Reviews on recent clinical trials最新文献

Background: The COVID-19 pandemic has significantly changed the implementation of clinical trials. A large focus has been directed on clinical trial design, timeline, and best practices. It has led clinical trial study teams to update the existing processes and perform a risk assessment to mitigate the impact of the COVID-19 pandemic according to ICH-GCP (Good Clinical Practice) requirements. Data management plays a crucial role in understanding the study team's needs and developing innovative solutions. The Clinical Data Manager (CDM) is a core clinical trial Study Team member, responsible for promptly collecting, managing, and delivering complete, highquality data.

Objective: The COVID-19 pandemic required the Clinical Data Manager (CDM) to respond to changing needs by adapting data collection tools, data review strategies, and data management processes to answer new questions and address new challenges. CDMs became responsible for identifying how the COVID-19 pandemic impacted current data management processes and documentation and implementing changes to reflect new ways of working. The present article reviews the impact of the COVID-19 pandemic on clinical trials and the solutions adopted by the Clinical Data manager.

Conclusion: The collection of COVID-19-related data points provides a better understanding of patient safety during the pandemic and proactively fulfills the growing regulatory interests. Strategies and innovative solutions adopted by the Clinical Data Manager serve as guidance for the clinical research team during the crisis to make the trials more robust and patient-centered.

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. The mechanisms leading to this pre-existing or acquired resistance, as well as the possible strategies to overcome this resistance have been put at the center of scientists' attention.

Case presentation: With the present report we present the case of a 70-year-old patient with mCRPC, who was apparently an enzalutamide non-responder, but a multimodal approach with enzalutamide continuation and irradiation to his symptomatic oligoprogressive disease converted him to a responder with clinical, biochemical and imaging response; furthermore, we discuss the existing data providing evidence for the use of metastasis-directed therapy in combination with androgen pathway inhibitors in order to overcome drug resistance in patients with oligoprogressive disease.

Conclusion: A considerable proportion of patients with oligometastatic or oligoprogressive prostate cancer who seem not to respond to androgen pathway inhibitors, such as enzalutamide, due to preexisting or acquired resistance, could benefit from MDT with a multimodal treatment approach. This strategy allows androgen pathway inhibitor continuation beyond biochemical progression and delays the switch to next-line systemic treatment.

Background: Available experimental and clinical evidence indicates that N-Acetyl cysteine (NAC) may have an analgesic role in specific pain conditions, particularly neuropathic pain. Thus, we hypothesized that NAC supplementation might be also helpful in decreasing pain and improving pain-related disability in patients with acute radiculopathy. We designed this study to investigate the potential use of NAC-adjunctive treatment to Nonsteroidal Anti- Inflammatory Drugs (NSAIDs) in patients with acute radiculopathy secondary to lumbar intervertebral disc herniation.

Methods: Sixty-two patients diagnosed with acute lumbar radiculopathy associated with disc herniation were randomly allocated to the NAC or the placebo groups. Besides naproxen at a dose of 500 mg twice a day, participants based on their allocation group started with NAC or matched placebo at a dose of 600 mg twice a day for eight weeks. The pain severity, measured by the Visual Analog Scale (VAS), and pain-related disability measured by the Oswestry Disability Index (ODI) were measured at baseline and weeks 2, 4, and 8 of treatment. Global improvement of symptoms rated by Patient and Clinical Global Impressions of Change (PGIC and CGIC) was also recorded at the end of week 8. All analyses were conducted on an Intentionto- Treat (ITT) analysis data set.

Results: A comparison of the VAS and ODI scores at weeks 2 and 4 of the treatment between the two groups did not show a significant difference. In contrast, from week 4 to week 8, we noticed a significantly greater reduction in the mean VAS and ODI scores in the NAC group compared to the placebo group (p-value <0.001 for both variables). In parallel with these results, also, more NAC-treated than placebo-treated patients achieved treatment success defined as ''very much'' or ''much improved'' on CGIC and PGIC scales, and these differences reached a significant level (p-value = .011 and p-value = .043).

Conclusions: This study suggested that NAC might be a relevant candidate for adjunct therapy in managing acute lumbar radiculopathy. Additional clinical trials are needed to validate these findings.

Background: Lower Gastrointestinal Bleeding (LGIB) is a common cause of admission to the Emergency Department (ED). Early colonoscopy is the exam of choice for evaluating LGIB, and an adequate colon cleansing is essential. High-volume solution 4L-PEG is largely used, but it has some limitations. Low-volume solution 2L-PEG may improve patient's tolerability and compliance, reducing the time of administration and speeding up the exam.

Patients and methods: We conducted a randomized 1:1, prospective observational monocentric study in 228 patients (144M/84F) with LGIB. 121 (69M/52F) received the High-Volume, while 107 (75M/32F) received Low-Volume. They completed a "satisfaction questionnaire" (taste and smell, mood, time of taking, general experience). We collected the results of the Boston Bowel Preparation Scale (BBPS) and the final diagnosis. The study was retrospectively registered on clinicaltrial.gov with protocol number NCT0536 2227.

Results: A mean value of BBPS 6,3 was achieved by both groups (p=0.57). Regarding smell, taste, mood and time of taking (1 to 5), we do not find any statistically differences. The overall satisfaction between the two preparations was 2.90 for low-volume compared to 3.17 for Highvolume (p=0.06). No side effects were reported. The proportion of patients without an evident source of bleeding was higher in High volume preparations compared to Low-volume (39% vs. 30%, respectively).

Conclusion: Low volume bowel preparation showed the same efficacy and tolerability with better satisfaction compared with high volume. Low-volume could represent an effective and more desirable preparation for patients in the ED.

Background: 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. They were randomly divided into two groups. The intervention group participated in an educational intervention for 12 weeks through telephone follow-up and social media. The Barthel Scale and the 36-item Short Form Survey (SF-36) were used for data collection. The chi-square and independent and paired t-tests were used to analyze the data.

Results: The mean age of 79 caregivers participating in the study was 46.16 ± 11.32 years. No significant differences were found between the two groups at baseline. However, the independent ttest showed significant differences in the psychological subscale (p <0.001) between the intervention and control groups after the intervention. In addition, the results of the paired t-test showed significant improvements in the intervention group in physical (p <0.001) and psychological (p <0.001) subscales.

Conclusion: The results of the current study support the effectiveness of telenursing in improving the quality of life of caregivers of older stroke patients.

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 anti- COVID-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. Lack of screening for asymptomatic COVID-19-infected subjects and inefficient management of diagnosed COVID-19 infections also pose some concerns and the need to fill the gaps among policies and strategies to reduce the pandemic in hospitals, healthcare services, and the general community. For this purpose, the development and deployment of rapid screening and diagnostic procedures are prerequisites in premises with high infection rates as well as to screen mass unaffected COVID-19 populations. Novel methods of variant identification and genome surveillance studies would be an asset to minimize virus transmission and infection severity. The proposition of this pragmatic review explores current paradigms for the screening of SARS-CoV-2 variants, identification, and diagnosis of COVID-19 infection, and insights into the late-stage development of new methods to better understand virus super spread variants and genome surveillance studies to predict pandemic trajectories.

Background: This study performed a meta-analysis to compare the safety and efficacy of argon plasma coagulation (APC) concerning suture (SUT) and surgery (SUR).

Methods: The One-Way tests were applied, with p <0.05 significant. The value of R2 was analyzed (heterogeneity), and the risk of bias of articles was evaluated.

Results: A total of 34 studies were found, eight about APC, twenty about SUT, and six about SUR. For the percentage of Weight Loss Regained (%WLR), the means for APC, SUT, and SUR were 19.39 ± 10.94, 26.06 ± 16.71, and 17.05 ± 9.85, and for success rate (%SR), the means were 89.75 ± 16.75, 86.80 ± 11.44, and 76.00 ± 21.57, respectively with p >0.05, with R² ≥ 50%.

Conclusion: The APC proved to be efficient and safe like the other techniques.

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.

Results: Our search resulted in 17 citations, of which 10 eventually fulfilled the inclusion criteria of our study. Promising results (improved tumor and nodal regression as well as higher pathologic complete response rate) have been occasionally documented with metformin use in some of the included studies. However, regarding survival and all-cause mortality, no significant difference has been found.

Conclusion: Metformin might constitute a highly promising radiosensitizer in neoadjuvant LARC treatment attracting much scientific interest. Due to the lack of studies with high evidence, further advanced research is required to enhance the existing knowledge about its potential value in this field.

Introduction: Infertility and its treatment methods among couples have psychological and social consequences. To encounter these consequences, coping strategies are commonly used, which are influenced by various factors, such as the attitude of couples toward infertility.

Objective: This study aims to determine the relationship between attitudes toward infertility and stress-coping strategies among couples undergoing Assisted Reproduction Treatment, referring to the infertility clinic of Al-Zahra Educational Center.

Methods: This study was a cross-sectional study performed on 153 couples referred to Al-Zahra Infertility Clinic in Rasht. Three instruments (demographic questionnaire, attitude, and Lazarus coping strategies questionnaire) were used with regard to the inclusion restrictions.

Results: Between the two variables of individual and social information factors and the attitude of couples toward infertility, only the duration of infertility factor revealed a significant relationship (p <0.05); and in explaining the relationship between individual and social variables and coping strategies, the lack of insurance in both genders with an emotion-oriented strategy, the female infertility factor in women with the confrontational adjustment domain, and treatment in a discontinuous way in both genders have a significant relationship with the problem-oriented domain (p <0.05). Accountability and problem-solving strategies in women and an escapeavoidance strategy in infertile men have been identified as the most important predictors of attitude toward infertility.

Conclusion: There is a relationship between attitudes toward infertility and coping strategies. However, the impact of community culture on the type of coping strategies used in this study has led to different results in some cases from other studies.