and 8 as DICA 3). Prolactis GG Plus® decreased the severity of abdominal pain both in DICA 2 (p =0.02) and DICA 3 patients (p =0.01), while FC decreased significantly in DICA 2 (p <0.02) but not in DICA 3 (p =0.123) patients. Acute diverticulitis occurred during the follow-up in two DICA 3 patients but none DICA 2 patients. Add-on therapy was required by eight DICA 2 (50%) and six DICA 3 patients (75%).

Conclusion: In newly diagnosed patients with DD, the symbiotic mixture Prolactis GG Plus® can be a potential treatment for moderate (DICA 2) DD as a single treatment.

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Background and objective: Abdominal pain is a frequent reason for admission to the Emergency Department. It may be a symptom of an underlying "organic" disease or a "functional" manifestation without an underlying anatomic or physiologic alteration. The evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Faecal calprotectin could be a useful diagnostic marker to distinguish between "organic" or "functional" form and its determination could be helpful to select patients for further examinations in the context of an emergency setting.

Materials and methods: This is an observational and retrospective study on 146 patients with abdominal pain and/or diarrhea (with or without rectal bleeding) admitted to the Emergency Department of Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, who collected a fecal sample to evaluate fecal calprotectin. We evaluated and correlated the level of fecal calprotectin with the final diagnosis they received.

Results: 50/146 patients (34,24%) received a diagnosis of acute diverticulitis, in particular, 14/50 (28%) were complicated and 36/50 (72%) were uncomplicated; 4/146 (2,7%) were cholangitis, 32/146 (21,9%) were colitis, 6/146 (4,1%) gastritis, 42/146 (28,7%), Irritable bowel syndrome and 12/146 (8,2%) Inflammatory bowel disease. For the differential diagnosis between Irriable or inflammatory bowel diseses, our study showed a VPP and a VPN of 100% meanwhile for the differential diagnosis between Acute complicated and uncomplicated diverticulitis, our study showed a VPP of 40% and a VPN of 84%.

Conclusion: In the emergency setting, faecal calprotectin could be a helpful marker to select patients with abdominal pain who need second-level radiological examinations or endoscopic procedures, guiding the emergency physician in the evaluation of such a complex and wideranging symptom.

Background: The aim of this study is to synthesize the existing evidence on various palliative care (PC) models for cancer patients. This effort seeks to discern which facets of PC models are suitable for various patient cohorts, elucidate their mechanisms, and clarify the circumstances in which these models operate.

Methods: A comprehensive search was performed using MeSH terms related to PC and cancer across various databases. The Preferred Reporting Items for Systematic Reviews and a comprehensive evidence map were also applied.

Results: Thirty-three reviews were published between 2009 and 2023. The conceptual PC models can be classified broadly into time-based, provider-based, disease-based, nurse-based, issue-based, system-based, team-based, non-hospice-based, hospital-based, community-based, telehealth-based, and setting-based models. The study argues that the outcomes of PC encompass timely symptom management, longitudinal psychosocial support, enhanced communication, and decision-making. Referral methods to specialized PC services include oncologist-initiated referral based on clinical judgment alone, via referral criteria, automatic referral at the diagnosis of advanced cancer, or referral based on symptoms or other triggers.

Conclusion: The gold standard for selecting a PC model in the context of oncology is a model that ensures broad availability of early PC for all patients and provides well-timed, scheduled, and specialized care for patients with the greatest requirement.