Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2020-01-21
Completion: 2026-12-31
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Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.
The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are: * Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association. * Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women. The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.
This study aims to investigate how metabolic health is related to arterial stiffness and daily blood pressure patterns. High blood pressure is one of the leading causes of heart disease worldwide, but cardiovascular risk is not determined only by average blood pressure values. Changes in blood vessel structure and metabolic function also play an important role in the development of cardiovascular disease. Arterial stiffness reflects how flexible or rigid the arteries are. It can be measured using carotid-femoral pulse wave velocity (cf-PWV), which is considered a reliable and widely used method to assess vascular health. Increased arterial stiffness is associated with aging and higher cardiovascular risk. At the same time, metabolic factors such as insulin resistance and central obesity are strongly linked to vascular damage. The triglyceride-glucose (TyG) index is a simple measure derived from routine blood tests and has been shown to reflect insulin resistance. Additional derived indices that combine TyG with body measurements (such as waist circumference and body mass index) may provide an even more comprehensive evaluation of metabolic risk. Another important aspect of cardiovascular regulation is how blood pressure changes throughout the day. Blood pressure naturally rises in the morning after waking, a phenomenon known as the morning blood pressure surge. When this increase is excessive, it has been associated with a higher risk of cardiovascular events such as stroke and heart attack. This study will evaluate the relationship between metabolic indices, arterial stiffness, and morning blood pressure patterns in adults undergoing ambulatory blood pressure monitoring as part of routine clinical care. The study will include both previously collected data and new participants evaluated using standardized methods. No additional interventions will be performed, and all data will be collected as part of routine clinical evaluation. The results of this study may help improve cardiovascular risk assessment by integrating simple metabolic markers with vascular measurements and daily blood pressure behavior, potentially allowing earlier identification of individuals at higher risk.
The purpose of this clinical trial is to determine how safe and effective (how well it works) the ELLEX TSLT device is for the treatment of Glaucoma and Ocular Hypertension using Transscleral Selective Laser Trabeculoplasty. Selective Laser Trabeculoplasty (SLT) is a type of laser therapy that uses short pulses of low-energy light to lower eye pressure. This treatment uses a lens in contact with the front part of the eye (called cornea) which may lead to complications. Transscleral Selective Laser Trabeculoplasty allows the doctor to perform the laser treatment without the lens coming into contact with the cornea, potentially offering a simpler, quicker and safer approach for both participants and doctors. Participants will be required to attend four study visits. The first visit will assess the disease, the second will involve the TSLT laser treatment for the participant's condition (glaucoma or ocular hypertension), and the final two visits, at 1 day and 30 days post-treatment, will evaluate the treatment's efficacy and the procedure's safety.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).
BACKGROUND: Physical exercise promotion is one of the main global goals of innumerous health and medical societies for preventing and managing noncommunicable chronic diseases (NCDs), being one of the main therapeutic for the patient with hypertension. Exercise in heated swimming pool has emerged as a potential alternative to physical exercise on the ground for the reduction of blood pressure (BP) of hypertensive patients, however, its effects on BP, as well as hemodynamic, metabolic, inflammatory and functional variables of older individuals with hypertension have not been investigated. PURPOSE: To evaluate the effects of heated water-based exercise (HEx) versus land-based exercise (LEx) on BP, arterial stiffness, endothelial function, metabolic, inflammatory and functional variables of older individuals with hypertension. METHODS: 60 older individuals (male and female) with hypertension (age \> 60 years) will be randomized in 2:2:1 ratio to HEx, LEx or control (CON) intervention. The feasibility and physiological adaptations (physical capacity, musculoskeletal and cardiovascular responses to stress, biological and biochemical markers associated with the pathophysiology of the disease and vascular adaptations) will be assessed before, after 12 weeks and after 24 weeks of follow-up. HEx and LEx training programs will be performed three times per week and will be performed for the firs 12 weeks of follow-up.
The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.
Real-World Study of PADN for the Treatment of PAH
Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis. There are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD. Untargeted metabolomics is an emerging powerful platform for the discovery of pathways linked to diseases. Its specificity can be further enhanced using transpulmonary gradient sampling. Part A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug/diet on pulmonary vasculature in experimental HF-related PVD. The "gold standard" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late. There is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data.
The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.
The goal of this clinical trial is to see if mirivadelgat will work in patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs. Researchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being. Participants will: Take mirivadelgat or a placebo once a day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Receive phone calls every one or two weeks to check on how things are going
Glaucoma is major cause of irreversible blindness and is characterized by optic nerve damage and visual field loss. Screening for glaucoma is challenging due to lack of a simple, accurate, cost-efficient and standardized process. Artificial intelligence, (AI) especially deep learning (DL) algorithms have potential to automate glaucoma detection, but have to be evaluated in real world settings, before public deployment. This study aims to evaluate the screening accuracy of a DL algorithm for glaucoma detection using colour fundus photographs (CFP) in a pragmatic randomised control trial (RCT). The algorithm will be tested in 1040 eligible patients with diabetes, recruited from the Diabetes \& Metabolism Centre's clinics under the Singapore Integrated Diabetic Retinopathy Program (SiDRP) and randomized to 2 arms: AI-assisted model vs current standard of care (grader assessment). The performance of both arms will be compared to performance of study ophthalmologist in diagnosing glaucoma. We hypothesize that the DL model has better screening performance in detecting glaucoma in the community, compared to the current practice method.
Portal vein thrombosis (PVT) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. Whether patients with acute esophagogastric variceal bleeding with occlusive PVT benefit from preemptive TIPS is still controversial. The present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive PVT treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive TIPS (performed during the first 1-3 days after endoscopic procedure). The primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.
Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. This study aims at providing additional evidence on the safety, efficacy and appropriate dosing of osilodrostat in patients with CS, who have hypertension.
The herbal medicine Qurs-e-Fishar to treat mild to moderate High blood pressure or hypertension comprises of Rauwolfia serpentina. A product of Hamdard Laboratories (Waqf) Pakistan. A Phase III Safety \& Efficacy Open-label, Single-Arm, Interventional, Multicenter, Study in mild to moderate hypertensive, adults (30 to 60 years of age) prescribed with study product for 12 weeks (84 days). Primary End Points: 1. Reduction in diastolic blood pressure less than 130 / 80 mmHg at the end of the study period (accepted by WHO) or if there was a fall of 20 / 10 mmHg or more in diastolic blood pressure as compared to baseline. 2. Type, frequency and severity of ADRs during the study period. Secondary End Points: 1\. Compliance of the prescribed study medication.
Glaucoma is an irreversible optic neuropathy. It is the second most common cause of blindness worldwide. Glaucoma can be treated with topical medications (eye drops), laser or surgery. Traditional surgery is invasive and has a high complication rate (hypotonia, endophthalmitis, cataracts, etc.). As a result, several types of micro-invasive surgery (MIGS) have been developed to reduce the risks of surgery while maintaining their effectiveness in lowering intraocular pressure (IOP). The ELIOS laser system is the only ophthalmological excimer laser designed for the surgical treatment of glaucoma. The aim of the procedure is to ablate the trabecular meshwork and inner wall of Schlemm´s canal ab interno, with the creation of 10 microchannels of 210 um in the trabeculum using the ELIOS laser with a wavelength of 308 nm, in order to improve trabecular outflow to achieve a reduction in IOP. The ELIOS laser is an example of Microinvasive Glaucoma surgery (MIGS) with published results demonstrating efficacy and safety. The ELIOS laser is already in use in France (AMM / CE mark achieved). Its use as part of a prospective interventional study will enable us to collect data in order to treat patients more effectively and improve the quality of care provided to glaucoma patients.
The purpose of this study is to learn more about the regulation of the veins of the abdomen by the autonomic (involuntary) nervous system, and how this may affect high blood pressure. Normally, the autonomic nervous system controls how much blood flows in the veins. In people with high blood pressure, however, the autonomic nervous system is changed. This change may affect the way blood flows in the veins of the abdomen which may play a role in their high blood pressure. About 32 participants will be screened for the study. The investigators estimate 16 will be eligible to participate in all of the study days.
The Jiaxing Birth Cohort (JBC) is the largest prospective cohort study to explore prenatal risk factors, early life feeding practice and growth pattern/ adiposity in Chinese children.Between 1999 and 2013, 338 413 mother-child pairs were recruited in Jiaxing area in south-east China.Children of the recruited women were followed up at 1-2, 3, 6, 9 and 12 months of age, and subsequently followed up every 6 months to 36 months of age (toddler stage), and every year to 6-7 years of age before they went to school (pre-school stage). Follow-up rate was 70.8% at the toddler stage and 68.9% at the pre-school stage up to June 2013.