Clinical trials

Standard chronic kidney disease (CKD) guidelines frequently restrict nut intake due to concerns regarding their phosphorus and potassium content. While uncontrolled phosphorus loading exacerbates secondary hyperparathyroidism, vascular calcification, and mortality, overly restrictive diets can preclude the intake of essential cardioprotective nutrients. Phytate (myo-inositol hexaphosphate), abundant in fiber-rich foods like pistachios, acts as a natural inhibitor of calcium salt deposition, potentially mitigating vascular calcification. Crucially, the phosphorus in nuts is largely organically bound as phytate, which resists enzymatic cleavage in the human gastrointestinal tract, significantly reducing its intestinal bioavailability. Given these properties, moderate pistachio consumption may offer cardiovascular benefits without compromising mineral metabolism. This study aims to evaluate the short-term effects of pistachio supplementation on circulating and urinary phosphorus, parathyroid hormone (PTH) in patients with CKD. This study is an open-label, randomized, controlled crossover clinical trial involving patients with stage 4 and 5 (non-dialysis) CKD. All participants will undergo a 1-week run-in period to initiate a standardized pre-dialysis renal diet (protein 0.8 g/kg/day, potassium 39 mg/kg/day, phosphorus 12 mg/kg/day). Following the run-in, participants will be randomized (1:1 ratio) to one of two 4-week dietary sequences of Pistachio Diet period (30 g/day of pistachios) or Control Diet period. The sequences will be separated by a 4-week washout period. Venous blood and 24-hour urine samples will be collected and serum biomarkers: Phosphorus, potassium, PTH, FGF23, MDA, fasting glucose, creatinine, lipid profile, high-sensitivity C-reactive protein (CRP), and alkaline phosphatase and urinary phosphorus, sodium, uric acid, and potassium will be measured.

The goal of this clinical trial is to learn if tirzepatide works to improve physical function in adults with heart failure and obesity. It will also learn about the safety of tirzepatide. The main questions it aims to answer are: Does tirzepatide improve how far participants can walk in 6 minutes? Does tirzepatide improve heart failure symptoms and quality of life? What side effects do participants have when taking tirzepatide? Researchers will compare tirzepatide to a placebo (a look-alike substance that contains no drug) to see if tirzepatide improves physical function in people with heart failure and obesity. Participants will: Get a weekly injection of tirzepatide or a placebo under the skin for 6 months Start at a low dose, which may be raised slowly based on how well they tolerate it Keep taking their usual heart failure medicines Visit the clinic for checkups, blood tests, heart ultrasounds, and a 6-minute walk test Answer questions about their quality of life and heart failure symptoms

Fractures of the lower extremities represent a significant proportion of injuries sustained by polytrauma patients, with a notable association with prolonged hospitalization, chronic disability, and impaired physical functioning. The occurrence of surgical site infections (SSI) represents a significant threat to the efficacy of osteosynthesis procedures. As with other traumas and surgical procedures, the secretion of inflammatory mediators is markedly elevated in this cohort of patients following surgery. Naringenin is one of the most prevalent flavonoids, occurring naturally in grapefruit and other citrus fruits. In vitro studies have demonstrated that naringenin may stimulate the release of osteogenic cytokines and suppress the production of pro-inflammatory factors, which can result in a reduction in bone resorption. Based on these findings, naringenin may prove an effective agent for accelerating the rate of fusion and controlling inflammation. Furthermore, it may enhance quality of life and augment functional activity.

This randomized controlled trial aims to evaluate the effectiveness of virtual reality and cryotherapy, used separately and in combination, in reducing postoperative pain and anxiety among women undergoing cesarean section under spinal anesthesia. Participants will be randomly assigned to one of three intervention groups or a control group according to the study design. Postoperative pain and anxiety will be assessed using validated measurement tools at predetermined time points after surgery. The findings of this study may provide evidence for safe, non-pharmacological interventions to improve postoperative recovery and patient comfort following cesarean section.

The present study will examine the effects of increasing dietary polyphenol intake by consumption of oregano and basil leaves, on plasma inflammatory and lipid factors and total urinary polyphenol levels in patients who have recently had unstable angina.

Pain management is a core competency in nursing practice, yet nursing students consistently demonstrate insufficient knowledge, unfavorable attitudes, limited competence, and low self-efficacy in this area. Artificial intelligence (AI)-based educational tools, particularly ChatGPT, have emerged as promising resources in nursing education; however, rigorous experimental evidence on their effectiveness remains scarce. This study is a two-arm, parallel-group randomized controlled trial (RCT) that aims to evaluate the effect of a ChatGPT-driven blended teaching model for pain management on nursing students' knowledge and attitudes toward pain, nursing competence, and learning self-efficacy. Eligible nursing students at Shahid Beheshti University of Medical Sciences (Tehran, Iran) will be randomly assigned in a 1:1 ratio to either: * Intervention group: ChatGPT-assisted blended clinical nursing rounds (8 sessions over 4 weeks, each 90 minutes, combining bedside rounds with AI-assisted pre- and post-round activities) * Control group: Traditional clinical nursing rounds (same number and duration of sessions, without any AI tools) Outcomes will be measured at baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up using validated instruments: the Nurses' Knowledge and Attitudes Survey Regarding Pain (NKASRP), the Nursing Student Competence Scale (NSCS), and the Nursing Students' Learning Self-Efficacy instrument (NLSE). Findings will provide empirical evidence to guide educational policy and curriculum design in nursing programs, with the goal of improving pain management education and patient care outcomes.

Problem-based learning (PBL) is a learner-centered educational approach that helps nurses improve clinical skills through group discussion, case analysis, and collaborative problem-solving. However, the way participants are assigned to learning groups may influence how effectively they learn. Differences in learning styles among group members can affect participation, confidence, interaction quality, and knowledge retention. The Felder-Silverman Learning Style Model (FSLSM) is a widely used framework that categorizes learners based on how they perceive, process, and understand information (e.g., active vs. reflective, visual vs. verbal). Organizing PBL groups according to similarities or differences in these learning styles may lead to different educational outcomes. This study is a parallel, two-arm randomized controlled clinical trial designed to compare the effects of homogeneous grouping (participants with similar learning styles placed in the same group) versus heterogeneous grouping (participants with diverse learning styles placed in the same group) on PBL outcomes among hospital nurses. Registered nurses employed in teaching hospitals affiliated with Shahid Beheshti University of Medical Sciences are randomly assigned to one of the two grouping strategies. All participants receive the same PBL curriculum focused on patient safety and medication safety. The only difference between groups is the method used to form discussion teams. The primary outcome is medication safety competence, measured using a validated questionnaire. Secondary outcomes include clinical reasoning competence and nursing care quality. Outcomes are assessed at baseline, immediately after the intervention, and eight weeks later to evaluate both immediate effects and short-term retention. The findings of this study are expected to clarify whether grouping nurses based on similar or diverse learning styles leads to better improvement and retention of critical clinical competencies. Results may help educators design more effective PBL programs in nursing education and clinical training settings.

Post-transplant obesity is a common complication after kidney transplantation, largely attributed to recovery from uremia, increased appetite, sedentary lifestyle, and long-term corticosteroid exposure. Obesity in kidney transplant recipients increases the risk of cardiovascular disease, post-transplant diabetes mellitus (PTDM), and may contribute to graft injury through hyperfiltration-related mechanisms, potentially leading to reduced graft survival. Current approaches for weight management in transplant recipients, including lifestyle modification, are often insufficient, while bariatric surgery carries considerable risks and concerns regarding altered absorption of immunosuppressive medications. Tirzepatide (Iranian brand name: Spartina), the first dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, has demonstrated superior effects on weight reduction and glycemic control compared with earlier GLP-1 receptor agonists in the general population. However, its use in kidney transplant recipients requires careful evaluation due to potential gastrointestinal adverse effects, dehydration risk, and possible interaction with calcineurin inhibitor absorption caused by delayed gastric emptying. This prospective single-arm pilot clinical trial aims to assess the preliminary safety and efficacy of tirzepatide in obese kidney transplant recipients with stable graft function. Outcomes include changes in anthropometric indices, percent weight change, gastrointestinal tolerability, immunosuppressive drug trough levels, and graft function over 24 weeks of treatment.

The goal of this clinical trial is to find out whether an artificial intelligence (AI)-powered research training course can improve nursing students' research skills, attitudes toward artificial intelligence, and readiness to use AI in research and education. The main questions this study aims to answer are: Does AI-powered research training improve nursing students' understanding of research methods? Does this training improve nursing students' attitudes toward artificial intelligence? Does the course increase nursing students' readiness and confidence to use artificial intelligence in research-related activities? Researchers will compare nursing students who take an AI-powered research training course with students who receive usual education without AI-based training. Participants will: Be randomly assigned to either the AI-powered research training group or the usual education group Complete online questionnaires about research skills, attitudes toward artificial intelligence, and readiness to use AI Attend assessments at three time points: before the course, immediately after the course, and three months later The AI-powered research training course includes structured sessions on research methods and the responsible use of artificial intelligence tools for literature review, research design, data analysis support, and academic writing. The results of this study may help improve research education and support the safe and effective use of artificial intelligence in nursing education and research.

Chronic active antibody mediated rejection (CAMR) is a therapeutic challenge in transplant recipients that does not respond well to conventional treatments for acute antibody mediated rejection (AMR). Annually, 5000 kidney transplants are lost in the United States due to CAMR. The two-year graft survival rate in CAMR is approximately 20%, highlighting the need for a more efficient therapy for CAMR and directly targeting donor specific antibody (DSA) producing cells and reducing CAMRThere is no established treatment for this problem. While many centers intensify and optimize the dosage of immunosuppressive drugs, treatments such as plasmapheresis, IVIG, and rituximab, although effective in treating AMR, have not been successful in reducing DSA or improving kidney graft survival in CAMR patients. Despite these treatments, two-year graft survival can increase up to 55%. The use of anti-plasma cell treatments like bortezomib has also yielded inconsistent results.

Mesenchymal stem cell (MSCs) therapy has already been studied in kidney transplant recipients (KTRs), and the available data showed that it is safe and well tolerated. The aim of this study was to evaluate the safety and efficacy of autologous MSCs in combination with standard therapy in KTRs with biopsy-proven chronic active antibody-mediated rejection (AMR). Patients with biopsy-proven chronic active AMR received treatment with autologous bone marrow-derived MSCs (3 × 106 cells/kg iv) after completion of standard therapy and were followed for up to 12 months. The primary endpoints were safety by assessment of adverse events. Secondary endpoints included assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts. A total of 3 patients were enrolled in the study before it was terminated prematurely because of adverse events. We found that AMR did not improve in any of the patients after treatment with MSCs. In addition, serious adverse events were observed in one case when autologous MSCs therapy was administered in the late phase after kidney transplantation, which requires further elucidation.

The aim of this clinical trial is to find out whether a synchrony-optimized education program for non-invasive ventilation (NIV) can help ICU patients use their ventilator more effectively and improve their comfort, symptoms, and psychological well-being. Researchers want to answer these main questions: Can a structured two-session NIV education program help patients use their ventilator more regularly and for longer periods? Does this type of training reduce anxiety, depression, and respiratory symptoms? Can synchrony training improve patients' comfort and reduce NIV-related problems such as mask leaks or sleep disturbances? Is this program more effective than the routine ICU education normally provided? What Will Happen in the Study Adults (18+) who are receiving NIV in the ICU will participate in this study. Participants will be randomly assigned to one of two groups: Intervention Group: Will receive the SYNC-NIV education program, consisting of: One hands-on session (20-40 minutes) teaching patients how to synchronize their breathing with the ventilator One supplementary session (45-60 minutes) covering mask management, preventing complications, reducing leaks, breathing exercises, equipment care, and alarm handling An educational booklet for continued support Control Group: Will receive the standard ICU education normally provided about the ICU environment, general care, communication, and monitoring. All participants will be evaluated at three times: before the intervention, the day after the program ends, and one week later.

Diabetes management presents a complex clinical scenario marked by several challenges, especially in chronic kidney failure. These include navigating potential drug interactions between oral antidiabetic therapies and other agents. Furthermore, these patients may experience various adverse drug effects, such as lactic acidosis, electrolyte abnormalities such as hypomagnesemia, fluid retention, and lipid derangements, which can further augment overall morbidity. Consequently, many patients receive insulin. However, prolonged intensive insulin therapy may be linked to several adverse outcomes, including an increased risk of hypoglycemia and weight gain. Hence, a common practice is to transition to medications commonly used other populations of patients. With their established benefits on glycemic control, cardiovascular health, renal benefits, and weight management, in conjunction with the aforementioned adverse effects associated with other oral antidiabetics agents, glucagon-like peptide-1 receptor agonists have emerged as an attractive therapeutic option for patients with kidney failure.

Amblyopia is one of the common, preventable and treatable causes of decreased acuity of one or both eyes without a specific organic cause. Common treatments include optical correction, patching (closing the healthy eye), perceptual learning, and drug treatments. The patient's low cooperation, reduction in effectiveness and long treatment period of common methods have led to the design of new treatments that eliminate these disadvantages, among which binocular vision treatments can be mentioned. The purpose of this study is to apply a new and innovative method under binocular conditions in the treatment of anisometropic amblyopia in adults. In this randomized clinical trial study, 30 people (15 patients in the case group and 15 patients in the control group) aged 18 to 40 years with amblyopia (decrease in best corrected vision worse than 0.3 logarithmic units in one of the eyes or the difference of the corrected minimum visual acuity of two lines between two eyes) in the form of two groups of 15 people (case and control) will be included in the study. Patients will be randomly divided into two groups: case and control. Interactive Binocular Treatment (I-BiT) is used in the case group and usual games without I-BiT system are used as placebo in the other group. For this purpose, the games will be presented in the control group in such a way that the two eyes will not be dissociated and the patient will see all the targets in the same way with his two eyes. I-BiT is a new method for the treatment of amblyopia in which a person plays age-appropriate games using special glasses in a 3D space. The stimuli are shown differently to the two eyes and both eyes are involved in the treatment process. The selection of people in two groups will be such that background variables such as age, sex, as well as the severity of amblyopia or vision loss in the two groups are the same and confounding factors are under control. First, all eye examinations such as measuring visual acuity, lateral vision, checking refractive errors with and without cycloplegic drops, checking the alignment of visual axes, and also checking the anterior and posterior segments of the eye are performed. After the definitive diagnosis of amblyopia, people in both groups will be asked to use the given virtual games in the same way for one month, 5 sessions per week, each session for 30 minutes. In order to control the amount of use of computer games by patients, the duration of time that people use games will be controlled and recorded online using software by design engineers. Patients will be examined before treatment, one month after treatment and also one month after stopping treatment.

The goal of this clinical trial is to find out if educational videos-especially interactive ones-can help people on dialysis better manage their treatment. Researchers want to answer the following main questions: Can interactive or conventional video-based education help patients better understand and follow their treatment plan? Does this type of education improve patients' ability to control their weight changes between dialysis sessions? Does this type of education improve patients' activation? Is interactive video education more effective than regular (non-interactive) video education? What Will Happen in the Study: Adults on hemodialysis will take part in the study. They will be randomly assigned to one of three groups: Group A: Will receive 10 interactive educational video sessions (30 minutes each). Group B: Will receive the same videos but in a non-interactive format. Group C (Control Group): Will receive routine education normally given at the dialysis center. Videos will be watched on a web platform. Interactive videos include pop-up questions and scenario-based feedback. All participants will be followed up immediately, 1 month, and 3 months after the program ends. What Participants Will Do: Watch educational videos over several days (totaling 5 hours). Answer questions and engage in follow-up group discussions. Complete surveys about their knowledge, treatment adherence, and health behaviors. Get weighed before and after dialysis sessions to monitor fluid retention. This study aims to improve how dialysis patients manage their condition and to help healthcare providers design better educational tools.

Cornerstone immunosuppressive therapy currently relies on immediate-release tacrolimus, a calcineurin inhibitor (CNI) that is potentially nephrotoxic and is more diabetogenic than cyclosporine A. A new formulation of tacrolimus has been launched: an extended-release formulation (Advagraf®/Astagraf XL®, Astellas company).

Immunotherapy has shown promise in treating hematological malignancies, including resistant B-ALL. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain regarding antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including CD19, with CAR-NK cells in resistant B-ALL. To further investigate the potential of anti-CD19 CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard treatment.

The goal of this clinical trial is to learn if thyme supplement enhances the effects of a low FODAMP diet on reducing clinical symptoms and improving the quality of life of patients with irritable bowel syndrome or not. The main questions it aims to answer are: 1. Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome? 2. Does consumption of thyme increase the quality of life score in patients with irritable bowel syndrome? Researchers will compare thyme supplementation with placebo to see if thyme supplement enhances the effects of a low FODAMP diet on clinical symptoms and quality of life in patients with irritable bowel syndrome. Participants will: 1. Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks. 2. Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet. 3. Visit the clinic at the beginning of the study and the end of the study for a check-up and score record

Immunotherapy has shown promise in the treatment of hematological malignancies, including multiple myeloma. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain in terms of antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including BCMA, with CAR-NK cells in multiple myeloma. To further investigate the potential of BCMA-targeted CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard therapy.