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NCT ID: NCT06429579 Recruiting - Clinical trials for Pulmonary Artery Hypertension

Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension

Start date: April 23, 2024
Phase: N/A
Study type: Interventional

This is a multi-center, perspective, and exploratory study aimed at evaluating the 3-years clinical outcome of Potts-shunt procedure for pediatric patients with severe pulmonary artery hypertension (PAH). The included criteria are as followed: 1)6 months < age ≤ 18 years; 2) ESC 2022 Group I PAH; 3) Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022; 4) Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc); 5) Informed consent form signed by the patient and their guardian. The excluded criteria are as followed: 1) ESC 2022 Group II-V PAH; 2) Poor right ventricular function: RVEF < 25% or RVFAC < 20%; 3) Deteriorated general condition: requiring ICU resuscitation or ECMO assistance; 4) Pulmonary artery pressure/main arterial pressure ratio < 0.7; 5) Six-minute walk distance < 150 meters (only applicable to patients aged 8 and above); 6) No significant improvement in RVEF under triple drug therapy. All of the pediatric patients with severe PAH who attend to pediatric cardiac outpatient clinic and meet the designed included criteria and excluded criteria will be enrolled in this study. All of the participants will be divided into two groups (Potts-shunt combined with conventional drug therapy group and only conventional drug therapy group) according to their individual health status (i.e., some contraindications of surgery) and their (or their parents') aspiration for Potts-shunts procedure. Follow-up is designed (eight-times follow-up) at the time of Potts-shunt procedure, post-operative ICU period, one month, three months, six months, one year, two years, and three years after Potts-shunt procedure or the rejection of Potts-shunt procedure. The items of follow-up include state of survival, whether or not have the lung transplantation (LTx), clinical manifestation, laboratory examination, function of right ventricle (detected by echocardiogram and cardiac magnetic resonance imaging), and the pulmonary circulation pressure (detected by right heart catheterization or Swan-Ganz catheterization). Primary outcome is the incidence rates of death or LTx three-years after Potts-shunt. Secondary outcomes are as followed: 1) Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure; 2) Three-year WHO cardiac functional and 6-minute walk distance after Potts-shunt procedure; 3) the NT-ProBNP levels three-years after Potts-shunt procedure; 4) Right ventricular function on echocardiography three years after Potts-shunt procedure; 5) Right ventricular function on cardiac magnetic resonance imaging three years after Potts-shunt procedure; 6) Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization three years after Potts-shunt procedure; 7) Three-year mortality or LTx incidence rates after only conventional drug therapy.

NCT ID: NCT06429553 Recruiting - Clinical trials for Spontaneous Cerebral Hemorrhage

Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

To observe the effect of minimally invasive intracranial hematoma aspiration and drainage combined with urokinase injection and drug therapy on prognosis of spontaneous cerebral hemorrhage.

NCT ID: NCT06429397 Recruiting - Pheochromocytoma Clinical Trials

First-line Anlotinib Combined With Penpulimab for Advanced Pheochromocytoma: A Single-arm, Multicenter, Prospective Phase II Study

Start date: May 15, 2024
Phase: Phase 2
Study type: Interventional

There is currently no standard first-line treatment for stage PPGL, and the 5-year survival rate of patients with advanced pheochromocytoma/paraganglioma (PPGL) is low, ranging from 30% to 60%. At present, several domestic teams have carried out clinical studies on the treatment of advanced PPGL with good efficacy. In the early stage, our center used anrotinib to treat advanced PPGL, and the overall effective rate reached 44%. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat advanced PPGL patients. The effective rate reached 66% (2/3). Therefore, the investigators plan to further conduct prospective studies to explore the efficacy and safety of anlotinib combined with PD-1 monoclonal antibody in the treatment of advanced PPGL, so as to bring benefits to patients with advanced PPGL.

NCT ID: NCT06429241 Recruiting - Crohn's Disease Clinical Trials

Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

Start date: April 8, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

NCT ID: NCT06429150 Recruiting - Multiple Myeloma Clinical Trials

Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

Start date: May 11, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.

NCT ID: NCT06429098 Recruiting - Clinical trials for Acute Myeloid Leukemia

Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia.

NCT ID: NCT06428903 Recruiting - Healthy Volunteer Clinical Trials

Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose

Start date: March 12, 2024
Phase: Phase 1
Study type: Interventional

Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food. The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.

NCT ID: NCT06428734 Recruiting - Hydrocephalus Clinical Trials

Clinical Outcome in Patients With INPH

Start date: May 15, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus (iNPH ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.

NCT ID: NCT06428188 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases

BAH247
Start date: May 29, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.

NCT ID: NCT06427642 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.