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NCT06585761

Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients

https://clinicaltrials.gov/study/NCT06585761

RECRUITING

The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.

NO

Heart Failure

measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention, At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL., 1 year|clinical examination for the presence and extent of improvement in signs and symptoms, Clinical examination depending on NYHA classification of the participants, 1 year

measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention, At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarker Il-6 serum concentration is measured in pg/mL, 1 year|Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention, TNF-Alpha serum concentration is measured in pg/ml, 1 year

measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers in heart failure patients before and after the intervention, At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers such as MDA which plasma concentration is measured in nM, 1 year

Kafrelsheikh University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-02-15

2025-06-30

2025-06-30

2024-09-05

2024-09-05

NCT06585748

Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization

https://clinicaltrials.gov/study/NCT06585748

RECRUITING

Bladder catheterization is a procedure frequently performed in emergency departments and may cause symptoms such as pain and discomfort in patients. This study hypothesizes that lidocaine spray application will improve patient compliance and comfort from the outset and facilitate smoother medical procedures. In our prospective, case-controlled study, the patients were divided into two groups: Group L (lidocaine) and Group P (placebo). Pain conditions after bladder catheterization were evaluated at 0 minutes (during the procedure) and 15, 30 and 60 minutes after the procedure. Face Legs Arm Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used. All time periods in Group L, FLACC score and Wang Baker scores were found to be statistically significantly lower.The differences between the first measurement and the measurements at 15-30-60 minutes of the FLACC score were found to be significantly higher in group P than in group L. As a result, we recommend that lidocaine spray be applied before urinary catheter insertion. This study showed that lidocaine spray increased patients\' sleep at the end and reduced the feeling of restlessness by reducing pain.

NO

Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure

Lidocaine and Pain, The FLACC scale assesses acute pain based on facial expression, leg position, activity, crying, and consolability Each category is scored from 0-2, with 0 indicating a calm patient and 10 indicating a visibly distressed patient ., 0., 15., 30., and 60. minutes

Lidocaine and comfort, Wong-Baker pain scale evaluates pain based solely on facial expressions. A score of 0 represents no pain, while a score of 10 represents unbearable pain ., 0., 15., 30., and 60. minutes

Ankara City Hospital Bilkent

MALE

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2022-07-01

2023-07-01

2024-12-01

2024-09-05

2024-09-05

NCT06585735

Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis.

https://clinicaltrials.gov/study/NCT06585735

NOT_YET_RECRUITING

A complex disease, Chronic Pancreatitis (CP) is caused by a wide range of factors, including smoking, alcoholism, autoimmune disorders, and obstruction of the major pancreatic duct. In patients who are genetically susceptible to the condition, these factors can result in damage to the acinar, ductal, and islet cells, as well as persistent inflammatory infiltration and fibrosis. Malnutrition is an ongoing concern for persons with CP, even though pain is the primary symptom in most cases. Complications that commonly arise during the disease's natural history include exocrine and endocrine pancreatic insufficiency and local changes (such as pseudocyst, biliary and duodenal blockage, splenic and portal vein thrombosis, and pancreatic cancer). Consequently, CP mortality is higher than that of the general population.

NO

Chronic Pancreatitis|Malnutrition

DIETARY_SUPPLEMENT: Proteolytic enzyme fortified protein supplement

Weight gain, Improvement in body weight at least by 10% of the original weight., 6 weeks

Improvement in body composition, Change in composition in medical body composition analyser (mBCA) test, 6 weeks|Improvement in body function 1, Muscle strength will be assessed by Jamar Hand grip Dynamometer at baseline and at the end of 6 weeks., 6 weeks|Improvement in body function 2, Muscle function will be assessed by SARC-F questionnaire at baseline and at the end of the 6 weeks, 6 weeks|Improvement in body function 3, Muscle performance will be assessed using a 6-minute walk test at baseline and at the end of the 6 weeks, 6 weeks|Improvement in pain, Improvement in pain (VAS 0-10), 6 weeks

Asian Institute of Gastroenterology, India

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2024-09-01

2025-03-31

2025-06-30

2024-09-05

2024-09-05

Asian Institute of Gastroenterology Hospitals, Hyderabad, Telangana, 500032, India

NCT06585722

Association Between Venous Excess Ultrasound Grading System and Acute Kidney Injury in the ICU Population

https://clinicaltrials.gov/study/NCT06585722

VExUS ICU

RECRUITING

Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. However, fluid responsiveness does not take fluid tolerance into account. Fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. Recent developments in point of care ultrasound e.g. the Venous excess ultrasound might help identify patients at risk of fluid overload. However its association with patient relevant outcomes in the ICU remains unclear.

NO

Fluid Overload|Kidney Injury|Make-30

Rate of acute kidney injury, Clinically relevant acute kidney injury in the ICU: a 200% rise in creatinine or the use of renal replacement therapy, within 30 days of admission to the ICU|Mortality, death of all causes, within 30 days of admission to the ICU|Rate of MAKE-30, a composite endpoint of mortality and acute kidney injury ( including renal replacement therapy), within 30 days of admission to the ICU

Lung ultrasound score, a score for lung aeration as assessed by ultrasound ranging from 0 to 36 where 0 is the normal physiological state, maximum of 3 times during the first 7 days of admission|Cardiac function as assed by ultrasound, determined by eyeballing and measurement of the tricuspid annular plane systolic excursion (\>16 is normal), maximum of 3 times during the first 7 days of admission

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2023-02-01

2024-09-05

2024-09-05

2024-09-05

2024-09-05

NCT06585709

OUD (Opioid Use Disorder) Target Trial

https://clinicaltrials.gov/study/NCT06585709

NOT_YET_RECRUITING

In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids. The investigators are trying to learn two things: 1. Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine? 2. Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS? In order to complete the study the investigators will ask participants to: * Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later. * Undergo study-treatment with 50-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks. * Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.

NO

Opioid Use Disorder

DEVICE: Active repetitive Transcranial Magnetic Stimulation (rTMS)|DEVICE: Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Number of participants with Relapse Free survival, The number of participants who have not met relapse criteria in the 12-week follow-up phase. Relapse is defined as a) any opioid use in 4 consecutive weeks, or b) any opioid use on 7 consecutive days., Up to 12 weeks

Number of participants with high ventral striatal reactivity using the Reassessment of Craving (ROC) task, Baseline|Number of participants with low ventral striatal reactivity using the Reassessment of Craving (ROC) task, Baseline

Duke University

Stanford University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2024-10-01

2026-07-31

2026-10-31

2024-09-05

2024-09-05

Duke University, Durham, North Carolina, 27705, United States

NCT06585696

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)

https://clinicaltrials.gov/study/NCT06585696

RECRUITING

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines. The study consisted of a 7-day screening period, Study Part 1 (randomized double-blind controlled study) and Period 2 (open-label study). Part I was a multicenter, randomized, double-blind, single-injection, active-drug parallel-controlled, non-inferiority design clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20101 in the treatment of moderate to severe glabellar stria compared with a single injection of Botox®; part 2 was an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines.

NO

Moderate to Severe Glabellar Striae

DRUG: CU-20101 treatment for Moderate to Severe Glabellar Striae

• Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection., • Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection., Stage 1: Screening period of 7 days, treatment + follow-up about 12 weeks, the longest 92 days; Stage 2: Treatment + follow-up for about 36 weeks. All together takes up to 344 days

Cutia Therapeutics（Wuxi）Co.,Ltd

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2024-06-11

2026-03-01

2026-05-01

2024-09-05

2024-09-05

Peking University First Hospital, Beijing, Beijing, 200443, China

NCT06585683

Post-Trial Tuberculosis Case Finding: a Substudy of CoVPN 3008 (Ubuntu)

https://clinicaltrials.gov/study/NCT06585683

CoVPN3008TB

NOT_YET_RECRUITING

This substudy aims to identify cases of tuberculosis after the Ubuntu clinical trial (CoVPN 3008) is completed.

NO

Tuberculosis

Proportion of participants with TB, The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method, Measured at Day 1, Day 4 and week 26|Association parameters of each demographic variable with confirmed TB., Proportions and 95% CIs will be estimated using the score method. A multivariate analysis will also be conducted using generalized linear regression models with TB as the outcome., Measured at Day 1, Day 4 and week 26|Proportion of participants with confirmed TB at the six-month follow visit out of the total number of participants that are screened at the six-month visit and who had confirmed TB at their enrollment visit., Proportion and 95% CI will be estimated using the score method., Measured at Day 1, Day 4 and week 26|Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB., TB risk scores will be computed from RNA sequencing data generated from each participant's baseline whole-blood sample (Tempus tube) provided upon enrollment into CoVPN 3008 (Ubuntu). Association of each score with confirmed TB will be assessed using cross-validated ROC curve analysis with area under curve (AUC) 95% CI estimated using the Delong method., Measured at Day 1, Day 4 and week 26

COVID-19 Prevention Network

ALL

ADULT, OLDER_ADULT

NETWORK

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-09-12

2025-10-04

2025-10-05

2024-09-05

2024-09-05

NCT06585670

Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases

https://clinicaltrials.gov/study/NCT06585670

MARiGOLD

RECRUITING

The proposed study is a block-randomized, controlled trial to evaluate the effects of a digital meditation and mindfulness practice on mental health in patients with non-infectious uveitis.

NO

Non-infectious Uveitis

OTHER: Calm Health - smartphone application

Anxiety Symptoms, The severity of anxiety symptoms of participants will be assessed by the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire, which is a diagnostic self-report scale that can be used to screen for and assess the severity of Generalized Anxiety Disorder (GAD). The questionnaire asks the participant to self-report the frequency of 7 different anxiety symptoms on a scale of 0 (\"not at all\") to 3 (\"nearly every day\") over the past two weeks. Scores ranging from 0-4 represent none to minimal anxiety, scores ranging from 5-9 indicate mild anxiety, scores 10-14 indicate moderate anxiety, and scores ranging from 15-21 indicate severe anxiety. A clinically meaningful improvement in anxiety symptoms is defined as a decrease of 1.5 points on the GAD-7., The primary outcome will be measured at 8 weeks.

Depression Symptoms, The severity of depressive symptoms of participants will be assessed by the 9-item Patient Health Questionnaire (PHQ-9), which is a diagnostic self-report scale that can be used to screen for and assess the severity of depression. The questionnaire asks the participant to self-report the frequency of 9 different depressive symptoms on a scale ranging from 0 ("not at all") to 3 ("nearly every day") over the last two weeks. Total scores ranging from 1- 4 indicate minimal depression, scores ranging from 5-9 indicate mild depression, scores ranging from 10-14 indicate moderate depression, scores 15-19 indicate moderately severe depression, and scores ranging from 20-27 indicate severe depression. A clinically meaningful improvement in symptoms of depression is defined as a decrease of 1.7 points on the PHQ-9., This secondary outcome will be measured at 8 weeks.|Perceived Stress, The severity of perceived stress in participants will be assessed by the 10-item Perceived Stress Scale (PSS-10), which is a self-report scale that can be used to evaluate the severity of stress that young people and adults aged 12 and above experience in their daily life, over the past month. The survey asks the participant about feelings related to unpredictability, overwhelm, loss of control, and coping with the pace of everyday life. The survey asks the participant to describe the frequency of these feelings on a scale ranging from 0 ("never") to 4 ("very often"). Higher scores indicate higher stress; scores ranging from 0-13 indicate low stress, scores ranging from 14-26 indicate moderate stress, and scores ranging from 27-40 indicate high perceived stress. A clinically meaningful improvement in perceived stress is defined as a decrease of 11 points on the PSS-10., This secondary outcome will be measured at 8 weeks.|Vision-Related Quality of Life, The vision-related quality of life of participants will be assessed by the 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), which measures the dimensions of self-reported vision-targeted health status that are most important for patients who have chronic eye diseases. The survey is designed to measure the influence of visual disability and visual symptoms on emotional well-being, social functioning, and daily visual functioning. Scores range from 0-100, with higher scores representing a higher vision-related quality of life. A clinically meaningful improvement in vision-related quality of life is defined as increase of 14 points on the NEI VFQ-25., This secondary outcome will be measured at 8 weeks.

University of California, San Francisco

Calm.com, Inc.

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2024-08-26

2025-08

2025-08

2024-09-05

2024-09-05

UCSF, San Francisco, California, 94158, United States

NCT06585657

Brain Visual Perception Training for Prevention and Control of Premyopia

https://clinicaltrials.gov/study/NCT06585657

NOT_YET_RECRUITING

The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training. The main questions it aims to answer are: Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children Participants will: The training group will receive 20 minutes of brain visual perception training once a day for a period of one year. Follow up check ups at the hospital every 3 months. Keep a diary of the values of axial length and refractive diopter.

NO

Myopia

DEVICE: brain visual training

change in axial length after 1 year, the difference in the change of axial length between the intervention group and the control group, 1 year after the baseline

change in cycloplegic spherical equivalent after 1year, the difference in the change of cyclopegic spherical equivalent between the intervention group and the control group, 1 year after the baseline

Shanghai Eye Disease Prevention and Treatment Center

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2024-09-01

2025-12-31

2026-03-31

2024-09-05

2024-09-05

NCT06585644

A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC

https://clinicaltrials.gov/study/NCT06585644

NOT_YET_RECRUITING

Evaluate the efficacy and safety of neoadjuvant furmonertinib combined with anlotinib and chemotherapy in patients with resectable stage II-III EGFR mutation-positive non-small cell lung cancer.

NO

Lung Cancer (NSCLC)

Objective Response Rate, According to RECIST 1.1, objective response rate (ORR) refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that response for a specific duration, including those with complete response (CR) and partial response (PR). Complete response is defined as the complete disappearance of all target lesions, with the shortest diameter of any pathological lymph nodes (including both target and non-target nodes) shrinking to less than 10mm. Partial response is characterized by at least a 30% reduction in the diameter of the target lesion compared to baseline levels. In this study, ORR is defined as the proportion of patients who completed neoadjuvant therapy before surgery and achieved either CR or PR based on CT evaluation three weeks after treatment., 3 Weeks

Major Pathological Response, The Major Pathological Response (MPR) is defined as the proportion of patients, among all those who have completed treatment, with less than 10% residual primary tumor under microscopic examination with hematoxylin and eosin (HE) staining., 3 Weeks|Complete Pathological Response, Complete Pathological Response (CPR) is defined as the proportion of patients, among all those who have completed treatment, in whom there is no residual cancer in the primary tumor and lymph nodes under HE staining microscopy., 3 Weeks|R0 Resection Rate, The R0 resection rate is defined as the proportion of patients whose surgical margins are negative and there is no residual tissue visible under the microscope after the operation among all patients who have completed treatment., 3 Weeks|Disease Free Survival, The disease-free survival (DFS) refers to the time from curative surgery to the time when the patient experiences recurrence or death due to disease progression., 5 years|Overall Survival, The overall survival (OS) is defined as the time from randomization to the occurrence of death from any cause in participants., 5 years|Treatment-Related Adverse Events, Treatment-related adverse events refer to the number of adverse events related to the neoadjuvant treatment regimen assessed according to CTCAE V4.0., 3 Months|Health-Related Quality of Life, The health-related quality of life (HRQOL) was evaluated according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 \& LC13, Version 3) for lung cancer patients., 5 years

Shanghai Pulmonary Hospital, Shanghai, China

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2024-10-01

2025-11-01

2030-06-01

2024-09-05

2024-09-05

NCT06585631

The Collaborative Care PrTNER Study

https://clinicaltrials.gov/study/NCT06585631

PrTNER

NOT_YET_RECRUITING

A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young Black and Latino men who have sex with men (YBLMSM) aged 15 to 24 through engagement in SU treatment.

NO

HIV|Substance Use Disorders|Substance Use|AIDS

BEHAVIORAL: CC PrTNER

PrEP uptake at 12 months, PrEP uptake from baseline to 12 month survey. Biomedical assessment of PrEP use at 12 months, Intraerythrocytic Tenofovir-Diphosphate (TVF-DP) from dried blood spot (DBS) \>700 fmol/punch (oral PrEP), 2+ on-time injections of Long-acting injectable cabotegravir (CAB-LA), 12 months|HIV virologic suppression at 12 months, Viral load \< 20 copies/mL from baseline to 12 months, 12 months|Number of days of past-28-day non-tobacco drug/alcohol use, Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months, 12 months

PrEP persistence, Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months, 12 months|Sustained viral suppression, Duration of time participants are virally suppressed from baseline to 12 months, 12 months|Uptake of HIV Antiretroviral therapy (ART) treatment, Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months, 12 months|Mean number of negative urine drug screens (UDS), Mean number of negative UDS at 12 months, 12 months|Substance-related problems, Substance-related problems as defined by Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), and Severity of Dependence Scale (SDS scores) from baseline to 12 months, 12 months

Children's Hospital of Philadelphia

Johns Hopkins University|Baltimore City Health Department|National Institutes of Health (NIH)|National Institute on Drug Abuse (NIDA)

MALE

CHILD, ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION

2024-09

2028-06

2028-06

2024-09-05

2024-09-05

Johns Hopkins Center for Adolescent and Young Adult Health, Baltimore, Maryland, 21205, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19146, United States

NCT06585618

A Multicenter Pediatric Deep Brain Stimulation Registry

https://clinicaltrials.gov/study/NCT06585618

DBS-R

RECRUITING

There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.

NO

Dystonia|Epilepsy in Children|Cerebral Palsy|Tourette Syndrome|Obsessive-Compulsive Disorder|Neurologic Disorder|Movement Disorders in Children|Movement Disorders|Deep Brain Stimulation

Development of a Multi-Center Pediatric DBS Registry, This study will define DBS as a therapeutic option for children with dystonia, other hyperkinetic movement disorders, or epilepsy., 5 years

Data Collection, Secondary objectives will focus on using the data collected to answer important research questions such as : 1. Which patients benefit from DBS? 2. Which clinical variables contribute to the responsiveness or nonresponsivness to DBS? 3. Which implant sites are preferred? 4. What are the long-term effects of DBS in the pediatric population? 5. How does DBS affect quality of life in pediatric patients?, 5 years

Boston Children's Hospital

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-07-30

2029-07-30

2029-07-30

2024-09-05

2024-09-05

NCT06585605

A Retrospective Survey-based Multicenter Study to Delineate the Molecular and Phenotypic Spectrum of Epilepsy-dyskinesia Syndromes

https://clinicaltrials.gov/study/NCT06585605

RECRUITING

The Epilepsy-Dyskinesia Study aims to advance the understanding of the clinical and molecular spectrum of epilepsy-dyskinesia syndromes, monogenic diseases that cause both movement disorders and epilepsy. Addressing challenges in rare disease research -such as small, geographically dispersed patient populations and a lack of standardized protocols- the study employs a multinational retrospective survey endorsed by the International Parkinson and Movement Disorder Society. This survey seeks to collect comprehensive data on clinical features, disease progression, age of onset, genetic variants, and concurrent neurological conditions, standardizing data collection across countries to provide a unified understanding of these conditions. Through retrospective review and molecular data analysis, the study aims to identify patterns and correlations between movement and seizure disorders, uncovering genotype-phenotype relationships. The initiative\&#39;s goals are to enhance understanding of epilepsy-dyskinesia syndromes, inform precision medicine approaches, and foster international collaboration.

NO

Epilepsy in Children|Dyskinesias|Movement Disorders in Children|Neurologic Disorder|Chorea|Myoclonus|Ataxia|Epilepsy|Dystonia Disorder|Movement Disorders

Creation of a Shared Clinical Database, The primary endpoint of this multi-center study will be the creation of the Epilepsy-Dyskinesia Study and the enrollment of 350 individuals in a shared database., 1 year|Understanding of Disease Spectrum, To comprehensively understand the spectrum and association of movement and seizure disorders on both clinical and molecular levels., 1 year|Assess the Impact of Movement Disorders on Health-Related Quality of Life, To assess the impact of movement disorders on health-related quality of life specifically within the context of epilepsy-dyskinesia syndromes., 1 year|Investigate the Efficacy of Symptomatic Treatments, Investigate the efficacy of symptomatic treatments in addressing both seizure and movement disorders, aiming to identify shared therapeutic strategies., 1 year

Boston Children's Hospital

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-07-01

2029-12-31

2029-12-31

2024-09-05

2024-09-05

NCT06585592

Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy

https://clinicaltrials.gov/study/NCT06585592

COMPLETED

Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO. The aim of this clinical study is to: 1. Found characteristic changes from baseline to the end of treatment. 2. Identify characteristic changes associated with treatment response. 3. Construct a multimodal and multiparameter prediction model by characteristic changes.

NO

Thyroid-Associated Ophthalmopathy

Percentage of participants with overall response, Overall response, 1 week after the end of treatment|Percentage of participants with overall response, Overall response, 24 weeks after the end of treatment|Percentage of participants with overall response, Overall response, 52 weeks after the end of treatment|Percentage of participants with overall response, Overall response, 104 weeks after the end of treatment

Incidence and characterization of nonserious treatment emergent adverse events (TEAEs), Safety and Tolerability, 1 week after the end of treatment|Incidence and characterization of nonserious treatment emergent adverse events (TEAEs), Safety and Tolerability, 52 weeks after the end of treatment|Change of Serum TRAb, 52 weeks after the end of treatment|Change of Serum thyroid function, inculde T3、T4、TSH, 52 weeks after the end of treatment|Change of Serum lipid parameter, including TG、TC、HDL、LDL, 52 weeks after the end of treatment

MRI, baseline|MRI, 52 weeks after the end of treatment|MRI, 1 week after the end of treatment

Shanghai Changzheng Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2017-01-01

2024-03-31

2024-03-31

2024-09-05

2024-09-05

NCT06585579

The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)

https://clinicaltrials.gov/study/NCT06585579

ORIGYNE

NOT_YET_RECRUITING

This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery.

NO

Cervicovaginitis

To confirm the performance of Mucogyne® ovule in wound healing promotion, The primary endpoint is a composite endpoint derived with the following criteria: * Inflammation evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Edema evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Abrasion evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Coalescence evaluated with a 3-point scale (none, partial, total) and not assessed. * Opening of the cervix (only for cervical wound) evaluated with a 4-point scale (closed, slightly open, open, gaping) and not assessed., Day 0 to day 21(+10)

To assess the aspect of the epithelium 3(+1) weeks after surgery, Criteria assessing the aspect of the epithelium (such as presence of mucosa, stroma, presence and quality of mucus, opening of the cervix, presence or absence of inflammation, edema, vulvo-vaginal abrasions, coalescence, adherence, leucorrhoea and bleeding at contact), Day 0 to day 21(+10)|To assess the performance of Mucogyne® ovule in symptoms relief, Vaginal symptoms (dryness, itching, burning, discharge) will be assessed by the patient using a 4-point scale (1 = absent, 2 = mild, 3 = moderate, 4 = severe) at 3 (+1) weeks after surgery, Day 0 to day 21(+10)|To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications, Postoperative side-effects (i.e. postoperative bleeding, infection and impairment of daily activities, etc.) will be assessed using a questionnaire. For the assessment of hemorrhage, the amounts of bleeding will be checked with a pictorial blood assessment chart., Day 0 to day 21(+10)|To assess change in clinical status, Change in clinical status will be assessed by the Investigator using Clinical Global Impressions scale, (CGI) at 3(+1) weeks after surgery, Day 0 to day 21(+10)|To assess compliance with the Medical Device use, Compliance with the Medical Device use will be assessed by number of days of use, Day 0 to day 21(+10)|To assess the safety of Mucogyne® ovule, Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution, Day 0 to day 21(+10)

Biocodex

FEMALE

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER

2024-10

2025-08

2025-11

2024-09-05

2024-09-05

NCT06585566

Alveolar Cleft Reconstruction With Cortical-Shells

https://clinicaltrials.gov/study/NCT06585566

NOT_YET_RECRUITING

The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements. The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.

NO

Alveolar Cleft

PROCEDURE: Cortical-shell graft

Vertical bone loss, The amplitude of radiographic vertical bone loss, 6 months consolidation period

Horizontal bone width, The amplitude of radiographic the horizontal bone width, 6 months consolidation period|Bone density, The radiographic bone density of the consolidated graft at the site of the reconstructed cleft, 6 months consolidation period

Beni-Suef University

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2024-10-01

2025-08-01

2025-10-01

2024-09-05

2024-09-05

NCT06585553

Atrophic Gastritis and OLGIM Stage

https://clinicaltrials.gov/study/NCT06585553

COMPLETED

Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.

NO

Intestinal Metaplasia

Diagnostic Performance of IM at Different Sites, Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of IM at different gastric sites for predicting OLGIM stage III/IV were calculated., 3 years

Shandong University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2022-07-01

2024-07-30

2024-08-25

2024-09-05

2024-09-05

NCT06585540

A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population

https://clinicaltrials.gov/study/NCT06585540

NOT_YET_RECRUITING

The purpose of this study is to evaluate the drug, Barhemsys (Amisulpride), on Postoperative Nausea and Vomiting following Bariatric surgery. Postoperative nausea and vomiting is any nausea or vomiting that occurs within 24 hours following surgery. Barhemsys is approved for the treatment and prevention of Postoperative Nausea and Vomiting in the United States by the U.S. Food and Drug Administration (FDA). You are being asked to take part in this study because you are going to receive anesthesia and nausea medication for your bariatric surgery. General anesthesia is used to put a person in a deep sleep, so they do not feel pain during surgery. If you choose not to participate in the study, you and your doctor will discuss which nausea medications will be provided to you under general anesthesia. If you do participate in the study, you will be randomly assigned (like flipping a coin) into one of two groups, but you won't be told which group you are in: * Group A will receive anesthesia and nausea medications that include dexamethasone, ondansetron, propofol and the study drug, Barhemsys * Group B will receive anesthesia and nausea medications that include dexamethasone, ondansetron, and propofol. Group B patients will not receive Barhemsys during anesthesia. Instead, Group B will receive a placebo. A placebo is a substance that is made to look like a drug but has no drug in it. This is so that no one knows you are in Group B. If you have Nausea after your surgery and you are in Group B, you may receive Barhemsys as a treatment or an additional placebo treatment. Half of group B is expected to receive Barhemsys and half will receive Placebo. If you continue to have nausea you will be provided additional medication to treat your symptoms. You will not be denied medications that are part of the standard of care for treating nausea following surgery. If you participate in this study, researchers will: Evaluate your medical history to make sure you are eligible to participate. Randomly assign you to either the group receiving anesthesia with Barhemsys or to the group receiving anesthesia without Barhemsys Collect information about your health before, during and after your bariatric surgery. Collect information about your nausea and the nausea medications you are prescribed as part of your normal care after your surgery. Your direct participation is expected to last for 24 hours after your surgery. Researchers may continue to access your medical records to follow how you are doing and audit data. Risks: All general anesthetics have some risk of reaction to medications given. Barhemsys is part of a class of medications that can cause chills, low potassium, low blood pressure or abdominal distension. Patients in the placebo group may experience more nausea. There is a risk of loss of confidentiality of your information. You will read about the steps we take to help keep your information private and secure later in this form. If you agree to take part in this study, and receive the study drug, Barhemsys, there may be a direct benefit to you as the study drug may be more effective at treating post surgery nausea and vomiting following bariatric surgery. We hope the information learned from this study will benefit other people who undergo Bariatric Surgery in the future. Taking part in this study is voluntary, and you may choose not to take part or may leave the study at any time. Choosing not to take part or leaving the study will not result in any penalty or loss of benefits to which you are entitled outside of this research.

NO

Post Operative Nausea and Vomiting

Number of Participants With "Complete Response" in the Post Anesthesia Care Unit, Complete response is defined as no occurrence of vomiting or retching, no nausea score ≥ 1 and no use of rescue medication during their Post Anesthesia Care Unit stay., Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes)

Incidence of complete response to established Post-operative Nausea and Vomiting, Effectiveness of Barhemsys in the treatment of established nausea or vomiting in the high-risk bariatric surgical population during Post Anesthesia Care Unit stay. Failure of complete response is defined as subject emesis or use of rescue medication during Post Anesthesia Care Unit stay following a treatment dose of Barhemsys., Until Patient leave Post Anesthesia Care Unit (60-90 minutes)|Number of participants with no nausea, Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No nausea" means no score ≥ 1., Up to 24 hours following surgery|Number of Participants with no Emesis, Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach), Up to 24 hours following surgery|Number of Participants With no Use of Rescue Medication, Any agent given in the post-operative period with the intention of providing anti-emetic rescue is counted as rescue antiemetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the postoperative period which would be expected, by virtue of its pharmacology, dosage, and route, to exert a clinically meaningful antiemetic effect was considered as rescue antiemetic medication, even if administered inadvertently or without the intention of providing rescue., Up to 24 hours following surgery|The Number of Participants With no Emesis, no Significant Nausea, and no Use of Rescue Medication, No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication., Up to 24 hours following surgery|The Number of Participants With no Significant Nausea, Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No significant nausea" means no score ≥ 4., Up to 24 hours following surgery

Benaroya Research Institute

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION

2024-09-09

2025-09

2026-01

2024-09-05

2024-09-05

NCT06585527

Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma

https://clinicaltrials.gov/study/NCT06585527

RECRUITING

The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant glioma will : * Be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy. * Be followed for 1 year after the injection to complete imaging studies, neurological function tests, and report adverse events. Using the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.

NO

Glioblastoma Multiforme|Glioma, Malignant

Incidence and severity of adverse events., All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to TS-2021., Up to 8 weeks|Overall survival, The overall survival for each patient receiving TS-2021 will be calculated., Up to 12 months

Objective response rate (ORR) determined by MRI scan review., Interval tumor size change will be measured., Up to 12 months|Progression Free Survival., Time after TS-2021 administration to clinical and radiographic disease progression, Up to 12 months

Beijing Neurosurgical Institute

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2024-08-29

2026-01-01

2026-01-01

2024-09-05

2024-09-05

NCT06585514

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus

https://clinicaltrials.gov/study/NCT06585514

NOT_YET_RECRUITING

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).

NO

Systemic Lupus Erythematosus (SLE)|Lupus Nephritis (LN)

Phase I: Dose-limiting toxicity (DLT), The incidence and type of dose-limiting toxicity (DLT)., 28 days post infusion|Phase I: Adverse events (AEs), The incidence and severity of adverse events (AE)., 30 days post infusion|Phase II: Objective response rate (ORR), Proportions of subjects achieving SLE Responder Index (SRI)-4 response, 3 months and 6 months post infusion

Phase I: Objective response rate (ORR), Proportions of subjects achieving SLE Responder Index (SRI)-4 response., 3 months and 6 months|Phase I: Long-term Adverse events (AEs), Total number, incidence and severity of AEs from 30 days to 2 years after CD19 CAR T infusion will be recorded., From 30 days after CD19 CAR T infusion to 2 years|Phase I: Pharmacokinetics, The proliferation and survival of CD19 CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR)., Up to 2 years post infusion|Phase II: Adverse events (AEs), The incidence and severity of adverse events., 2 years post infusion|Phase II: Pharmacokinetics, The proliferation and survival of CD19 CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR)., Up to 2 years post infusion|Phase II: Overall survival (OS) and during of response (DOR), Overall survival (OS) is defined the time from the initial CD19 CAR T cell infusion to death for any cause. During of response (DOR) is defined as the date when response criteria are first met to the date of relapse or death caused by SLE in the absence of documented relapse., Up to 2 years post infusion

Beijing GoBroad Hospital

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2024-10-01

2025-09-30

2025-12-31

2024-09-05

2024-09-05

NCT06585501

A Study of Treatment Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China

https://clinicaltrials.gov/study/NCT06585501

REHEARSAL

ENROLLING_BY_INVITATION

This study will be conducted to retrospectively evaluate the treatment patterns in first-line, second-line, and subsequent lines of therapy for HER2-positive Gastric Cancer/Gastroesophageal Junction Cancer (GC/GEJC) patients.

NO

Gastric Cancer|Gastroesophageal Junction Cancer

OTHER: No drug

Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens, 72 months

Percentage of HER2 sample type and testing method among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC, 72 months|Percentage of re-biopsies and re-biopsies with HER2-positive results among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC, 72 months|Real-world Progression-Free Survival, 72 months|Real-world Time to Discontinuation, 72 months|Real-world Time to Next Treatment 1, 78 months|Overall Survival, 78 months

Daiichi Sankyo

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-08-15

2025-03-31

2025-03-31

2024-09-05

2024-09-05

Beijing Cancer Hospital, Beijing, China|The First Affiliated Hospital of Fujian Medical University, Fuzhou, China|Zhejiang Provincial People's Hospital, Hangzhou, China|Harbin Medical University Cancer Hospital, Harbin, China|Affiliated Cancer Hospital of Shandong First Medical University, Jinan, China|Liaoning Cancer Hospital & Institute, Shenyang, China|The First Hospital of China Medical University, Shenyang, China|The First Affiliated Hospital of Soochow University, Suzhou, China|Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China

NCT06585488

A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants with Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplification

https://clinicaltrials.gov/study/NCT06585488

NOT_YET_RECRUITING

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.

NO

Metastatic Solid Tumors|Advanced Non-squamous Non-small-cell Lung Cancer|Advanced Colorectal Cancer|Advanced Pancreatic Ductal Adenocarcinoma|Advanced Gastric Cancer|Advanced Gastroesophageal Junction Cancer|Advanced Esophageal Adenocarcinoma

Phase 1a: Number of Participants Experiencing Adverse Events (AEs), Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCICTCAE\] Version \[v\] 5.0), timing, seriousness, and relationship to study drug(s); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria, Up to approximately 2 years|Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038, defined as the highest dose at which 30% of the participants experienced a DLT or the highest dose administered, respectively., Up to approximately 2 years|Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-53038, The potential RDFE(s) of BGB-53038 as monotherapy or in combination with other antitumor therapies (tislelizumab or cetuximab) will be determined based on the totality of safety, tolerability, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available., Up to approximately 2 years|Phase 1b: Overall Response Rate (ORR), ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1, Up to approximately 2 years|Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-53038, The RP2D of BGB-53038 as monotherapy or in combination with other antitumor therapies (tislelizumab or cetuximab) will be determined based on safety, long-term tolerability, PK, preliminary antitumor activity, and any other relevant data, as available, Up to approximately 2 years

Phase 1a: Single-dose and steady-state area under the concentration-time curve (AUC) of BGB-53038, Up to approximately 2 years|Phase 1a: Single-dose and steady-state Half-life (t1/2) of BGB-53038, Up to approximately 2 years|Phase 1a: Single-dose and steady-state maximum observed plasma concentration (Cmax) of BGB-53038, Up to approximately 2 years|Phase 1a: Single-dose and steady-state trough concentration (Ctrough) of BGB-53038, Up to approximately 2 years|Phase 1b: ORR, ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1., Up to approximately 2 years|Duration of Response (DOR), DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator., Up to approximately 2 years|Time to Response (TRR), defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1, Up to approximately 2 years|Disease Control Rate (DCR), DCR is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) lasting ≥ 24 weeks as assessed by the investigator per RECIST v1.1, Up to approximately 2 years|Progression Free Survival (PFS), PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first., Up to approximately 2 years|Phase 1b: Overall Surival (OS), defined as the time from the date of first dose of study drug until the date of death from any cause, Up to approximately 2 years|Phase 1b: Number of Participants Experiencing Adverse Events (AEs), Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by the NCI-CTCAE v5.0), timing, seriousness, and relationship to study drug(s), Up to approximately 2 years|Plasma concentrations of BGB-53038, Up to approximately 2 years

BeiGene

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

2024-12

2026-12

2026-12

2024-09-05

2024-09-05

NCT06585475

Investigation of the Effectiveness of Structured Education According to Premenstrual Syndrome Symptom Map

https://clinicaltrials.gov/study/NCT06585475

COMPLETED

In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test.

NO

Premenstrual Syndromes|Education|Menstrual Cycle Disorder

BEHAVIORAL: Structured training according to premenstrual syndrome symptom map

Premenstrual syndrome assessment scale, a scale used to measure the degree of premenstrual syndrome, pre-intervention, 2 month after intervention|premenstrual syndrome specific life satisfaction scale, Premenstrual syndrome specific life satisfaction scale evaluates life satisfaction of women with PMS, pre-intervention, 2 month after intervention|DAS depression stress anxiety assessment scale, DAS depression stress anxiety assessment scale, evaluates psychological symptoms, pre-intervention, 2 month after intervention|VAS pain score, 1.421 / 5.000 VAS pain score measures pain score, pre-intervention, 2 month after intervention

Sakarya University

FEMALE

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

2023-11-01

2024-06-10

2024-08-05

2024-09-05

2024-09-05

Sakarya University, Sakarya, 54050, Turkey

NCT06585462

Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity

https://clinicaltrials.gov/study/NCT06585462

NOT_YET_RECRUITING

The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

NO

Cardiometabolic Disease

DRUG: AMG 513|DRUG: Placebo

Number of Participants With Treatment-emergent Adverse Events (TEAE), Approximately 178 days (Part A) and 225 days (Part B)

Maximum Observed Drug Concentration (Cmax) of AMG 513, Day 1 up to Day 57|Time to Cmax (Tmax) of AMG 513, Day 1 up to Day 57|Area Under the Concentration-time Curve (AUC) of AMG 513, Day 1 up to Day 57

Amgen

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

2024-09-16

2026-03-17

2026-03-17

2024-09-05

2024-09-05

NCT06585449

A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease

https://clinicaltrials.gov/study/NCT06585449

NOT_YET_RECRUITING

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose of ALN-HTT02.

NO

Huntington's Disease

DRUG: ALN-HTT02|DRUG: Placebo

Frequency of Adverse Events (AEs) in the Double-blind Part of the Study, Up to 12 months|Frequency of AEs in the Open-label Part of the Study, Up to 12 months

Change from Baseline in Levels of Mutant Huntingtin (mHTT) in Cerebrospinal Fluid (CSF), Baseline up to Month 12 in the Double-blind Part of the study; Baseline up to Month 12 in the Open-label Part of the study|Concentrations of ALN-HTT02 in Plasma, Area Under the Plasma Concentration-time Curve (AUC) Maximum Observed Plasma Concentration (Cmax) Time to Maximum Plasma Concentration (Tmax), Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study|Concentrations of ALN-HTT02 in Cerebrospinal Fluid (CSF), Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study|Concentrations of ALN-HTT02 in Urine, Fractional Excretion of ALN-HTT02, Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study

Alnylam Pharmaceuticals

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

2024-09-30

2027-12-15

2028-07-05

2024-09-05

2024-09-05

NCT06585436

Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments

https://clinicaltrials.gov/study/NCT06585436

COMPLETED

The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.

NO

Caries Arrested

PROCEDURE: partial caries removal

post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 7 days|post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 3 months|post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 12 months|post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 18 months

Al-Azhar University

ALL

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2023-02-01

2024-05-01

2024-08-01

2024-09-05

2024-09-05

Al Azhar university, Cairo, 11651, Egypt

NCT06585423

Tolerability of an Anesthesia-free Tonometer Tip

https://clinicaltrials.gov/study/NCT06585423

NOT_YET_RECRUITING

The purpose of this study is to compare the tolerability and comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.

NO

Glaucoma

DIAGNOSTIC_TEST: Sterile commercially available bandage contact lens|DIAGNOSTIC_TEST: Medical grade silicone of a thickness <100 µm|DIAGNOSTIC_TEST: Medical grade silicone of a thickness >100 µm

Patient tolerability rating of different tips, Tolerability of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip, Baseline|Patient comfort rating of different tips, Comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip, Baseline

Duke University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC

2024-10

2025-10

2025-10

2024-09-05

2024-09-05

Duke Eye Center, Durham, North Carolina, 27710, United States

NCT06585410

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

https://clinicaltrials.gov/study/NCT06585410

NOT_YET_RECRUITING

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. The study is looking at: * The side effects cemiplimab might cause * How well cemiplimab works

NO

Cutaneous Squamous Cell Carcinoma (CSCC)

DRUG: Cemiplimab|PROCEDURE: Standard of care

Event-Free Survival (EFS) as assessed by the investigator, Up to 1 year|EFS as assessed by the investigator, Up to 3 years

Composite Complete Response (CCR) for Target Lesion (TL), Experimental Arm, At week 13|Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL), Experimental Arm, Baseline and at week 13|Incidence of Treatment Emergent Adverse Events (TEAEs), Up to 3 years|Severity of TEAEs, Up to 3 years|Size of surgical defect, At week 13|Size of biopsy defect, At week 13

Regeneron Pharmaceuticals

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

2025-01-28

2029-06-03

2029-06-03

2024-09-05

2024-09-05

NCT06585397

ICF-Based Evaluation of the Upper Extremity in Children With Quadriparetic Cerebral Palsy

https://clinicaltrials.gov/study/NCT06585397

COMPLETED

Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, non-progressive damage to the developing brain before, during, or after birth. The worldwide prevalence of CP is 2-3 per 1000 live births. Spastic CP accounts for approximately 85% of all CP cases. Among the types of spastic CP, quadriparetic CP (QCP) is the most severe and accounts for 20% of spastic CP cases. Individuals diagnosed with quadriparetic cerebral palsy (QCP) are restricted from participating in daily life activities due to inadequate upper extremity function (spasticity, muscle weakness, inability to perform isolated movements, and limitation of supination movements). In order to correctly evaluate children diagnosed with QCP and determine treatment priorities, it is very important to evaluate them based on the International Classification of Functioning, Disability, and Health (ICF). In the literature, there is no study that evaluates the upper extremity of individuals with isolated QCP based on ICF. The aim of this study is to examine the upper extremity functions of individuals with isolated QCP diagnosis within the framework of ICF.

NO

Upper Extremity Spasticity|Quadriplegic Cerebral Palsy

OTHER: Grup 1

Modified Ashworth Scale (MAS), It is a 6-point scale that measures the resistance of the muscle to passive movement by passively moving it through the normal range of motion of the joint. Within the scope of the study, the upper extremity muscles; shoulder flexors, shoulder extensors, elbow flexors, elbow extensors, forearm pronators, wrist flexors, wrist extensors, and fingers will be evaluated with MAS., baseline|Manual Ability Classification System (MACS), It is used to classify how children with CP use their hands to handle objects in daily activities. The EBSS identifies 5 levels. The EBSS levels are functional descriptions based on a child's usual, self-initiated ability to handle objects in daily activities. The levels are based on children's ability to handle objects independently and their need for assistance or adaptations to perform manual activities in daily life., baseline|Functional Independence Measure for Children (WeeFIM), It was developed to assess the functional independence levels of children with developmental disabilities in their daily living activities. The scale consists of 6 sections: self-care (6 items), sphincter control (2 items), transfers (3 items), movement (2 items), communication (2 items), and social and cognitive status (3 items). There are a total of 18 items in the sections. All items in the sections are scored from 1 to 7. 1 point indicates full dependency; 7 points indicate full independence. A total of 18 (full dependency) points and a maximum of 126 (full independence) points can be obtained., baseline

Acıbadem Atunizade Hospital

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-08-01

2024-09-01

2024-09-01

2024-09-05

2024-09-05

Acıbadem Altunizade Hospital, İstanbul, AA, 34662, Turkey

NCT06585384

Safety of a Strategy Combining Etanercept Administration with Repeated Contrast Ultrasound in Patients with Alzheimer&#39;s Disease

https://clinicaltrials.gov/study/NCT06585384

BRAINWAVES

NOT_YET_RECRUITING

Alzheimer's disease (AD) is a clinico-pathological entity combining multiple and varied neuropathological lesions with characteristic abnormal accumulations (amyloid Beta (Aβ) plaques and neurofibrillary degeneration (NFD)), neuroinflammation, as well as neuronal and synaptic suffering. To date, only symptomatic treatments are available, with no proven effect on neuropathological lesions or on the clinical course of the disease. Anti-TNF alpha could be a therapeutic agent of choice in the treatment of central nervous sytem (CNS) diseases with an inflammatory component, such as AD. Unfortunately, their high molecular weight prevents them from passively crossing the blood brain barrier (BBB). In a pilot study published in 2006, etanercept was administered intrathecally to AD patients with encouraging clinical effects. Transient opening of the tight junctions between the endothelial cells of the BBB by delivering High Intensity Focalised Ultrasounds (HIFU) in combination with an intravenous injection of microbubbles is a strategy that could improve bioavailability. Studies suggest that the oscillation of microbubbles in the ultrasound field generates microcurrents that induce shear forces responsible for a transient opening of the BBB. Ultrasound can be focused or unfocused and open the BBB diffusely or selectively over defined regions of the brain. This technique was first used to open the BBB in humans in 2001. Transient opening of the BBB is also thought to modulate the immune response in the CNS, leading to a reduction in the intracerebral load of Aβ. In an Alzheimer's mouse model, several studies using ultrasound devices to open the BBB have shown a reduction in the intracerebral load of Aβ (up to 75%) and an improvement in the memory faculties and cognitive performance of the animals. In humans, two clinical trials have assessed the safety of using ultrasound-assisted BBB disruption devices in AD patients. These were the Sonocloud® (Carthera) and ExAblate® (InSightec) devices. The Sonocloud® device is an extra-dural ultrasound emitter implanted under local anaesthetic. Enrolment was completed in October 2020, but the results of the trial are not yet available (NCT03119961). The phase I study on 5 patients evaluating the ExAblate® device coupled with the injection of gas microbubbles demonstrated reversible opening of the BBB with no serious adverse effects for the patients. No effect on intracerebral Aβ load or cognitive or behavioural improvement was demonstrated. The ExAblate® device is not implantable and is therefore less invasive than the Sonocloud® device. However, it requires MRI monitoring and the transducers used often generate high levels of heat, requiring the use of a water cooling system to avoid the risk of transducer deterioration. In this project, our aim is to assess the safety of using a non-focused ultrasound device, the General Electric VIVID S70 clinical device (CE mark G1 023782 0112 ), to perform BBB ruptures in patients suffering from AD, combined with the administration of etanercept, whose bioavailability would thus be improved.

NO

Alzheimer Disease

To assess the safety of a strategy combining 9 weeks of etanercept administration with 5 weeks of repeated contrast ultrasound of 2 sessions per day, 5 days per week (from the fifth week of etanercept treatment) in patients with Alzheimer&#39;s disease., Number of patients presenting related adverse events (CTCAE v4.0), from Day1 of repeated contrast ultrasound to Month 3 after the end of repeated contrast ultrasound

Fondation Ophtalmologique Adolphe de Rothschild

ALL

ADULT, OLDER_ADULT

NETWORK

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2025-03

2027-09

2027-09

2024-09-05

2024-09-05

NCT06585371

Evaluation of a 6-month Intragastric Balloon

https://clinicaltrials.gov/study/NCT06585371

NOT_YET_RECRUITING

Post-market observational, adaptive, single-arm clinical study to evaluate the percentage of total weight loss after treatment with an intragastric balloon. Patients will be followed for 6 months after the device is installed.

NO

Obesity and Overweight

Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon, To analyze the percentage of total weight loss 6 months after installation of the intragastric balloon, the following formula will be used: Percentage of total weight loss = kilos lost/initial weight x 100, From the installation of the balloon to the end of treatment at 6 months

Number of Adverse event occurrence assessed by clinical evaluation, Adverse event monitoring through medical clinical evaluation, From the installation of the balloon to the end of treatment at 6 months|Weight changes 6 months after installation of the balloon assessed by anthropometric balance in in-person consultations, Patients will be weighed on an anthropometric balance during in-person consultations, From the installation of the balloon to the end of treatment at 6 months|BMI changes 6 months after the installation of the intragastric balloon assessed by BMI calculation in in-person clinical consultations, To analyze the BMI changes, the BMI will be calculated in the follow-up medical consultations by dividing the weight (in kg) by the square of the height (in meters), according to the following formula: BMI = weight/(height x height), From the installation of the balloon to the end of treatment at 6 months|Abdominal circumference changes 6 months after the intragastric balloon installation assessed by measuring tape in in-person clinical consultations, To measure abdominal circumference, during in-person medical consultations, the patient will stand with arms extended at the side of the body, feet apart and parallel. The measuring tape will be positioned around the abdomen, midway between the lower costal margin and the iliac crest., From the installation of the balloon to the end of treatment at 6 months

MEDICONE PROJETOS E SOLUCOES PARA A INDUSTRIA E A SAUDE LTDA

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-09-15

2025-03-15

2025-10-31

2024-09-05

2024-09-05

NCT06585358

DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis

https://clinicaltrials.gov/study/NCT06585358

DoseTB

NOT_YET_RECRUITING

The goal of this observational study is to investigate whether model-informed precision dosing (MIPD), as a clinical support for early individualised dosing in addition to the national TB care program, can optimise the drug exposure of TB drugs during TB treatment. Main research questions: In adult patients with drug-susceptible pulmonary tuberculosis, can the use of current dose recommendations and information received from MIPD help clinicians in a timely manner to optimise the drug exposure of TB drugs in the early treatment phase i.e. time from PK sampling to dose adjustment (keep or adjust dose)? Specific aims I. To perform a process evaluation of early MIPD for rifampicin, isoniazid, pyrazinamide and ethambutol during active TB treatment. II. To study the target attainment of first-line TB drugs with MIPD. III. To evaluate model precision of predicted versus detected drug concentrations. Drug concentrations will be measured in study participants during TB treatment and drug exposure and optimal dose predicted by MIPD, using pharmacokinetic population models.

NO

Tuberculosis, Pulmonary

Proportion of predicted dose, Proportion of participants with predicted doses of rifampicin, isoniazid and/or pyrazinamide within 5 days from sampling (%), Within the first 5 days from sampling

Proportion reaching predicted drug exposure, For participants with dose-predicted treatment, proportion who will reach the target levels for rifampicin, isoniazid and/or pyrazinamide after MIPD, Through study completion, an average of one month|Model precision, Precision of the model comparing predicted drug levels to the detected drug levels (%), Through study completion, an average of one month

Karolinska Institutet

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-10-01

2026-10

2027-09

2024-09-05

2024-09-05

NCT06585345

Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia

https://clinicaltrials.gov/study/NCT06585345

RECRUITING

Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.

NO

Acute-Leukemia

BIOLOGICAL: CD7 CAR-T cell

Number of Adverse Events, Adverse events are evaluated with CTCAE V4.03, 12 months|Overall response rate (ORR), ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%., 24 months

Duration of overall response (DOR), Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up, 24 months|Progression-free survival(PFS), PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up., 24 months|Overall survival(OS), OS will be assessed from the CAR-T cell infusion to death or last follow-up, 24 months

the duration of CAR T-cells in vivo, the time of CAR-T cells' persistence in blood and the copies of CAR-T cells, 24 months|CAR-T related cytokine expression, CAR-T related cytokine expression, 24 months

The General Hospital of Western Theater Command

YakeBiotech Ltd.

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2024-02-18

2027-12-31

2030-11-01

2024-09-05

2024-09-05

The General Hospital of Western Theater Command, Chengdu, Sichuan, China

NCT06585332

Handgrip and Respiratory Dysfunction in HD Patients.

https://clinicaltrials.gov/study/NCT06585332

RECRUITING

Hereditary neurodegenerative diagnosis of Huntington's disease (HD) is associated with a progressive deterioration of the respiratory system function . This fact contributes strongly to the increased risk of aspiration pneumonia as a primary cause of death in people with HD. But regularly objective monitoring of the airway system condition is in common clinical practice almost impossible for high time requirements and the need for specialized expensive devices . This drives the need for a simpler and more cost-effective screening tool. In recent years published studies, working with all ages and genders, show correlation between hand grip strength (HGS) and respiratory parameters. As a second simple screening tool, we chose a short questionnaire called the Index of pulmonary dysfunction.

NO

Huntington Disease

Maximal Hand grip strength, Unit of Measure: kg Assessment followed recommendation of The American Society of Hand Therapists. HSG is measured using DHD-1 digital hand dynamometer (SAEHAN®,Seahan Corporation)., Up to 35 weeks (once on a single screening visit)|Voluntary peak cough flow, Unit of measure: l/min Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines., Up to 35 weeks (once on a single screening visit)|Maximal expiratory pressure, Maximal inspiratory pressure, Unite of measure: cmH2O Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines., Up to 35 weeks (once on a single screening visit)

Index of Pulmonary dysfunction, Questionnaire of four questions. Scale range: 0-11 points A higher score indicates a worse pulmonary condition., Up to 35 weeks (once on a single screening visit)

General University Hospital, Prague

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-04-01

2024-10

2024-10

2024-09-05

2024-09-05

NCT06585319

Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19

https://clinicaltrials.gov/study/NCT06585319

COMPLETED

Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms. This work explores the therapeutic effects of both, on the early treatment of patients with severe COVID-19. The hospital stay, quick COVID-19 severity index (qCSI) and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone, compared to the controls treated with dexamethasone alone.

NO

COVID 19

DRUG: Collagen-polyvinylpyrrolidone|DRUG: Pirfenidone 1200 mg

Number of patients that survived the COVID-19 infection, After each of the treatments that were given for seven days, the evolution of the patients was recorded., From enrollment until one month of follow up

Materno-Perinatal Hospital of the State of Mexico

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2020-02-01

2021-06-30

2024-08-31

2024-09-05

2024-09-05

Monica Pretelini Saenz Maternal Perinatal Hospital, Toluca, State Of Mexico, 50120, Mexico

NCT06585306

High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Sedative Gastroscopy

https://clinicaltrials.gov/study/NCT06585306

NOT_YET_RECRUITING

Obese patients often have fat accumulation in the head and neck, increased soft tissue in the oropharynx, decreased lung compliance, decreased lung volume and residual volume, and some obese patients also suffer from obstructive sleep apnea. Therefore, obese patients may experience hypoxemia during sedative gastroscopy. High-flow nasal cannula oxygen therapy (HFNC) can provide patients with high-flow (20-70 L/min) and adjustable oxygen concentration (21%-100%) through a special nasal prong catheter. It has the function of warming and humidifying the air, relieving pressure on the nasal mucosa, maintaining airway patency and moisture, reducing the risk of nasal bleeding. In addition, HFNC can generate positive airway pressure (3-7 cmH2O), increase end-expiratory volume, help with alveolar recruitment, prevent atelectasis, and reduce shunts. The flow rate of HFNC is positively correlated with the nasopharyngeal pressure. At a flow rate of 50 L/min, the nasopharyngeal pressure can exceed 3 cmH2O. Obese patients are prone to upper airway obstruction under sedation or anesthesia. The use of HFNC at 70 L/min perioperatively can reduce hypoxemia in patients, but discomfort in the nasopharynx may occur at this flow rate. The optimal flow rate for clinical use of HFNC has not been established. Meta-analysis shows that when the oxygen flow rate during painless esophagogastroduodenoscopy is greater than 30 L/min, it can significantly reduce the incidence of hypoxemia in patients. Therefore, for obese patients undergoing painless esophagogastroduodenoscopy, the investigators propose using HFNC at three different flow rates: 30 L/min, 50 L/min, and 70 L/min, to provide guidance on the optimal flow rate for clinical use of HFNC.

NO

Hypoxia|Obesity|Gastrostomy

BEHAVIORAL: jaw lift, increasing oxygen flow, mask ventilation, intubation

incidence of hypoxia, 75% ≤ SpO2 \< 90% for \<60 s, through gastroscopy completion, an average of 6min

incidences of subclinical respiratory depression and severe hypoxia, (90% ≤ SpO2 \< 95%) and (SpO2 \< 75% for any duration or 75% ≤ SpO2 \< 90% for ≥60 s), through gastroscopy completion, an average of 6min|occurrence of adverse reactions other than hypoxia, body movements, vomiting, reflux, bronchospasm, through gastroscopy completion, an average of 6min|airway intervention measures, jaw lift, increasing oxygen flow, mask ventilation, intubation, through gastroscopy completion, an average of 6min

XiaoLiang Wang

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION

2024-10-10

2025-09-20

2025-10-20

2024-09-05

2024-09-05

Nanjing First Hospital, Nanjing, Jiangsu, 210006, China

NCT06585293

Comparability of Fingerprick vs Venous Blood for Tacrolimus Monitoring

https://clinicaltrials.gov/study/NCT06585293

NOT_YET_RECRUITING

Organ transplant rejection occurs when the immune system attacks the transplanted organ. To prevent rejection, transplant-patients are given immunosuppressant drugs which can suppress the immune system from attacking the transplanted organ. Patients who have had a kidney-transplant take immunosuppressant drugs such as tacrolimus, but the dosage must be closely monitored through regular blood tests to avoid complications like organ failure and kidney damage. The current practice at Nottingham University Hospitals NHS Trust is that kidney-transplant patients being monitored for tacrolimus have regular blood samples taken by venepuncture (vein), and the samples are sent to the laboratory to be measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS), a technique used in chemistry to identify and quantify substances in a sample. Patients will also often have their blood-creatinine measured to get an idea of kidney health. Visits to the GP/hospital for this type of blood collection can be disruptive to a patient's daily life and stretches resources of the NHS. An alternative blood sample collection process involves the use of a hand-held blood collecting device called a Mitra device, designed to allow patients to collect samples at home through a finger-prick and send them by post for analysis. This method is especially beneficial for those who find hospital visits challenging or venepuncture painful. This study aims to develop an LC-MS/MS method for measurement of tacrolimus and creatinine, using finger-prick samples collected on the Mitra device. To do this, kidney-transplant patients who are having routine venepuncture to measure tacrolimus and creatinine will simultaneously have a finger-prick sample collected using the Mitra device. Both the venepuncture sample and finger-prick samples will be analysed using existing LC-MS/MS technology to determine tacrolimus and creatinine values. The LC-MS/MS analysis method for the finger-prick samples collected using the Mitra device will be optimised and then results obtained using this method will be compared to the results obtained from venepuncture-collected samples to ensure consistency of results. Agreement of results between the two analysis methods will confirm the suitability of LC-MS/MS method for the measurement of tacrolimus and creatinine using samples collected using the Mitra device.

NO

Immunosuppression

DEVICE: Mitra Microsampling Device

Validation of an in-house LC-MS/MS method and L4L-Analyst quantitative software for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device., Validation of an in-house LC-MS/MS method for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device to UKAS standards, in accordance with ISO 15189, for routine clinical practice., 6 months

Questionnaire to assess whether the new sample collection method improves patient experience, Patient satisfaction questionnaire using a 5-point likert scale, 6 months

Nottingham University Hospitals NHS Trust

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-09-01

2025-02-01

2025-02-01

2024-09-05

2024-09-05

Nottingham University Hospitals NHS Trust, Nottingham, NG7 2UH, United Kingdom

NCT06585280

Assistive Device Satisfaction

https://clinicaltrials.gov/study/NCT06585280

NOT_YET_RECRUITING

Assistive devices are of critical importance for the independence and participation of disabled individuals in society and there is an increasing interest in them today. When the literature is examined, it is seen that there are few studies evaluating the use of orthotic and prosthetic assistive devices in terms of patient satisfaction. The aim of this study is to investigate the satisfaction of individuals using assistive devices in a multifaceted way.

NO

Assistive Technology|Orthosis|Prosthesis|Device

Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) is a survey used to assess the satisfaction of individuals using technological assistive devices. The first version of the survey, developed by Demers et al. in 1996 to assess the satisfaction of using assistive technological devices, consists of 24 items., 5 minute|Orthotics and Prosthetics Users Survey (OPUS), It is preferred to maintain activity development awareness in prosthesis and orthosis applications, to evaluate changes in quality of life, to make quality assessments and to evaluate patients; functional status and satisfaction with prosthesis and orthosis services., 5 minute

Istanbul Medipol University Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-09-15

2024-10-15

2024-10-15

2024-09-05

2024-09-05

NCT06585267

Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis

https://clinicaltrials.gov/study/NCT06585267

SYNC01- P4

NOT_YET_RECRUITING

Development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement surgery for the treatment of knee arthritis.

NO

Complete Questionnaires Following TKR Surgery

Validate final questionnaire, Validation of final questionnaire, From first post-op visit to 12month follow-up

Invibio Ltd

Oxford University Innovation

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-10-01

2025-12-31

2025-12-31

2024-09-05

2024-09-05

NCT06585254

tVNS in Long COVID-19

https://clinicaltrials.gov/study/NCT06585254

RECRUITING

A prior open label study has shown that transcutaneous vagus nerve stimulation \[tVNS\] can improve the health of some patients with postacute sequelae of SARS-CoV-2 infection (PASC), severely affected enough to also fulfill criteria for myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). The purpose of this study is to compare two sets of stimulus parameters to determine the one that best improves the health-related quality of life of these patients over a period of 6-weeks. Patients using their assigned device for at least 30 of the 42 possible opportunities will receive the best device for an additional 6-week period.

NO

Long Covid Also Fulfilling Criteria for Chronic Fatigue Syndrome

DEVICE: Transcutaneous vagus nerve stimulator

The Chalder Fatigue Questionnaire (CFQ), The Chalder Fatigue Questionnaire (CFQ) is used as a measure of fatigue. The CFQ consists of 11 items and uses likert scoring 0, 1, 2, 3, providing a full scale range of 0-33, where lowest score is least fatigue., End of 6 week|Change in Short Form Health Survey (SF-36), The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. SF-36 will be assessed for physical function score improved from baseline by 0.6 SD or 14%., baseline and End of 6 week blinded phase|Visual Analog Scale (VAS) measuring Fatigue, Participants will be asked to mark the level of their fatigue along the line.of 0 (no fatigue) to 10 (Worst fatigue imaginable). Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|VAS to measure Widespread Pain, Participants will be asked to mark the level of their bodywide pain along the line.of "no bodywide pain" to "Worst bodywide pain imaginable". Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|VAS measuring Postexertional malaise (PEM), Participants will be asked to mark the level of their PEM along the line of "no PEM" to "Worst PEM imaginable". Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|VAS measuring brain fog, Participants will be asked to mark the level of their brain fog along the line of "no brain fog" to "Worst brain fog imaginable". Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|Global Clinical Assessment of Change, Global Clinical Assessment of Change --+3 or +2 on a scale ranging from +3 \[very much improved\] thru 0 \[no change\] to -3 \[very much worse\], End of 6 week blinded phase

Heart Rate Variability, Participants will attach a device invented by the co-investigator which detects ECG and can quantify R-R intervals compute root mean square of successive differences (RMSSD) between normal heartbeats. The RMSSD reflects the beat-to-beat variance in heart rate and is the primary time-domain measure used to estimate the vagally mediated changes reflected in HR., End of 6 week blinded phase

Icahn School of Medicine at Mount Sinai

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2024-09

2026-12-31

2026-12-31

2024-09-05

2024-09-05

Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States

NCT06585241

A Study to Investigate the Immunogenicity of mRNA COVID-19 Variant-containing Vaccine Formulations in Adults to Prevent COVID-19

https://clinicaltrials.gov/study/NCT06585241

NOT_YET_RECRUITING

The purpose of this study is to investigate the immunogenicity of mRNA COVID-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously vaccinated adults.

NO

SARS-CoV-2

BIOLOGICAL: mRNA-1273 Variant-containing Formulation

Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants, Day 29|Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 Variants, Day 29

Number of Participants with Serious Adverse Events (AEs), AEs Leading to Study Withdrawal, and AEs of Special Interest, Day 1 through Day 29

ModernaTX, Inc.

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION

2024-09-06

2024-10-29

2025-10-29

2024-09-05

2024-09-05

NCT06585228

Detecting Cardiac Thrombi in Acute Ischemic Stroke on Cardiac CT Versus Transoesophageal Echocardiography

https://clinicaltrials.gov/study/NCT06585228

MtH-DETECT

RECRUITING

Rationale: Cardiac CT acquired during the acute stroke imaging protocol (acute cardiac CT) has recently been shown to have a superior diagnostic yield than transthoracic echocardiography, which is currently the most commonly used method to screen for structural sources of cardioembolism in patients with acute ischemic stroke. The most common finding on acute cardiac CT are cardiac thrombi located in the left atrium (LA) and specifically the left atrial appendage (LAA). The higher diagnostic yield of acute cardiac CT compared to TTE is partially explained because CT allows for better visualization of the LAA, but also because cardiac thrombi may dissolve in the first days after stroke. Whether acute cardiac CT is the optimal diagnostic modality for LA thrombi in stroke patients is unknown, since data comparing it to transoesophageal echocardiography (TEE), which is the reference standard to detect LA thrombi, are lacking. The general hypothesis of this study is that acute cardiac CT is the optimal method to detect LA thrombi in ischemic stroke patients, since TEE can miss LA thrombi that dissolve in the first days after stroke. Objectives: 1. Determine whether acute cardiac CT has a higher diagnostic probability of detecting LA thrombi compared to TEE or repeated cardiac CT in the subacute phase of ischemic stroke by assessing the rate at which LA thrombi dissolve in the first days after ischemic stroke occurrence. 2. Determine the positive predictive value of acute cardiac CT compared to TEE for the detection of LA thrombi. Study design: Prospective, single-centre, observational cohort Study population: 39 patients of 18 years or older with acute ischemic stroke and a LA thrombus detected on cardiac CT acquired during the acute stroke imaging. Main study parameters/endpoints: 1. Rate at which LA thrombi visualized on acute cardiac CT dissolve in the first days after ischemic stroke. 2. False-positive rate for detection of left atrial thrombi on acute cardiac CT compared to TEE. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Clinical and imaging patient data which are obtained as part of standard care will be prospectively collected after written informed consent. Patient with a LA thrombus on acute cardiac CT will undergo TEE for research purposes after obtaining written informed consent. TEE is semi-invasive and associated with a small risk of major complications (\<0.2%). Patients will also be exposed to additional radiation (1.4 mSV) due to sequential cardiac CT after TEE. The Radiation Dose Committee deemed this to be an intermediate risk. In a small minority of patients (\<10%), another cardiac CT will be acquired 2 minutes after this sequential cardiac CT to ensure a clear, final assessment of the presence of an atrial appendage thrombus. This will result in a total additional radiation of 3 mSV for the two additional cardiac CT's. The Radiation Dose Committee deemed this to be an intermediate risk. As part of standard care, patients will be contacted for follow-up evaluation by a trained stroke nurse at 90 days. As a result of ischemic stroke, some patients become incapacitated to an extent they are unable to give informed consent. In these cases, the legal representative will be asked for informed consent. Decreased leveI of consciousness or aphasia are typical clinical characteristics of cardioembolic stroke. Therefore, it is pivotal to also include incapacitated acute ischemic stroke patients. Excluding these patients from the study would render the study non-representative of the study's target population (acute ischemic stroke patients with cardioembolic stroke due to LA thrombus).

NO

Ischemic Stroke|Cardioembolic Stroke|Thrombus; Embolism|Left Atrial Thrombosis|Left Atrial Appendage Thrombosis

DIAGNOSTIC_TEST: Cardiac Computed Tomography|DIAGNOSTIC_TEST: Transesophageal echocardiography|DIAGNOSTIC_TEST: Repeated Cardiac Computed Tomography

Proportion of patients with a left atrial thrombus, The proportion of patients with a LA thrombus detected on acute cardiac CT that dissolves in the first days after stroke, defined as thrombi that are seen on initial cardiac CT but are no longer visible on TEE and repeated cardiac CT., The assessment of a left atrial thrombus is performed when the patient arrives at the Emergency Department and undergoes the acute stroke imaging protocol including a cardiac CT.|Positive predictive value of acute cardiac CT compared to TEE., Positive predictive value of acute cardiac CT compared to TEE., The assessment of a left atrial thrombus is performed when the patient arrives at the Emergency Department and undergoes the acute stroke imaging protocol including a cardiac CT. The TEE is performed <7 days after the cardiac CT.

Other pre-defined high-risk and non-high-risk sources of embolism on cardiac CT and TEE, Other high-risk and non-high-risk sources that have been detected on cardiac CT and TEE., Cardiac CT is performed and assessed when the patients arrives at the Emergency Department. The TEE is performed <7 days after the cardiac CT.|Clinical impact of cardiac thrombi, The clinical impact of detecting cardiac thrombi and other sources of embolism on acute cardiac CT and TEE, including any impact on stroke etiology according to Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria, The clinical data of patients with a thrombi is collected on arrival at the Emergency Department and follow-up is performed at 90 days and 2 years to assess functional outcome, recurrent stroke and cardiovascular events

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-09-01

2026-07-01

2026-10-01

2024-09-05

2024-09-05

Amsterdam University Medical Center (UMC), Amsterdam, Noord-Holland, 1105AZ, Netherlands

NCT06585215

Standardization of Physician-Modified Stent Grafts for Abdominal Aortic Aneurysms

https://clinicaltrials.gov/study/NCT06585215

RESTORE

ENROLLING_BY_INVITATION

This study explores the use of physician-modified stent grafts (PMSGs) for treating abdominal aortic aneurysms that are unsuitable for open surgery or standard endovascular grafts. Custom-made fenestrated endografts are not viable in urgent or symptomatic cases due to lengthy manufacturing times. Although off-the-shelf branched devices are more readily available, they present challenges such as high costs, extensive thoracic coverage, limited long-term data, and anatomical restrictions. Parallel graft techniques are also associated with concerns regarding their durability. PMSG procedures, however, are not standardized and rely heavily on the physician's experience and expertise. The aim of this comprehensive study is to establish expert consensus on the indications, planning protocols, and procedural techniques for PMSGs.

NO

Abdominal Aortic Aneurysm|Endovascular Procedures|Stents|Vascular Surgical Procedures

Expert Consensus on PMSG Indications and Techniques, To achieve expert consensus on aspects regarding indications, planning and performing PMSGs in the treatment of abdominal aortic aneurysms, as determined by the completion of a modified Delphi consensus., 30.06.2025

Survey-Based Review of PMSG Strategies and Techniques, To conduct a survey-based scoping review to identify the predominant strategies and techniques utilized in the execution of PMSGs for interventions on abdominal aortic aneurysms., 30.06.2025|Comparison of 3D-Printed Models and CT-Based Planning, To test the hypothesis that 3-D printed models offer an advantage in terms of fenestration precision compared to CT based planning methods., 30.06.2025

Ente Ospedaliero Cantonale, Bellinzona

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2014-06-14

2025-06-30

2025-06-30

2024-09-05

2024-09-05

Centro Vascolare Ticino, Servizio di Chirurgia Vascolare e Angiologia, Lugano, Ticino, 6900, Switzerland

NCT06585202

Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis

https://clinicaltrials.gov/study/NCT06585202

RECRUITING

This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.

NO

Atopic Dermatitis

DRUG: ATI-2138

Incidence and severity of treatment emergent adverse events (TEAEs), From baseline up to two weeks after treatment (Day 98)

Change from baseline Eczema Area and Severity Index (EASI) Over Time, Up to Week 12|Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time, Up to Week 12|Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time, Up to Week 12|Change in IGA score over time, Up to Week 12|Change from baseline in AD Body Surface Area (BSA) over time, Up to week 12|Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time, Up to Week 12|ATI-2138 trough concentration ng/mL, Day 1 to Week 12|ATI-2138 peak concentration (Cmax) ng/mL, Day 1 to Week 12

Aclaris Therapeutics, Inc.

ALL

ADULT

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2024-08-19

2025-04

2025-05

2024-09-05

2024-09-05

Aclaris Investigational Site, Encino, California, 91436, United States|Aclaris Investigational Site, San Diego, California, 92123, United States|Aclaris Investigational Site, Plainfield, Indiana, 46168, United States|Aclaris Investigational Site, Austin, Texas, 78759, United States|Aclaris Investigational Site, San Antonio, Texas, 78213, United States

NCT06585189

CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS4]

https://clinicaltrials.gov/study/NCT06585189

COMPLETED

The goal of this non-interventional study is to emulate the KEYNOTE-189 randomized controlled trial of pembrolizumab for the treatment of metastatic non-small cell lung cancer using real-world, electronic health record data. The main questions this study aims to answer are: 1. Do patients with metastatic non-small cell lung cancer (NSCLC) treated with pemetrexed, cisplatin/carboplatin, and pembrolizumab have improved real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) compared with patients treated with pemetrexed and cisplatin/carboplatin alone? 2. How do the results of this non-interventional study compare to those of the KEYNOTE-189 randomized controlled trial?

NO

Metastatic Non Small Cell Lung Cancer

DRUG: Pembrolizumab|DRUG: Pemetrexed|DRUG: Cisplatin|DRUG: Carboplatin

Real-world overall survival (rwOS), Time from study treatment initiation to death, Study treatment initiation to death or censoring|Real-world progression-free survival (rwPFS), Time from study treatment initiation to disease progression or death, Study treatment initiation to disease progression, death, or censoring

Aetion, Inc.

AbbVie|Amgen|AstraZeneca|Bayer|Gilead Sciences|Janssen, LP|Pfizer

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2010-02-01

2023-04-13

2023-04-13

2024-09-05

2024-09-05

NCT06585176

Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City

https://clinicaltrials.gov/study/NCT06585176

RECRUITING

Gastroesophageal Reflux Disease (GERD) is a condition characterized by the reflux of gastric and duodenal contents into the esophagus, primarily manifested by symptoms such as acid regurgitation and heartburn. GERD significantly affects patients' daily lives and health-related quality of life. Prolonged gastroesophageal reflux can lead to repeated irritation of the esophageal mucosa by gastric acid and acidic gastric contents, resulting in the replacement of normal squamous epithelium in the lower esophagus with metaplastic columnar epithelium. This pathological change, known as Barrett's Esophagus (BE), is considered a precancerous lesion for esophageal adenocarcinoma.

NO

Gastroesophageal Reflux Disease|Epidemiology|Risk Factors

The prevalence of GERD in Xiamen city, Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disorder in the world. In this study, we will study the incidence of GERD in Xiamen city., 3 months.|The percentage of reflux esophagitis, The percentage of participants diagnosed with reflux esophagitis using endoscopy among patients with baseline symptoms., 3 months.|The percentage of Barrett esophagus, The percentage of paticipants diagnosed with pathological Barrett esophagus using endoscopy monitoring among patients with baseline symptom in gastroenterology department will be calculated., 3 months.

The life quality of GERD patients who were diagnosed by endoscopy, The life quality of GERD patients with different main symptoms before PPI test will be measured via the 50-item short form health survey , in which higher scores mean a better quality of life., 3 months.|The sensitivity of GERD-Q for diagnosis of GERD, The sensitivity of GERD-Q for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD., 3 months.|The specificity of GERD-Q for diagnosis of GERD, The specificity of GERD-Q for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD., 3 months.

Zhongshan Hospital (Xiamen), Fudan University

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-08-01

2025-08-30

2026-11-30

2024-09-05

2024-09-05

NCT06585163

Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension

https://clinicaltrials.gov/study/NCT06585163

NOT_YET_RECRUITING

This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.

NO

Healthy

DRUG: Hydrocodone Bitartrate|DRUG: Doxapram Hydrochloride

Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Incidence, nature, and severity of TEAEs, Day 1 to Day 5|Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs, Changes from baseline in physical examination, vital signs, 12-lead ECG assessment and pulse oximetry, Day 1 to Day 5

Plasma PK Parameters (Cmax), Maximal plasma concentrations for hydrocodone and doxapram, Day 2 and Day 4|Plasma PK Parameters (AUC0-inf), Plasma area under the curve for hydrocodone and doxapram, Day 2 and Day 4|Plasma PK Parameters (Tmax), Time to maximal plasma concentrations for hydrocodone and doxapram, Day 2 and Day 4

Quivive Pharma, Inc.

National Institute on Drug Abuse (NIDA)

ALL

ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE

2024-09

2024-12

2024-12

2024-09-05

2024-09-05

Cleveland Clinic Main Campus, Cleveland, Ohio, 44195, United States

NCT06585150

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

https://clinicaltrials.gov/study/NCT06585150

NOT_YET_RECRUITING

The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it is in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers want to see if obeldesivir can help participants' symptoms get better faster. The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV in nonhospitalized adult participants with acute RSV infection.

NO

RSV Infection

DRUG: Obeldesivir|DRUG: Obeldesivir Placebo

Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) through Day 15, The RiiQ symptom scale is a 13-item questionnaire rated on a 4-point scale. Each symptom is rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity., Day 1 up to Day 15|Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 29, Up to 29 days|Percentage of Participants Experiencing Laboratory Abnormalities Through Day 29, Up to 29 days|Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation, First dose date up to Day 60

Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15, The RiiQ symptom scale is a 13-item questionnaire rated on a 4-point scale. Each symptom is rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity., Day 1 up to Day 15|Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29, RSV-related LRTI will be defined by symptoms (eg, cough, shortness of breath, wheezing, expectoration \[coughing up mucus\]) as assessed by the RiiQ symptom scale., Day 1 up to Day 29|Time to RSV-Related Hospitalization or all-Cause Death Through Day 29, RSV-related hospitalization is defined as ≥ 24 hours of acute care for a reason related to RSV, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with RSV., Day 1 up to Day 29|Time to RSV-Related Medically Attended Visit (MAVs) or all-Cause Death Through Day 29, Day 1 up to Day 29|Change from baseline in RSV Viral Load Through Day 3, Baseline, Day 3|Change from Baseline in RSV Viral Load Through Day 5, Baseline, Day 5|Change from Baseline in RSV Viral Load Through Day 7, Baseline, Day 7|Change from Baseline in RSV Viral Load Through Day 10, Baseline, Day 10|Change from Baseline in RSV Viral Load Through Day 15, Baseline, Day 15|Pharmacokinetic (PK) Parameter: AUCtau of GS-441524, AUCtau is defined as the area under the concentration versus time curve over the dosing interval., Day 1 to Day 5|PK Parameter: Ctrough of GS-441524, Ctrough is defined as the concentration at the end of the dosing interval, Day 1 to Day 5|PK Parameter: Cmax of GS-441524, Cmax is defined as the maximum observed concentration of drug in plasma., Day 1 to Day 5

Gilead Sciences

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

2024-09

2025-09

2025-09

2024-09-05

2024-09-05

NCT06585137

Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment

https://clinicaltrials.gov/study/NCT06585137

NOT_YET_RECRUITING

The goal of this two-group parallel randomized controlled study is to determine the effect of a web-based mind-body-based awareness program based on Meleis Transition Theory on fertility awareness and readiness levels in women receiving infertility treatment.

NO

Infertility, Female

Fertility Awareness Scale, This scale was developed to measure fertility awareness in women. The scale is Likert-type and has 19 items and two sub-dimensions (Body Awareness, Cognitive Awareness). Items in the scale are scored from 1 to 5 (1-Never, 2-Rarely, 3-Occasionally, 4-Most of the time and 5-Always) and there are no reverse-scored items. Possible scores in total for the scale are 19-95, 10-50 for the "Body Awareness" sub-dimension, and 9-45 for the "Cognitive Awareness" sub-dimension. If the total score is between 19-43, the awareness level is interpreted as ''low'', if it is between 44-69, it is ''medium'', and if it is between 70-95, it is interpreted as ''high''., A pre-test will be administered before the study begins. Then, a post-test will be administered three times, 1 day after the OPU procedure, then at 3 months and 6 months.|Fertility Preparedness Scale for Women Receiving Fertility Treatment, The scale, consisting of 23 questions, was created to measure the readiness of women preparing to become pregnant. The scale consists of 3 sub-dimensions: "hope and awareness", "relaxed body and brain" and "positive feelings and thoughts". Since the scale items consist only of positive expressions, the scores obtained are calculated as they are. The scores of the items are 5, 4, 3, 2, and 1, respectively. The minimum score is 23, the maximum score is 115 on the scale, and a high score indicates that fertility preparedness is strong. The median score on the scale is 56. A score of 56 or higher on the scale indicates that the woman feels more prepared for pregnancy, while a lower score indicates that she feels less prepared., A pre-test will be administered before the study begins. Then, a post-test will be administered three times, 1 day after the OPU procedure, then at 3 months and 6 months.

Introductory Information Form, Follicle-stimulating hormone (FSH) and estradiol (E2) levels, number of oocytes collected, embryo transfer status, and blood pregnancy test results will be taken from the patient file and added to the form., FSH and E2 levels will be monitored on the 2nd-3rd day of the menstrual cycle, the number of oocytes collected on the 16th day of the cycle, embryo transfer status on the 18th day of the cycle, and pregnancy test on the 28th day of the cycle.

Hacettepe University

FEMALE

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

2025-07-01

2026-07-01

2027-07-01

2024-09-05

2024-09-05

NCT06585124

Flow Cytometry for the Study of T-Cell Populations in Hemophagocytic Lymphohistiocytosis Associated With Lymphomas

https://clinicaltrials.gov/study/NCT06585124

LA-HLH

RECRUITING

The goal of this study is to explore the associations between T cell activation and the occurrence of hemophagocytic lymphohistiocytosis (HLH) in patients with newly diagnosed lymphomas. The specific aims are: Prediction of Lymphoma-Associated HLH (LA-HLH): Compare flow cytometric T cell activation markers with the H-score to predict LA-HLH. Identification of new markers for predicting HLH in patients with aggressive lymphoma. Description of the incidence rate of LA-HLH. Assessment of the outcomes of LA-HLH identified by flow cytometric analysis or the H-score. This prospective, single-center observational study will include 150 patients newly diagnosed with aggressive lymphoma within one year. Peripheral blood samples will be taken at diagnosis alongside routine blood chemistry tests for flow cytometric analysis of the T-lymphocyte activation profile. Data on disease characteristics will be collected to calculate the H-score, HLH-2004 score, and OHI score for diagnosing HLH. The flow cytometry results will be compared with these scores to evaluate their effectiveness in diagnosing LA-HLH.

NO

Lymphoma|Hemophagocytic Lymphohistiocytoses

DIAGNOSTIC_TEST: Flow Cytometry

Assocation of flow cytometry parameters on peripheral blood with the H-score, the standard for the diagnosis of lymphoma-associated HLH, Diagnostic rate of flow cytometry for lymphoma-associated HLH, 2 years

Determine the incidence of LA-HLH, incidence rate, 2 years|To evaluate the outcome of patients with LA-HLH, overall survival, 2 years|Define the rate of complete responses to lymphoma treatment, Complete remission rate, 2 years

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-05-01

2025-05-01

2026-05-01

2024-09-05

2024-09-05

Stefan Hohaus, Rome, Lazio, 00168, Italy

NCT06585111

Effect of Individual Counseling Interventions Based On Health Action Process Approach Model On Breastfeeding Duration

https://clinicaltrials.gov/study/NCT06585111

COMPLETED

The aim of this prospective, randomized controlled experimental clinical trial was to examine the effect of individual counseling interventions based on the Health Action Process Approach Model on breastfeeding duration in twin pregnancies. Women in the intervention group received breastfeeding education using motivational interviewing techniques, while women in the control group received routine clinical education and no intervention. Hypotheses of the study: H1: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding self-efficacy than the control group. H2: Women who received individual intervention based on the SESY model have higher prenatal breastfeeding intentions than the control group. H3: Postnatal breastfeeding self-efficacy of women who received individual intervention based on SESY model is higher than the control group. H4: Breastfeeding motivation of women who received individual intervention based on the SESY model is higher than the control group. H5: Women who received individual intervention based on the SESY model had higher rates of exclusive breastfeeding than the control group. The women in the intervention group were given breastfeeding education with motivational interviewing techniques at 28-38 weeks of pregnancy in the prenatal period and 1-3 days, 1-2 weeks, 4-6 weeks, 4th month and 6th month in the postpartum period. The women in the control group did not receive any training by the researcher.

NO

Breast Feeding

OTHER: Intervention

Breastfeeding duration of twin babies until the sixth month postpartum after counseling, The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk., Postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months

Duration of exclusive breastfeeding of twin babies after consultation until the sixth month after birth, The duration of breastfeeding the twins was measured using a breastfeeding follow-up form after the counseling intervention using motivational interviewing techniques. The breastfeeding follow-up form included questions about the number of breastfeedings in the last 24 hours and the mothers' formula feeding status. Mothers who breastfed 9-12 times were considered to have breastfed their babies sufficiently. Mothers who breastfed their babies 6 times or less did not breastfeed their babies enough. Babies of mothers who give formula to their babies are interpreted as not receiving enough breast milk., postpartum 1-3 days, postpartum 1-2 weeks, postpartum 4-6 weeks, postpartum 4 months and postpartum 6 months|Breastfeeding Intention Level, The breastfeeding intention level of mothers of twin babies was measured with the breastfeeding intention scale in the prenatal period.The scale is a 5-point Likert scale. Items are scored from strongly disagree 1 to strongly agree 5. A minimum of 7 and a maximum of 35 points can be obtained from the scale. The higher the total score obtained from the scale, the higher the breastfeeding intention of pregnant women expecting twins. The scale can be used in both primiparous and multiparous pregnant women from the 20th gestational week until delivery. The scale can be easily completed by literate individuals., In the prenatal period between 28-38 weeks of gestation|Prenatal Breastfeeding Self Efficacy Level, The prenatal breastfeeding self-efficacy level of the mothers of twin babies was measured with the prenatal breastfeeding self-efficacy scale after breastfeeding training with motivational interviewing techniques. The scale consists of a total of 19 items and four subgroups. Each item of the scale is classified as "1=Not at all sure", "2=Slightly sure", 3=Quite sure", 4=Very sure", 5= Completely sure". It is graded on a 5-point Likert scale. The lowest score that can be obtained from the total scale is 19 and the highest score is 95. It is evaluated over the total score. The higher the score, the higher the perception of breastfeeding self-efficacy., In the Prenatal period between 28-38 weeks of gestation|Postnatal Breastfeeding Self Efficacy Scale Level, The postpartum breastfeeding self-efficacy levels of the mothers of twin babies were measured with the postnatal breastfeeding self-efficacy scale after breastfeeding training with motivational interviewing techniques. The Breastfeeding Self-Efficacy Scale developed by Dennis in 1999 consists of 33 items. Dennis developed the short form of the Breastfeeding Self-Efficacy Scale in 2003 by reducing it to 14 items. The Short Form Breastfeeding Self-Efficacy Scale is a 5-point Likert-type scale with 1= "I am never sure" and 5 = "I am always sure". The higher the score, the higher the breastfeeding self-efficacy., Postpartum 1-3 days, postpartum 4-6 weeks, and postpartum 4th month.|Breastfeeding Motivation Level in Mothers of Twin Babies, The level of breastfeeding motivation in mothers of twin babies was measured by motivational interviewing techniques and breastfeeding motivation scale after breastfeeding education. The scale consists of 24 items. The scale was adapted into Turkish by Mızrak and Özerdoğan in 2017. The scale consists of 6 sub-dimensions. These are; integrated regulation first sub-dimension 13,14,16,19,15,21,18,24,22,23, intrinsic motivation and identified regulation second sub-dimension 11,8,16,3,14.6,8,11,13, internalized regulation-social approval third sub-dimension 4,5, internalized regulation-social pressure fourth sub-dimension 7,9, external regulation-infant health fifth sub-dimension 2,12. and external regulation-additional benefits sixth sub-dimension 20,1,17,10. Scale items are graded from 1=strongly disagree to 4=strongly agree., 1-3 days postpartum, 4-6 weeks postpartum, and 4th month postpartum

Ege University

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

2022-09-15

2023-09-15

2023-09-15

2024-09-05

2024-09-05

Ege University, İzmir, Bornova, 35030, Turkey

NCT06585098

The Effect of Game-Based Virtual Reality Application on the Development of Postoperative Care Skills of Nursing Students for Hysterectomy

https://clinicaltrials.gov/study/NCT06585098

COMPLETED

This study aimed to determine the effect of game-based virtual reality application on nursing students' self-confidence in postoperative care knowledge, skills, satisfaction and learning following hysterectomy surgery.

NO

Nursing|Hysterectomy|Game-Based Learning

OTHER: game based learning

Satisfaction with Educational Methods Survey, This is a survey developed by Gürpınar and also used in his research. This survey consists of 16 statements. One of these statements is the statement that asks whether or not the student is satisfied with the education by saying "I am generally satisfied with this educational method". The other statements are generally composed of statements that can determine the opinions about the effect of the educational method on learning and future working life. It is prepared in a 5-Likert type and is scored from 1- strongly disagree to 5- strongly agree, as the score increases, the satisfaction with the educational method is measured and as the score decreases, the dissatisfaction with the method is measured. A minimum of 16 and a maximum of 80 points can be obtained in the evaluation., immediately after game-based virtual reality application and simulation method|Student Satisfaction and Self-Confidence in Learning Scale, The scale has two sub-dimensions and 13 statements presented as "satisfaction with learning" and "self-confidence". The expressions of satisfaction with learning; "comfort with the learning system", "variety of learning rates", "facilitation", "motivation" and five statements evaluating the suitability of the simulation, the expressions of self-confidence; "adequacy in scope", "necessity of content", "skill improvement", "available resources" and information on how to get help to solve clinical problems in the simulation. It was coded as the 13th item in the scale. A 5-point Likert type was prepared and 1-definitely disagree and 5-definitely complete until the score is given. The minimum score that can be obtained is 13, the maximum score is 65. It is understood that happiness and self-confidence increase as the score increases. The internal discounts of the scale change as 0.94., immediately after simulation method|Postoperative Care Knowledge Test After Hysterectomy Surgery, This test was created by the researcher in accordance with the relevant literature in order to determine the knowledge levels of students regarding postoperative care after total abdominal hysterectomy surgery.The test consists of 11 questions, 1 point is calculated for each question answered correctly, and the highest score is prepared according to the number of questions. The prepared knowledge test was evaluated by five experts specialized in Women's Health and Diseases Nursing and their suggestions were received. The necessary changes were made to the knowledge test with the suggestions received and its final form was given., immediately before and after simulation application|Management of Postoperative Care After Hysterectomy Surgery Clinical Skills Guide, This is a clinical skills guide created by the researcher in accordance with ERAS protocols and relevant literature on the subject of Management of Care of Patients Who Have Undergone Total Abdominal Hysterectomy Surgery, which is part of the Women's Health and Diseases Nursing Course content. "Management of Postoperative Care After Hysterectomy Surgery Clinical Skills Guide" was created to measure the procedures that students will perform in the hybrid simulation application and to benefit from the meeting to be held with educators and students after the application. The statements were scored from 1 to 3 and prepared in the form of a 3-point Likert scale. Opinions were received from 8 experts regarding the ''Clinical Skills Guide for Management of Postoperative Care After Hysterectomy Surgery''. Expert opinion analysis was performed and the Content Validity Index (CVI) was found to be 0.944., during simulation application|Form for Determining Students' Opinions on Game-Based Virtual Reality Application, This form was developed by the researcher by reading the relevant literature to determine whether students were satisfied or not based on their evaluations regarding the teaching of postoperative care after hysterectomy using a game-based virtual reality application. The form consists of 16 propositions. Students chose one of the three-point Likert-type statements (agree, partially agree, disagree)., immediately after the game-based virtual reality application

Ege University

The Scientific and Technological Research Council of Turkey

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER

2023-03-15

2024-03-15

2024-07-17

2024-09-05

2024-09-05

Ege Üniversitesi Kadın Sağlığı Ve Hemşireliği, İzmir, Eyalet/Yerleşke, 1, Turkey

NCT06585085

Physical Activity and Sedentary Behavior During Pregnancy

https://clinicaltrials.gov/study/NCT06585085

PREGMOUV

NOT_YET_RECRUITING

Our main objective is to evaluate the intervention that best enables women's adherence to physical activity (PA). Our hypothesis is that identifying types of interventions suitable for pregnant women (in-person PA sessions, videoconferences or mixed format) could help improve their PA level and simultaneously reduce their sedentary behavior (SB).

NO

Pregnant Woman

BEHAVIORAL: In person PA sessions|BEHAVIORAL: Interactive videoconference PA sessions|BEHAVIORAL: In person and by videoconference (mixed format) PA sessions.

Women's adherence to PA at the end of the second trimester, measurement of the PA level, measured by accelerometer, expressed in MET.minutes/week by wearing a tri-axial accelerometer on the hip, between 24 and 30 weeks of gestation

women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester, measurement of sedentary time (defined as a state of wakefulness characterized by an energy expenditure less than or equal to 1.5 METs) between getting up and going to bed using a tri-axial hip accelerometer, between 24 and 30 weeks of gestation|Women's participation at PA sessions, For women in groups B, C and D, rate of sessions completed on the number of eligible sessions according to their randomization group and the socio-demographic criteria, After 39 weeks of gestation, end of planned participation in sessions|Pregnancy and Postpartum Evolution of PA Time, PA time measured with a tri-axial accelerometer at the hip, at 4 distinct times: between 24+0d and 30+0d weeks of gestation, between 32+0d and 37+6d weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum|Evolution in sedentary behavior during pregnancy and postpartum, sedentary time (defined as wakefulness characterized by an energy expenditure less than or equal to 1.5 METs) between getting up and going to bed will be compared according to each intervention modality. Sedentary behavior will be measured by wearing a tri-axial accelerometer on the hip, at 4 distinct times: between 24 and 30 weeks of gestation, between 32+0day and 37+6day weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum|Women's perception of the determinants of their level of physical activity and sedentary behaviour, Qualitative study by means of semi-structured telephone interviews with a minimum of 100 women, i.e. a minimum of 25 women per group, a number to be adapted according to the data saturation that will be obtained, during the 31 days after at the inclusion in the study and between 35 and 39 weeks of gestation|Impact of physical activity on maternal antenatal morbidity, occurrence of maternal pathology during pregnancy (gestational arterial hypertension \[PAS ≥ 140 mm Hg and a PAD ≥ 90 mm Hg occurring after 20 weeks of gestation\] and/or, pre-eclampsia \[hypertension with albuminuria \> 0.3g/L per 24 hours\] and/or gestational diabetes diagnosed by orally induced hyperglycaemia after 23 SA), At delivery|Impact of sedentary behaviour on maternal antenatal morbidity, occurrence of maternal pathology during pregnancy (gestational arterial hypertension \[PAS ≥ 140 mm Hg and a PAD ≥ 90 mm Hg occurring after 20 weeks of gestation\] and/or, pre-eclampsia \[hypertension with albuminuria \> 0.3g/L per 24 hours\] and/or gestational diabetes diagnosed by orally induced hyperglycaemia after 23 SA), At delivery|Impact of physical activity on perpartum maternal morbidity, A composite criterion: "occurrence of 3rd or 4th degree perineal lesions and/or occurrence of immediate postpartum haemorrhage (blood loss \> 500mL in the 24 hours after delivery)", 24 hours after delivery|Impact of sedentary behaviour on perpartum maternal morbidity, A composite criterion: "occurrence of 3rd or 4th degree perineal lesions and/or occurrence of immediate postpartum haemorrhage (blood loss \> 500mL in the 24 hours after delivery)", 24 hours after delivery|Impact of physical activity on postpartum maternal morbidity, : presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11), 6 months postpartum|Impact of sedentary behaviour on postpartum maternal morbidity, : presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11), 6 months postpartum|Impact of physical activity on the experience of childbirth, Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE), 4 weeks postpartum|Impact of sedentary behaviour on the experience of childbirth, Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE), 4 weeks postpartum|Impact of physical activity on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy, Score obtained in the WHOQOL-Bref questionnaire, between 24 and 30 weeks of gestation|Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy, Score obtained in the WHOQOL-Bref questionnaire, between 24 and 30 weeks of gestation|Impact of physical activity on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy, Score obtained in the WHOQOL-Bref questionnaire, between 32 and 37 SA+6day weeks of gestation|Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy, Score obtained in the WHOQOL-Bref questionnaire, between 32 and 37 SA+6day weeks of gestation|Impact of physical activity on the quality of life of pregnant women at 2 months postpartum, Score obtained from the WHOQOL-Bref questionnaire, between 6 and 10 weeks postpartum|Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum, Score obtained from the WHOQOL-Bref questionnaire, between 6 and 10 weeks postpartum|Impact of physical activity on the quality of life of pregnant women at 6 months postpartum, Score obtained from the WHOQOL-Bref questionnaire, between 20 and 24 weeks postpartum|Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum, Score obtained from the WHOQOL-Bref questionnaire, between 20 and 24 weeks postpartum|Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy, ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, between 24 and 30 weeks of gestation|Impact of sedentary behaviour on the occurrence of urinary incontinence in the 2nd trimester of pregnancy, ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, between 24 and 30 weeks of gestation|Impact of physical activity on the occurrence of urinary incontinence in the 3rd trimester of pregnancy, ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, between 32 and 37 SA+6day weeks of gestation|Impact of sedentary behaviour on the occurrence of urinary incontinence in the 3rd trimester of pregnancy, ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, between 32 and 37 SA+6day weeks of gestation|Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum, Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, between 20 and 24 weeks postpartum|Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum, Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, between 20 and 24 weeks postpartum|Impact of physical activity on sexual quality of life, Score on the FSFI Female Sexual Function Index questionnaire, between 20 and 24 weeks postpartum|Impact of sedentary behaviour on sexual quality of life, Score on the FSFI Female Sexual Function Index questionnaire, between 20 and 24 weeks postpartum|Impact of physical activity on early neonatal morbidity, a composite criterion: "Apgar score \<7 at 5 min and/or arterial pH \<7.10 and/or transfer and/or intra-hospital transfer to a neonatal unit", At delivery|Impact of sedentary behaviour on early neonatal morbidity, a composite criterion: "Apgar score \<7 at 5 min and/or arterial pH \<7.10 and/or transfer and/or intra-hospital transfer to a neonatal unit", At delivery|Impact of physical activity on the newborn's birth weight, occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves), At delivery|Impact of sedentary behaviour on the newborn's birth weight, occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves), At delivery|Cost-effectiveness analysis from the point of view of health insurance of the proposed intervention methods, Cost-effectiveness incremental study (including modelling of the gains linked to the reduction in C-section), Data collected during the pregnancy and until 2 month of post-partum|cost-utility study analysis from the point of view of health insurance of the proposed intervention methods, Cost-utility study (based on the usefulness felt by women) from the point of view of health insurance using the EQ5D-5L (5 Level Euroqol 5 Dimensions) and a mapping analysis of the WHOQOL-Bref, Data collected during the pregnancy and until 6 month of post-partum

University Hospital, Clermont-Ferrand

Réseau de Santé en Périnatalité d'Auvergne|ASM Omnisports - Pôle Sport-Santé|Office Municipal du Sport - Espace Sport Santé|Observatoire national de l'activité physique et de la sédentarité|Ville de Clermont-Ferrand|Ministère de la Santé et de la Prévention

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH

2024-09

2027-10

2027-10

2024-09-05

2024-09-05

CHU de Clermont-Ferrand, Clermont-Ferrand, 63000, France

NCT06585072

Pancreatic Cancer and Diabetes Mellitus

https://clinicaltrials.gov/study/NCT06585072

NOT_YET_RECRUITING

The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are: 1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same? 2. Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition. The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.

NO

Pancreatic Cancer|Surgery|Diabetes Mellitus

Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus), The diagnosis of glucose disorders should be made applying criteria of the American Diabetes Association., From enrollment to five years after the end of the surgery

Overall Survival, From enrollment to five years after the end of the surgery|Disease-Free Survival, From enrollment to five years after the end of the surgery

Shanghai Changzheng Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2024-09-03

2026-09-01

2026-09-01

2024-09-05

2024-09-05

NCT06585059

Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers

https://clinicaltrials.gov/study/NCT06585059

NOT_YET_RECRUITING

This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).

NO

Advanced Non-small Cell Lung Cancer

DRUG: TQB2928 injection + Almonertinib Mesilate Tablets

Phase II recommended combination doses (RP2CD), The recommended dosage for drug combination therapy in the second phase of clinical trials (i.e. Phase II clinical trials)., Baseline up to 24 months|Objective Response Rate (ORR), Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria., Up to 2 years|Duration of Response (DOR), Defined as the time from first documented response to documented disease progression., Up to 2 years|Progression-free survival (PFS), Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause., Up to 2 years|Time to Progression, The time from randomization to obtaining the first objective relief., Up to 2 years

Elimination half-life (t1/2), The time required for plasma drug concentration to decrease by half., Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)|Area under the plasma concentration-time curve (AUC0-last), The area enclosed by the plasma concentration curve against the timeline., Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)|Apparent Plasma Clearance (CL), Apparent plasma clearance of TQB2928., Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)|Apparent volume of distribution(Vz), The ratio of the amount of TQB2928 in the body to the blood concentration., Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)|Steady-state trough concentration (Css-min), Minimum concentration during dosing., Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)|Immunogenicity: anti-drug antibody (ADA), Incidence of anti-drug antibody (ADA)., From the time of informed consent signed through 90 days after the last dose|Adverse Events (AE) rate, The occurrence and severity of all AEs., From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

2024-09

2025-12

2026-12

2024-09-05

2024-09-05

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

NCT06585046

The Risk Factors and Its Prognosis of Hyperglycemia Secondary to Pancreatic Surgery

https://clinicaltrials.gov/study/NCT06585046

COMPLETED

The goal of this observational study is to learn about post-pancreatic surgery diabetes mellitus(PCRD).The main questions it aims to answer are: 1. What are the clinical characteristics of PCRD? 2. What are the related factors for PCRD? All patients with pancreatic surgery have been given standardized treatment fot the condition. The researchers will summarize the risk factors for PCRD from the PCRD group.

NO

Pancreatic Surgey|Diabetes Mellitus

Incidence of glycaemic disorders（prevalence of diabetes） (postoperative fasting blood glucose/HbA1C), The main objective of this study was the incidence of glucose metabolism disorders in patients treated with pancreatic surgery in our centre., (within 5 years after surgery)

overall survival, within 5 years after surgery|Disease-Free Survival, within 5 years after surgery

Shanghai Changzheng Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2017-01-01

2024-08-01

2024-08-01

2024-09-05

2024-09-05

NCT06585033

Placebo Effect in Spinal Cord Electrical Stimulation for Pain

https://clinicaltrials.gov/study/NCT06585033

PISCES

NOT_YET_RECRUITING

Objective: To evaluate if spinal cord stimulation (SCS) performs better than placebo (no stimulation) in the long term to reduce persistent neuropathic leg pain refractory to medication and other conservative treatments in patients who have undergone lumbar spinal surgery. Study design: Multicenter, double blind, randomized, sham-controlled trial. After a positive SCS test trial, participants (18-70 years) will be implanted with a non-rechargeable SCS system providing active, subthreshold stimulation and followed for 12 months in a blinded cross-over design. The primary outcome measure is the difference in change in leg pain intensity scores using the Numeric Rating Scale (NRS) between a 3-month period with optimized subthreshold stimulation, and a 3-month period with no stimulation, as compared to baseline. Quality of life, physical functioning, sleep quality, return to work, and reduction in medication use will also be investigated. Background: Up to 20% of patients who have undergone lumbar spinal surgery experience persistent back/leg pain leading to long-term reduction in functionality and quality of life. SCS is an established and safe, minimally invasive treatment for these patients when no further surgery is indicated and conservative therapies have been found to be ineffective. Placebo-controlled studies, comparing active and sham stimulation, were lacking until recently as traditional SCS relied on the patient feeling the stimulation (paresthesia). Technological progress with development of paresthesia-free stimulation forms now allows for the execution of placebo-controlled studies. A recent trial showing no significant difference in long-term effectiveness between active SCS and sham suffers from significant methodological shortcomings. This necessitates further sham-controlled studies to determine the effectiveness of SCS.

NO

Chronic Postoperative Pain

Comparison between active subthreshold spinal cord stimulation and sham stimulation in reducing neuropathic leg pain, The difference in change in neuropathic leg pain intensity scores measured by the numeric rating scale (NRS) questionnaire between a 3-month period with subthreshold stimulation and a 3-month period with sham stimulation, as compared to baseline, Baseline and 3+3 months

Comparison between active subthreshold spinal cord stimulation and sham stimulation, Physical functioning measured using the Oswestry Disability Index (ODI) questionnaire, Baseline and 3, 6 and 12 months|Comparison between active subthreshold spinal cord stimulation and sham stimulation, • Quality of life measured using the EuroQoL-5D-5L (EQ-5D-5L) questionnaire, Baseline and 3, 6 and 12 months|Comparison between active subthreshold spinal cord stimulation and sham stimulation, Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire., Baseline and 3, 6 and 12 months|Comparison between active subthreshold spinal cord stimulation and sham stimulation, Medication use, Baseline and 3, 6 and 12 months|Comparison between active subthreshold spinal cord stimulation and sham stimulation, Number of hours worked per week, Baseline and 3, 6 and 12 months|Comparison between active subthreshold spinal cord stimulation and sham stimulation, The difference in change in neuropathic leg pain intensity scores measured by the numeric rating scale (NRS) questionnaire after patient has chosen preferred stimulation from the 6-month to the 12-month follow-up., Baseline and 12 months

Sahlgrenska University Hospital, Sweden

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2024-09-15

2026-08-31

2026-08-31

2024-09-05

2024-09-05

NCT06585020

Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection

https://clinicaltrials.gov/study/NCT06585020

AKAPI

NOT_YET_RECRUITING

Treatment of Mycobacterium xenopi (MX) lung disease is not-well- tolerated and concerned a growing number of patients, especially with chronic pulmonary diseases or immunosuppression. The outcome of these patients is poor, and treatment is very long. Indeed, this duration is based on the date of sputum conversion. Treatment should be continued until 12 months after sputum conversion. In the vast majority patients have converted after 6 months of treatment, so a 18 months duration in total. Unfortunately, few data are available for MX, as it is rare in USA, but it is the second NTM isolated in France and concerns an increasing number of patients. As it is uncommon in USA, no clinical studies conducted by the pharmaceutical laboratory will be planned. In a murine model of MX infection, the only drug which decreased the number colony formant units in mice lungs, was amikacin. Until now, amikacin was only available intravenously and used only for patients with very severe disease, because of renal and auditory toxicity. Amikacin liposome inhalation suspension (ARIKAYCE®) is amikacin sulfate encapsulated in liposomes for inhalational delivery. ARIKAYCE® increases amikacin uptake into alveolar macrophages, a refuge for NTM organisms; allows biofilm penetration; and limits systemic amikacin exposure ARIKAYCE® has already be tested in a randomized study on M. avium complex (MAC) refractory pulmonary infections. In this study, the culture conversion rate in the ARIKAYCE® group was higher than standard regimen group.

NO

Mycobacterium; Xenopi|Lung Diseases

variation of sputum conversion rate in ARIKAYCE® addition group compared to standard treatment, 3 months

variation of time to culture conversion between both groups, at 3 month|variation of mortality between both groups, at 12 months|variation of mortality between both groups, at 24 months

Centre Hospitalier Universitaire, Amiens

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

2024-10

2026-08

2027-08

2024-09-05

2024-09-05

NCT06585007

Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer

https://clinicaltrials.gov/study/NCT06585007

MEDCARE

RECRUITING

Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.

NO

Castration-resistant Prostate Cancer|Oligoprogressive

RADIATION: Radiotherapy|PROCEDURE: metastasectomy

Overall Survival, Overall Survival, will be calculated from the day of randomisation until death from any cause, wichever came first, assessed up to 5 years.

Quality of life scoring EORTC QLQ-C30, Quality of life scoring using the EORTC QLQ-C30, Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24|Quality of life scoring EORTC QLQ-PR25, Quality of life scoring using the EORTC QLQ-PR25, Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24|Quality of life scoring EQ-5D-5L, Quality of life scoring using the EQ-5D-5L., Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24|Cancer Specific Survival, Cancer Specific Survival, will be calculated from the day of randomisation until prostate cancer death, assessed up to 5 years.|Radiographic progression free survival, Radiographic progression free survival, will be calculated from the day of randomisation until the first day of progression (local, nodal or metastatic). Imaging is performed every 6 months during follow-up or at any time in case of PSA progression or symptoms, assessed up to 5 years.|Progression-directed therapy induced acute or late toxicity scoring, Acute and late toxicity as a result of radiotherapy will be scored using the Common Toxicity Criteria Version 5.0 and metastasectomy related toxicity will be scored using Clavien Dindo scoring system., Toxicity will be scored every follow-up visit, assessed up to 5 years after progression-directed therapy.

Universitaire Ziekenhuizen KU Leuven

MALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

2023-12-19

2029-01-20

2029-01-20

2024-09-05

2024-09-05

University Hospitals Leuven, Leuven, Belgium

NCT06584994

Investigating the Role of Genetics in Disease Predisposition

https://clinicaltrials.gov/study/NCT06584994

ENROLLING_BY_INVITATION

Gametogenesis is the production of sperm and eggs; it takes place through the process of meiosis. Gametogenesis is subject to the acquisition of mutations as with other processes in the body. Many of these mutations are somatic, meaning that they occur during life as part of the process of cell division rather than being passed down from parents. When somatic mutations take place during gametogenesis, there is the potential for hereditary genetic consequences. However, the processes that cause the mutations during gametogenesis and the implications they have for heritability and disease predisposition are poorly understood. The goal of this research is to provide a detailed description of the genetic changes in gonadal tissues, and to understand how mutations acquired during the production of germ cells (sperm and eggs) contribute to the predisposition to a wide range of rare diseases and cancer predisposition in future offspring.

NO

Predisposition, Genetic|Cancer|Mutation|Fertility Disorders

How often mutations accumulate in healthy reproductive tissues, Establish how often mutations (changes in DNA) accumulate in healthy reproductive tissues (testes and ovaries)., 7 years

Identification and Characterisation of Mutations, Determine the genetic changes in gonadal tissues, including the frequency, type, and nature of mutations acquired during germ cell production, and identify the genes and cellular processes that these mutations may alter., 7 years|Comparative Analysis of Mutation Rates, Compare mutation rates in gonadal tissues across different age groups, sexes, and individuals with or without cancer predisposition syndromes., 7 years|Inheritance and Transmission Risk, Assess the inheritance risk and rate of transmission of pathogenic mutations by analysing the proportion of germ cells carrying these mutations in affected individuals and comparing them to unaffected donors., 7 years

The Wellcome Sanger Institute

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2021-06-20

2027-03-01

2027-03-01

2024-09-05

2024-09-05