View clinical trials related to Randomized Controlled Trial.
Filter by:This study is a single-center, prospective, randomized controlled trial that aims to compare the efficacy and safety of a new indocyanine green (ICG) administration protocol with the current guideline-recommended protocol for near-infrared (NIR) fluorescence imaging in laparoscopic anatomical hepatic resection. Primary liver cancer is a common malignancy worldwide. Laparoscopic liver resection has become increasingly popular due to its minimally invasive nature. During open and laparoscopic liver resection surgery, ICG, a fluorescent dye, is widely used to visualize liver segments and define tumor margins. However, there is a lack of high-level evidence regarding the timing and dosage of ICG administration in current protocols. In our preliminary study, we discovered a new method of pre-mixing ICG with albumin, which creates a more stable conjugate that could enhance fluorescence imaging during NIR laparoscopic hepatectomy. This study will include 100 patients with primary liver malignancies who are scheduled for laparoscopic anatomical hepatic resection. The patients will be randomly assigned in a 1:1 ratio to either the new ICG-albumin protocol (experimental group) or the standard ICG alone protocol (control group). The primary outcome will be the efficacy of fluorescence imaging, which will be evaluated using a 5-point scoring system by three independent experts. Secondary outcomes will include operation time, blood loss, tumor margin status, complications, length of stay, long-term recurrence, and survival. The hypothesis of this study is that pre-binding ICG with albumin creates a more stabilized fluorescent complex, which could significantly improve the efficacy of fluorescence navigation and hepatectomy outcomes compared to standard ICG alone. This study aims to provide high-quality evidence on optimal protocols for ICG use in laparoscopic fluorescent image-guided liver surgery. The results of this study could help establish standardized guidelines to improve the application of this important navigation technique and enhance surgical precision and outcomes for liver cancer patients worldwide. The study protocol will be approved by the Ethics Review Board and publicly registered before enrollment starts. All participants will be required to provide informed consent. This study will be conducted in compliance with the Declaration of Helsinki and national regulations on human subject protection to ensure ethics, privacy, and safety.
OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of 2 new modalities of the Mediational Intervention for Sensitizing Caregivers (MISC) in caregivers from general population, specifically, in teachers at primary school children who are also parents. The main QUESTIONS it aims to answer are: - Are the new versions of MISC (MISC-T for Teachers, and MISC-SA or Self-Administered) efficient to a) improve the quality of caregivers-child interaction, and b) benefit children mental health, compared with a control group defined as Treatment as Usual (TAU)? - Is there any effect-transference to the school-setting despite the MISC is trained out of the school setting? re the new versions of the MISC efficient to benefit teachers' well-being at work in terms of lower burn-out, higher perceived self-efficacy or better classroom climate? PARTICIPANTS will randomly receive one of the 3 versions of MISC: MISC-T (administered by videoconference in teams of 6-10 teachers), MISC-SA (self-administered by the participants in weekly sessions with Genially), and MISC-R (self-administered by the participants but mainly based in readings and cognitive exercises instead of video-feedback, the core element of MISC-T and MISC-SA). COMPARISONS: Researchers will compare all 3 groups among them to see to what extent: - MISC-T shows efficacy compared with MISC-R (TAU; control group) - MISC-SA shows efficacy compared with MISC-R (TAU; control group) - MISC-T is more efficient than MISC-SA
Objectives: (1) To analyze the effectiveness of adding a group-based form of Acceptance and Commitment Therapy (ACT) to the treatment as usual (TAU) for preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain at baseline and after psychological treatment. (2) To examine the effectiveness of ACT on the improvement of pain interference, pain-related and behavioral variables in degenerative lumbar pathology preoperative patients after lumbar spine surgery in comparison with TAU. (3) To measure the proximal and distal effects of ACT in preoperative patients with degenerative lumbar pathology who had the surgery after ACT program completion in comparison with proximal and distal TAU surgery effects on pain related variables. Method: A 12-month randomized controlled trial (RCT) will be conducted at Hospital del Mar (Barcelona). Only those preoperative degenerative lumbar pathology patients with psychosocial risk factors for chronic post-surgical pain will be randomized to pre-surgical ACT group or to TAU. Evaluations will be completed before treatment (baseline), after ACT therapy (3 months), a first follow-up (6 months from baseline alias 3 months after surgery), second follow-up (9 months from baseline alias 6 months after surgery), and final follow-up (15 months from baseline alias 12 months from surgery). Participants: 80 adult preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain will be randomly assigned to two arms: ACT + TAU vs TAU. Primary outcome: Pain interference. Secondary outcomes: pain intensity, pain catastrophising, pain acceptance, pain disability, kinesiophobia, depression symptoms, anxiety symptoms, psychological flexibility, and quality of life. Main statistical analyses: Intention-to-Treat analyses that will include all participants who undergo random allocation, using multiple imputation to replace missing values. General linear mixed-effects models will be performed using Restricted Maximum Likelihood to estimate the parameters. Calculation of between-groups effect sizes using Cohen's d and of the number-needed-to-treat.
Efficacy and safety evaluation of tolvaptan in the treatment of patients with right heart failure caused by pulmonary arterial hypertension
This study is a single-blinded, randomized, parallel controlled trial.The purpose of this experiment is to confirm how "Yijinjing" treatment affects hand function, handgrip strength, pain, morning stiffness, and mood disorder in RA patients compared to routine care.
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate
This study have like aim to examine whether insulin secretagogues have a potential ergogenic effect leading to a better exercise performance and post-exercise recovery in healthy individuals after a resistance training session. METHODS: This is a randomized, double-blind, placebo-controlled, clinical trial. The sample will consist of 44 men. Subjects will be randomly allocated (block randomization, www.randomizer.org) to the following groups: placebo (PFG, n=22) and sulphonylurea (GFS, n=22). The study will consist of 3 visits 7 days apart. On visit 1 the participants will ask to sign an informed consent form and will carry out medical evaluation with anthropometric assessment. At that visit they will perform a one-repetition maximum test of the upper limbs by using the horizontal bench press and of the lower limbs by using the 45º leg press. On visit 2, they will perform a second round of similar 1-RM tests to determine workloads for the study session [sulphonylurea (gliclazide) vs. placebo]. The experimental exercise session will be held on visits 3. Gliclazide modified release 60 mg (Diamicron® MR) or placebo (starch, sodium lauryl sulfate and Aerosil) will be orally administered as matched capsules (same color, flavor, smell and size) 8 hours before the beginning of exercise session, double-blind. In the experimental session, first, warm-up on the bench press and leg press, both with workload at 50% of 1-RM will be carried out. After a 2-minute rest, the resistance training session will be started. It will consist of 4 sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until concentric failure. The bench press exercises will be followed by the leg press exercises with no interval between them. A 2-minute interval will allowed after each series of exercises. Measurements for heart rate (HR) and Visual Analogue Scale (VAS) for Pain will be taken before, between each series of exercises and 24 and 48 hours after session. Venous blood samples will be obtained before, immediately after, 24 and 48 hours after, for determining serum levels of creatine kinase isoenzyme MM and lactate dehydrogenase. Capillary blood for glucose determination will be collected from the digital pulp using a glucometer before and immediately after. Resistance training volume will be calculated for each type of exercise as well as total training volume for each session as a product of exercise workload and number of series and repetitions.
Objective: To evaluate the efficacy of a peer-led pain management program (PAP) in improving pain self-efficacy, reduce pain, enhancing use of drugs and non-drug methods and quality of life among nursing home residents Hypothesis: PAP lead by peer volunteer (PV) is more effective than receive usual care and pain management pamphlet, in reducing pain intensity, enhancing pain self-efficacy, use of drugs and non-drug methods, health-related quality of life upon completion of the PAP (week 12) and over time (week 24). Design and subjects: Clustered randomized controlled trial with nursing homes as cluster; 288 residents will be recruited from 12 nursing homes. Each nursing home will be randomly allocated to experimental group (PV led PAP), control group (receive usual care and pain management pamphlet). Study instruments: Brief Pain Inventory, Pain Self-Efficacy Questionnaire, Use of drugs and non-drug methods log book, Short Form Health Survey-12 and process evaluation. Intervention: 12-week PAP (one 1-hour session per week). Outcome measures: Pain intensity, pain self-efficacy, use of non-drug pain relief methods, perceived health-related quality of life and experience in participating PAP, to be collected at baseline (T0), week 12 (T1), and week 24 (T2). Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for within-group and between- group comparisons. Expected results: Significant reduction in pain and enhancement in pain-related parameters, making peers support models in elderly care.
Peripheral neuropathy is currently the second most common side effect after chemotherapy, second only to the side effects of blood toxicity. A variety of chemotherapy drugs may induce peripheral neurotoxicity, and cause by the cumulative dose of chemotherapy drugs. Symptoms include sensory parasthesia, feeling dull or numbness, glove-like feeling distributed in the palm. The currently most effective way is to interrupt the treatment or adjust the dose of chemotherapeutic drugs, but it is easy to make patients discontinue chemotherapy. The purpose of this study is to explore the impact of acupuncture on neurological symptoms and quality of life. Three kinds of questionnairs will be used:(1) Brief pain inventory- short form to assess the extent of pain, and the impact of daily life. (2) FACT/GOG-NTX-13 (Version 4) to assess changes in neurological symptoms; (3) WHOQOL-BREF to assess changes in the quality of life of patients. The course of treatment was evaluated for nine weeks. Changes in neurological function and quality of life will be evaluated before treatment, the third week of treatment, the sixth week of treatment, till the ninth week. The aim of this study is to confirm that acupuncture can improve peripheral neuropathy after chemotherapy, in order to enhance breast cancer patients' quality of life, and provide the new opportunity for integrative therapy between Chinese and Western medicine. Keywords：acupuncture , chemotherapy-induced peripheral neuropathy
Background Coronary heart disease has become a serious challenge to China with its high prevalence and mortality. The impaired glucose regulation is prevalent in patients with cardiovascular disease. However, there are few drugs that interfere early with impaired glucose regulation. Ginkgo biloba extract is not only a commonly used drug for cardiovascular diseases, but also has a significant effect in reducing blood sugar. Therefore, this study used a single case randomized controlled trial to explore the efficacy of Ginkgo biloba pills in the treatment of coronary heart disease patients with impaired glucose regulation. Methods This is a randomized, double-blind, placebo-controlled, three-period crossover trial for a single subject.A total of 12 subjects will be recruited in this trial. The trial is divided into three cycles, one cycle has two treatment periods. Ginkgo biloba pills and placebo will be randomized during the treatment period. The test period will be lasted 58 weeks and subjects will take 48 weeks. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria.