Find Clinical Trials

About This Study

Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE. C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy. Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear

Design

Interventions / Regimen

• Other: Blood sampling — Four blood samples will be collected, in conjunction with the collection of samples already programmed for assistance during pregnancy: blood sampling for the B-test (within the 13th week of gestation), at the blood test centre of the Institute for Maternal and Child Health, IRCCS Burlo Garofolo; blood sampling for toxoplasmosis or blood sugar level, upon execution of the morphological ultrasound scanning (around the 20th and 34th weeks of gestation), at the blood test centre of the Institute for Maternal and Child Health, IRCCS Burlo Garofolo, as well. Finally, 40 days after delivery, during routine gynaecological control after the puerperium.
• Other: Blood sampling — For patient of group 2, the blood sample will be collected at the time of the diagnosis of PE and 40-50 days after delivery in Obstetrics and Gynaecology Department of the institute or in Department of Biomedical Sciences, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

Primary Outcomes

• Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies (8-12 weeks of gestation)
• Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies (8-12 weeks of gestation)
• Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies (20-24 weeks of gestation.)
• Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies (20-24 weeks of gestation.)
• Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies (34-38 weeks of gestation.)
• Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies (34-38 weeks of gestation.)
• Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies (40-50 days after delivery.)
• Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies (40-50 days after delivery.)

About This Study

Hypertension is associated with endothelial dysfunction, an early event in the development of cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation and vascular injury; however, their relationship with blood pressure and microvascular endothelial function in untreated hypertension remains insufficiently understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive adults and adults with newly diagnosed, untreated primary hypertension. In addition, the study will investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and established circulating biomarkers of endothelial activation. The findings may improve understanding of the role of EEVs in early hypertension and support their potential use as non-invasive biomarkers of endothelial dysfunction and cardiovascular risk.

Design

Primary Outcomes

• Plasma endothelial extracellular vesicle concentration (Baseline)

About This Study

The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease. The main question\[s\] it aims to answer are: 1. Are patients with advanced lung disease able to tolerate semaglutide therapy? 2. Are we able to titrate semaglutide therapy to a target weight? Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.

Design

Interventions / Regimen

• Drug: Semaglutide Pen Injector — Once weekly subcutaneous injection

Primary Outcomes

• Tolerability (12 weeks)

About This Study

This study is to establish non-inferiority of a preservative free formulation of Bimatoprost ophthalmic solution 0.01% (YSBP) of YS Life Science Co., Ltd. compared to LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of AbbVie INC in subjects with primary open angle glaucoma (POAG) or ocular hypertension.

Design

Interventions / Regimen

• Drug: Bimatoprost ophthalmic solution 0.01% YSBP — YSBP
• Drug: bimatoprost ophthalmic solution 0.01% (Lumigan®) — Lumigan®

Primary Outcomes

• Intra-Ocular Pressure (Week 12)

About This Study

An observational study of patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage, employing multimodal neuromonitoring.

Design

Interventions / Regimen

• Drug: Induced hypertension with norepinephrine — Induced hypertension with norepinephrine and/or dobutamine to attain clinically established goals of cerebral perfusion pressure in a stepwise fashion, according to clinical routine.
• Drug: Endoluminal Spasmolysis — Endoluminal spasmolysis of cerebral arteries using i.a. Nimodipine, according to clinical protocol and neurointerventionist discretion.

Primary Outcomes

• Mean Flow Velocity (MFV) (Up to 12 hours post intervention)

About This Study

The goal of this registry is to better understand how primary biliary cholangitis develops over time, including the role of disease-related biomarkers, complications of the disease, and symptom burden. Patients with primary biliary cholangitis treated at participating centres in Austria will be invited to take part in this prospective registry. Participation in an associated biobank is optional. Clinical and laboratory data will be collected, and patients will be followed regularly through scheduled clinic visits. In addition, biological samples (serum, plasma, and, if available, liver tissue) may be collected and stored in the biobank for future research.

Design

Primary Outcomes

• Transplant-free survival (Through study completion, an average of 5 years)

About This Study

The investigators want to explore the relationship between different configurations of hypertension and the incidence of cardiovascular events by the guidelines reference range and EMINCA recommended reference range. Then the investigators want to enroll twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up. Echocardiographic measurement parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.

Design

Interventions / Regimen

• Other: Left ventricular hypertrophy — Hypertension with normal left ventricular geometry and left ventricular concentric remodeling
• Other: Left ventricular non-hypertrophy — Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy

Primary Outcomes

• Emerging atrial fibrillation (Through study completion, on average once a year.)
• Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death (Through study completion, on average once a year.)
• Emerging transient ischemic attack (TIA) or stroke (Through study completion, on average once a year.)

About This Study

The purpose of this study is to learn whether avoiding alcohol can improve heart and blood vessel health in adults who regularly drink alcohol and have high blood pressure. High blood pressure is a major risk factor for cardiovascular disease (CVD), including heart attack and stroke. In this randomized, controlled trial, men and women aged 26 to 49 years who regularly consume alcohol and have high blood pressure will be assigned by chance to either stop drinking alcohol or continue their usual drinking habits for 8 weeks. Researchers will compare changes in blood pressure and other cardiovascular disease risk factors between the two groups. The information gained from this study may help researchers and health care providers better understand the effects of alcohol consumption on cardiovascular health and whether alcohol abstinence can reduce heart disease risk, especially in adults with high blood pressure.

Design

Interventions / Regimen

• Behavioral: Alcohol Abstinence — Participants will be instructed to abstain from alcohol for 8 weeks and maintain their usual lifestyle, including diet and physical activity. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to receive educational materials and personalized feedback based on phosphatidylethanol (PEth), sleep, and heart rate variability data to support alcohol abstinence. During these meetings, participants will also complete assessments of alcohol use, physical activity, and dietary intake. At week 4, participants will complete a dried blood spot PEth test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.
• Other: Control arm — Participants will be asked to maintain their usual lifestyle, including alcohol consumption, diet, and physical activity, and will not have access to their study data during the intervention. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to complete questionnaires on alcohol use, physical activity, and diet. At week 4, participants will complete a dried blood spot phosphatidylethanol (PEth) test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.

Primary Outcomes

• Change in in-laboratory central and peripheral blood pressure (Baseline and after the 8-week intervention)
• Change in nighttime central and peripheral blood pressure (Baseline and after the 8-week intervention)

About This Study

Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.

Design

Primary Outcomes

• Decline in BIS (we will record Bispectral Index (BIS) for a quite 20 min no tactile contact or noise that could raise the BIS inadvertently)

About This Study

Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading modifiable contributor to cardiovascular disease and death. Our society has already identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of healthy living. Healthy sleep should be incorporated as the fourth pillar, as clearly supported by the extensively available scientific evidence. Targeting sleep is considered the new frontier in cardiovascular prevention. In fact, recent scientific evidence encourages consideration of including sleep disturbances in the top 10 potentially modifiable cardiovascular risk factors. Sleep-disordered breathing affect 30-80% of patients with hypertension. The personalized management of hypertension is challenging due to; i) the misclassification of hypertensive patients (affecting 1 out of 3 patients); ii) the lack of adequate treatment of high mortality risk hypertensive phenotypes today is an unmet clinical need; iii) unawareness of the impact of sleep-disordered breathing as a modifiable risk factor for hypertension. Importantly, the investigators already made the seminal observations showing that the treatment for sleep-disordered breathing reduces blood pressure in the hypertensive phenotypes with the highest mortality risk. Given the need for novel strategies to treat hypertension and, supported by our data, the investigators propose to study and treat sleep-disordered breathing to improve hypertension control. METASLEEP will go beyond current state-of the-art providing a new paradigm for the accurate hypertension classification and treatment. This project will open up a new avenue on the therapeutic potential of the management of sleep-disordered breathing in hypertension.

Design

Interventions / Regimen

• Device: CPAP or usual practice — CPAP (continuous positive airway pressure) is a machine that uses mild air pressure to keep breathing airways open while you sleep.
• Device: Monitoring and intervention in follow-up — Each participating center can incorporate monitoring and intervention in the follow-up of patients into their work dynamics. Through the use of mobile applications, you can monitor the variables of: weight, diet, lifestyle, exercise and sleep. This intervention will help the patient to improve in different aspects of their health.

Primary Outcomes

• Changes in nocturnal blood pressure (At 6 and 18 months)

About This Study

This study is a randomized controlled trial with two parallel groups connected at Al-Thawra Modern General Hospital in Sana'a, Yemen. It aims to compara the effect of two different vitamin D3 supplementation regimens during pregnancy on the risk of pre-eclampsia among women with confirmed vitamin D deficiency. Pregnant women attending antenatal care and diagnosed with vitamin D deficiency will be screened for eligibility. Eligible participants will be randomly assigned to one of two intervention groups:one group receiving vitamin D3 50,000 IU every two weeks and the other group receiving vitamin D3 5,000 IU weekly,in addition to standard antenatal care. The study will include singleton pregnancies between 8\_18 weeks of gestation with serum 25-hydroxyvitamin D level below 25 ng /mL . Women with chronic conditions that may affect pregnancy outcomes or vitamin D metabolism will be excluded. Participants will be followed throughout pregnancy to assess the development of pre-eclampsia and other maternal and fetal outcomes.

Design

Interventions / Regimen

• Dietary Supplement: Vitamin D3 — Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
• Dietary Supplement: Vitamin D3 — Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.

Primary Outcomes

• Incidence of Pre-eclampsia events (From 20 weeks of gestation until delivery)

About This Study

The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster relationships between the healthcare sector and schools through community engagement and outreach as well as contributing to the decolonization of normative paediatric blood pressure reference values. To date, there has been no nation-wide project in South Africa to determine nationally representative normal blood pressure reference values, nor to estimate the true prevalence of hypertension in the paediatric population of the country. This study will provide critical information on the understanding of blood pressure and hypertension in children, especially of African ancestry. Not only will this effort contribute to the development of the first nationally representative normal reference values of blood pressure but will also benefit healthcare providers in the sector with a clear guideline on the management of high blood pressure in children as developed by experts working with these challenges daily.

Design

Interventions / Regimen

• Diagnostic Test: Blood pressure screening — Blood pressure and anthropometric measurements will be performed in children and adolescents between ages 5-18 years to develop South African nomograms that will aid in the development of clinical practice guidelines to optimise hypertension care in South Africa youth.

Primary Outcomes

• To determine and compute nationally representative normative reference values for blood pressure in children (Through study completion, an average of 1 year)
• To determine and compute nationally representative normative reference values for blood pressure in children (Through study completion, an average of 1 year)
• To develop clinical practice guidelines for the management of childhood hypertension in South Africa (Through study completion, an average of 1 year)