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NCT ID: NCT06066840 Recruiting - Safety and Efficacy Clinical Trials

Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement

Start date: August 1, 2022
Phase: Phase 4
Study type: Interventional

Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The investigators try to observe the efficacy and safety of application of vedolizumab, anti-CD25 monoclonal antibody and rapid reduction of glucocorticoids in the treatment of grade 3-4 steroid-refractory aGVHD(SR-aGVHD) with lower gastrointestinal involvement.

NCT ID: NCT06066775 Recruiting - Clinical trials for Brain Aging Related Conditions

Endocrine Glucose & Lipids Metabolism and Brain Aging: a Longitudinal Study

Start date: July 4, 2023
Phase:
Study type: Observational

With aging, brain aging leads to a general decline in cognitive ability, and the prevalence of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) increases. The prevalence of abnormal glucose and lipid metabolism also increased with age. The imbalance of glucose and lipid metabolism is closely related to brain aging related conditions and diseases, and the relationship between glucose and lipid metabolism and brain aging has not been fully elucidated. Phase 1: Baseline investigation (community-based survey) Aims: To investigate whether glucose and lipids are the risk factors for brain aging-related conditions, such as mild cognitive impairment. Subjects and Methods: A community-based survey will be carried out in 10000 natural population aged >=50 years selected from 10-12 communities stratified according to geographic regions (Ciyao, Huafeng, Dongzhuang, Heshan, Geshi, Jiangji, Gangcheng, Fushan, Dongshu, Sidian, Baxianqiao, and Xiangyin, etc) in Ningyang County, Taian City, Shandong Province. A comprehensive examination including questionnaire (including the MMSE and ADL evaluation for the participants), anthropometric measurements, biochemical analysis will be performed in each study participant. In particular, the investigators randomly selected 1000-2000 participants performing MRI of the brain to evaluate the brain aging related conditions. Phase 2: Cohort follow-up Aims : To examine glucose and lipids metabolism levels and their changes that modify the risk of brain aging-related conditions. Subjects and Methods: To recruit and follow all 10000 participants for at least 3-5 years. In particular, all 1000-2000 participants with the baseline MRI examination will perform the MRI examination again for the follow-up.

NCT ID: NCT06066593 Recruiting - Stroke, Ischemic Clinical Trials

Prediction Model for Chronic Intracranial Arterial Occlusion With Radiomic Features

Start date: August 1, 2023
Phase:
Study type: Observational

Chronic intracranial arterial occlusion is associated with a "bidirectional stroke risk," with a significantly increased risk of both ischemic stroke and cerebral hemorrhage. Currently, Western CTAP products, in combination with clinical expertise, offer some predictive value for assessing the risk of ischemic events by evaluating compensatory pathways and overall perfusion in chronic intracranial arterial occlusion. However, there is limited support for assessing the risk of hemorrhagic events. Our proposed project aims to address a significant scientific challenge: the precise assessment of long-term stroke risk in asymptomatic patients with chronic intracranial arterial occlusion using a machine learning-based approach. The rapidly advancing field of machine learning provides a rich set of solutions for tackling this problem. In this project, we intend to develop a deep learning-based segmentation model for key brain regions using multimodal CT scans. Subsequently, we will automate the extraction of radiomic features and CT perfusion parameters, followed by the application of machine learning techniques to construct a stroke risk prediction model tailored for patients with chronic intracranial arterial occlusion.

NCT ID: NCT06066528 Recruiting - Obesity Clinical Trials

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

SYNCHRONIZE™-2
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.

NCT ID: NCT06066203 Recruiting - Clinical trials for Non-hodgkin's Lymphoma

A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies

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

Phase I main objectives: To observe the safety and preliminary efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies, to determine the DLT and MTD, or MAD, and to determine RP2D. Phase II Main objective: To explore the efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies.

NCT ID: NCT06066151 Recruiting - Anemia Clinical Trials

The Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome

Start date: September 10, 2023
Phase: N/A
Study type: Interventional

The goal of this single arm, open-label study is to learn about the efficacy of Minayo Iron-rich Yeast Drink with SOD on females who are aged 18-35 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is: - whether the serum ferritin level in blood is improved after the intervention 14 qualified participants will be enrolled to drink the product "Minayo Iron-rich Yeast Drink with SOD" for four weeks, once a day. Four site visits will be made for each participant so that all relevant clinical data will be captured and recorded for data analysis and reporting. Researchers will compare the final blood test result (hemoglobin concentration level, Glutathione (GSH), Superoxide Dismutase (SOD)) against the baseline to conclude whether the product will be effective in improving Anemia and skin conditions.

NCT ID: NCT06066112 Recruiting - Schizophrenia Clinical Trials

Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body

Start date: September 20, 2023
Phase: Phase 1
Study type: Interventional

The experiment adopts a single center, randomized, open, single dose, two cycle, and double crossover design. The subjects were randomly divided into TR and RT groups. In the first cycle, they received the test or control formulation on an empty stomach or after a meal. After a cleaning period, they entered the second cycle and received the control or test formulation in the same state. The cleaning period between the two cycles was 7 days.

NCT ID: NCT06066034 Recruiting - Clinical trials for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance

Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

Polycystic ovary syndrome (PCOS) is a common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. Due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has increased. Its clinical manifestations are heterogeneous, with typical clinical manifestations being oligomenorrhea or amenorrhea, infertility, hirsutism, and polycystic ovarian changes under ultrasound. Women affected by PCOS face significant reproductive challenges, seriously affecting their quality of life and increasing their psychological burden.LRG1 has various regulatory functions, including glucose and lipid metabolism, IR, angiogenesis, organ fibrosis, and inflammation. LRG1 can activate the transcription factor SREBP1 and participate in liver lipid synthesis in obese mice. SREBP1c is the active form of SREBP1. Research has shown that SREBP1c can directly or indirectly participate in the development of IR. Therefore, the investigators speculate that LRG1 may play a certain role in the progression of PCOS through SREBP1c.Understanding the local changes or metabolic characteristics of follicular fluid in patients with PCOS can help elucidate the pathogenesis of PCOS. Therefore, in this study,the investigators aim to detect changes in serum and follicular fluid LRG1, SREBP1c, and related hormone levels, and explore their role in the pathogenesis of PCOS from a systemic and ovarian perspective, providing new ideas for the prevention and treatment of PCOS and IR.

NCT ID: NCT06066008 Recruiting - Clinical trials for X-linked Retinoschisis

Safety and Efficacy Study of Novel Gene Therapy ZM-01 for X-linked Retinoschisis Patients

Start date: September 25, 2022
Phase: Early Phase 1
Study type: Interventional

This trial is meant to evaluate the safety and efficacy of ZM-01 of X-linked retinoschisis. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.

NCT ID: NCT06065813 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer

Start date: August 8, 2022
Phase: Phase 2
Study type: Interventional

Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer