NCT Number,Study Title,Study URL,Acronym,Study Status,Brief Summary,Study Results,Conditions,Interventions,Primary Outcome Measures,Secondary Outcome Measures,Other Outcome Measures,Sponsor,Collaborators,Sex,Age,Phases,Enrollment,Funder Type,Study Type,Study Design,Start Date,Primary Completion Date,Completion Date,First Posted,Results First Posted,Last Update Posted,Locations,Study Documents
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",,60,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",,100,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",NA,60,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",,136,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",NA,80,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",PHASE3,554,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",,6000,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",NA,140,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,NA,156,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",PHASE2,44,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",NA,275,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",,100,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",,500,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",,500,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",NA,144,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,NA,10,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",,2121,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",PHASE3,100,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",PHASE1,30,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",PHASE1|PHASE2,18,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",,800,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",PHASE1,177,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,NA,101,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",PHASE1,80,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",PHASE1,54,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,NA,54,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",NA,50,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",PHASE3,369,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,,20,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",PHASE1,5,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",,46,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",,30,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",PHASE1|PHASE2,200,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","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/45/NCT06585345/Prot_000.pdf"
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",,70,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",PHASE2|PHASE3,36,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",NA,882,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",,50,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","Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/93/NCT06585293/SAP_000.pdf"
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",,200,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",,150,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",NA,50,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",PHASE4,100,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",,39,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",,100,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","Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/15/NCT06585215/SAP_000.pdf"
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,PHASE2,15,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",,304,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2010-02-01,2023-04-13,2023-04-13,2024-09-05,,2024-09-05,,"Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/89/NCT06585189/Prot_SAP_000.pdf"
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",,1600,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,PHASE1,8,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",PHASE2,240,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,NA,78,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",,150,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",NA,68,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",NA,84,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",NA,630,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",,150,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",PHASE1,20,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",,382,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",NA,50,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",PHASE2,190,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",PHASE3,246,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","Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/07/NCT06585007/ICF_000.pdf"
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",,1000,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2021-06-20,2027-03-01,2027-03-01,2024-09-05,,2024-09-05,,
NCT06584981,"Effect of PECS II, Parasternal and Serratus Plane Blocks on Postoperative Pain in MIDCAB Surgery",https://clinicaltrials.gov/study/NCT06584981,,NOT_YET_RECRUITING,"AIM: It was aimed to evaluate the effectiveness of pectoral nerve block (PECS II), parasternal and serratus plane blocks in postoperative analgesia in minimally invasive cardiac surgery (MIDCAB).

INTRODUCTION: The frequency of minimally invasive cardiac surgery has increased in recent years. With this method, Coronary artery bypass graft (CABG) operations can be performed without sternotomy. It is a beneficial method for early postoperative mobilization, early recovery and better aesthetic appearance. Since there is a surgical intervention between the ribs, pain control is important in these patients.

METHOD: In the preoperative evaluation of patients planned for CABG, PECS II, parasternal and serratus plane blocks are routinely recommended for postoperative pain control. Consent for the procedure is obtained from patients who accept this procedure. After induction and before the surgical incision, these block applications are performed under sterile conditions under the guidance of ultrasonography. Standard intravenous analgesic agents are applied to our patients who do not accept block applications. The hospital core system files of our patients who underwent cardiac surgery with minimally invasive intervention in our hospital between January 1, 2021 and December 31, 2021 will be scanned retrospectively. Patients with and without block application will be divided into two groups. From our patients' files; Demographic data, extubation time, drain site and incision site pain at the 1st, 2nd, 4th, 12th, 24th, 48th and 72nd hours after extubation will be noted. In addition, it will be noted whether there is a need for additional rescue analgesia in cases where block is performed. The data obtained will be evaluated statistically and the results will be published in national or international scientific journals.",NO,"Pain, Postoperative|Coronary Artery Disease","PROCEDURE: pectoral nerve block (PECS II), parasternal and serratus plane blocks|OTHER: analgesic","Analgesic efficiency, drain site and incision site pain at the 1st, 2nd, 4th, 12th, 24th, 48th and 72nd hours after extubation will be noted",,,Hisar Intercontinental Hospital,,ALL,"ADULT, OLDER_ADULT",NA,100,OTHER,INTERVENTIONAL,Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SCREENING,2024-09,2024-10,2024-10,2024-09-05,,2024-09-05,,
NCT06584968,Improving the Application Skill of the Semmes-Weinstein Monofilament Test,https://clinicaltrials.gov/study/NCT06584968,,NOT_YET_RECRUITING,"The Semmes-Weinstein Monofilament Test is one of the most widely used and objective clinical tests for assessing the sense of touch. Some guides include standard instructions for the application of the Semmes-Weinstein Monofilament Test. With monofilaments applied correctly by the instructions, patients' threshold values can be determined accurately. However, there are disagreements about the accuracy of the pressure applied by the therapist who applies the monofilament to the patient. The investigators aimed to compare the application of the Semmes-Weinstein Monofilament Test to undergraduate students of the occupational therapy department by teaching it using classical methods and visual feedback.",NO,Training|Students,OTHER: training with visual feedback|OTHER: classical learning,"Application duration of the Semmes-Weinstein Monofilament Test, The application duration of the Semmes-Weinstein Monofilament Test will be recorded in seconds., just before the intervention and just after completion of the intervention|The applied force of the Semmes-Weinstein Monofilament Test, The applied force of the Semmes-Weinstein Monofilament Test will be recorded in grams., just before the intervention and just after completion of the intervention|Intervals between the Semmes-Weinstein Monofilament Test applications, Intervals between the Semmes-Weinstein Monofilament Test applications will be recorded in seconds., just before the intervention and just after completion of the intervention",,,Hacettepe University,Çankırı Karatekin University,ALL,"CHILD, ADULT, OLDER_ADULT",NA,60,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER,2024-09-01,2024-10-30,2024-11-30,2024-09-05,,2024-09-05,"Hacettepe University, Ankara, Turkey",
NCT06584955,Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies,https://clinicaltrials.gov/study/NCT06584955,,NOT_YET_RECRUITING,The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.,NO,Hematological Malignancies,,"Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year",,,M.D. Anderson Cancer Center,,ALL,"ADULT, OLDER_ADULT",NA,20,OTHER,INTERVENTIONAL,Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE,2024-12-31,2025-07-31,2027-07-31,2024-09-05,,2024-09-05,,
NCT06584942,Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients with Cannabis Use Disorder (Pilot Study),https://clinicaltrials.gov/study/NCT06584942,,NOT_YET_RECRUITING,"The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis. Suvorexant is an FDA-approved medication to treat insomnia. We think that suvorexant may reduce activity in certain parts of the brain associated with cannabis use. We are studying if this medication does affect brain activity in these areas.

For this study, we will ask participants to complete four study visits over approximately 14 days. Each study visit will include interviews and questionnaires. All participants will be asked to take suvorexant, an FDA approved medication for treatment of insomnia, for 14 days. They will complete two one-hour functional Magnetic Resonance Imaging (fMRI) scans: one before starting the study medication and one after 14 days of taking the study medication. MRI is used in typical medical settings and is considered to be safe.",NO,Cue-reactivity|Cannabis Use Disorder|Functional MRI|Orexin Antagonist,,"Change in Insula Activation to Cannabis Cues During a Cue Reactivity Task Measured by fMRI (Time Frame: baseline, Day 14), This task will measure brain reactivity to cannabis vs. neutral images. A whole-brain fixed-effects general linear model (GLM) will be run using image regressors (cannabis, neutral images) and motion confound regressors. Beta maps comparing cannabis with neutral images will be created for each subject. Multiple comparisons will be FDR corrected. Beta weights for the cannabis image \&gt; neutral image contrasts will be extracted from the anterior insula across all voxels within each ROI., Baseline, Day 14",,,Massachusetts General Hospital,,ALL,ADULT,PHASE4,10,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE,2024-11-15,2025-10-31,2025-10-31,2024-09-05,,2024-09-05,,
NCT06584929,Rural Smoking Cessation,https://clinicaltrials.gov/study/NCT06584929,,NOT_YET_RECRUITING,"Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.",NO,Smoking Cessation,DRUG: Nicoderm CQ nicotine patch|DRUG: Nicorette Nicotine Lozenges,"Number of participants abstinent from all combustible tobacco products, Biochemically-confirmed 7-day abstinence from all combustible tobacco products at 3 months., 3 months","Cigarettes per day (CPD), Number of cigarettes smoked per day., 1 and 3 months",,"Masonic Cancer Center, University of Minnesota",,ALL,"ADULT, OLDER_ADULT",NA,272,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION,2024-12-01,2028-10-01,2029-08-31,2024-09-05,,2024-09-05,,
NCT06584916,A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN),https://clinicaltrials.gov/study/NCT06584916,,ENROLLING_BY_INVITATION,The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.,NO,Obesity|Overweight,DRUG: Orforglipron|DRUG: Placebo,"Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5, Week 52","Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment, Week 52|Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5, Week 52|Change from Baseline in Body Weight, Baseline, Week 52|Change from Baseline in Waist Circumference, Baseline, Week 52|Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5, Week 24",,Eli Lilly and Company,,ALL,"ADULT, OLDER_ADULT",PHASE3,480,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT",2024-09,2026-01,2026-01,2024-09-05,,2024-09-05,"General Surgery MIST Division Loc. 4, Bellaire, Texas, 77401, United States",
NCT06584903,Safe Indoor Temperature Limit for Fans,https://clinicaltrials.gov/study/NCT06584903,,COMPLETED,"Extreme heat events are a significant global threat to health and wellbeing, and result in more morbidity and mortality than all other natural disasters combined. Thus, a key priority is identifying effective and accessible heat resilience solutions to protect individuals from the potentially fatal consequences of heat stress. Within a range of ambient conditions, a fan has been recognized a low-cost heat resilience solution. However, when ambient temperatures exceed skin temperatures (e.g., above 35°C), a fan will incur greater dry heat gain which may be counterbalanced with evaporation of sweat from the skin surface. However, at a critical indoor temperature, the rate of heat gain will exceed the rate of evaporation resulting in net heat gain. The critical indoor temperature has yet to be determined. The purpose of this present study is to identify the indoor temperature at which a fan results in greater cardiovascular and thermal strain relative to still air in young adults using a simulated heat wave scenario of a warming room.",NO,To Determine At What Indoor Temperature a Fan Will Incur Greater Cardiovcascular and Thermal Strain Relative to Still,,"Rate Pressure Product, At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes|Core Temperature, Every minute for the 180 minute experimental trial|Whole-Body Sweat Rate, Net difference in body mass (pre versus post) using a balance scale placed below the chair of the participant, Assessed every 10 minutes of exposure up to 180 minutes.|Skin Temperature, Measured at 4 skin locations (chest, arm, thigh, and calf) using wireless iButtons affixed to the skin with surgical tape, Every minute for the 180 minute experimental trial|Blood Pressure, Measured with an electrocardiogram-gated automated cuff, At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes|Heart Rate, Measured with a 3-lead electrocardiogram, Every minute for the 180 minute experimental trial",,,Lakehead University,,ALL,ADULT,NA,10,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION,2024-01-20,2024-04-30,2024-04-30,2024-09-05,,2024-09-05,,
NCT06584890,Capabilities ofArtificial Intelligence Models in Externation Decision of Patient Who Followed in Intensive Care Unit (),https://clinicaltrials.gov/study/NCT06584890,ICU,NOT_YET_RECRUITING,"This clinical study aims to evaluate the effectiveness of General Artificial Intelligence (AI) models, specifically ChatGPT and Gemini, in assisting with the decision-making process for discharging patients from the Intensive Care Unit (ICU) to a general ward or home. The timing of ICU discharge is a critical decision that significantly impacts patient outcomes and the efficient use of ICU resources. This study seeks to determine whether AI models can accurately and efficiently predict the optimal time for patient discharge, supporting clinicians in making informed decisions.

The primary hypothesis is that AI models can improve the accuracy and speed of discharge decisions compared to traditional methods. The study will assess the agreement between the AI model predictions and the decisions made by ICU specialists. Additionally, the study will compare the performance of ChatGPT and Gemini AI models to identify which model offers the most reliable and timely discharge decisions.

By exploring the potential of AI in clinical decision-making, this research could contribute to the development of innovative tools for ICU management, ultimately enhancing patient care and optimizing ICU operations. The findings could lead to the integration of AI models into clinical decision support systems, facilitating more accurate and efficient patient management in the ICU.",NO,Artificial Intelegence,OTHER: decision,"accuracy, The primary outcome is the accuracy of the AI models (ChatGPT and Gemini) in predicting the optimal timing for ICU discharge. Accuracy will be measured by comparing the AI models\&#39; predictions with the actual decisions made by ICU specialists. This outcome will be quantified using statistical metrics such as sensitivity, specificity, and the area under the ROC curve (AUC)., 1 year","models comparison, The study will compare the performance of the two AI models, ChatGPT and Gemini, in predicting ICU discharge. This outcome will be assessed by evaluating the accuracy, agreement with clinical decisions, and time efficiency of each model., 1 year|utilzation, The effect of AI-assisted decision-making on ICU resource utilization, such as the length of stay and bed occupancy rates, will be evaluated. This outcome will assess whether AI-driven discharge decisions lead to more efficient use of ICU resources., 1 year",,Kanuni Sultan Suleyman Training and Research Hospital,,ALL,"ADULT, OLDER_ADULT",,398,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-09-15,2025-09-15,2025-09-30,2024-09-05,,2024-09-05,"Health Science University İstanbul Prof Dr Cemil Taşcıoğlu City Hospital, Istanbul, Küçükçekmece, 34303, Turkey",
NCT06584877,Investigating How Childhood Tumours and Congenital Disease Develop,https://clinicaltrials.gov/study/NCT06584877,,ENROLLING_BY_INVITATION,"Every cell and every organ in the human body derives from a fertilised egg. As the fertilised egg divides, a human being develops and grows. The process of how the fertilised egg divides and forms a human being is very sophisticated and is directed by the genetic information, the DNA, that is present in every cell.

When errors, mutations, in the DNA code arise, the orderly process of human development can be disrupted. This can lead to the development of tumours during childhood and congenital diseases (that is, abnormalities that children are born with).

The aim of this study is to define exactly which DNA errors underpin childhood tumours and congenital diseases.",NO,Childhood Tumor|Congenital Disorders,,"Description of the genetic mutations of each tumour and congenital anomaly., For each tumour a catalogue of mutations will be derived from sequencing reads. The catalogues will be compared across tumour types / anomalies to identify the mutations that drive individual tumour types / anomalies. The life history of each tumour / anomaly will be determined.

Methylation data will be analysed to derive a methylation profile for each tumour. The profiles of individual tumours will then be compared with each other to see whether tumour-type specific methylation profiles exist., 9.5 years",,,The Wellcome Sanger Institute,,ALL,"CHILD, ADULT, OLDER_ADULT",,600,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2017-02-02,2026-02-28,2026-02-28,2024-09-05,,2024-09-05,,
NCT06584864,Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children.,https://clinicaltrials.gov/study/NCT06584864,,RECRUITING,"The aim of the study is to assess the influence of ultrasound examination of the lumbar spinal canal on the effectiveness of lumbar puncture. An open-label, randomized interventional study.",NO,Meningitis|Pediatric Disorder,,"Obtaining cerebrospinal fluid after the first attempt at lumbar puncture, Obtaining cerebrospinal fluid after the first attempt at lumbar puncture (at least 0.5 ml in volume, with a red blood cell count of \<10,000/mm3)., 1 day","obtaining cerebrospinal fluid - < 10,000/mm3 - at any attempt, obtaining cerebrospinal fluid (volume min. 0.5 ml, with erythrocyte count \< 10,000/mm3) in subsequent puncture attempts, 1 day|obtaining cerebrospinal fluid - > 10,000/mm3 - at any attempt, obtaining bloody cerebrospinal fluid (volume min. 0.5 ml, with erythrocyte count \> 10,000/mm3), 1 day|total number of puncture attempts to obtain cerebrospinal fluid, total number of puncture attempts to obtain cerebrospinal fluid in each patient (next puncture will be understood as another puncture of the skin with a needle), 1 day|unsuccessful puncture - failure to obtain cerebrospinal fluid, total number of participants with unsuccessful puncture - failure to obtain cerebrospinal fluid, 1 day|duration of puncture, Mean duration of puncture for each patient Measured from the moment of puncturing the skin with the needle to the moment of obtaining cerebrospinal fluid or removal of the needle in the case of unsuccessful puncture.

Measured in seconds., 1 day|assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the experience of the physician performing the lumbar puncture, Difference in success rate depending on experience - measured by the number of punctures performed so far) puncture: 0-5 low experience, 6-15 medium experience, \>15 high experience., 1 day|assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the patient's BMI z-score, Difference in success rate depending onthe patient's BMI z-score, 1 day",,Medical University of Warsaw,,ALL,"CHILD, ADULT",NA,120,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC,2024-03-01,2025-03-01,2025-06-01,2024-09-05,,2024-09-05,,
NCT06584851,3D-Microscopic Muscle Architecture in Cerebral Palsy,https://clinicaltrials.gov/study/NCT06584851,3D-MMAP,RECRUITING,"The focus of this study is to understand and define the mechanisms of the altered muscle development and growth on a microscopic level within a long-term perspective in children with cerebral palsy and to relate these findings to muscle macroscopic properties defined by muscle imaging, to neuromuscular symptoms and to treatment.

This study aims to (1) evaluate intrinsic microscopic muscle properties of young growing children with CP, and (2) to evaluate these muscle properties in relation to macroscopic properties, neuromuscular symptoms and to treatment.

Improved understanding of changes in microscopic muscle properties, and how they relate to macroscopic properties and to the neuromuscular symptoms as well as how they are influenced by treatment, has the potential to delineate CP phenotypes prone to intervention and to optimize treatment protocols or develop new treatments, leading to new avenues for improving function in CP.

The method to study microscopic muscle properties involves analysis of muscle biopsies (histological / immunohistochemistry analysis, SC and IC culture, gene expression). Biopsies will be collected using the minimally invasive percutaneous needle microbiopsy technique, suitable for collecting repeated samples over time in the same individual while still leading to sufficient tissue of good quality for subsequent analysis1,2. For the children with CP, the local hospital's tradition of applying general anesthesia for delivering BTX injections will be exploited to collect the muscle samples prior to the BTX session and the one-year follow-up, or general anesthesia planned for orthopedic surgery or diagnostic imaging such as MRI, etc. For the collection of the samples 3 months before the BTX session, as well as 3 months and 6 months after BTX injections, the common approach for microbiospy collection will be applied, with local sedation on the skin (Rapydan©) and fascia (Xylocaine©) and local anesthesia by using Kalinox© (nitrous oxide in oxygen) under supervision of the University Hospital PROSA team. Biopsies of TD muscles will be collected in children with no history of neurological disorder, nor musculoskeletal problems at the level of the gastrocnemius or semitendinosus, at the time of upper limb orthopedic or trauma surgery and thus always under general anesthesia. Ultrasound guided percutaneous muscle biopsy has been performed in children (2 months-18 years)3,4 and has proven to be safe and well-tolerated. A pilot study (S61110) was conducted to confirm that the microbiopsy technique is suitable for the analysis of microscopic muscle properties and is well-tolerated in children with CP.

Two specific research goals are planned, with hypotheses emerging from literature.",NO,Spastic Cerebral Palsy,,"Muscle fiber size, Cross sectional area in µm of the fiber. Muscle fiber size will be assessed on cryosection stained with an antibody cocktail specific to laminin, myosin heavy chain (MHC)-I, MHC-IIA, MHC-IIB, MHC-embryonal and immunofluorescent detection will be done using appropriate secondary antibodies., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Muscle fibre type proportion, For each muscle, muscle fiber proportion will be assessed on cryosection stained with an antibody cocktail specific to laminin, myosin heavy chain (MHC)-I, MHC-IIA, MHC-IIB, MHC-embryonal and immunofluorescent detection will be done using appropriate secondary antibodies., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Capillary density, Capillaries /mm2 fiber and capillary to fiber ratio. Capillaries will be detected in-situ. Capillaries will be assessed using CD31 staining., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Satellite cell density, Number of satellite cells/mm2. Satellite cells will be detected in-situ. Co-localization of satellite cells will be assessed using Pax7 staining in conjunction with MHC-I/laminin, DAPI and CD31. Abundance of satellite cell content (Pax7+/DAPI+) will be counted and their association with the different fiber types will be identified., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Myogenic differentiation potential by means of fusion index for SC (satellite cells), SCs will be isolated by Fluorescence-Activated Cell Sorting (FACs) based on the presence of surface markers CD56.Behaviour of SCs will be analysed using a cell proliferation assay and a myogenic or adipogenic differentiation assay., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Myogenic differentiation potential by means of fusion index for MABs (mesoangioblasts), MABs will be isolated by Fluorescence-Activated Cell Sorting (FACs) based on the presence of surface markers ALP., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Overall change in muscle belly length of the medial gastrocnemius muscle and the semitendinosus muscle, Estimation of the muscle belly length by 3DfUS. Muscle volume will be normalized to anthropometric growth., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Overall change in muscle volume of the medial gastrocnemius muscle and the semitendinosus muscle, Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Overall changes in muscle activation patterns, Estimation of the muscle activation patterns using instrumented spasticity assessment., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline","Overall changes in collagen content, Estimation of the collagen content (µg/mg) collected from a micro biopsy from the medial gastrocnemius muscle and the semitendinosus muscle., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Overall change in muscle composition of the medial gastrocnemius muscle and the semitendinosus muscle by means of echo-intensity, Muscle composition can be indirectly estimated based on echo-intensity. Echo-intensity represents the gray scale of the ultrasonography image and can be related to the muscle content of contractile and non-contractile elements. The echo-intensity is extracted and expressed on an 8bit gray scale in arbitrary units (the tones of a grayscale image with a bit depth of 8 ranges from 0 (black) to 255 (white) and all the 254 shades of gray in between)., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline|Overall change in muscle tendon length of the medial gastrocnemius muscle and the semitendinosus muscle, Through a study participation of 1,2 years, depending on the trajectory: one evaluation moment at baseline (BTX injection), or 1 evaluation moment extra 1,2 years after baseline (combined with a second BTX injection), or 5 evaluations 3 months pre baseline, baseline, 3 months after baseline, 6 months after baseline and 1,2 years after baseline., Through a study participation of 1,2 years depending on the trajectory: 1 evaluation moment at baseline, 1 follow-up 1,2 years after, or 5 evaluations: 3 months pre, baseline, 3 months after, 6 months after and 1,2 years after baseline",,Universitaire Ziekenhuizen KU Leuven,,ALL,CHILD,,130,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2019-05-02,2028-12,2028-12,2024-09-05,,2024-09-05,"UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium",
NCT06584838,Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft,https://clinicaltrials.gov/study/NCT06584838,,NOT_YET_RECRUITING,The aim of this study is to investigate the differences in graft failure between patients that underwent ACL reconstruction using allograft tendons and patients that underwent ACL reconstruction using autograft tendons in patients older than 40 y.o. and after at least 2 years of follow-up. The hypothesis of the study is that there will be a difference in graft failure and patient reported functional outcomes between allograft and autograft ACL reconstruction.,NO,ACL|ACL Injury,,"To compare the difference in graft failure between allograft vs autograft ACL reconstruction, Clinical evaluation measuring the percentage in graft failure between allograft and autograft ACL reconstruction, from 2 years after surgical procedure","To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction, Clinical evaluation collecting Tegner Lysholm Score (max, 100 - min. 0) (100 = no disability; 0= maximum siability), from 2 years after surgical procedure|To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction, Clinical evaluation collecting the Visual Analogue Scale for Pain (VAS) (min.0 - max. 10) (0= no pain; 100 maximum pain), from 2 years after surgical procedure|To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction, Clinical evaluation collecting the International Knee Document Comitee Score (IKDC) (min. 0 - max. 100) (0= lowest level of function; 100= highest level of fuction), from 2 years after surgical procedure",,Università Vita-Salute San Raffaele,,ALL,"ADULT, OLDER_ADULT",,40,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-12,2025-01,2025-02,2024-09-05,,2024-09-05,,
NCT06584825,Enhanced Vitals Monitoring After Major Surgery Trial,https://clinicaltrials.gov/study/NCT06584825,,NOT_YET_RECRUITING,"The aim of this clinical trial is to examine the feasibility of an enhanced vital sign monitoring solution in-hospital and at-home. This study includes adult patients undergoing inpatient medium- to high-risk vascular or abdominal surgery. Researchers will compare the enhanced vitals monitoring group to the standard of care group to see if it may change post-operative management and outcomes. The primary question it aims to answer is if enhanced monitoring of surgical patient vitals can increase the number of days at home alive in the first 30 days after surgery. Participants in the intervention group will test two vitals monitoring devices, one in the hospital and one at home. They will also be asked to complete several questionnaires and a follow up phone call.",NO,Surgery|Post Operative Complications|Quality of Recovery|General Surgery|Vascular Surgery|Urology|Gynecology,,"Days Alive At Home (DAH30), Number of days within 30 days of surgery when participants are alive and at home, without visiting an emergency department or urgent care centre or being admitted to a hospital. Home refers to their own home, or a residence of a relative, friend or acquaintance, but excludes a nursing home or a rehabilitation facility.

If a participant visits an emergency department or urgent care centre, or is admitted to a hospital any time between midnight and 23:59 on a given day, they will lose that day as a day alive at home. If they remain in the care facility past midnight into the next day, then they lose 2 days alive at home. They will continue to lose days alive at home until the day in which they are home from midnight for an entire day. In other words, a day alive at home can be counted only when participants spend an entire day from midnight to 23:59 at home, without being stay at an emergency department, an urgent-care centre or a hospital., Within 30 days after surgery, with the day of surgery as day 0","Major Morbidity, Complications associated with 30-day mortality: major bleeding, myocardial injury after noncardiac surgery (includes myocardial infarction), myocardial infarction (3rd Universal Definition), sepsis, infection without sepsis, acute kidney injury with new dialysis, stroke, venous thromboembolism and congestive heart failure) within 30 days postoperatively, Within 30 days after surgery, with the day of surgery as day 0|Mortality, All cause mortality within 30 days of surgery, Within 30 days after surgery, with the day of surgery as day 0|Emergency Department visit(s) after discharge, This outcome describes if a participant visited an emergency department after discharge within 30 days of surgery, and if so, a count of how many times., Within 30 days after surgery, with the day of surgery as day 0|Readmission(s), This outcome describes if a participant was readmitted to hospital after initial discharge from hospital within 30 days of surgery, and if so, for how long and how many times., Within 30 days after surgery, with the day of surgery as day 0|Urgent walk-in clinic visit(s), This outcome describes if a participant visited an urgent walk-in clinic after discharge within 30 days of surgery, and if so, a count of how many times., Within 30 days after surgery, with the day of surgery as day 0|Family doctor clinic visit(s), This outcome describes if a participant visited a family doctor clinic after discharge within 30 days of surgery, and if so, a count of how many times. This will include details of planned (for suture/staple removal, or other reason) vs. unplanned, Within 30 days after surgery, with the day of surgery as day 0|Surgeon clinic contact(s), This outcome describes if a participant visited their surgeon after discharge within 30 days of surgery, and if so, a count of how many times. This will also include details of whether it was a planned (for suture/staple removal, or other reason) vs. unplanned visit and an email, phone call or clinic visit., Within 30 days after surgery, with the day of surgery as day 0|Post-Operative Length of Stay, The amount of time a patient is in hospital after their operation., The time from the date of the surgery to the date of discharge from the hospital, up to 30 days after surgery|Quality of Recovery at 10 days postoperatively, Measured using the Quality of Recovery-15 (QoR-15) score. QoR-15 scale is a validated tool to assess the quality of postoperative recovery. It consists of 15 likert questions in two parts.

Part A consists of 10 questions asking a patient how they have been feeling in the previous 24 hours with regards to factors such as sleeping and eating. Responses are given on an 11 point likert scale from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\].

Part B consists of five questions which ask the patient if they have experienced specific adverse events (for example, pain, nausea/vomiting or anxiety). Responses are given on an 11 point likert scale from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\].

This questionnaire is administered either over the phone, online or on paper., 10 days after surgery|Quality of Recovery at 30 days postoperatively, Measured using the Quality of Recovery-15 (QoR-15) score. QoR-15 scale is a validated tool to assess the quality of postoperative recovery. It consists of 15 likert questions in two parts.

Part A consists of 10 questions asking a patient how they have been feeling in the previous 24 hours with regards to factors such as sleeping and eating. Responses are given on an 11 point likert scale from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\].

Part B consists of five questions which ask the patient if they have experienced specific adverse events (for example, pain, nausea/vomiting or anxiety). Responses are given on an 11 point likert scale from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\].

This questionnaire is administered either over the phone, online or on paper., 30 days after surgery with the day of surgery as day 0","Completion of the intervention, The primary feasibility outcome is defined as more than 80% of participants completing the monitoring protocol, with a priori definition of the completion being monitoring in-hospital and at home each for 3 times a day for 3 days (or the duration of the hospital stay, whichever is shorter)., 30 days after surgery with the day of surgery as day 0|Participant Recruitment Rate, The proportion of patients recruited who provided consent out of all meeting the clinical inclusion criteria, Preoperatively, at the time of recruitment, up to 1 month prior to surgery.|Participant Exclusion Rate, The proportion of patients excluded out of all patients screened, Preoperatively, at the time of screening and recruitment, up to 1 month prior to surgery.|Participant Withdrawal Rate, The proportion of patients who withdrew from the study out of all enrolled patients., Preoperatively, at the time of recruitment, up to 30 days post-operatively|Participant patterns of use of monitoring devices, How frequently did patients use the monitoring devices and for what duration. This will be based on data collected from the devices., Up to 30 days after surgery, with the day of surgery as day 0|Device issues encountered, Issues that participants reported encountering with the monitoring devices. Reported as an open ended question in the patient daily log sheet, Up to 30 days after surgery, with the day of surgery as day 0|Reasons for device removal, What were the reasons that patients took the monitors on and off (e.g. charging/battery life, showers, eating, mobilization/physiotherapy) as reported as an open ended question in the patient daily log sheet, Up to 30 days after surgery, with the day of surgery as day 0|Interruptions in vitals monitoring, Description of instances of interruption in monitoring that were more than 4 hours, Up to 30 days after surgery, with the day of surgery as day 0|In-Hospital Enhanced Monitoring Device System Usability Scale, Patient feedback about enhanced monitoring device usability of the in-hospital enhanced monitoring device. The System Usability Scale (SUS) is a patient-reported measurement which includes ten 5-point likert scale questions from 1 to 5, with one being strongly disagree and 5 being strongly agree. The suitability of using SUS for evaluating medical devices has been well established., At the time of discharge from hospital, from 2 to 30 days postoperatively|At-Home Enhanced Monitoring Device System Usability Scale, Patient feedback about enhanced monitoring device usability of the in-hospital enhanced monitoring device. The System Usability Scale (SUS) is a patient-reported measurement which includes ten 5-point likert scale questions from 1 to 5, with one being strongly disagree and 5 being strongly agree. The suitability of using SUS for evaluating medical devices has been well established., 30 days after surgery, with the day of surgery as day 0|Care escalation frequency, The frequency of vital sign derangements detected by enhanced monitoring and the resulting care escalation categorized by type of vital measure within the duration of monitoring. This will be determined based on data from the devices and as reported by the patients nurse., Up to 30 days after surgery, with the day of surgery as day 0|Response time, Time between vital sign alert and care escalation. This will be determined based on data from the devices and as reported by the patients nurse.

xii. logistics of device use (time spent on education, initiation, discontinuation, cleaning, collection, and troubleshooting of devices) xiii. issues that arise in the workflow, Up to 30 days after surgery, with the day of surgery as day 0|Logistics of Enhanced Monitoring Implementation, Description of the logistics of implementing the intervention. This includes a description of time spent on education, initiation, discontinuation, cleaning, collection, and troubleshooting of the devices by the study coordinator., Up to 30 days after surgery, with the day of surgery as day 0|Workflow Issues, A qualitative description of issues that arise in the workflow of implementing the intervention., Up to 30 days after surgery, with the day of surgery as day 0|Adverse Events, Any patient-reported adverse events, Up to 30 days after surgery, with the day of surgery as day 0|Patient Feedback, An evaluation of potential harm or safety issues gathered from a feedback questionnaire filled out by the participant at the end of the enhanced monitoring period. The Feedback questionnaire uses a 5 point likert scale (1-5), where 1 = Strongly disagree...3 = Neutral...5 = Strongly agree. The questionnaire asks patients to rate how they feel about the following statements:

i. Their ability to move around after surgery ii. Their daily activities (e.g. going to the bathroom, eating, showering) iii. Making them anxious about your health? There is also one open ended question for participants to add any other feedback they have related to enhanced monitoring, 30 days after surgery, with the day of surgery as day 0|Study Costs, Overall study costs spent and difference of costs between intervention group and standard care group, Pre-study and up to time of publication|Questionnaire Completion, Completion rates of all questionnaires administered, From time of enrollment to 30 days after surgery with the day of surgery as day 0|Method of Questionnaire Completion, Number of participants that completed questionnaires over the phone, online or on paper., From time of enrollment to 30 days after surgery with the day of surgery as day 0|Support needed for questionnaires, Number of participants that required either caregiver or family member or technical support to complete questionnaires., From time of enrollment to 30 days after surgery with the day of surgery as day 0",University of British Columbia,,ALL,"ADULT, OLDER_ADULT",NA,110,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER,2024-09-03,2025-02-28,2025-03-31,2024-09-05,,2024-09-05,,
NCT06584812,"Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects",https://clinicaltrials.gov/study/NCT06584812,,NOT_YET_RECRUITING,"This study is designed to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel.",NO,Acute Coronary Syndrome|Ischemic Stroke,DRUG: Tiprogrel|DRUG: Tiprogrel|DRUG: Clopidogrel|DRUG: Ticagrelor,"PK parameters： Cmax, Maximum Concentration of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： Cmax, Maximum Concentration of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： AUC, Area under the plasma concentration curve of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： AUC, Area under the plasma concentration curve of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： Tmax, Time to maximum concentration of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： Tmax, Time to maximum concentration of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： T1/2, Half life of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： T1/2, Half life of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Tiprogrel, ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation, Day 1 to Day 14 in each period|PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Clopidogrel, ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation, Day 1 to Day 14 in each period|PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Ticagrelor, ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation, Day 1 to Day 14 in each period|Safety parameters: Number of Participants With Treatment-Related Adverse Events, Day 1 to Day 14 in each period",,,"Tianjin Institute of Pharmaceutical Research Co., Ltd",,ALL,ADULT,PHASE1,14,OTHER_GOV,INTERVENTIONAL,Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE,2024-09-10,2025-01-30,2025-05-01,2024-09-05,,2024-09-05,"Beijing Tiantan Hosptial, Capital Medical University, Beijing, China",
NCT06584799,Venoactive Drug Treatment of Pelvic Venous Disorders,https://clinicaltrials.gov/study/NCT06584799,VENOTREAT,RECRUITING,"Venoactive drug (VAD) therapy is one of the most effective methods of treating chronic venous diseases (CVD). Numerous studies have proven its high efficacy in relieving symptoms of CVD, such as leg pain and swelling, leg heaviness and fatigue. Pelvic venous disorders (PeVDs) represent a group of pathological conditions including varicose veins of the pelvis and vulva, and compression stenoses of the left renal and common iliac veins. Although PeVDs are associated with venous lesions of the pelvis and retroperitoneum and have specific clinical manifestations, they are one of the forms of CVD and constitute a separate cohort. A number of studies on the VAD usage in PeVD indicate the wide possibilities of this type of treatment in eliminating chronic pelvic pain (CPP), the most dramatic symptom of PeVD, which is the main cause of disability and decreased quality of life, social and daily activity in women with PeVD. Currently, a variety of VADs are presented on the pharmaceutical market, which, according to the product labels, provide effects not only on the venous outflow from the lower extremities, but also on venous hemodynamics in the pelvis. At the same time, a literature analysis shows that micronized purified flavonoid fraction (MPFF) has the greatest evidence base obtained in the efficacy and safety studies of VADs in PeVD. Nevertheless, patients are rarely interested in the scientific dossier of drugs, and in the real practice the patients with PeVD and CPP most often ask: ""What is the best drug to use for the CPP relief?"" This is quite understandable, as it is CPP in PeVD that results not only in disability, but also in family conflicts, psycho-emotional stress and depressive states. In this regard, patients seek to get rid of pain as soon as possible and strive to use the most effective drug. An extensive scientific base of comparative studies on the use of various VADs in patients with CVD and PeVD has been accumulated to date. However, the literature is lack of any data on the comparative efficacy and safety of VADs in the treatment of patients with PeVD. This, in turn, makes not possible for doctors and patients to choose the optimal and most effective drug based on the objective research data. All the above has predetermined the purpose of the planned study as evaluating the efficacy and safety of different VADs in the treatment of female patients with PeVD.",NO,Pelvic Venous Disorders,DRUG: diosmin-containing venoactive drug,"Severety of the chronic pelvic pain, Evaluation of the efficacy of venoactive drug treatment on chronic pelvic pain by using visual analogue scale, Every weekly until 8 weeks according to a visual analogue scale from 0 to 10 points, 10 points is the worst result","Side and adverse effects, Assessment of the frequency and type of of side and adverse effects of venoactive drug therapy, during the treatment until 8 weeks",,Pirogov Russian National Research Medical University,,FEMALE,ADULT,PHASE3,150,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,2024-09,2025-01,2025-02,2024-09-05,,2024-09-05,"Pirogov Russian National Research Medical University, Moskva, 117513, Russian Federation","Study Protocol and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/99/NCT06584799/Prot_ICF_000.pdf"
NCT06584786,Therapeutic Effects of Jing Si Herbal Tea for COPD,https://clinicaltrials.gov/study/NCT06584786,,RECRUITING,"Chronic obstructive pulmonary disease (COPD), a leading cause of global mortality, significantly impairs health-related quality of life (HRQL). COPD is characterized by airway inflammation and lung tissue damage. Jing Si herbal tea (JSHT) is known to have anti-inflammatory effects but has not been explored for treating COPD. This study investigated the potential of JSHT as an adjuvant therapy for COPD. This randomized controlled study focused on patients with COPD in the exacerbation and stable phases. The control group received the standard treatment, and the JSHT group received the standard treatment plus JSHT. Both groups underwent HRQL assessments, blood tests, and cellular studies involving five different groups to assess the effect of JSHT on damage-associated molecular patterns (DAMPs) and inflammatory markers.",NO,Airway Disease,COMBINATION_PRODUCT: Jing Si herbal tea (JSHT)|OTHER: Placebo,"COPD Assessment Test (CAT), The Taiwan Society of Pulmonary and Critical Care Medicine offers the Chinese version of the COPD Assessment Test (CAT) on the website (http://tspccm.org.tw). This test consists of eight items designed to evaluate COPD symptoms. These symptoms include cough, phlegm production, chest tightness, breathlessness, limitations in daily activities, confidence in leaving the house, sleep disturbances, and energy levels. Each symptom is rated on a scale from 0 to 5, culminating in a total CAT score ranging from 0 to 40. A higher score reflects more severe COPD symptoms. A score of 10 or higher is indicative of a significant symptom burden., Assess at baseline and three months of treatment|Modified Medical Research Council (mMRC), The Modified Medical Research Council (mMRC) scale was used to evaluate dyspnea. This scale, comprising a 5-point grading system ranging from 0 to 4, measures dyspnea severity. A score of 0 indicates dyspnea only during intense exercise, while a sore of 4 represents breathlessness at rest., Assess at baseline and three months of treatment|Brief Symptom Rating Scale (BSRS-5), The 5-item Brief Symptom Rating Scale (BSRS-5) was used to assess psychological distress. It consists of five items: feeling tense, being easily angered, feeling depressed, feeling inferior to others, difficulty with sleep, and suicidal thoughts. The scale is a 5-point scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptoms., Assess at baseline and three months of treatment",,,"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation",,ALL,"ADULT, OLDER_ADULT",EARLY_PHASE1,120,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT,2022-01-01,2024-12-31,2024-12-31,2024-09-05,,2024-09-05,"Taipei Tzu Chi Hospital, New Taipei City, Xindan, 23142, Taiwan","Study Protocol, https://cdn.clinicaltrials.gov/large-docs/86/NCT06584786/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/86/NCT06584786/SAP_001.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/86/NCT06584786/ICF_002.pdf"
NCT06584773,Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients,https://clinicaltrials.gov/study/NCT06584773,QIS,RECRUITING,"In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.",NO,Disorder Related to Renal Transplantation,DRUG: Everolimus|DRUG: standard maintenance immunosuppression,"Occurrence of acute rejection and/or positive viremia for CMV, First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients., From enrollment to the end of treatment at 52 weeks",,,University of Sao Paulo General Hospital,Carlucci G Ventura|Daniel R Salomon|Fabiana Agena|Flavio J de Paula|Francine B Lemos|Gislene Bezerra|Helcio Rodrigues|Maria da Luz Fernandes|Nelson Zocoler Galante|Noemia B de Lima|Paschoalina Romano|Patricia S Souza|Vivian Onuchic|Elias David Neto,ALL,ADULT,PHASE4,80,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,2015-06,2024-08,2025-07,2024-09-05,,2024-09-05,"Renal Transplantation Service, Sao Paulo, 05403-900, Brazil",
NCT06584760,Research on the Impact of Chronic Pelvic Pain on Endometriosis,https://clinicaltrials.gov/study/NCT06584760,,NOT_YET_RECRUITING,"Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. It is closely related to gynecological diseases such as endometriosis (EMs), adenomyosis, pelvic inflammatory disease (PID), uterine leiomyoma, residual ovarian syndrome, pelvic venous congestion syndrome (PCS), etc. But its pathophysiology is very complex and still needs further exploration. Recent studies have shown that central sensitization is an important mechanism for the sustained existence of CPP.

Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as preoperative endometriosis related questionnaire surveys such as such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as in vitro detection results such as preoperative venous blood, intraoperative pathological tissue immunohistochemistry, ELISA, transcriptome sequencing in patients with endometriosis.",NO,Chronic Pelvic Pain|Endometriosis,,"Chronic pelvic pain, Using Simplified McGill Pain Questionnaire (SF-MPQ) for scoring, Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)|In vitro detection results, The results of immunohistochemistry, ELISA, and transcriptome sequencing of preoperative venous blood and endometrial tissue excised during surgery in patients with endometriosis, Venous blood within 3 days before surgery; Endometriosis sample excised during surgery",,,The Fourth Affiliated Hospital of Zhejiang University School of Medicine,,FEMALE,ADULT,,60,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-09,2027-09,2027-09,2024-09-05,,2024-09-05,"The Fourth Affiliated Hospital of Zhejiang University School of Medicine, No. N1, Shopping Mall Avenue, Yiwu, Zhejiang, 322000, China",
NCT06584747,Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy,https://clinicaltrials.gov/study/NCT06584747,DIAMOX-TEP,NOT_YET_RECRUITING,This study compares two methods for assessing brain blood flow. PET scan will be use with a drug called Acetazolamide and compare its effectiveness to the standard scintigraphy method. The goal is to see if the PET scan is just as good as the traditional method in measuring how well the brain's blood vessels respond to the drug.,NO,Cerebrovascular Circulation,DIAGNOSTIC_TEST: PET scan,"diagnostic performance of the 18F-FDG PET, The primary endpoint is the sensitivity of the examination in detecting a decrease in cerebral vascular reserve (CVR). The presence or absence of a decrease in CVR for each patient will be determined by clinical consensus, based in particular on spontaneous follow-up (clinical progression, cerebral ischemic episodes, etc.) and/or on the progression after revascularization in cases where it is performed., 12 months","contribution of late 18F-FDG PET metabolic information, To study the contribution of late 18F-FDG PET metabolic information: Late 18F-FDG PET metabolic images will be analyzed using Scenium® software, which enables stereotaxic normalization and the expression of uptake in terms of standard deviations relative to a database of normal subjects. The corresponding values will be compared based on the clinical progression of patients after revascularization., 12 months",,Centre Antoine Lacassagne,,ALL,"ADULT, OLDER_ADULT",NA,22,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC,2024-10,2026-10,2026-10,2024-09-05,,2024-09-05,"Centre Antoine Lacassagne, Nice, 06000, France",
NCT06584734,Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients,https://clinicaltrials.gov/study/NCT06584734,EXE-HDF,ACTIVE_NOT_RECRUITING,"Introduction: Cardiovascular diseases are the leading cause of morbidity and mortality in hemodialysis patients, primarily due to structural cardiac changes that lead to diastolic dysfunction. Furthermore, this population has a high prevalence of sedentary behavior and increased mortality associated with it. Recent studies have implemented exercise regimens in the chronic kidney disease population, demonstrating improvements in various parameters related to cardiovascular disease.

Objectives: To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function.

Materials and Methods: This is a quasi-experimental study (before-and-after type) that will be conducted in two phases. In the first phase (rest), both incident and prevalent hemodialysis patients will receive treatment for 3 months. A baseline echocardiogram will be performed and then repeated at the end of the first phase to determine left ventricular diastolic function parameters. The second phase of the study (intradialytic exercise) will take place during the following 3 months, with an echocardiogram performed at the beginning and end of this phase. Systematic, prescribed, and supervised intradialytic aerobic exercise (intradialytic pedaling) will be implemented. Additionally, a 6-minute walk test and a validated physical activity questionnaire will be administered monthly during both phases of the study.",NO,Renal Dialysis|Hemodiafiltration|Diastolic Dysfunction|Kidney Failure|Resistance Training|Quality of Life,OTHER: Not exercise|OTHER: Exercise during hemodiafiltration session,"Evaluation of diastolic dysfunction, Diastolic function will be assessed following the 2016 guidelines from the American and European Societies of Echocardiography. The study will be performed by certified cardiologists using a Vivid Q GE ultrasound machine with a 3.5 MHz transducer. Key measurements include early (E wave) and late (A wave) transmitral flow velocities, E/A ratio, and tissue Doppler imaging (TDI) to determine septal and lateral e' waves. The E/e' ratio will be calculated. Left atrial (LA) volume will be measured and indexed to body surface area. Tricuspid regurgitation (TR) velocity will be assessed using continuous Doppler. Based on these parameters, diastolic dysfunction will be classified into grades 1, 2, 3, or indeterminate, according to current guidelines, considering whether the ejection fraction (EF) is reduced or preserved. The determination of left atrial strain will be performed using tissue Doppler imaging in an apical 4-chamber view with the speckle tracking method., Basal measure (Previous exercise), 3 months after withdrawn of previous exercise during dialysis, 3 months after structured exercise during dialysis","6 minute walk test, The test will be performed on the first day of the hemodialysis session (Monday or Tuesday) before the dialysis session, with a frequency of every 4 weeks. The test will be conducted based on the guidelines of the American and European Thoracic Societies by two medical interns, who are trained to perform the test, Basal measure (Previous exercise), 3 months after withdrawn exercise, 3 months after structured exercise|VO2 max, Cardiopulmonary exercise test with cycle ergometer will be made by a specialized sports physician to the patients to asses training zones, in this test we will measure any improvement on VO2max (ml/min/kg), 3 months after withdrawn of previous exercise, 3 months after structures exercise",,Instituto Nacional de Cardiologia Ignacio Chavez,,ALL,"ADULT, OLDER_ADULT",NA,41,OTHER,INTERVENTIONAL,Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT,2023-09-17,2024-09-30,2024-10-30,2024-09-05,,2024-09-05,"Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, 14080, Mexico",
NCT06584721,Short Foot Exercises and Anti-pronation Taping on Low Back Pain Associated With Hyper Pronation,https://clinicaltrials.gov/study/NCT06584721,,NOT_YET_RECRUITING,"The aim of this randomized clinical trial is to find the comparison of Short foot exercises and anti-pronation taping on low back pain associated with hyper pronation on reducing back pain improving range of motion of foot, back and foot posture.",NO,Low Back Pain,OTHER: Anti-pronation taping (Low dye taping) + Conventional therapy|OTHER: Short Foot Exercises + Conventional PT,"Range of motion (Goniometer), It is a tool used to measure the range of motion of joint (0-180). Record the starting measurement, remove the goniometer, and allow the patient to move the joint through the available range of motion. Replace and realign the goniometer. Read and record the measurement., 4 weeks|Numeric Pain Rating Scale NPRS, The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain., 4 weeks|Foot Posture Index, It is a tool which provides quantitative data about foot posture. It has total six items. Talar head palpation, observation of curves above and below the lateral malleolus, a bulge in the region of the talonavicular joint, eversion and inversion of the calcaneus, congruence of the medial longitudinal arch, adduction and abduction of the forefoot in relation to the rear foot. Total score between (- 12 and + 12). (0 and + 5 normal feet) ;( + 6 to + 9 pronated feet) ;( ≥ + 10 highly pronated feet) ;( - 1 to - 4 supinated feet); - 5 to - 12 indicate highly supinated., 4 weeks|Oswestry Disability Index, The ODQ scale was utilized to quantify the limitations in regular daily life activities. It depends on 10 segments with six levels each, evaluating the restriction of different activities of day to day living. The qualities range from 0 (the best wellbeing state) to 100 (the most worsening wellbeing state). For each segment of the poll, the absolute plausible score is 5., 4 weeks",,,Riphah International University,,ALL,ADULT,NA,40,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT,2024-08-27,2025-08-27,2025-08-27,2024-09-05,,2024-09-05,"Rawal Surgical Hospital, Nawababad, Wah Cantt, Wāh, Punjab, Pakistan",
NCT06584708,Effect of Low-Volume HIT vs. MIC Exercise in Individuals With Increased BMI,https://clinicaltrials.gov/study/NCT06584708,,RECRUITING,"To compare the effect of low volume high intensity training and moderate intensity continuous exercise on Rate Pressure Product (RPP) and functional capacity. Limited literature available on effectiveness of Low-volume HIIT in comparison of other Aerobic interventions in obese individuals. In our community, people are sedentary and not involved in routine exercise because of increased weight, so Low volume HIIT would be safe and convenient for such individuals to perform. There is also limited studies available on female gender so both genders are included in this study.",NO,Overweight and Obesity,OTHER: Low-volume high intensity interval training|OTHER: Moderate intensity continuous exercise,"Rate Pressure Product, Changes from baseline to 2 weeks and 4 weeks after the intervention, measured through product of heart rate and systolic blood pressure, is a very reliable indicator of myocardial oxygen demand. An RPP above 20,000 mmHg per minute is considered healthy, whereas anything below 16,000 mmHg is considered insufficient., 2 weeks, 4 weeks|Functional Capacity, Changes from baseline to 2 weeks and 4 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional/exercise capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support., 2 Weeks, 4 Weeks",,,Riphah International University,,ALL,ADULT,NA,36,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION,2024-02-15,2024-09,2024-09,2024-09-05,,2024-09-05,"Cantonment General Hospital, Saddar, Rawalpindi, Punjab, 46060, Pakistan",
NCT06584695,Analgesic Efficacy of External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy,https://clinicaltrials.gov/study/NCT06584695,,NOT_YET_RECRUITING,To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy.,NO,Analgesic Efficacy|External Oblique Intercostal Block|Subcostal Transversus Abdominis Plane Block|Open|Nephrectomy,DRUG: Transversus abdominis plane block|DRUG: External Oblique Intercostal Plane Block|DRUG: Control group,"Degree of pain, Degree of pain by Numerical rating scale (NRS)score. NRS (0 pain represents ""no pain"" while 10 pain represents ""the worst pain imaginable""). scores will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery, when the (NRS) was \> 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded., 24 hours after surgery","Mean arterial pressure, Mean arterial pressure will be recorded intraoperative till the end of surgery., Till the end of surgery (up to 2hours)|Heart rate, Heart rate will be recorded intraoperative till the end of surgery., Till the end of surgery (up to 2hours)|Opioids consumption, Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 pain represents ""no pain"" while 10 pain represents ""the worst pain imaginable""). when the (NRS) was \> 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded., 24 hours after surgery|Morphine consumption, When the numeric rating scale (NRS) was \>4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.

Each patient will be instructed about postoperative pain assessment with the NRS score. NRS (0 pain represents ""no pain"" while 10 pain represents ""the worst pain imaginable"").NRS will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery., 24 hours after surgery.|Time to rescue analgesia., Time to rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated., 24 hours after surgery|Incidence of complications, Incidence of complications will be recorded such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication, 24 hours after surgery",,Cairo University,,ALL,"ADULT, OLDER_ADULT",NA,63,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",2024-09-10,2025-02-01,2025-02-01,2024-09-05,,2024-09-05,"Cairo University, Cairo, 11796, Egypt",
NCT06584682,Effects of Sub Occipital Muscle Inhibition Technique on Hamstring Flexibility in Post-laminectomy Patients.,https://clinicaltrials.gov/study/NCT06584682,,RECRUITING,to find out the effects of sub-occipital muscle inhibition technique in combination with upper cervical spine exercises on hamstring muscle flexibility in post-laminectomy patients.,NO,Hamstring Tightness,OTHER: Sub-occipital muscle inhibition technique|OTHER: conventional therapy,"Active knee extension test, Patient is supine, unaffected limb on support surface and the examined limb elevated so that hip in 90 degree of flexion and knee to extended position perpendicular to ground. A lag of 20 degrees is considered normal from full extension, less than 20 degrees is considered as hamstring muscle tightness, two weeks|Numeric pain rating scale, The NPRS is a self-reported, or clinician administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form., two weeks|Modified Oswestry disability index, The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. There are 10 questions, for each question there is a possible 5 points; 0 for the first answer, 1 for the second answer, etc., two weeks",,,Riphah International University,,ALL,"ADULT, OLDER_ADULT",NA,44,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,2024-08-01,2024-12,2025-01,2024-09-05,,2024-09-05,"Health and wellness rehabilitation center, Swābi, KPK, Pakistan",
NCT06584669,Investigation of Krill Oil in Women with Premenstrual Syndrome,https://clinicaltrials.gov/study/NCT06584669,,COMPLETED,"In this study the effects of different dosages and preparations of krill oil in comparison to placebo on symptoms of premenstrual syndrome in healthy, female adults will be assessed.",NO,Premenstrual Syndrome,,"Measurement of reduction in premenstrual symptoms in the late luteal phase, Reduction in premenstrual symptoms in the late luteal phase, as measured by the Daily Record of Severity of Problems (DRSP), following supplementation with 2 g krill oil compared to placebo. All other products are assessed as secondary outcomes., Daily from baseline to study completion, up to 6 months","Measurement of total DRSP score in mid follicular phase, Measures the overall severity of symptoms using the Daily Rating of Severity of Problems (DRSP) scale during the mid-follicular phase. It combines daily ratings to reflect symptom intensity for this specific phase., Daily from baseline to study completion, up to 6 months|Measurement of physical Items Subscore, The Physical Items Subscore assesses the severity and frequency of physical symptoms experienced by participants, such as fatigue, headaches, and muscle pain. These symptoms are evaluated daily using a standardized scale, where each symptom is rated based on intensity and impact on daily functioning. The scores in scale points are combined to create a subscore representing the overall physical symptom burden., Daily from baseline to study completion, for up to 6 months|Measurement of mood Items Subscore, This subscore assesses the severity of mood-related symptoms, such as anxiety and irritability, rated daily on a standardized scale. Scores in scale points reflect the overall emotional symptom burden., Daily from baseline to study completion, up to 6 months|Measurement of physical Items Subscore, The Physical Items Subscore assesses the severity and frequency of physical symptoms experienced by participants, such as fatigue, headaches, and muscle pain. These symptoms are evaluated daily using a standardized scale, where each symptom is rated based on intensity and impact on daily functioning. The scores in scale points are then combined to create a subscore representing the overall physical symptom burden., Daily from baseline to study completion, for up to 6 months.|Measurement of total Score on Q-LES-Q SF, Evaluates overall quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). This score reflects the combined daily assessments of various life satisfaction and enjoyment domains given in scale points., Daily from baseline to study completion, up to 6 months|Measurement of quantity of analgesics consumed, Tracks the number of analgesic doses taken daily by participants. This measure reflects the overall usage of pain relief medication throughout the study., Daily from baseline to study completion, up to 6 months|Measurement of total mood disturbance score on POMS, Assesses the overall mood disturbance using the Profile of Mood States (POMS) scale. This score given in scale points combines daily ratings to indicate the intensity of mood disturbances experienced by participants., Daily from baseline to study completion, for up to 6 months|Measurement of proportion of responders with 50% reduction in late luteal phase symptoms, Measures the percentage of participants who show a 50% reduction in symptoms during the late luteal phase. This reflects the effectiveness of the intervention in alleviating symptoms during this phase., Daily from baseline to study completion, up to 6 months|Measurement of Omega-3 Index, Assesses the Omega-3 Index by measuring the percentage of EPA and DHA in red blood cells. This reflects the level of Omega-3 fatty acids, indicating dietary intake and compliance., Baseline and at 6 months post-intervention|Measurement of global assessment score at visits 4 and 6, Evaluates overall health and symptom severity during study visits 4 and 6 using a standardized scale. This score reflects participants\&#39; general condition at these specific time points., At 4 and 6 months",,Aker BioMarine Human Ingredients AS,,FEMALE,ADULT,NA,179,INDUSTRY,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION",2012-02-23,2013-04-11,2013-08-23,2024-09-05,,2024-09-05,,
NCT06584656,Understanding Cerebral Blood Flow Dynamics for Alzheimer's Disease Prevention Through Exercise,https://clinicaltrials.gov/study/NCT06584656,flADex,NOT_YET_RECRUITING,"Dementia is one of the leading causes of disability worldwide. Underlying biological mechanisms are crucial in preclinical stages of Alzheimer's disease (AD). Alterations in cerebral blood flow (CBF) and their relationship with AD blood-based biomarkers may be fundamental at early stages of the pathology. Physical exercise is a trigger to modify these biological mechanisms. Therefore, flADex aims to examine the acute effects of different types of exercise (resistance vs. aerobic vs. control) on CBF, AD blood-based biomarkers, and its cognitive implications in older adults. The hypothesis is that acute resistance or aerobic exercise will fluctuate levels of blood-based biomarkers, and will exert acute CBF changes combined with cognitive implications.",NO,"Healthy Aging|Cognitive Function 1, Social|Cerebrovascular Circulation|Blood Flow",,"Change in Cerebral Blood Flow (CBF), Specific acquisition parameters for Pseudo continuous Arterial Spin Labeling (pCASL) sequence are used to determinate global and regional CBF in resting condition. Structural T1 sequence (only pre-condition) is used to coregisted the pCASL and delineate regions of interest for CBF. Time-of-flight angiography (TOF) (before pCASL pre-condition and before first pCASL post-condition) sequence is used to identify the carotid arteries. The unit of measurement of the CBF is expressed as milliliters per 100 grams of brain tissue per minute (mL/100 g/min)., 30 minutes before the experimental condition; and 20 minutes, 27 minutes and 34 minutes minutes after the experimental condition","Change in Alzheimer disease blood-based biomarkers (Aβ42/40 ratio), The following biomarkers will be assessed: Amyloid-beta 42 (Aβ42), Amyloid-beta 40 (Aβ40). Aβ42 and Aβ40 will be combined to report Aβ42/40 ratio. Unit of measurement: Aβ42/40 is a ratio (no units) and represents the relative concentration of Aβ42 to Aβ40., 5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition|Change in Alzheimer disease blood-based biomarkers (p-tau217, p-tau181, NfL and GFAP), The following biomarkers will be assessed: phosphorylated tau protein at positions 217 and 181 (p-tau217, p-tau181), Glial Fibrillary Acidic Protein (GFAP) and Neurofilament Light Chain (NfL). Unit of measurement: p-tau217, p-tau181, NfL and GFAP are commonly measured in picograms per milliliter (pg/mL)., 5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition|Change in growth factors (BDNF), Brain-Derived Neurotrophic Factor (BDNF) will be measured. Unit of measurement: BDNF is commonly measured in picograms per milliliter (pg/mL)., 5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition|Change in growth factors (IGF-1), Insulin-Like Growth Factor 1 (IGF-1) will be measured. Unit of measurement: IGF-1 is commonly measured in nanograms per milliliter (ng/mL)., 5 minutes before the experimental condition; and 0 minutes, 50 minutes and 70 minutes after the experimental condition|Change in episodic memory, Episodic memory will be assessed using the Picture Sequence Memory Test from the Cognitive NIH Toolbox. The Cognitive NIH Toolbox is a computer-based battery which is available in Spanish. The Picture Sequence Memory Test measures episodic memory by deriving the participant's score from the cumulative number of adjacent pairs of pictures remembered correctly over two learning trials. The variable used for the for the PSMT is the theta score: The number of adjacent pairs placed correctly for each of trials 1 and 2 is converted to a theta score. This is a representation of the given participant estimated ability in the task., 15 minutes before the experimental condition; and 60 minutes after the experimental condition|Change in inhibition/attention, The Flanker task measures inhibitory control and attention by using the inverse efficiency score of incongruent trials. The inverse efficiency score is calculated as reaction time/accuracy (RT/ACC)., 15 minutes before the experimental condition; and 60 minutes after the experimental condition|Mood status, Mood status will be evaluated using the validated scale Profile of Mood States (POMS). The POMS scale is a psychological assessment tool used to measure and evaluate a person's mood states. It consists of a questionnaire with a list of 15 adjectives or mood descriptors, where individuals rate how they have been feeling on a scale typically ranging from ""Not at all"" to ""Extremely"". We use an abbreviated version of the scale with 15 ítems. The ítems are divided into 5 dimensions: depression, vigour, anger, tension and fatigue. The final score is: (\[depression\]+\[anger\]+\[tension\]+\[fatigue\]) - \[vigour\]., POMS will be measured 60 minutes before the experimental condition; and 70 minutes after the experimental condition|Feeling scale, Emotional response will be evaluated using the feeling scale (FS). The FS is an 11-point scale ranging from -5 (very bad) to +5 (very good) used to measure an individual's emotional feeling in terms of pleasure or displeasure at a specific moment., Feeling scale will be measured 1 minute before the experimental condition; and 1 minute after the experimental condition","Enjoyment, Enjoyment of Physical activity will be assessed using the Physical activity Enjoyment scale (PACES): The PACES is an 18-item scale but we will use the reduced and validated version of 8 items, assessing in a range of 1 to 7 a series of sensations or moods with respect to its opposite, so that it is easier and more practical for participants., 5 minutes after the experimental condition|Physical engagement (in aerobic condition and resistance condition), Perceived exertion of exercise (RPE) will be assessed using the OMNI-Resistance Exercise Scale (OMNI-RES) of perceived exertion from 0-10., During the experimental condition at minute 12, minute 20, and minute 30|Repetitions in reserve (in resistance condition), The Repetitions in Reserve (RIR) will be assessed after each exercise in the resistance condition. RIR method is a self-regulation technique used in strength training to gauge exercise intensity. It involves estimating how many more repetitions you could perform before reaching failure after completing a set., During the resistance condition after each exercise at minutes 5, 6, 7, 8, 9, 10, 11, 12 / 14, 15, 16, 17, 18, 19, 20, 21 / 23, 24, 25, 26, 27, 28, 29, 30|Cognitive engagement, Cognitive engagement will be assessed by the Cognitive Load Measurement scale. The Cognitive Load Scale is a 9 ítem scale used to assess the mental effort or cognitive load experienced by individuals when engaging in a task, particularly in educational or learning contexts. It involves a self-reported measure where participants rate their perceived mental effort on a scale, ranging from 1 very low mental effort; to 9 very high mental effort., During the experimental condition at minute 12, minute 20, and minute 30",Universidad de Granada,,ALL,OLDER_ADULT,NA,20,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE",2024-09-01,2025-03-02,2025-03-02,2024-09-05,,2024-09-05,,
NCT06584643,Evaluation of Serum Gasdermin D Level As a Potential Biomarker of Disease Activity in Vitiligo Patients,https://clinicaltrials.gov/study/NCT06584643,,NOT_YET_RECRUITING,Assessment the serum level of Gasdermin D level in vitiligo patients. Correlate its level with disease activity scores using Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores and with different disease parameters.,NO,Serum Gasdermin D in Vitiligo,,"Assessment the serum level of Gasdermin D level in vitiligo patients, estimate the serum level of Gasdermin D level in vitiligo patients and correlate its level with disease activity and various disease parameters., basline",,,Assiut University,,ALL,"CHILD, ADULT, OLDER_ADULT",,84,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-11,2025-11,2025-12,2024-09-05,,2024-09-05,,
NCT06584630,Molecular Classification of Endometrial Cancer: Impact on Adjuvant Treatment Planning.,https://clinicaltrials.gov/study/NCT06584630,,ACTIVE_NOT_RECRUITING,Molecular classification that has been recently incorporated in FIGO classification of endometrial cancer is a new triage tool for the better management of endometrial cancer patients.,NO,Endometrial Cancer,,"Multidisciplinary Team Board decision change, MDT decision for adjuvant treatment (Rate of adjuvant treatment change), 2 years (study completion)",,,Aristotle University Of Thessaloniki,,FEMALE,"ADULT, OLDER_ADULT",,80,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-09-01,2024-12-31,2025-12-31,2024-09-05,,2024-09-05,,
NCT06584617,The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing,https://clinicaltrials.gov/study/NCT06584617,,RECRUITING,"The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. It will also learn about the safety of medical device Berovenal®.

The main questions it aims to answer are:

* Does medical device Berovenal® lower the size of diabetic foot ulcer?
* What medical problems do participants have when using medical device Berovenal®?

Researchers will compare medical device Berovenal® to a reference device (device with similar purpose of use).

Participants will:

* Use medical device Berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their symptoms and the number of times they use medical device Berovenal® or a reference device",NO,Diabetic Foot Ulcer,,"Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area., 8 weeks","Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers, 8 weeks|Evaluation of clinical efficacy based on median time until complete Index ulcer closure, 8 weeks|Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80%, 4, 6 and 8 weeks|Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area, 2, 4, 6 and 8 weeks|Evaluation of clinical efficacy based on improvement in the subject's reported quality of life assessed by the Wound-QoL, 2, 4, 6 and 8 weeks|Evaluation of safety based on proportion of target wounds with a documented wound infection, 8 weeks|Evaluation of safety occurrence of adverse events, device failures or complaints, 8 weeks|Evaluation of clinical efficacy based on wound healing process, The analysis will inolve evaluation wound depth, presence of granulation tissue, exsudate and infection at individual time points., 2, 4, 6 and 8 weeks",,VULM s.r.o.,,ALL,"ADULT, OLDER_ADULT",NA,66,INDUSTRY,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,2023-05-17,2025-03,2025-12,2024-09-05,,2024-09-05,,
NCT06584604,Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation.,https://clinicaltrials.gov/study/NCT06584604,PESCA,NOT_YET_RECRUITING,"Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.",NO,Intensive Care Unit|Mechanical Ventilation|Critical Illness,,"Esophageal pressures measured by the balloon catheter at different filling volumes, To obtain a calibration method for the oesophageal balloon catheter in patients ventilated with a support mode and breathing spontaneously. Two, often used balloon catheters will be tested., 45 minutes","To compare the calibration method and the derived values while spontaneously breathing with the calibration method and the derived values while ventilated in a passive mode., After measurements were done during spontaneously breathing patients, measurements were done during mandatory ventilation, while patient is passive, 45 minutes",,Leiden University Medical Center,,ALL,"ADULT, OLDER_ADULT",,40,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-10,2026-10,2027-01,2024-09-05,,2024-09-05,,
NCT06584591,NEUROBALANCE Training to Improve Postural Control in Individuals with Traumatic Brain Injury,https://clinicaltrials.gov/study/NCT06584591,,NOT_YET_RECRUITING,"Our proposed study, \&#34;NEUROBALANCE,\&#34; aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.

The study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.

This research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.",NO,"Traumatic Brain Injury|TBI|Diffuse Axonal Brain Injury|Brain Injuries, Traumatic",,"Berg Balance Scale (BBS), A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint., Baseline, post 4-week training, 2-month follow-up","Functional Gait Assessment (FGA), To assess dynamic balance during walking, unlike BBS, it is not prone to the ceiling effect(Van Bloemendaal et al., 2019). FGA will be used as the secondary outcome measure of balance function and gait. FGA comes under the ICF domains of 'Activity' and 'Body Function.', Baseline, post 4-week training, and 2-month follow-up|Mini Balance Evaluation Systems Test (MBT), To identify the risk of falls (Yingyongyudha et al., 2016) with a high internal consistency with BBS and similar advantage of FGA, i.e., no ceiling effect. MBT will be used as the secondary endpoint of the balance function., Baseline, post 4-week training, and 2-month follow-up|Trunk Impairment Scale (TIS), To estimate the trunk motor impairment(Verheyden et al., 2004). The scale ranges from 0 to 23 and assesses static and dynamic postural control., Baseline, post 4-week training, and 2-month follow-up|Center of Pressure (COP) Displacement, To evaluate the body sway in response to the perturbations of the posturography platform., Baseline, post 4-week training, and 2-month follow-up|TMS-evoked EEG Potentials (TEP), A neurophysiological outcome measure of cortical reactivity. TEPs can directly measure cortical reactivity without being affected by the distal components of the nervous system, especially in neurological populations(Keser et al., 2022). In contrast to motor-evoked potentials, TEPs also offer the advantage of eliciting cortical responses at TMS intensity below the resting motor threshold., Baseline, post 4-week training, and 2-month follow-up|EEG Corticocortical Functional Connectivity, The imaginary part of coherence (iCOH) measured from the source-space EEG time-series will be used as an outcome measure of corticocortical connectivity, representing sensorimotor functional integration., Baseline, post 4-week training, and 2-month follow-up|EEG-to-EMG Corticomuscular Connectivity, EEG-to-EMG directed transfer function (DTF) will be used as an outcome measure of causal information flow from cortical areas to the leg muscles (Artoni et al., 2017; Peterson \&amp; Ferris, 2019). This measure is intended to capture changes in the efferent communication due to combined interventions., Baseline, post 4-week training, and 2-month follow-up.|EMG Muscle Coactivation, EMG co-contraction index will be used as an outcome measure of muscle activation between the antagonist and agonist muscle pair involved in reactive balance control., Baseline, post 4-week training, and 2-month follow-up.|Quality of Life after Brain Injury (QOLIBRI), A 37-item questionnaire to assess the level of satisfaction with different aspects of Quality of Life (QoL), on a scale of 1 (not at all satisfied) to 5(very satisfied); QOLIBRI is categorized under the ICF domain of 'Participation.', Baseline, post 4-week training, and 2-month follow-up.|Physical Activity Enjoyment Scale (PACES), An 18-item questionnaire with a 7-point Likert scale (higher scores represent increased activity enjoyment) has high reliability and validity(Murrock et al., 2016). The PACES scores will be used during training to assess the enjoyability of the balance exercises., Post 4-week training|Dizziness Handicap Inventory (DHI), A 25-item questionnaire with a 3-point scale to evaluate how dizziness or unsteadiness has affected daily activities in the last month. (Jacobson \&amp; Newman, 1990)., Baseline, post 4-week training, and 2-month follow-up.",,Kessler Foundation,,ALL,"ADULT, OLDER_ADULT",NA,45,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",2024-10,2027-03,2027-09,2024-09-05,,2024-09-05,,
NCT06584578,Exercise Nutrition and Body Composition,https://clinicaltrials.gov/study/NCT06584578,FitNutrBC-12,ACTIVE_NOT_RECRUITING,"Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition

The purpose of the study was to examine the effect of 12 weeks of different exercise training modalities and nutritional guidance on body composition.This study was conducted voluntarily by individuals who applied to a private health center in the Safranbolu district of Karabük and received medical nutrition treatment. It was conducted on four groups as Pilates, Yoga, WB-EMS and control and lasted 12 weeks in total. The training period of the participants in the group other than the control group was 2 days a week and 45 minutes per day, and 3 exercises consisted of warm-up, main part and cool-down parts. Some body composition assessments were made to the participants before and after their 12-week exercises. Body composition measurements (height, body weight, body mass index, body fat and muscle percentage) and systolic and diastolic blood pressure measurements were taken. Maximum heart rate (HRmax) (beats/min), average HR (beats/min), total calories burned (kcal) were determined to determine and monitor the load and intensity of each exercise for 12 weeks, and the Borg Scale was applied to the participants after each exercise to determine the degree of difficulty they perceived from the exercise they did and to evaluate their enjoyment of the exercises. Also, A personalized nutrition program prepared by a specialist dietitian for 12 weeks.",NO,Obesity|Overweight|Weight Loss|Muscle Maintenance,OTHER: Whole-Body Electromyostimulation|OTHER: Pilates|OTHER: Tai Chi|OTHER: Nutritional counseling,"Muscle mass changes from baseline assessment to 12 week follow-up assessment, Muscle mass changes from baseline assessment to 12 week follow-up assessment as determined my Bio Impedance Analysis, From baseline assessment to 12 week follow-up assessment","Body Fat Content changes from baseline assessment to 12 week follow-up, Changes of Body Fat Content (in %) from baseline assessment to 12 week follow-up assessment as determine by Bio Impedance Analysis, From baseline assessment to 12 week follow-up assessment|Body Fat Mass changes from baseline assessment to 12 week follow-up assessment, Body Fat Mass (kg) changes from baseline assessment to 12 week follow up assessment as determine by Bio Impedance Analysis, From baseline assessment to 12 week follow up assessment|Body mass changes from baseline assessment to 12 week follow-up assessment, Changes of body mass (weight in kg) from baseline assessment to 12 week follow-up assessment as determined by Bio Impedance Analysis, From baseline assessment to 12 week follow-up assessment|Body water changes from baseline assessment to 12 week follow-up assessment, Changes of body water from baseline assessment to 12 week follow-up assessment as determined by Bio Impedance Analysis, From baseline assessment to 12 week follow-up assessment",,Karabuk University,,ALL,"ADULT, OLDER_ADULT",NA,400,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",2023-06-15,2025-12-31,2026-03-31,2024-09-05,,2024-09-05,"Karabuk University, Karabük, Centre, 78200, Turkey",
NCT06584565,A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke,https://clinicaltrials.gov/study/NCT06584565,,RECRUITING,"Through a multicenter prospective AIS cohort study, we analyze the potential association of human proteome, microbiome and metabolome alterations with AIS prognosis, searching for key proteins, differential organisms and metabolites, combining experimental data at multiple molecular levels with computational models, and establishing early prediction models through machine learning-based prediction algorithms. While closely tracking the recurrence of stroke in AIS patients, we evaluate the predictive value of human proteome, microbiome and metabolites for stroke recurrence through a nested case-control study, which provides key reference information for exploring the unknown residual risk of AIS recurrence.",NO,"Ischemic Stroke, Acute",OTHER: microbiome; metabolomics; proteomics,"Incidence of new cardiovascular events and death, any stroke /TIA/ myocardial infarction/Vascular death, within 12 months after onset","Brain Injury Conditions, Clinical investigators evaluate brain injury conditions according to head CT or MR, which including the signs of infarct lesions, hemorrhagic transformation post-infarction or cerebral edema., 3, 12 months after ischemic stroke|Small Vessel Disease Burden, Clinical investigators evaluate small vessel disease burden according to head CT or MR, which including the signs of white matter degeneration, lacunar infarctions, cerebral microbleeds or enlarged perivascular spaces., 3, 12 months after ischemic stroke|Cerebrovascular Pathology, Clinical investigators evaluate cerebrovascular pathology according to head CT or MR, which including the signs of vascular stenosis, vascular dissection or collateral circulation compensation., 3, 12 months after ischemic stroke|Modified Rankin Scale ( mRS ) score, The MRS score is primarily used to measure the degree of disability and daily living ability of patients. The MRS score ranges from 0 to 6, with a total of 7 levels. The higher the score, the more severe the disability and the worse the prognosis., 7 day and 3, 12 months after ischemic stroke|National Institutes of Health Stroke Scale ( NIHSS ) score, The NIHSS score is commonly used to assess the degree of neurological impairment in patients with acute stroke. The NIHSS consists of 11 items, with a total score ranging from 0 to 42. Each item has different scoring criteria, typically ranging from 0 (normal) to 4 (most severe)., 7 day and 3, 12 months after ischemic stroke|Activity of Daily Living Scale ( ADL ) score, The ADL score is primarily used to measure a person's ability to perform basic daily activities. This study uses the Barthel Index scoring method, which ranges from 0 to 100 points, with scoring items including eating, bathing, grooming, dressing, bowel control, bladder control, toileting, transferring, mobility and stairs. A higher score indicates greater independence, while a lower score indicates greater dependence., 7 day and 3, 12 months after ischemic stroke|Mini-mental State Examination ( MMSE ) score, The MMSE (Mini-Mental State Examination) is a tool used to assess cognitive function, including orientation, memory, attention, language skills, calculation ability, and visuospatial skills. It is commonly used to screen for dementia in older adults. The MMSE has a total score of 30 points: a score of 24-30 suggests normal cognitive function, 18-23 indicates mild cognitive impairment, and 0-17 indicates moderate to severe cognitive impairment., 3, 12 months after ischemic stroke|Montreal Cognitive Assessment ( MOCA ) score, The MoCA is a tool used to assess cognitive impairment. Compared to the MMSE, the MoCA is more sensitive, particularly for detecting mild cognitive impairment (MCI). The MoCA has a total score of 30 points: a score of 26-30 suggests normal cognitive function, 18-25 indicates mild cognitive impairment (MCI), and 0-17 indicates moderate to severe cognitive impairment. Typically, individuals with lower educational levels (less than 12 years of education) receive an additional point as an adjustment to their total score., 3, 12 months after ischemic stroke|Hamilton Depression Scale ( HAMD ) score, The HAMD is a clinical scale used to assess the severity of depression. This study uses the 17-item version (HAMD-17), which covers a range of symptoms, including mood, sleep, appetite, and somatic symptoms. The total score ranges from 0 to 52, with each item rated based on the severity of symptoms, typically from 0 (no symptoms) to 4 (severe symptoms)., 3, 12 months after ischemic stroke|Hamilton Anxiety Scale ( HAMA ) score, The HAMA is a clinical scale used to assess the severity of anxiety symptoms. It consists of 14 items, each evaluating different symptoms related to anxiety. These symptoms cover both psychological and somatic manifestations of anxiety. Each item is rated based on the severity of symptoms, with scores ranging from 0 (no symptoms) to 4 (very severe symptoms)., 3, 12 months after ischemic stroke",,"Nanfang Hospital, Southern Medical University",,ALL,"ADULT, OLDER_ADULT",,400,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-01-30,2028-12-31,2028-12-31,2024-09-05,,2024-09-05,"Nanfang Hospital,Southern Medical University, Guangzhou, Guangdong, 510515, China",
NCT06584552,LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema),https://clinicaltrials.gov/study/NCT06584552,,NOT_YET_RECRUITING,"The LaCE study is a double-blind, randomised, placebo-controlled trial examining the effectiveness of the probiotic Lactobacillus paracasei LPB27 in treating eczema in young children.",NO,Eczema|Allergy,DIETARY_SUPPLEMENT: Lactobacillus Paracasei LPB27|OTHER: Maltodextrin,"Proportion of patients achieving treatment success, Clinically meaningful reduction (\>= 8.7 points) in SCORAD index between baseline and 12 weeks without the use of rescue medication (systemic immunosuppression and/or biologic agents), Between baseline and 12 weeks","Mean change in SCORAD index, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in SCORAD index, From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|First use of rescue medication, Time from baseline to first use of rescue medication, up to 12 weeks, From baseline to time of starting rescue medication (up to 12 weeks)|Mean change in RECAP, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Recap of Atopic Eczema (RECAP) score. The RECAP score ranges from a minimum of 0 to a maximum of 28, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in IDQOL, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Infant Dermatitis Quality of Life (IDQOL) score. The IDQOL score ranges from a minimum of 0 to a maximum of 30, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in EASI, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Eczema Area and Severity Index (EASI) score. The EASI score ranges from a minimum of 0 to a maximum of 72, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in IGA, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Investigator Global Assessment for Atopic Dermatitis (IGA) score. The IGA score ranges from a minimum of 0 to a maximum of 4, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in POEM, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in Patient-Oriented Eczema Measure (POEM) score. The POEM score ranges from a minimum of 0 to a maximum of 28, with higher scores indicating worse outcomes., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Use of topical corticosteroids, Mean weight (in grams) of topical corticosteroids used by participants during the 12 weeks of the study., From baseline to 12 weeks|Mean change in TOPICOP score, Mean change from baseline to 12 weeks in the Topical Corticosteroid Phobia (TOPICOP) score. The TOPICOP score ranges from a minimum of 0 to a maximum with 100, with higher scores indicating greater levels of phobia., From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in gut microbiota, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in alpha diversity, beta diversity and short chain fatty avid levels measured from stool samples, From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)|Mean change in skin microbiota, Mean change from baseline to 12 weeks (or time of starting rescue medication, whichever occurs earlier) in alpha and beta diversity measured from skin swabs, From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)",,The University of New South Wales,Evolution Health Pty Ltd,ALL,CHILD,PHASE2,100,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT",2024-09,2026-03,2026-09,2024-09-05,,2024-09-05,"Sydney Children's Hospital, Randwick, New South Wales, 2031, Australia|Sydney Children's Hospital, Sydney, New South Wales, 2038, Australia",
NCT06584539,Eco-labels on Restaurant Menus,https://clinicaltrials.gov/study/NCT06584539,,NOT_YET_RECRUITING,The goal of this study is to determine whether eco-labels denoting more sustainable menu items improve the healthfulness of participants' entrée and appetizer selections from a restaurant menu. US adults will complete a restaurant ordering task in which they will select menu items to order from a mock restaurant menu modeled after a popular US sit-down restaurant. Participants will be randomized to a restaurant menu with or without eco-labels denoting more sustainable menu items. The investigators will record participants' selections from the menu. Participants will also answer survey questions.,NO,Nutrition|Food Selection|Food Preferences|Dietary Habits|Healthy Diet,BEHAVIORAL: Eco-Labels,"Healthfulness of participants' entrée and appetizer selections, The study will assess the healthfulness of participants' entrée and appetizer selections as the average Ofcom Nutrient Profiling Model score of the entrees and appetizers the participants select in the restaurant ordering task. Ofcom Nutrient Profiling Model scores will be calculated for each item participants select. Items receive higher Ofcom scores when they contain lower calorie, saturated fat, sodium, and sugar density, higher protein and fiber density, and more fruits, vegetables, legumes, and nuts. The investigators will calculate the average score across participants' entrée and appetizer selections. The Ofcom Nutrient Profiling Model score ranges from 0 to 100, where higher scores indicate healthier products., Through study completion, an average of 15 minutes","Healthfulness of participants' restaurant selections, The study will assess the healthfulness of participants' restaurant selections as the average Ofcom Nutrient Profiling Model score of the menu items the participants select in the restaurant ordering task. Ofcom Nutrient Profiling Model scores will be calculated for each item participants select. Items receive higher Ofcom scores when they contain lower calorie, saturated fat, sodium, and sugar density, higher protein and fiber density, and more fruits, vegetables, legumes, and nuts. The investigators will calculate the average score across participants' selections. The Ofcom Nutrient Profiling Model score ranges from 0 to 100, where higher scores indicate healthier products., Through study completion, an average of 15 minutes|Calories selected from all items, The study will assess the number of calories participants select in the restaurant ordering task, calculated as the total number of calories selected across all menu items the participant selected in the restaurant ordering task. Higher values indicate higher calories selected., Through study completion, an average of 15 minutes|Calories selected from entrees and appetizers, The study will assess the number of calories participants select from entrees and appetizers in the restaurant ordering task, calculated as the total number of calories selected across entrees and appetizers the participant selected in the restaurant ordering task. Higher values indicate higher calories selected., Through study completion, an average of 15 minutes|Sodium selected from all items, The study will assess the amount of sodium participants select in the restaurant ordering task, calculated as the total sodium (in milligrams) selected across all menu items the participant selected in the restaurant ordering task. Higher values indicate higher sodium selected., Through study completion, an average of 15 minutes|Sodium selected from entrees and appetizers, The study will assess the amount of sodium participants select from entrees and appetizers in the restaurant ordering task, calculated as the total sodium (in milligrams) selected across entrees and appetizers the participant selected in the restaurant ordering task. Higher values indicate higher sodium selected., Through study completion, an average of 15 minutes|Saturated fat selected from all items, The study will assess the amount of saturated fat participants select in the restaurant ordering task, calculated as the total saturated fat (in grams) selected across all menu items the participant selected in the restaurant ordering task. Higher values indicate higher saturated fat selected., Through study completion, an average of 15 minutes|Saturated fat selected from entrees and appetizers, The study will assess the amount of saturated fat participants select from entrees and appetizers in the restaurant ordering task, calculated as the total saturated fat (in grams) selected across entrees and appetizers the participant selected in the restaurant ordering task. Higher values indicate higher saturated fat selected., Through study completion, an average of 15 minutes|Sugar selected from all items, The study will assess the amount of sugar participants select in the restaurant ordering task, calculated as the total sugar (in grams) selected across all menu items the participant selected in the restaurant ordering task. Higher values indicate higher sugar selected., Through study completion, an average of 15 minutes|Sugar selected from entrees and appetizers, The study will assess the amount of sugar participants select from entrees and appetizers in the restaurant ordering task, calculated as the total sugar (in grams) selected across entrees and appetizers the participant selected in the restaurant ordering task. Higher values indicate higher sugar selected., Through study completion, an average of 15 minutes|Fiber selected from all items, The study will assess the amount of fiber participants select in the restaurant ordering task, calculated as the total fiber (in grams) selected across all menu items the participant selected in the restaurant ordering task. Higher values indicate higher fiber selected., Through study completion, an average of 15 minutes|Fiber selected from entrees and appetizers, The study will assess the amount of fiber participants select from entrees and appetizers in the restaurant ordering task, calculated as the total fiber (in grams) selected across entrees and appetizers the participant selected in the restaurant ordering task. Higher values indicate higher fiber selected., Through study completion, an average of 15 minutes|Protein selected from all items, The study will assess the amount of protein participants select in the restaurant ordering task, calculated as the total protein (in grams) selected across all menu items the participant selected in the restaurant ordering task. Higher values indicate higher protein selected., Through study completion, an average of 15 minutes|Protein selected from entrees and appetizers, The study will assess the amount of protein participants select from entrees and appetizers in the restaurant ordering task, calculated as the total protein (in grams) selected across entrees and appetizers the participant selected in the restaurant ordering task. Higher values indicate higher protein selected., Through study completion, an average of 15 minutes|Carbon footprint of all items selected, The study will assess the carbon footprint of all items that participants select in the restaurant ordering task, calculated as the total carbon footprint (in CO2-equivalents) selected across all items the participant selected in the restaurant ordering task. Higher values indicate a larger carbon footprint of selected items., Through study completion, an average of 15 minutes|Carbon footprint of entrees and appetizers selected, The study will assess the carbon footprint of all entrees and appetizers that participants select in the restaurant ordering task, calculated as the total carbon footprint (in CO2-equivalents) selected across all entrees and appetizers the participant selected in the restaurant ordering task. Higher values indicate a larger carbon footprint of selected items., Through study completion, an average of 15 minutes|Noticing of eco-labels, The study will assess noticing of the eco-labels with 1 item: ""When you were selecting items to order, did you notice any other labels next to menu items?"" Response options will be ""yes"" (coded as 1) and ""no"" (coded as 0)., Through study completion, an average of 15 minutes|Thinking about the environmental effects of food, The study will assess thinking about the environmental effects of food while ordering with 1 item: ""When you chose what to order from the menu, how much did you think about each of the following characteristics? Environmental sustainability."" Response options will range from ""Not at all"" (coded as 1) to ""A great deal"" (coded as 5). Higher scores indicate more thinking about the environmental effects of food while ordering., Through study completion, an average of 15 minutes|Thinking about the healthfulness of food, The study will assess thinking about the healthfulness of food while ordering with 1 item: ""When you chose what to order from the menu, how much did you think about each of the following characteristics? Healthfulness."" Response options will range from ""Not at all"" (coded as 1) to ""A great deal"" (coded as 5). Higher scores indicate more thinking about the healthfulness of food while ordering., Through study completion, an average of 15 minutes|Thinking about the taste of food, The study will assess thinking about the taste of food while ordering with 1 item: ""When you chose what to order from the menu, how much did you think about each of the following characteristics? Taste."" Response options will range from ""Not at all"" (coded as 1) to ""A great deal"" (coded as 5). Higher scores indicate more thinking about the taste food while ordering., Through study completion, an average of 15 minutes|Perceived sustainability of sustainable menu items, The study will assess perceived sustainability of sustainable menu items with 1 item: ""How environmentally sustainable do you think this item is?"" For this question, participants will be randomized to view an image of 1 of 13 more sustainable menu items. For participants in the ecolabels arm, the item will display an ecolabel. Response options will range from ""Not at all"" (coded as 1) to ""Extremely"" (coded as 5). Higher scores indicate higher perceived sustainability., Through study completion, an average of 15 minutes|Perceived healthfulness of sustainable menu items, The study will assess perceived healthfulness of sustainable menu items with 1 item: ""How healthy do you think this item is?"" For this question, participants will be randomized to view an image of 1 of 13 more sustainable menu items. For participants in the ecolabels arm, the item will display an ecolabel. Response options will range from ""Not at all"" (coded as 1) to ""Extremely"" (coded as 5). Higher scores indicate higher perceived healthfulness., Through study completion, an average of 15 minutes|Perceived tastiness of sustainable menu items, The study will assess perceived tastiness of sustainable menu items with 1 item: ""How tasty do you think this item is?"" For this question, participants will be randomized to view an image of 1 of 13 more sustainable menu items. For participants in the ecolabels arm, the item will display an ecolabel. Response options will range from ""Not at all"" (coded as 1) to ""Extremely"" (coded as 5). Higher scores indicate higher perceived tastiness., Through study completion, an average of 15 minutes|Perceived sustainability of unsustainable menu items, The study will assess perceived sustainability of unsustainable menu items with 1 item: ""How environmentally sustainable do you think this item is?"" For this question, participants will be randomized to view an image of 1 of 13 less sustainable menu items. Response options will range from ""Not at all"" (coded as 1) to ""Extremely"" (coded as 5). Higher scores indicate higher perceived sustainability., Through study completion, an average of 15 minutes|Perceived healthfulness of unsustainable menu items, The study will assess perceived healthfulness of unsustainable menu items with 1 item: ""How healthy do you think this item is?"" For this question, participants will be randomized to view an image of 1 of 13 less sustainable menu items. Response options will range from ""Not at all"" (coded as 1) to ""Extremely"" (coded as 5). Higher scores indicate higher perceived healthfulness., Through study completion, an average of 15 minutes|Perceived tastiness of unsustainable menu items, The study will assess perceived tastiness of unsustainable menu items with 1 item: ""How tasty do you think this item is?"" For this question, participants will be randomized to view an image of 1 of 13 less sustainable menu items. Response options will range from ""Not at all"" (coded as 1) to ""Extremely"" (coded as 5). Higher scores indicate higher perceived tastiness., Through study completion, an average of 15 minutes","Liking of the eco-label, The study will assess the extent to which participants like the eco-label with 1 item: ""I like this label."" Response options will range from ""Strongly disagree"" (coded as 1) to ""Strongly agree"" (coded as 5). The investigators will dichotomize responses into agree (4 or 5, indicating participants like the ecolabel) vs. disagree or neutral (1-3, indicating participants do not like the ecolabel)., Through study completion, an average of 15 minutes|Wanting to see the eco-label on restaurant menus, The study will assess the extent to which participants want to see the eco-label on restaurant menus with 1 item: ""I want to see this label on menus next to foods that are more environmentally sustainable."" Response options will range from ""Strongly disagree"" (coded as 1) to ""Strongly agree"" (coded as 5). The investigators will dichotomize responses into agree (4 or 5, indicating participants want to see the label on restaurant menus) vs. disagree or neutral (1-3, indicating participants do not want to see the label on restaurant menus)., Through study completion, an average of 15 minutes|Label helpfulness in choosing more environmentally sustainable foods, The study will assess the extent to which participants think the ecolabel helps them choose more sustainable foods with 1 item: ""This label would help me choose more environmentally sustainable foods."" Response options will range from ""Strongly disagree"" (coded as 1) to ""Strongly agree"" (coded as 5). The investigators will dichotomize responses into agree (4 or 5, indicating participants think the ecolabel helps them choose more sustainable foods) vs. disagree or neutral (1-3, indicating participants do not think the ecolabel helps them choose more sustainable foods)., Through study completion, an average of 15 minutes|Perceptions of control over making sustainable eating decisions, The study will assess the extent to which participants perceive that the ecolabel makes them feel more in control of making sustainable eating decisions with 1 item: ""This label makes me feel more in control of making sustainable eating decisions."" Response options will range from ""Strongly disagree"" (coded as 1) to ""Strongly agree"" (coded as 5). The investigators will dichotomize responses into agree (4 or 5, indicating participants perceive the ecolabel increases control over making sustainable eating decisions) vs. disagree or neutral (1-3, indicating participants do not perceive that the ecolabel increases control)., Through study completion, an average of 15 minutes",Harvard Pilgrim Health Care,Stanford University,ALL,"ADULT, OLDER_ADULT",NA,3100,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION,2024-09,2024-09,2024-09,2024-09-05,,2024-09-05,"Harvard Pilgrim Health Care Institute, Boston, Massachusetts, 02215-3325, United States",
NCT06584526,Effects of Aerobic and Strength Exercice on Nociplastic Pain in Temporomandibular Disorders,https://clinicaltrials.gov/study/NCT06584526,,NOT_YET_RECRUITING,"Chronic temporomandibular disorders are common in the general population. Nociplastic pain seems to be present in this pathology, with an hypersensitivity to touch, pressure and movement observed in both local and remote areas, as weel as comorbidities such as fatigue, sleep disturbance, difficulty to focus attention and memory disturbance. The best evidence-based treatment of temporomandibular disorders consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic and strength exercises showed to be effective in subjects with chronic pain and nociplastic pain, by inducing an hypoalgesic effect. However, there isn\&#39;t investigation about the effects of theses types of exercise in subjects with temporomandibular disorders and nociplastic pain. Thus, the aim of the study is to determine if adding aerobic or strength exercise to an effective physical therapy programme is more effective than physical therapy alone to improve nociplastic pain in subjects with temporomandibular disorders.",NO,"Temporomandibular Disorders (TMD)|Nociplastic Pain|Aerobic Exercise|Strengthening Exercises|Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint",,"Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post), Bilateral measure with digital algometer, applying a perpendicular pressure of 0.5 kg/cm2/s on: masseter, temporal, upper trapezius, SCOM, quadriceps tendon, achilles Tendon., Baseline - 6 weeks (final) - 12 weeks","Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (post), Fonseca Anamnestic Index. 10 questions with a three-point scale: 0 = no, 5 = sometimes and 10 = yes; total score from 0 good function, to 100 worst., Baseline - 1 month (final) - 3 months|Change of baseline in Strength at 6 weeks (final) and 12 weeks (post), Handgrip strength will be assessed with a Jamar dynamometer, maximal isometric strength, 2 times.

Maximal strength of upper trapezius, quadriceps and gastrocnemius will be assessed with a digital dynamometer ActivForce, maximal isometric strength, 2 times.

Before assessing strength, a 10 minutes warm up of the muscles will be done:

* Upper trapezius: shoulder elevations
* Quadriceps: squat
* Gastrocnemius: heel elevations
* Handgrip: press a ball, Baseline - 6 weeks (final) - 12 weeks|Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post), Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device., Baseline - 6 weeks (final) - 12 weeks|Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post), Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem), Baseline - 6 weeks (final) - 12 weeks|Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post), Patient sitting for 5 minutes to rest, and then heart rate is assessed with a Polar H10 sensor., Baseline - 6 weeks (final) - 12 weeks|Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (post), Hospital Anxiety and Depression Scale: 2 subscales, one for anxiety and the other one for depression. Each scale score is from 0 (less) to 21 (worst), Baseline - 6 weeks (final) - 12 weeks|Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post), Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point., Baseline - 6 weeks (final) - 12 weeks|Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post), Tampa Scale of Kinesiophobia: from 10 to 40 (Likert scale 4 points: 1 = totally disagree; 2 = disagree; 3 = agree; 4 = totally agree). Cut-off: 23., Baseline - 6 weeks (final) - 12 weeks|Adherence at 6 weeks (final) and 12 weeks (post), ATTEMPT questionnaire to evaluate adherence to exercises post-intervention. 6 items, Likert scale 5 punts ( 1 = totally disagree; 2 = disagree; 3 = neutral; 4 = agree; 5 = totally agree). From 6 to 30, a change of 4 indicates a change., 6 weeks (final) - 12 weeks",,Universitat Internacional de Catalunya,,ALL,ADULT,NA,51,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT,2024-09-09,2025-07-31,2025-07-31,2024-09-04,,2024-09-04,,
NCT06584513,Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.,https://clinicaltrials.gov/study/NCT06584513,BE-SAFE,NOT_YET_RECRUITING,"Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.",NO,Benzodiazepines Deprescribing|Sleep Problems,"OTHER: Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements","BSH discontinuation, Number of patients with BSH discontinuation according to self-/informal carer-disclosure. Discontinuation is defined as the intake of a maximum of one tablet within the previous 14 days., 12 months after enrollment|Quality of sleep, Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia., 12 months after enrollment","Use of a substitute medication for sleep, Use of a substitute medication for sleep, according to self-/informal carer disclosure, 2 months, 6 months, and 12 months after enrollment|BSH discontinuation discussion with HCP, Number of patients who discussed BSH discontinuation with a HCP during the last month at M01 and M02, and during the last 4 months at M06, 1 month, 2 months, and 6 months after enrollment|Benzodiazepines (BSH) discontinuation or dose reduction, Number of patients with BSH discontinuation or dose reduction, according to self-/informal carer disclosure. Defined as the intake of a maximum of one tablet within the previous 14 days., 2 months and 6 months after enrollment|BSH adverse events, Number of patients with adverse effects of BSHs within 12 months of follow-up, according to self/informal carer disclosure, that is:

* Falls leading to emergency room visit or hospitalisation
* Fall-related fractures leading to emergency room visit or hospitalisation. As a sensitivity analysis, facial, fingers/toes, and ankle fractures that are less likely to be osteoporotic fractures will be excluded.
* Delirium leading to emergency room visit or hospitalisation
* Hospitalisations
* Death from any cause, 12 months after enrollment|Quality of sleep, Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia., 2 months and 6 months after enrollment|BSH standardized daily dose intake, Standardized daily dose intake based on equivalent doses for BSH (lorazepam-equivalent)., 2 months, 6 months, and 12 months after enrollment|Health-related quality of life, Health-related quality of life measured by the European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L). Consists of a visual analogue scale and short descriptive system questionnaire, corresponding to 5 severity levels of health state, higher level indicating more severe problems., 2 months, 6 months, and 12 months after enrollment|Withdrawal symptoms from BSH discontinuation, Number of patients with withdrawal symptoms from BSH discontinuation measured by the Clinical Institute Withdrawal Assessment Scale (CIWA-B). Questionnaires composed of 20 questions, with scale that range from 0-4, which are added up to give a total score. Higher scores indicate more severe levels of withdrawal symptoms., 2 months and 6 months after enrollment|Level of shared decision making (SDM), Level of SDM, using CollaboRATE scale. It ranges from 0-9, higher scores corresponding to higher level of efforts of SDM made during consultations., 1 month after enrollment",,"Insel Gruppe AG, University Hospital Bern","Universitat Autonoma de Barcelona|Oslo University Hospital|National and Kapodistrian University of Athens|Institute of Psychiatry and Neurology, Warsaw|CHU UCL Namur|Université Catholique de Louvain",ALL,OLDER_ADULT,NA,470,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",2024-10-15,2026-02-01,2026-02-01,2024-09-04,,2024-09-04,"Centre Hospitalier Universitaire CHU UCL Namur, Yvoir, 5530, Belgium|National and Kapodistrian University of Athens, Athens, 10679, Greece|Oslo University Hospital, Nydalen, 4950, Norway|Institute of Psychiatry and Neurology, Warsaw, 02-957, Poland|Universitat Autònoma de Barcelona, Barcelona, 08041, Spain|Department of General Internal Medicine, University Hospital Bern (Inselspital), Bern, 3010, Switzerland",
NCT06584500,Effect of Dry Needling on Gluteus Medius Contraction in Greater Trochanteric Pain Syndrome: a Pilot RCT Protocol,https://clinicaltrials.gov/study/NCT06584500,,NOT_YET_RECRUITING,"Grater trochanteric pain syndrome is a hip related pathology that causes lateral hip pain and lack of strength in abductor muscles such as the gluteus medius, which hinders functional activities and daily life, such as standing, walking, sleeping on the affected side... Lack of strength and eccentric control of the gluteus medius may be related to the apparition of myofascial trigger points that are susceptible to treatment with dry needling.

In this study, two groups of patients with greater trochanteric pain syndrome will be treated with dry needling, some of them with real dry needling, and others with sham dry needling. Ultrasound will be used to assess whether real dry needling in the pelvitrochanteric musculature improves the potential contraction of the gluteus medius, in relation to a baseline measurement and to sham dry needling.

This study is a randomised clinical trial protocol, pilot study, so there will be no previous references for the sample of both study groups. 3 dry needling interventions will be performed in 3 consecutive weeks, leaving 1 week between each intervention. Data will be collected for the variables to be investigated (potential contraction, pain, function, strength...) before the first intervention, after each intervention, 1 month after the last intervention and at 3 months.",NO,Greater Trocantheric Pain Syndrome,,"Potential Contraction with M-Mode, The primary variable in this study will measure the potential contraction of the gluteus medius. This variable will be assessed using a Sonoscape E2 ultrasound machine with a 5 cm linear probe and the highest scanning speed. The probe will be positioned at the midpoint of the line connecting the anterior and posterior superior iliac spines. In longitudinal scanning, M-mode will be placed cranially to the hip joint capsule. Thickness will be measured from the inner surface of the fascial borders, with the unit of measurement in millimeters (mm). The contraction potential will be the difference between the thickness of the gluteus medius at rest and the thickness at 80% of the maximum voluntary isometric contraction., From enrollment to the end of treatment at 4 months","WOMAC hip scale, This is a scale validated in Spanish to measure disability. Barratt et al. recommend the use of condition-specific outcome measures, such as the VISA-G, which is not validated in Spanish. The WOMAC scale has been used to measure disability in patients with Greater Trochanteric Pain Syndrome (GTPS) who speak Spanish., From enrollment to the end of treatment at 4 months|Hip Abduction Strength, This will be defined as the amount of force measured by a manual dynamometer during a maximum voluntary isometric contraction. Strength is measured in kilograms (kg) using an Activforce 2 Dynamometer ACTVDIN® model. Participants will lie supine, with the test leg in an anatomical position at 0º hip rotation, and the opposite leg slightly flexed. The dynamometer will be positioned 5 cm proximal to the lateral malleolus, held externally by the examiner, who will stand on the same side as the tested leg. The contraction will be maintained for five seconds, and three measurements will be taken to obtain an average value. If compensatory movements are detected during a measurement, it will not be recorded, and another measurement will be taken., From enrollment to the end of treatment at 4 months|Pain, Participants will indicate their pain intensity on a 100 mm horizontal line, with \&#34;no pain\&#34;; at the far left (score 0) and \&amp;#34;worst imaginable pain\&amp;#34;; at the far right (score 10), in relation to the most intense pain episode experienced during daily activities. The Visual Analogue Scale (VAS) has been shown to effectively detect changes in pain, with a minimum clinically significant difference established at 13 mm., From enrollment to the end of treatment at 4 months|Passive Hip Range of Motion, It will be measured using an 18 cm plastic universal goniometer (Sammons Preston-Rolyan®). The following movements will be measured: flexion, extension, internal rotation, external rotation, and abduction until the end range without pain. Each movement will be measured three times, and the average value will be used in the analysis., From enrollment to the end of treatment at 4 months",,University of Alcala,,ALL,"ADULT, OLDER_ADULT",NA,40,OTHER,INTERVENTIONAL,"Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT",2024-10-15,2025-09-08,2025-11-08,2024-09-04,,2024-09-04,,
NCT06584487,Proximal Metatarsal Osteotomy in Correction of Hallux Valgus,https://clinicaltrials.gov/study/NCT06584487,,NOT_YET_RECRUITING,The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy,NO,Hallux Valgus and Bunion,,"The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale)., Pain-Function-Alignment, baseline","Post operative radiographic changes in standing AP view foot and standing lateral view foot., In standing AP view foot

* The hallux valgus angle HVA in degrees.It is the angle between long axis of 1st metatarsal and proximal phalanx of big toe
* The intermetatarsal angle IMA in degree
* The distal metatarsal articular angle DMAA in degree
* The 1st metatarsal length in centimeter In standing lateral view foot
* The inclination angle of the 1st metatarsal in degree In standing AP view foot
* The hallux valgus angle HVA in degree
* The intermetatarsal angle IMA in degree
* The distal metatarsal articular angle DMAA in degree
* The 1st metatarsal length in centimeter In standing lateral view foot
* The inclination angle of the 1st metatarsal, Baseline",,Assiut University,,ALL,"CHILD, ADULT, OLDER_ADULT",,15,OTHER,OBSERVATIONAL,Observational Model: |Time Perspective: p,2024-10-10,2025-09,2025-10,2024-09-04,,2024-09-04,,
NCT06584474,The EFFECT of NEBULIZED AZITHROMYCIN AS THERAPY for BRONCHOPULMONARY DYSPLASIA,https://clinicaltrials.gov/study/NCT06584474,,NOT_YET_RECRUITING,The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.,NO,"Bronchopulmonary Dysplasia|Premature|Ventilation, Mechanical",,"Development of BPD (bronchopulmonary dysplasia), Developed BPD :Yes or No If patient fulfilled criteria of BPD ; patient is born at or less than 32 weeks gestational age and still need oxygen and or respiratory support at the 28 day or more postnatal age and/or 36 weeks postmenstrual age., 28 days of life and/or 36 weeks postmenstrual age|Lung Ultrasound assessment, Lung ultrasound score The score is calculated by the following points at different lung zones using lung ultrasound 0: A lines

1. 3 or more nonconfluent B lines
2. confluent B lines
3. C profile or consolidation, 14 days postnatal age.",,,Alexandria University,,ALL,CHILD,NA,100,OTHER,INTERVENTIONAL,Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT,2024-10-02,2025-10-02,2025-11-02,2024-09-04,,2024-09-04,,