Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2026-09-01
Completion: 2030-02-28
Search thousands of clinical trials by condition, location, and eligibility criteria
Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.
Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview. Research Procedures: The target sample size is 135 individuals diagnosed with current Major Depressive Disorder and 85 healthy controls. To meet this target, the recruitment target is set at 220 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.
ChatGPT provides quick access to information, research support, and study materials, but concerns remain regarding its reliability, accuracy, and inability to offer personalized care principles essential in nursing. Although previous studies show its high accuracy in clinical responses, over-reliance on AI-generated medical information necessitates cautious use. The study will explore both the benefits and limitations of ChatGPT in nursing education, particularly in hypertension learning.
Pulmonary arterial hypertension (PAH) is a progressive condition with high morbidity, frequent hospitalizations, and risk of right heart failure. Despite advances in treatment, poor adherence remains a major challenge. This randomized controlled study assesses whether remote monitoring can improve treatment adherence, clinical outcomes, and side effect management in PAH patients on oral therapy.
This study aims to evaluate the safety and efficacy of DNN.31.19.026 compared with Cosopt® for the treatment of ocular hypertension or primary open-angle glaucoma.
The goal of this observational study is to learn about the optimal dose of spironolactone treatment and the long-term outcomes on cardiovascular and cerebrovascular events in patients with lateralized PA who are unwilling to undergo surgery. The main question it aims to answer is: 1. What is the long-term effect of spironolactone treatment for lateralized PA? 2. What is the optimal dose of spironolactone treatment for the relief of renin inhibition in patients with lateralized PA? Participants will receive spironolactone treatment as part of their regular medical care for more than 12 months, and their clinical indicators, including blood pressure, biochemical remission, cardiovascular and renal damage, and the incidence of cardiovascular and cerebrovascular events, will be analyzed.
This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.
According to the American College of Obstetricians and Gynecologists (ACOG), pregnancy-induced hypertension is defined as a new onset of systolic and/or diastolic blood pressure ≥140/90 mmHg after 20 weeks of gestation, with at least 4 hours between two blood pressure measurements, and blood pressure can return to normal after childbirth. Preeclampsia is defined as the presence of proteinuria or multi-organ dysfunction on the basis of pregnancy-induced hypertension. Obese women are a high-risk group for preeclampsia, and the preventive use of low-dose aspirin (LDA) is one of the currently recognized effective interventions. Obesity, as an independent risk factor for preeclampsia, can increase the risk of the disease by 2 to 3 times. With the rising global obesity rate, the prevention and control of preeclampsia in obese pregnant women has become an important challenge in the field of perinatal medicine. The WHO report indicates that the incidence of preeclampsia in obese women is significantly higher, with a 20-30% increase in preeclampsia risk for every 5-unit increase in BMI. The incidence of preeclampsia in obese women can reach 15-25%. At present, the clinical application of oral aspirin for the prevention of preeclampsia in China mainly follows authoritative consensuses such as the "Guidelines for the Diagnosis and Treatment of Hypertensive Disorders in Pregnancy (2020)", which recommends that high-risk pregnant women (such as those with obesity, chronic hypertension, and a history of preeclampsia in the previous pregnancy) take low-dose aspirin (50-150 mg/d) orally from 12 to 16 weeks of gestation for prevention. However, in actual clinical practice, a dose of 100 mg/d is commonly used, and there is still a lack of clear guidance on whether the dose needs to be adjusted for obese pregnant women. At present, the dose of aspirin mainly used in China is still 100 mg, while foreign studies are more inclined to use 150 mg. Therefore, this study is designed to conduct a randomized controlled trial to compare the efficacy and safety of 100 mg and 150 mg aspirin in preventing preeclampsia in obese pregnant women, to optimize the LDA strategy for the prevention of preeclampsia and provide high-quality evidence for clinical practice.
Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.
The goal of this prospective cohort study is to examine how different parameters of assisted reproductive technologies (ART) are associated with the perinatal outcome in individuals with singleton or multiple gestations. The main questions it aims to answer are: Are ART pregnancies associated with a higher risk of: * Small for gestational age neonates? * Fetal growth restriction, either early- or late-onset? * Development of preeclampsia? * Stillbirth (intrauterine fetal death after 22 weeks not due to known anomalies)? * Are certain ART parameters-such as the type of fertilization (e.g., IVF vs. ICSI), embryo stage at transfer, use of fresh vs. frozen embryos, or ovarian stimulation protocols-more strongly associated with adverse outcomes? Are ART pregnancies associated with placental and umbilical cord abnormalities, including: * Placenta previa? * Vasa previa? * Single umbilical artery? * Velamentous or marginal cord insertion? Researchers will compare outcomes between pregnancies conceived through ART and those conceived spontaneously. Participants will: * Be individuals aged 18 or older undergoing routine first-trimester ultrasound between 11 and 14 weeks of gestation * Provide detailed medical, obstetric, and ART-related information * Undergo routine prenatal assessments, including ultrasound evaluations of fetal growth, Doppler studies, and placental characteristics * Have perinatal outcomes such as gestational age at birth, mode of delivery, birthweight, and complications systematically recorded Statistical models will be used to adjust for confounding factors such as maternal age, BMI, parity, and smoking. The aim is to better understand how ART and specific ART parameters may influence maternal and neonatal health and to improve counseling and clinical care for people using fertility treatments.
The goal of this clinical trial is to evaluate whether a structured blinking exercise can improve symptoms and signs of dry eye disease (DED) in adults with glaucoma who are using topical intraocular pressure-lowering medications. The study will also assess the effects of the intervention on tear film stability, blink function, and participant adherence to the exercise. The main questions this study aims to answer are: Does a two-week structured blinking exercise reduce dry eye symptoms, as measured by the Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE) questionnaires? Does the blinking exercise improve objective measures of ocular surface health, including non-invasive tear break-up time (NITBUT) and blink dynamics? Researchers will compare glaucoma patients receiving topical medications (intervention group) with glaucoma suspects not using topical therapy (control group) to evaluate the effectiveness of the blinking exercise on dry eye outcomes. Participants in both groups will receive instruction on a standardized blinking exercise protocol consisting of repeated close-squeeze-open blinking cycles performed three times daily for two weeks. Participants will attend study visits at baseline, 2 weeks (post-intervention), and 4 weeks (follow-up). At each visit, participants will complete validated dry eye questionnaires and undergo non-invasive assessments of tear film stability, blink characteristics, and meibomian gland function. Adherence to the blinking exercise will be monitored using self-reported logs or reminders.
The primary goal is to predict the clinical outcomes of mother and baby using blood glucose and other routinely collected clinical data in pregnancy to predict adverse outcomes at birth in women with GDM. The secondary goal is to develop models to predict optimal blood glucose testing schedules for pregnant women. Exploratory Objectives are (1) to understand patterns of dosage and / or medication choice and (2) to describe different phenotypes of gestational diabetes based on multiple data input.
The purpose of this Phase 1 trial is to determine the safety over 1-2 months of topic sterile human recombinant insulin on subjects with optic neuropathies (glaucoma, ischecmic optic neuropathy, and optic disc drusen).
Despite the many associated health benefits, more than half of Veterans do not achieve enough regular physical activity. The investigators' prior work has demonstrated that gamification, a method commonly used for health promotion, can lead to sustained increases in physical activity if it is designed using insights from behavioral economics to enhance social incentives. In this study, the investigators will compare the effectiveness of behaviorally designed gamification that encourages Veterans to collaborate or compete on physical activity levels and examine clinical outcomes as well as costs, barriers and facilitators to implementation of the program within Veterans Affairs.
Our previous study (Huang HC, Pan HY, Wang TD, Circ Cardiovasc Interv 2023;16:e012779) demonstrated that when renal artery stimulation continues to trigger systolic blood pressure increases (\>=20 mmHg increase compared to baseline) after the initial procedure, patients show poor blood pressure reduction 6 months following renal denervation. Based on this finding, we designed a proof-of-concept trial comparing two approaches: a guided strategy versus conventional renal denervation. In the guided strategy, we perform additional ablations of main and/or branch renal arteries if immediate post-procedure stimulation still elevates systolic blood pressure (\>=20 mmHg increase compared to baseline). The conventional approach involves no repeat procedures. This trial aims to determine whether the guided strategy leads to better clinical outcomes, measured by 6-month ambulatory blood pressure changes, and to establish the value of using intraprocedural feedback to assess and guide renal denervation treatment.
People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.
Patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. Part of this risk is due to changes in the structure and function of the blood vessels throughout the body. It is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. Optical coherence tomography (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple, quick and non-invasive test that you may have previously had during a visit to the optician. The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's blood vessels in patients with hypertension and chronic kidney disease compared to healthy individuals and also to see if any differences seen improve with treatment.
Tobacco use remains persistently high across South Asia, despite numerous public health efforts, and continues to significantly contribute to the burden of non-communicable diseases (NCDs) such as cardiovascular disease, hypertension, diabetes, and stroke. Community pharmacists-widely accessible and trusted within their communities-are an underutilized resource for delivering public health interventions. Graphic health warnings (GHWs), recommended by the World Health Organization (WHO), have been shown to promote smoking cessation, but are rarely paired with personalized counseling by healthcare providers. This study aims to evaluate both the effectiveness and cost-effectiveness of integrating GHWs with pharmacist-led personalized counseling at primary healthcare pharmacies in Bangladesh and Pakistan. A cluster randomized controlled trial (RCT) will be conducted, enrolling 3,240 adult participants in Bangladesh and \~160 participants in Pakistan (for feasibility study) from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW only (distribution of printed booklets); (2) GHW + counseling (pharmacist-led counselling sessions based on booklets at baseline and six months, with monthly SMS reminders); or (3) standard care (usual pharmacy services with no additional materials). The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. The primary outcome is self-reported 7-day point prevalence abstinence at 12 months (validated where feasible). Secondary outcomes include reduction in cigarettes per day, quit attempts, readiness to quit, awareness of tobacco harms, diet and physical activity scores, quality of life, blood pressure control among hypertensive participants, and cost-effectiveness. Feasibility outcomes in Pakistan include recruitment rate, participant retention, intervention fidelity and acceptability. Bayesian statistical models will be used to assess efficacy, and economic evaluations will determine the cost-effectiveness of the interventions. The findings aim to inform scalable public health strategies for tobacco control and NCD prevention in resource-limited settings.
The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia. The main question the study aims to answer is: 1. Does taking 150 mg of aspirin reduce the occurrence of preeclampsia more effectively than taking 75 mg of aspirin in pregnant women at high risk of preeclampsia? 2. Are there differences in stillbirth and newborn birth weight between the two aspirin doses? The study will include 224 pregnant women aged 18-45 years who are between 11 and 14 weeks of pregnancy and are identified as being at high risk for preeclampsia. Participants will be randomly assigned to one of two groups. * Participants in the low-dose group will take 75 mg of aspirin once daily at bedtime. * Participants in the high-dose group will take 150 mg of aspirin once daily at bedtime. Participants will continue their assigned aspirin dose until 36 weeks of pregnancy and will be followed every 2 weeks until delivery. The study will record whether participants develop preeclampsia and whether stillbirth occurs. The birth weight of each newborn will also be measured within 3 hours of birth. The study hypothesis is that 150 mg of aspirin will result in a lower incidence of preeclampsia than 75 mg of aspirin in pregnant women at high risk of preeclampsia.
Renal denervation is a new method to lower blood pressure (BP) in hypertensive patients by reducing the impact of sympathetic nervous system. Its efficacy has been demonstrated in resistant hypertension and in lowering BP in essential hypertension as compared to a sham procedure in untreated hypertensive patients. This procedure is safe without any serious adverse events. However its effects during pregnancy are unknown. Normal pregnancy is associated with an increase of sympathetic activity at rest and upon cardiovascular reflexes stimulation which returns to baseline after delivery. These changes maintain optimal utero placental blood flow. But excessive stimulation of sympathetic activity may play a role in preeclampsia. Drugs that may affect the sympathetic nervous system are considered as safe in pregnant women. So there are reasonable evidence that renal denervation performed before pregnancy should not have deleterious effects for the fetus. The efficiency of renal denervation being greater in young patient and in women, a greater proportion of BP normalization can be expected in this population of young women .