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NCT ID: NCT05820152 Recruiting - Clinical trials for Leber Hereditary Optic Neuropathy (LHON)

Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND1 Mutations

Start date: August 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this clinical study is to evaluate the safety, tolerability and preliminary efficacy of NFS-02 in the treatment of LHON caused by mitochondrial ND1 gene mutation. This study will enroll subjects aged ≥ 18 years old and ≤ 75 years old to receive a single unilateral intravitreal (IVT) injection of NFS-02 to evaluate its safety, tolerability and preliminary efficacy. The clinical manifestations of all subjects are to be reduced visual acuity caused by LHON associated with ND1 mutation, with laboratory test showing G3460A mutation (a CLIA-certified laboratory) and reduced visual acuity lasted for > 6 months and < 10 years.

NCT ID: NCT05820035 Active, not recruiting - Clinical trials for Paroxysmal Supraventricular Tachycardia

A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

PSVT
Start date: March 9, 2023
Phase: N/A
Study type: Interventional

The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation(PFA) Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia(PSVT)

NCT ID: NCT05819762 Recruiting - Clinical trials for Hematologic Malignancy

Evaluation of ClearLLab LS Screening Panel

Start date: May 25, 2023
Phase:
Study type: Observational [Patient Registry]

This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.

NCT ID: NCT05819684 Recruiting - Clinical trials for Advanced Solid Tumor

A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors

Start date: April 18, 2023
Phase: Phase 1
Study type: Interventional

This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

NCT ID: NCT05819398 Recruiting - Clinical trials for Hidradenitis Suppurativa

Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Start date: April 10, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

NCT ID: NCT05819060 Not yet recruiting - Clinical trials for Recurrent Ovarian Cancer

The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

Start date: April 30, 2023
Phase: Phase 2
Study type: Interventional

The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.

NCT ID: NCT05818995 Active, not recruiting - Clinical trials for Chronic Kidney Disease

Therapeutic Drug Use for CKD Patients

Start date: July 1, 2022
Phase:
Study type: Observational

Chronic kidney disease (CKD), characterized as renal dysfunction, is recognized as a major public health problem with high morbidity and mortality worldwide. This study aimed to analyze the common drug use and combinations of different stages and types of CKD patients. The study is a multicenter retrospective study involving three hospitals. Investigators reviewed and analyzed all patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022. Chronic kidney disease was defined as eGFR less than 60 mL/min per 1·73 m(2) or the presence of albuminuria. The study selected seven types of drugs based on hospital electronic medical record data, including β Receptor blockers, angiotensin converting enzyme inhibitor blockers, angiotensin II receptors, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, and calcium channel blockers. Chi-square test, Mann-Whitney Wilcoxon test, and Kruskal Wallis test will be used for statistical analysis. The main purpose of this study is to provide evidence for promoting rational drug use in CKD patients by describing the drug use. The secondary purpose of the study is to explore the efficacy, safety and economy of SGLT-2 inhibitors in diabetes nephropathy (DN).

NCT ID: NCT05818982 Recruiting - Clinical trials for Advanced Esophageal Squamous Cell Carcinoma

To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC

Start date: February 9, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.

NCT ID: NCT05818917 Enrolling by invitation - Clinical trials for Advanced Solid Tumors

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of FHND5071 as a Single Agent in Adult Patients With Advanced Solid Tumors

Start date: July 7, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first-in-human, open-label dose-escalation study to determine the MTD and/or recommended Phase 2 dose (RP2D) and assess the DLT of FHND5071. The safety, tolerability, and PK of FHND5071 will be assessed in adult patients with advanced solid tumors. The total number of evaluable subjects in the study will depend upon the number of dose-escalations necessary. It is estimated that approximately 24 evaluable subjects will be enrolled in the dose-escalation part of this study. This multicenter study will be conducted in the United States. Dose-escalation of FHND5071 will follow two sequential parts: 1. a modified accelerated titration design in single subject cohorts with a starting dose level of 40 mg, where the FHND5071 dose would be doubled in each dose cohort until the subject in a current cohort experience a Grade ≥2 adverse event that is at least possibly related to FHND5071 in the opinion of the Investigator and the Medical Monitor; 2. a modified 3+3 escalation design in cohort of 3-6 subjects, where the FHND5071 dose would be escalated in ≤100% increments determined by the Safety Review Committee (SRC) until 2 of 3 or 2 of 6 subjects experience a DLT. In both parts of dose escalation, FHND5071 will be administered orally once daily (QD) in 28-day treatment cycles. Escalation cohorts may explore alternative doses or different schedules, if deemed appropriate by the Safety Review Committee.

NCT ID: NCT05818904 Recruiting - Clinical trials for Arthrofibrosis of Knee

Ultrasound Imaging of Fibrotic Tissue

Start date: May 1, 2023
Phase:
Study type: Observational [Patient Registry]

This project intends to collect the ultrasonic spectrum information of shoulder and knee joint fibrotic tissue, and use machine learning to study the mechanism of fibrosis tissue ultrasound imaging, and then build a model and finally establish the relationship between joint stiffness and fibrosis formation. In this study, the broadband ultrasound imaging method for joint fibrosis has the potential to create a method for ultrasonic localization, staining and evaluation of joint fibrosis, laying the foundation for the research of new conservative treatment methods and surgical positioning for fibrosis, and for reducing the occurrence of joint fibrosis rate, improve joint function of patients, and return to family and society earlier and better