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NCT ID: NCT06348940 Active, not recruiting - Cancer Patients Clinical Trials

Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients

Start date: March 12, 2023
Phase: N/A
Study type: Interventional

The majority of cancer patients experience varying degrees of psychological distress and physical symptoms due to the presence of cancer or the process of treatment. These symptoms are closely associated with inflammatory markers and patient prognosis, highlighting the urgent need for effective psychological intervention methods. Behavioral activation, an emerging psychological intervention approach, requires further investigation regarding its potential in alleviating negative emotions among cancer patients. Therefore, the investigators conducted a randomized controlled trial (RCT) to investigate whether (1) behavioral activation can ameliorate negative emotions and physical symptoms in cancer patients; (2) behavioral activation can contribute to improved survival outcomes for these patients; and (3) behavioral activation can enhance NLR levels and other clinical indicators among individuals with cancer. The investigators aimed to recruit a total of 390 cancer patients, comprising 170 individuals diagnosed with esophageal and gastric cancer, 100 individuals with colorectal cancer, and 120 individuals with lung cancer. These patients were recruited from the Department of Oncology at the Second Affiliated Hospital of Anhui Medical University between March 2023 and November 2023. They were randomly allocated into two groups: an intervention group (behavioral activation+care as usual, BA+CAU) and a control group (care as usual, CAU). The intervention group underwent an eight-week behavioral activation program (see Detailed Description) designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles. Both the intervention group and the control group received standard care along with conventional treatment for their respective cancers. This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical inflammatory indicators among cancer patients. Furthermore, it may potentially enhance patient survival rates, thereby offering a novel approach for psychological intervention in cancer patients and contributing to multidisciplinary treatment and management strategies. The intervention measures employed in this study do not involve any pharmacological treatments or hazardous activities. For illiterate or less educated patients, the informed consent process and questionnaire collection will be conducted using methods that ensure their full comprehension (e.g., verbal explanations, visual aids). Additionally, patients with evident cognitive impairments were excluded from the study. The investigators have implemented a questionnaire system on the WJX website (https://www.wjx.cn/) to collect patient information through both paper and electronic questionnaires. The psychological measurement questionnaires are stored electronically, while socio-demographic data and clinical indicators are collected in the hospital's medical record management system. Subsequently, all data is summarized and saved in local Excel files and SPSS files for specialized analysis by data analysts. Patient names are anonymized within the database, ensuring strict confidentiality of personal information such as contact details and home address. Possible statistical methods include descriptive statistical analysis, generalized estimating equation or repeated measures analysis of variance, structural equation modeling, correlation analysis and regression, survival analysis, etc.

NCT ID: NCT06348433 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, which is characterized by social interaction and communication defects, rigid repetitive behaviors, and often accompanied by speech development retardation. According to the report released by the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC), according to the statistical data analysis in 2020, one out of every 36 8-year-old children (2.76%) was confirmed to have autism spectrum disorder (ASD). This ratio is higher than that published in December 2021, when the prevalence rate of 8-year-old children was 1/44 (2.3%) according to the statistics in 2018. Although ASD has a high incidence, there is still a lack of effective treatment measures for autism at present. Drug treatment can only partially alleviate some related symptoms, such as irritability and aggressiveness. Other interventions mainly focus on behavioral and educational interventions, which have limited help to patients. The high cost also leads to a huge burden on families and health care systems. Therefore, finding targeted treatment measures and treatment mechanisms for ASD as soon as possible has become an urgent problem for us to solve.Faced with limited treatment options, as many as a third of parents try various dietary pattern interventions to help their autistic children. In recent years, ketogenic diet, as a diet mode with extremely low carbohydrate, high fat, proper amount of protein and other nutrients, has attracted wide attention. In this mode, increased lipolysis puts the body in a ketosis state, thus ensuring energy supply.Although ketogenic diet (KD) has been proved to be effective in reducing the core symptoms in autistic patients and mouse models, the specific mechanism of KD in autism spectrum disorder (ASD) is still not completely clear.This study aims to evaluate the efficacy of ketogenic diet in improving core symptoms, sleep disorders and gastrointestinal symptoms of ASD children, explore the changes of excitation/inhibition (dorsolateral prefrontal cortex) in prefrontal cortex of ASD children before and after ketogenic diet intervention, and try to reveal the mechanism of ketogenic diet in treating ASD.

NCT ID: NCT06348004 Active, not recruiting - Cirrhosis Clinical Trials

The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics

Start date: February 1, 2024
Phase:
Study type: Observational

The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge.

NCT ID: NCT06347614 Active, not recruiting - Prostate Cancer Clinical Trials

Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study

Two-step RP
Start date: September 1, 2021
Phase:
Study type: Observational

The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?

NCT ID: NCT06344767 Active, not recruiting - Breast Cancer Clinical Trials

Positive ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-negative Primary Tumor

Start date: September 1, 2023
Phase:
Study type: Observational

To investigate the treatment pattern and efficacy of patients with negative primary ER lesion but positive ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).

NCT ID: NCT06344312 Active, not recruiting - Clinical trials for Stroke, Acute Ischemic

Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Evaluate the effectiveness of Yangxue Qingnao Granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism

NCT ID: NCT06342167 Active, not recruiting - Radiotherapy Clinical Trials

Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma

Start date: March 14, 2024
Phase: Phase 2
Study type: Interventional

At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC). Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT.

NCT ID: NCT06340061 Active, not recruiting - Glaucoma Clinical Trials

The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.

Start date: October 20, 2022
Phase:
Study type: Observational

The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma

NCT ID: NCT06333665 Active, not recruiting - Surgery Clinical Trials

PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes of Patients With Esophageal Squamous Cell Cancer Undergoing Minimally Invasive Esophagectomy

Start date: February 20, 2024
Phase:
Study type: Observational

To date, there is controversy as to whether type II diabetes mellitus is associated with adverse short- and long-term outcomes in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy. At the same time, to the best of our knowledge, the impact of metformin use and glycemic control on short- and long-term outcomes in this patient population is also controversial. Therefore, this study aims to test the hypothesis that diabetes mellitus is associated with reduced survival in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy and that treatment with metformin and/or good glycemic control (HbA1c<7.0%) is associated with improved survival.

NCT ID: NCT06327230 Active, not recruiting - Acute Pancreatitis Clinical Trials

The Application of Thoracic Epidural Analgesia in Patients With Acute Pancreatitis

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Acute pancreatitis (AP) is one of the most common diseases of the digestive system, with its incidence increasing year by year. 15%-25% of patients will develop severe acute pancreatitis (SAP), characterized by necrosis and infection of the pancreas and surrounding tissues, as the investigators as multiple organ dysfunction syndrome (MODS), with a mortality rate as high as 17%. Currently, there is a lack of effective measures in clinical practice to regulate the early inflammation and immune response in acute pancreatitis. Animal experimental studies have confirmed that TEA, by blocking the abdominal sympathetic nerves, increases arterial blood flow and venous capacity, improves pancreatic perfusion insufficiency caused by AP, and alleviates metabolic acidosis. Simultaneously, TEA can suppress the secretion of catecholamines during the stress state of acute pancreatitis, reducing the release of inflammatory mediators and thereby inhibiting the inflammatory response. Our team's earlier animal experiments have further confirmed that TEA improves intestinal inflammation in mice with pancreatitis. This improvement is marked by a significant reduction in the concentrations of inflammatory cytokines such as IL-1β and TNF-α. Additionally, there is an observed alteration in the intestinal microbiota, characterized by an increase in the proportion of beneficial bacteria. Based on these findings, it is speculated that TEA, by reducing catecholamine release and downregulating sympathetic activity, effectively mitigates inflammation and stress responses in patients with pancreatitis. Furthermore, TEA dilates small arteries in blocked segments, thereby improving blood flow and microcirculation within the affected area. Indirectly, TEA increases vagal nerve activity, which in turn slows down the progression of intestinal ischemia, consequently reducing the impact of the "second hit" caused by the translocation of intestinal bacteria and endotoxins into the bloodstream, which exacerbates acute pancreatitis. Despite these promising results, clinical data on the efficacy of TEA in acute pancreatitis remains insufficient. Moreover, the precise mechanisms by which TEA influences the progression and severity of acute pancreatitis are yet to be fully elucidated. In order to further validate the clinical therapeutic effects of TEA and gain a deeper understanding of its mechanisms, the investigators have conducted this clinical study.