Reviews on recent clinical trials最新文献

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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.

Background: Functional dyspepsia (FD) is felt as a discomfort or pain on the center line or upper abdomen. In this study, we aimed to compare the effects of Govarcin herbal capsule and Metoclopramide for alleviating gastrointestinal symptoms in patients with FD.

Methods: Totally, 106 patients enrolled in a double-blind, clinical trial study. The participants had FD and were divided into two groups receiving Govarcin and Metoclopramide by block randomization. The patients were treated for four weeks, taking one Govarcin capsule or Metoclopramide tablet after each meal. The rate of improvement in patients was assessed by mitigation of clinical symptoms, including epigastric pain, fullness, discomfort, nausea, vomiting and heartburn. Also, before and after intervention, we used Nepin questionnaire and ROME III. SPSS statistics 25 software was used for data analyzing.

Results: Clinical symptom score changes between Govarcin and Metoclopramide patients' groups showed that there was no significant difference in any of the clinical symptom scores (except for heartburn, p-value=0.012) between the study groups. Nepean score in Govarcin group before and after treatment were 19.3±4.8 and 8.9±2.8, respectively (p-value<0.001). For Metoclopramide group, these values were 19.8±3.5 and 9.4±2.1 respectively (p-value<0.001). No significant difference was found in terms of Nepean score between the Govarcin and Metoclopramide groups (p-value=0.995).

Conclusion: Govarcin herbal capsule can be used to remedy symptoms in patients with FD. It seems that Govarcin is as effective as Metoclopramide in fighting symptoms of FD as no significant difference in efficacy has been demonstrated between them.

Background: Paragangliomas of the urinary tract are exceptionally uncommon, and sporadic case reports of primary paraganglioma of the prostate have been reported in the literature.

Methods: Systematic research in PubMed/Medline and Scopus databases concerning primary prostatic paraganglioma was performed by two independent investigators.

Results: This analysis included 25 adult males, with a mean age of 49.8 ± 22.4 years. 32% of included patients had a history of hypertension. Problems during urination (52%), blood loss (44%), either as hematuria or hemospermia, and catecholamine-related symptoms (36%) comprised the most frequently reported clinical manifestations. Digital rectal examination found a palpable nodule in 36% of patients, while prostatic specific antigen (PSA) was normal in all tested patients. Abdominal ultrasound (44%), computed tomography (44%) and magnetic resonance imaging (28%) helped to identify the primary lesion. 24-hour urine epinephrine, norepinephrine and vanillylmandelic acid (VMA) levels were elevated in 90%, 80% and 90% of included patients. Open surgical excision of the mass was performed in 40%, transurethral resection in 8%, open radical prostatectomy in 24%, transurethral resection of the prostate in 16% and robot-assisted radical prostatectomy in 4% of included patients.

Conclusion: Due to atypical clinical manifestation and scarcity of prostatic paraganglioma, urologists should be aware of this extremely rare entity.

Aims: Iron deficiency anemia (IDA) is one of the disorders recently associated with an increase in insulin resistance (IR) and, consequently, diabetes mellitus (DM) affection by causing oxidative stress. In this study, we look at how IDA may contribute to developing type II diabetes mellitus (T2DM), controlling diabetes, and reducing IR in women with T2DM.

Methods: In this single group, clinical interventional study, we enrolled 40 women with T2DM and IDA. Before and after intervention with ferrous sulfate tablets, their blood glucose (BG) levels and IR levels were evaluated. This study was approved by the Ethics Committee of Qom University of Medical Sciences (ethics code: IR.MUQ.REC.1397.031) and registered at the Iranian Center for Clinical Trials (No. IRCT20170215032587N3). A significant level was considered p <0.05.

Result: The mean age of patients was 48.18 ± 4.6 years, with 5.3-5.8 years duration of T2DM. After the intervention, the mean fasting blood glucose (FBG) level reached 198.53 ± 48.11 to 170.93 ± 37.41, which was significant (p <0.0001). Also, hemoglobin A1C level reached from 8.49 ± 0.9 to 7.96 ± 0.58, which was significant (p <0.0001). Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) demonstrating a significant reduction of IR levels after intervention with ferrous sulfate tablets (p <0.018).

Conclusions: IDA treatment in patients with T2DM can significantly reduce the BG and IR levels. To better control BG, checking iron status and its correction may provide better clinical outcomes in these patients.

Dupilumab is a fully humanized IgG4 monoclonal antibody, inhibiting IL-4 and IL-13 signaling, which are the main cytokines involved in type 2 inflammatory diseases. Its introduction was a breakthrough in the treatment of moderate-to-severe atopic dermatitis, but it is also used in other inflammatory diseases, including asthma, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis. Recent advances in the understanding of inflammatory pathways have revealed that Th2-type inflammation is involved in a wider range of diseases than previously thought. The aim of our review is to examine off-label therapeutic indications of dupilumab, including bullous dermatoses (pemphigus, bullous pemphigoid) and alopecia areata, and to investigate its potential applications in cancer patients on anti-PD1 therapy.

Background: Mitochondrial dysfunction and impaired mitophagy are integral to myocyte loss and the progression of heart failure. Urolithin A (UA), a microbiota-produced metabolite of ellagitannins and ellagic acid, is a known stimulator of mitophagy and mitochondrial biogenesis that has shown cardioprotective effects in experimental models.

Methods: A randomized, double-blind, placebo-controlled 2×2 crossover trial was conducted on 10 patients with HF with reduced ejection fraction (HFrEF). The trial design involved two 4- week intervention periods of UA (500 mg BID) and placebo, separated by a 2-week washout phase. The patients underwent two-dimensional echocardiogram examination as well as blood sampling at the beginning and end of each period.

Results: All patients completed the study. The results failed to reveal any significant effect of UA supplementation on echocardiographic measures (LVEF, LVEDD, LVESV, and TAPSE). Plasma concentrations of pro-BNP, glucose, and CRP (p >0.05) were also not altered. Serum HDL-C levels were increased with UA compared with placebo (+6.46 ± 2.33 mg/dL, p =0.026), whereas other lipid indices (LDL-C, triglycerides, total cholesterol, and VLDL-C) remained unchanged (p >0.05).

Conclusion: The results of the present study do not support any positive effect of UA supplementation in improving echocardiographic and biochemical indices of HFrEF. Further studies with higher doses of UA and longer supplementation duration are encouraged to be conducted.

Background: Cancer and infectious diseases are one of the greatest challenges of modern medicine. An unhealthy lifestyle, poor drug use, or drug misuse contribute to the rise in morbidity and mortality brought on by these illnesses. The inadequacies of the medications now being used to treat these disorders, along with the growing issue of drug resistance, have compelled researchers to look for novel compounds with therapeutic promise. The number of infections and diseases has significantly abated due to vaccine development and use over time, which is described in detail. Several novel vaccines can now be produced by manipulating Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), Messenger Ribonucleic acid (mRNA), proteins, viral vector Recombinant, and other molecules due to advances in genetic engineering and our understanding of the immune defense.

Objective: The main topic of discussion is cancer-based vaccinations, which were developed less than a decade ago but have already been used to treat a wide range of both life-threatening and deadly diseases. It contains clinical studies for cancer vaccines against kidney, liver, prostate, cervix, and certain RNA-based cancer vaccines against breast and bladder cancer.

Results: Numerous studies using various DNA and RNA-based methods have been conducted on the basis of cancer, with 9-10 diseases related to DNA and 8-9 diseases associated with RNA. Some of these studies have been completed, while others have been eliminated due to a lack of research; further studies are ongoing regarding the same.

Conclusion: This brief discussion of vaccines and their varieties with examples also discusses vaccine clinical trials in relation to cancer diseases in this DNA and RNA-based cancer vaccine that has had successful clinical trials like the cervical cancer drug VGX-3100, the kidney cancer drug Pembrolizumab, MGN-1601, the prostate cancer drug pTVG-HP with rhGM-CSF, the melanoma cancer drug proteasome siRNA, and the lung cancer drug FRAME-001.