Find Clinical Trials

About This Study

In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. To determine whether surgical treatment can help enhance postoperative liver reserve function and improve patient prognosis.

Design

Interventions / Regimen

• Procedure: Laparoscopic splenectomy and azygoportal disconnection — The laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team.

Primary Outcomes

• Liver reserve function ICG-K at 3 months after surgery. (3 months)
• Liver reserve function ICG-K at 6 months after surgery. (6 months)
• Liver reserve function ICG-K at 12 months after surgery. (12 months)
• Liver reserve function ICG-K at 24 months after surgery. (24 months)
• Liver reserve function ICG-R 15 at 3 months after surgery. (3 months)
• Liver reserve function ICG-R 15 at 6 months after surgery. (6 months)
• Liver reserve function ICG-R 15 at 12 months after surgery. (12 months)
• Liver reserve function ICG-R 15 at 24 months after surgery. (24 months)

About This Study

The goal of the clinical trial is to understand the effect of two resistance training protocols employing different loading intensities (% of 1 repetition maximum; 1-RM), but with standardized effort intensity (2 repetitions in reserve; RIR) on post-exercise and ambulatory blood pressure in aging females. The main questions it aims to answer are: * to examine the acute effects of low (50% 1-RM) and high (80% 1-RM) load intensity resistance exercise with a standardized high effort intensity on post-exercise hypotension and ambulatory blood pressure responses in aging females; * deepen the understanding of the mechanisms underlying acute reductions in blood pressure in response to resistance exercise performed at different load intensities. To this end, autonomic activity will be estimated alongside the measurement of central arterial compliance (i.e., carotid artery), and serum biomarkers of endothelial function; * document the affective valence and enjoyment associated with low (50% 1-RM) and high (80% 1-RM) load intensity resistance exercise when performed at a high perceived effort. Researchers will compare the effect of: 1) a low load (LL-RE) intensity protocol consisting of 3 sets of each exercise at 50% 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2); 2) high load (HL-RE) intensity protocol consisting of 3 sets of each exercise at 80% of 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2); 3) and a control condition (CON) consisting of a standardized non-fatiguing cognitive task. Participants will participate in: * A preliminary assessment visit; * Two familiarization visits to validate the exercise prescriptions; * Three experimental visits (CON, LL-RE, HL-RE).

Design

Interventions / Regimen

• Other: Condition LL-RE — LL-RE condition will consist of a 5-minute warm-up (slow-paced walking) and the following exercises: leg press, chest press, leg curl, and seated row. Three sets will be performed for each exercise with a 3-minute rest period between sets/exercises. Each exercise will be executed through a full range of motion, with participants encouraged to follow a 2-sec eccentric phase (guided by a mobile app metronome and supervised by an exercise physiologist) and to perform the concentric phase as fast as possible. Participants will be informed to: stop the set when they perceive to have reached the RIR target. • LL-RE: The low load intensity protocol consists of 3 sets of each exercise at 50% 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2).
• Other: Control — Control condition: During the control condition, participants will sit quietly in a room maintained at a temperature of 22-24°C to prevent any influence on blood pressure values, for 60 minutes. During this period, they will perform a standardized non-fatiguing cognitive task: watching Earth, a documentary following the migration paths of four animal families.
• Other: Condition HL-RE — HL-RE condition will consist of a 5-minute warm-up (slow-paced walking) and the following exercises: leg press, chest press, leg curl, and seated row. Three sets will be performed for each exercise with a 3-minute rest period between sets/exercises. Each exercise will be executed through a full range of motion, with participants encouraged to follow a 2-sec eccentric phase (guided by a mobile app metronome and supervised by an exercise physiologist) and to perform the concentric phase as fast as possible. Participants will be informed to: stop the set when they perceive to have reached the RIR target. • HL-RE: The high load intensity protocol consists of 3 sets of each exercise at 80% of 1-RM, performed until reaching a hard perceived effort intensity (i.e., RIR-2).

Primary Outcomes

• Change in blood pressure post-exercise (Before the start of the condition (t = 0 minute), at the end of the condition (t = 60 minutes), each 20 min for 1 hour post-condition (t = 80, 100, 120 minutes))
• Change in ambulatory blood pressure (During 24 hours after the condition)

About This Study

Perioperative anesthesiologists can benefit from easily obtainable hemodynamic variables detecting or quantifying the lack of an adequate compensatory capacity of the cardiovascular system in order to optimize patient management and improve patient outcomes. Parameters of the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy) of the MostCare system, specifically cardiac cycle efficiency has been proposed as such variables. Yet, their value in anesthesia and especially in hypertensive patients is not studied. The goal of the PRAM-in-HYPO study is to prospectively evaluate the relationship between cardiac reserve and efficiency and cardiovascular risk factors in patients wo will undergo major surgical procedures using the state-of-the-art hemodynamic monitors. Also the investigators aim to build a predictive model to identify patients with decreased cardiac reserve due to hypertension and other cardiovascular risk factors, who are susceptible to post-induction hypotension. The investigators seek to include high-risk patients or patients presenting for major surgery, who are monitored with an advanced hemodynamic monitor to adequately evaluate the differences in cardiac reserve and cardiac efficiency.

Design

Interventions / Regimen

• Diagnostic Test: Passive leg raising — All patients who met the inclusion criteria will be placed head down flat and feet up at a 45° angle for 30 seconds. Hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected before, during and after the test until the end of the surgery. The total duration of the intervention (passive leg raising) is 30 seconds. The total duration of hemodynamic parameters recording is expected to be 60-600 minutes.

Primary Outcomes

• Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus (From the start of surgery until the end of surgery)
• Difference of mean CCE, dP/dt, SVI, CPI, Ea at the 30th second of passive leg raising by hypertension and diabetes mellitus (From the start of passive leg raising test until the end of the test)

About This Study

Pulmonary arterial hypertension (PAH) is a rare and progressive disease characterized by increased pressure in the pulmonary arteries, leading to right heart failure and premature death. Although combination therapy has improved outcomes, many patients remain at intermediate or high clinical risk despite treatment. When patients do not reach low-risk status, treatment escalation is recommended. However, different escalation strategies are used in clinical practice, including increasing the dose of existing medications or adding a third drug that targets a different biological pathway. There is limited prospective randomized evidence directly comparing these approaches. The ASCEND-PAH study is a prospective, randomized, open-label clinical trial designed to compare two therapeutic escalation strategies in adults with PAH who remain at intermediate or high risk despite dual therapy with an endothelin receptor antagonist and sildenafil. Participants will be randomized to either: (1) escalation to triple therapy with the addition of a prostacyclin pathway agent, or (2) optimization of dual therapy by increasing the dose of sildenafil. The primary objective is to compare the proportion of patients who improve their risk category according to the COMPERA 2.0 four-stratum risk model within 3 to 6 months after randomization. Secondary outcomes include changes in functional status, exercise capacity, biomarkers, clinical worsening, safety, and treatment persistence

Design

Interventions / Regimen

• Drug: Prostacyclin Pathway Agent — Addition of a prostacyclin pathway agent (inhaled iloprost or oral selexipag) to ongoing dual therapy with an endothelin receptor antagonist and sildenafil as part of therapeutic escalation to triple therapy. The specific agent will be selected according to clinical judgment and availability. Dosing will follow approved labeling and routine clinical practice.
• Drug: Sildenafil Dose Optimization — Optimization of sildenafil dose within approved dosing ranges as part of dual therapy with an endothelin receptor antagonist. Dose adjustments will be performed according to clinical practice to achieve maximal tolerated and guideline-recommended dosing without addition of a new PAH pathway agent at randomization.

Primary Outcomes

• Improvement in Risk Stratification According to the COMPERA 2.0 Four-Stratum Model (Between 3 and 6 months after randomization (assessment closest to 6 months within the predefined window))

About This Study

The purpose of this study is: 1. To evaluate the efficacy of Songling Xuemaikang Capsules(SLXMKC) with grade 1 hypertension. 2. To reveal the potiential effects of SLXMKC on vascular function and structure of patients with grade 1 hypertension. 3. To explore the underlying mechanisms of the therapeutic effects of SLXMKC on the intervention of grade 1 hypertension.

Design

Interventions / Regimen

• Drug: Songling Xuemaikang Capsules — 3 capsules at a time, three times a day, duration: 12 weeks
• Behavioral: Lifestyle intervention — everyday, duration: 12 weeks
• Drug: Placebo — 3 capsules at a time, three times a day, duration: 12 weeks

Primary Outcomes

• Change from Baseline in the Mean 24h Systolic Blood Pressure at 4,12 weeks (Baseline and Week 4,12)

About This Study

The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD). This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.

Design

Interventions / Regimen

• Drug: Ascorbic acid solution (American Regent Laboratories Inc.) — Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min.
• Drug: Saline — Placebo (saline) will be administered

Primary Outcomes

• Efficacy of infusion of ascorbic acid (30 minutes)
• Efficacy of infusion of ascorbic acid (60 minutes)
• Efficacy of infusion of ascorbic acid (90 minutes)
• Efficacy of infusion of ascorbic acid (120 minutes)

About This Study

The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.

Design

Interventions / Regimen

• Procedure: Stent Implantation — Aspirin (100 mg) and clopidogrel (75 mg) were administered 3-5 days before endovascular treatment. The endovascular procedure was performed under general anesthesia. Intravenous heparin was administered during the stent procedure to increase the activated clotting time to \> 250 s. An 8F guiding catheter was delivered to the internal jugular vein near the skull base. A 6F Navien intermediate guide catheter was then placed into the distal transverse sinus near the torcula through the 8F guiding catheter. A microguidewire was navigated across the stenosis using a microcatheter, followed by the deployment of a self-expanding stent (eg, Precise or Wallstent) adjusted to the normal sinus venous diameter adjacent to the stenosis. Venography and manometry were performed after the procedure. Postoperatively, all patients received dual antiplatelet medications for 3 months and then received a single antiplatelet (either aspirin or clopidogrel).
• Drug: Acetazolamide-based medical therapy — The medical treatment consisted of acetazolamide (0.5-4 g/day) and short-term mannitol (bolus of 0.25-1 g/kg body weight) for a duration of about 1 week or repeated lumbar punctures to reduce intracranial pressure (20 mL each), as well as analgesics for headaches. The initial dosage of acetazolamide was 0.5 g daily in two divided doses, followed by dosage increases of one tablet every week up to a maximum dosage of 4 g/day. The dosage escalation was stopped if the participant had papilledema grade \<1 in both eyes, unless the presence of other symptoms such as headache or tinnitus suggested that the dosage escalation should continue. The dosage for the participants who were unable to tolerate the study drug was decreased gradually to a minimum of one half tablet daily.
• Behavioral: Weight loss — The weight loss program included a low-calorie diet (≤425 kcal/day) with a target weight loss of approximately 5-10%.

Primary Outcomes

• Perimetric Mean Deviation (PMD) (6 months)

About This Study

\[Primary Objective\] To demonstrate the superiority of the change in mean sitting systolic blood pressure (MSSBP) and hemoglobin A1c (HbA1c)on week 12 of the combination therapy of THP-00101 (dapagliflozin 10 mg) and THP-00102 (telmisartan 80 mg) compared to THP-00101 or THP-00102 monotherapy among subjects with type 2 diabetes mellitus accompanied by essential hypertension. \[Secondary Objective\] To comparatively evaluate secondary efficacy and safety in the THP-00101 monotherapy group, THP-00102 monotherapy group, THP-00101 and THP-00102 combination therapy group, and THP-00101 and THP-00103 (telmisartan 40 mg) combination therapy group among subjects with type 2 diabetes mellitus accompanied by essential hypertension.

Design

Interventions / Regimen

• Drug: THP-00101 — Dapagliflozin 10 mg
• Drug: THP-00102 — Telmisartan 80 mg
• Drug: THP-00103 — Telmisartan 40 mg
• Drug: THP-00104 — Placebo of Dapagliflozin 10mg
• Drug: THP-00105 — Placebo of Telmisartan 80mg
• Drug: THP-00106 — Placebo of Telmisartan 40mg

Primary Outcomes

• Changes in Hemoglobin A1c (HbA1c) (12 weeks)
• Changes in Mean Sitting Systolic Blood Pressure (MSSBP) (12 Weeks)

About This Study

* Preeclampsia (PE) affects \~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. * Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. * Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. * Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. * Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. * The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. * The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of \>90th centile will be used to define high risk of PE and offer IOL from 37w. * If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.

Design

Interventions / Regimen

• Diagnostic Test: sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation — A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation

Primary Outcomes

• Rate of term Preeclampsia development (4 weeks)

About This Study

The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

Design

Primary Outcomes

• Target blood pressure control rate (12weeks after administration)
• Target blood glucose achievement rate (12weeks after administration)

About This Study

EvalSel can precisely assess the salt intake of hospitalized patients in nephrology and cardiology or in medical consultation. It can determine salt consumption to the nearest gram. The objectives of this food frequency questionnaire are to arrive at a precise dietary diagnosis and to quickly identify the dietary errors made by the patients. EvalSel is useful for doctors to quickly obtain an assessment of the salt consumption of their patients, so they can refer them to dietitians if necessary. It can be used on the day of admission to hospital or during medical follow-ups to know the evolution of their consumption over the long term and improve their care.

Design

Interventions / Regimen

• Other: Questionnaire — These patients complete the food frequency questionnaire in order to validate it for lower sodium consumptions. The experimental group has already received dietary advices regarding salt consumption during during their recent consultations.

Primary Outcomes

• Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria values (through study completion an average of 18 months)

About This Study

This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.

Design

Interventions / Regimen

• Drug: inhaled mosliciguat — Dose level 1, 2, or 3 for inhalation
• Device: Dry Powder Inhaler — Dry powder inhaler for mosliciguat delivery

Primary Outcomes

• Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation (Baseline, Week 16)