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## Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product. - NCT ID: NCT06315946 - Study ID: 17E3241 - Status: COMPLETED - Start Date: 2018-10-04 - Completion Date: 2019-03-11 - Lead Sponsor: Oystershell NV ### Study Description Evaluate the efficacy of the test medical device (Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover). ### Conditions - Skin Tags ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pixie® skin tag - Wortie® Skin Tag Remover ### Outcomes Primary Outcomes - Percentage of subjects with successful treatment Secondary Outcomes - Number of treatments - Visual aspect - Macrophotographs on skin tag remission - Evaluation of the skin condition - Degree of pain - Recording of adverse events ### Location - Facility: DERMSCAN - PharmScan, Villeurbanne, N/A, 69100, France @@
## Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children - NCT ID: NCT06315933 - Study ID: S-K1093 - Status: RECRUITING - Start Date: 2020-01-13 - Completion Date: 2026-12 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description In the past, a large number of animal studies have suggested that anesthesia exposure has potential neurotoxic effects, resulting in persistent cognitive and behavioral deficits. At present, there is still a lack of sufficient clinical research evidence to prove whether anesthesia exposure has long-term effects on neurodevelopment. The existing clinical research data suggests that a single short-time anesthesia exposure in young children does not affect long-term neurodevelopmental outcomes. Early onset scoliosis, including congenital scoliosis, is a type of scoliosis deformity that occurs before the age of 10. Posterior scoliosis correction surgery is one of the common treatment. There is currently no research indicating the impact of early single or multiple long-duration anesthesia exposure on the neurological development of children with congenital scoliosis. The aim of this study is to determine the long-term effect of general anesthesia exposure on neurocognitive function and behavior in children with congenital scoliosis, in order to provide reference for related clinical work. ### Conditions - General Anesthetics Toxicity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - General anesthesia ### Outcomes Primary Outcomes - full-scale intelligence quotient, FSIQ Secondary Outcomes - Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI), Working Memory Index (WMI), Processing Speed Index (PSI) - CBCL Total score, CBCL Internalizing score, CBCL Externalizing score - SDQ Emotional symptoms, SDQ conduct problems, SDQ hyperactivity, SDQ peer problems, SDQ total difficulties, SDQ prosocial behaviors, SDQ impact factor ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department - NCT ID: NCT06315920 - Study ID: AFMS-MREC 009/2021 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-07-01 - Lead Sponsor: Oman Medical Speciality Board ### Study Description Introduction: This study focuses on the treatment of painful crises in Sickle Cell Disease (SCD) patients using Paracoxib, a non-opioid, compared to Morphine. It addresses the need for alternative medications that reduce opioid dependency while providing effective analgesia.Objectives:Primary: Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises.Secondary: Reduce opioid use/dependence, decrease the length of hospital stays, and monitor side effects related to Paracoxib.Methodology: A double-blinded randomized controlled trial, conducted in a tertiary care emergency department. The study includes adult SCD patients with moderate to severe crises, excluding non-VOC pain, certain medications, and specific medical conditions. The sample size is 226 patients, split equally into two groups.Intervention: Patients receive either Morphine or Paracoxib, with periodic assessment of vital signs and pain. Additional Morphine is administered if required. Data collection and analysis are meticulously planned.Expected Outcomes: Improvement in SCD pain management, reduction in opioid usage, and potential benefits in terms of hospital stays and patient satisfaction. ### Conditions - Sickle-Cell Disease With Crisis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Parecoxib - Morphine ### Outcomes Primary Outcomes - Pain reduction at 60 mins. Secondary Outcomes - Adverse Events/Side Effects - The need of rescue pain medications - Recurrent visit ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Development and Validation of a Brief Food Noise Questionnaire - NCT ID: NCT06315907 - Study ID: PBRC 2024-012 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-25 - Completion Date: 2024-05-28 - Lead Sponsor: Pennington Biomedical Research Center ### Study Description The purpose of the research is to develop and test the reliability and validity of a brief questionnaire to measure food noise. ### Conditions - Eating Behavior ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Responses to survey questions ### Outcomes Primary Outcomes - Scores on the food noise questionnaire Secondary Outcomes ### Location - Facility: Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70806, United States @@
## Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study) - NCT ID: NCT06315894 - Study ID: PI-22-191 - Status: RECRUITING - Start Date: 2023-10-03 - Completion Date: 2025-09 - Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia ### Study Description SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition. ### Conditions - Post-COVID Condition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SuperCAP Program ### Outcomes Primary Outcomes - Change in Self-reported Cognitive Functioning Secondary Outcomes - Change in Performance-based Cognitive Functioning - Change in Depression Symptoms - Change in Anxiety Symptoms - Change in Daily Activities Functioning - Change in Physical Activity - Change in Quality of Life ### Location - Facility: Germans Trias I Pujol Hospital, Badalona, Barcelona, 08916, Spain @@
## Informing Oral Nicotine Pouch Regulations to Promote Public Health - NCT ID: NCT06315881 - Study ID: OSU-23116 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2025-12-31 - Lead Sponsor: Ohio State University Comprehensive Cancer Center ### Study Description This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs. ### Conditions - Tobacco-Related Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Biospecimen Collection - Cigarette - Nicotine Oral Pouch - Nicotine Oral Pouch - Nicotine Oral Pouch - Nicotine Oral Pouch - Smokeless Tobacco - Survey Administration - Text Message-Based Navigation Intervention ### Outcomes Primary Outcomes - Increased nicotine delivery - Liking - Craving/withdrawal suppression - Rate of switching to ONP - Rate of switching to ONPs Secondary Outcomes ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Breast Cancer Subtype Characterization Through Patient's Derived Organoids. - NCT ID: NCT06315868 - Study ID: 5590 - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2027-06-15 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for BC patients lacking targeted therapies, such as TNBC, or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies.The refinement of 3D-cultivation techniques, experienced in the last decade, has allowed cultivation of patients-derived cancer cells in organotypic structures, named patient-derived organoids (PDO), which preserve histologic, genomic and transcriptomic features of primary tumors. PDO allow propagation, pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting, thus representing a promising tool in the development of personalized therapies ### Conditions - Breast Cancer - Organoids ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - evaluate the histological and molecular conformity (yes/no) between PDO and matched primary and/or recurrent BC sample, in order to develop a live biobank of ER/PR+, HER2+ and TNBC PDO. - evaluate the sensitivity of ER/PR+, HER2+ and TNBC PDO to novel therapeutic agents in clinical trials for BC or other cancer types Secondary Outcomes - test the sensitivity of PDO to splicing-targeting treatments, either alone or in combination with other therapies - test the synergizing effects of agents splicing-targeting treatments to immunotherapies by co-culture experiments with autologous immune cells ### Location - Facility: IRCCS Fondazione Policlinico A. Gemelli, Roma, N/A, 00168, Italy @@
## Leveraging Telehealth to Improve Oral Health Among Cancer Survivors - NCT ID: NCT06315855 - Study ID: STUDY00006928 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-12-25 - Lead Sponsor: Georgetown University ### Study Description The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors. ### Conditions - Oral Mucositis - Periodontal Diseases - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Telehealth Intervention (THI) ### Outcomes Primary Outcomes - mucositis - gingival inflammation and periodontal disease - tooth decay - oral health related quality of life Secondary Outcomes - systemic inflammation - overall health related quality of life - comorbidities ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients - NCT ID: NCT06315842 - Study ID: CSAPG-44 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf ### Study Description The objective of this clinical trial is to investigate the impact of implementing a tool for adjusting the level of diagnostic and therapeutic intensity in the clinical practice of physicians attending hospitalized patients.The goal of this clinical trial is to investigate the impact of a tool for adjusting diagnostic and therapeutic intensity in hospitalized patients. The main question it aims to answer is: Is there a difference in patient mortality when using the aforementioned tool? The participating physicians will be grouped into 4 groups (5 physicians each). Each group will progressively (every 3 months) incorporate the use of the aforementioned tool into their usual clinical practice. ### Conditions - Acute Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col. - Usual clinical practice ### Outcomes Primary Outcomes - In-hospital Patient Mortality at 90 days from hospital discharge Secondary Outcomes - In-hospital Patient Mortality at 6 months from hospital discharge - In-hospital Patient Mortality at 1 year from hospital discharge - Delirium Incidence - Pressure Ulcer Incidence - Hospital stay - Hospital readmission for any reason - Hospital readmission for same reason - Patients admitted to the Intensive Care Unit (ICU) - Calls to the "on-call doctor" - Healthcare expenditure - Mortality at ICU ### Location - Facility: Consorci Sanitari Alt Penedes i Garraf, Vilafranca Del Penedès, Barcelona, 08720, Spain @@
## Artificial Intelligence-based Video Analysis to Detect Infantile Spasms - NCT ID: NCT06315829 - Study ID: IRB00429753 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Johns Hopkins University ### Study Description Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment. The purpose of this study is to develop a computer program that can reliably differentiate infantile spasms from similar, yet benign movements in videos. This computer program will learn from videos taken by parents of study participants. Quickly recognizing and treating infantile spasms is crucial for ensuring the best developmental outcomes. ### Conditions - Infantile Spasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Spasm Vision ### Outcomes Primary Outcomes - Model Sensitivity (Recall) - Model Specificity - Model Positive Predictive Value (Precision) - Model Negative Predictive Value Secondary Outcomes ### Location - Facility: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States @@
## Virtual Reality Used During Tooth Extraction and Extirpation Treatment - NCT ID: NCT06315816 - Study ID: DokuzEU-1 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-30 - Lead Sponsor: Murat Bektaş ### Study Description This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years. ### Conditions - Anxiety and Fear - Tooth Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - virtual reality glasses used during tooth extraction and extirpation treatment ### Outcomes Primary Outcomes - Anxiety Means - Fear Means Secondary Outcomes ### Location - Facility: Hakkari University, Hakkari, Merkez, N/A, Turkey @@
## Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen - NCT ID: NCT06315803 - Study ID: ChinaPLAGH20230601 - Status: COMPLETED - Start Date: 2023-06-23 - Completion Date: 2024-02-01 - Lead Sponsor: Yi Mao ### Study Description The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question\[s\] it aims to answer are:* The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography.* The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster.Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score. ### Conditions - Lumbar Disc Herniation - Percutaneous Endoscopic Lumbar Discectomy - Three-dimension Ultrasound - Learning Curves ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Real-time 3D Xplane ultrasound ### Outcomes Primary Outcomes - the first success rate - number of punctures - number of radiographies - puncture time Secondary Outcomes - operator confidence score - operative time - incidence of puncture relevant complications - satisfaction of patients ### Location - Facility: Chinese PLA General Hospital, Beijing, Beijing, 100853, China @@
## Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia - NCT ID: NCT06315790 - Study ID: TN BTX-A Trial - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2025-10-01 - Lead Sponsor: Henrik Schytz ### Study Description This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1. ### Conditions - Trigeminal Neuralgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Botulinum toxin A - Isotonic saline ### Outcomes Primary Outcomes - Proportion of responders in botulunim toxin A and placebo group Secondary Outcomes - Biomarkers - Tear fluid CGRP - 50 % reduction - 75 % reduction - Prolonged 30 % reduction - Change in paroxysms - PGI-C - PENN Facial Pain Scale-Revised (PENN-FPS-R) - Patient's guess - Dropouts - Side effects ### Location - Facility: Danish Headache Center, Glostrup, N/A, 2600, Denmark @@
## GREM1, HAS2 and PTGS2 Gene Expression Following the in Vitro Maturation (IVM) - NCT ID: NCT06315777 - Study ID: FRGS/1/2021/SKK01/UKM/02/1 - Status: RECRUITING - Start Date: 2021-07-01 - Completion Date: 2024-07-31 - Lead Sponsor: National University of Malaysia ### Study Description Poor ovarian reserve (POR) is an adverse prognostic factor for In-Vitro Fertilization (IVF) success. Numerous established data showed low live birth rates per IVF cycle; 6 to 10%, including the usage of In-Vitro Maturation (IVM). In Malaysia, POR incidence increases mainly from cancer survival, endometriosis, and autoimmune diseases women; therefore, IVM implementation is paramount. In the molecular level, the low competence oocytes showed a low expression of GREM1, HAS2 and PTGS2 in human cumulus cells, thus leading to poor oocyte quality(OQ). Various IVM media had been formulated to enhance the competency and quality of the oocytes to date. Therefore, our study aims to elucidate the GREM1, HAS2 and PTGS2 gene expression as oocyte developmental competency markers among POR women following IVM and tailored to the IVF outcome. ### Conditions - Increased Oocyte Death - in Vitro Maturation - GREM1 Gene Mutation - Cumulus Cell ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - cumulus cell oocytes complex (COC) among women with poor ovarian reserve ### Outcomes Primary Outcomes - normal ovarian reserve - poor ovarian reserve Secondary Outcomes ### Location - Facility: Advanced Reproductive Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 56000, Malaysia @@
## Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients - NCT ID: NCT06315764 - Study ID: Hypertensive patients - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-05-30 - Lead Sponsor: Cairo University ### Study Description In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Reflexology ### Outcomes Primary Outcomes - Insomnia severity index - Short form 36 quality of life questionnaire (SF-36): - Blood pressure measurements: Secondary Outcomes ### Location - Facility: Heba Mousa, Cairo, N/A, 11517, Egypt @@
## Efficacy and Safety of Gemlapodect in Adults and Adolescents With Tourette Syndrome - NCT ID: NCT06315751 - Study ID: NOE-TTS-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2026-12-31 - Lead Sponsor: Noema Pharma AG ### Study Description This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS. Adolescents will be enrolled after a sentinel cohort of adults is complete. ### Conditions - Tourette Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gemlapodect - Placebo ### Outcomes Primary Outcomes - Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R) Secondary Outcomes - Impact on patient functioning - Change in PUTS - Safety and Tolerability of gemlapodect - Assessment of suicidality and suicidal ideation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis - NCT ID: NCT06315738 - Study ID: ST266-NEC-201 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2027-08 - Lead Sponsor: Noveome Biotherapeutics, formerly Stemnion ### Study Description The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC. ### Conditions - Necrotizing Enterocolitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ST266 ### Outcomes Primary Outcomes - Safety and Tolerability endpoint: incidence of adverse events - Safety and Tolerability endpoint: incidence of serious adverse events - Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression Secondary Outcomes - Efficacy endpoint: Time to pneumatosis resolution - Efficacy endpoint: Time to full enteral nutrition assessment - Efficacy endpoint: Incidence of abdominal surgical intervention - Efficacy endpoint: Change in Neonatal Sequential Organ Failure Assessment (nSOFA) score ### Location - Facility: BayCare Health System-St. Joseph's Women's Hospital, Tampa, Florida, 33607, United States @@
## Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D) - NCT ID: NCT06315725 - Study ID: 2024-10504 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2027-09-01 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time.Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level.To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study.Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker. ### Conditions - Type 1 Diabetes (T1D) - Healthy Subjects ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sweet taste perception with/without sweet taste blockade ### Outcomes Primary Outcomes - Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals - Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption. Secondary Outcomes - Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Inspiratory Muscle Training in Burned Adults - NCT ID: NCT06315712 - Study ID: 004201 - Status: COMPLETED - Start Date: 2021-01-15 - Completion Date: 2023-09-11 - Lead Sponsor: Qassim University ### Study Description The study outlines burn injury impact, emphasizes need for long-term rehabilitation. Study assesses inspiratory muscle training efficacy in improving respiratory strength, lung function, and exercise capacity in adult burn patients. ### Conditions - Burn Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - inspiratory exercise - Pulmonary rehabilitation ### Outcomes Primary Outcomes - maximal inspiratory pressure - maximal inspiratory pressure - maximal expiratory pressure - maximal expiratory pressure - Forced expiratory volume in 1 second - Forced expiratory volume in 1 second - forced vital capacity - forced vital capacity - Forced expiratory volume in 1 second/ forced vital capacity ratio - Forced expiratory volume in 1 second/ forced vital capacity ratio Secondary Outcomes - Functional exercise capacity - Functional exercise capacity ### Location - Facility: Faculty of Physical Therapy, Cairo University, Giza, Dokki, 11432, Egypt @@
## Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome - NCT ID: NCT06315699 - Study ID: QL000001 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-12-30 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description This study focuses on therapeutic targets for cognitive, motor, and social impairments in Williams syndrome by reversing brain myelin defects caused by GTF2I. The primary objective of the study was to test and evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome. ### Conditions - Williams Syndrome - Child - Neurodevelopmental Delay ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Clemastine Fumarate Tablets - fructose ### Outcomes Primary Outcomes - Anisotropy Score (FA) - Radial diffusion rate (RD) - Apparent dispersion coefficient（ADC） - Magnetization transfer ratio（MTR） - SRS Score 2(Social Response Scale2) score - Peabody（Motion Estimation Timewarp）score - Gesell Development Scale Secondary Outcomes - Differential pressure across valves - Thyroid hormone value - Conners Parent Symptoms Questionnaire Score - Vailand-3 scale - CSHQ Children's Sleep Habits Questionnaire Score ### Location - Facility: Qilu Hospital of Shandong University, Tainan, Shangdong, 250012, China @@
## The Dynamic Monitoring of Cerebrospinal Fluid ctDNA - NCT ID: NCT06315686 - Study ID: MA-ENDO-202209 - Status: RECRUITING - Start Date: 2022-09-29 - Completion Date: 2024-12-31 - Lead Sponsor: Jiangsu Province Nanjing Brain Hospital ### Study Description Focusing on advanced EGFR mutation in NSCLC patients with leptomeningeal metastasis, vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was used to dynamically monitor ctDNA in cerebrospinal fluid (CSF), analyze the ctDNA gene mutation profile of CSF in different patients, and explore the relationship between ctDNA and efficacy and prognosis. ### Conditions - NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - pemetrexed ### Outcomes Primary Outcomes - The progression-free survival time（PFS） Secondary Outcomes - Incidence of Treatment-Emergent Adverse Events ### Location - Facility: Nanjing Brain Hospital, Suzhou, Jiangsu, 210029, China @@
## Digital Assessment of Speech and Fine Motor Control in ALS - NCT ID: NCT06315673 - Study ID: STUDY00024562 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-03-30 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description This is a single-session, case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease. Patients with motor neuron disease (including amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA)) and age-matched healthy controls will be enrolled. Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer (BioSensics LLC, Newton, MA). We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised (ALFRS-R) \[1\]. We will also compare assessment data between the patient and control groups. ### Conditions - Amyotrophic Lateral Sclerosis - Primary Lateral Sclerosis - Progressive Muscular Atrophy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Digital Speech and Handwriting Assessment ### Outcomes Primary Outcomes - Speaking rate during a standardized passage - Residual on spiral tracing task Secondary Outcomes - ALS Functional Rating Scale- Revised (ALSFRS-R) - Forced vital capacity (FVC) - Upper motor neuron function - Strength testing ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## VR Based Therapy to Treat Anxiety in Dual Diagnosis - NCT ID: NCT06315660 - Study ID: P-2021-627 - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2026-04 - Lead Sponsor: Mental Health Centre Sct. Hans ### Study Description Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual diagnosis is therefore a challenging condition to treat, and the group typically represents the most vulnerable individuals in society. Historically, research on dual diagnosis has been underprioritized, and thus, we still do not know enough about how to best assist this vulnerable group.However, new studies indicate that virtual reality programs can reduce anxiety in patients with psychotic disorders. They achieve this by providing access to a virtual therapist and lifelike environments where patients can challenge their thoughts about the dangers of navigating the world. For both psychotic disorders and substance abuse, we know that anxiety often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on dual diagnosis patients, where it is crucial in maintaining substance abuse and functional impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is too resource-intensive in addition to an already intensive treatment process.This study investigates whether the resource barrier can be overcome and whether hospitalized dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes after discharge when their anxiety is treated through partially automated virtual reality therapy. ### Conditions - Dual Diagnosis - Psychosis - Agoraphobia - Social Anxiety Disorder - Substance Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Miljeu Therapy - Virtual Reality based CBT for Anxiety ### Outcomes Primary Outcomes - Oxford Agoraphobic Avoidance Scale - Client Satisfaction Questionnaire - Systems Useability Scale Secondary Outcomes - Timeline Followback - The Six-item Positive and Negative Symptom Syndrome Scale - The Social Functioning Scale - The Questionnaire about the Process of Recovery ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison Between Different Techniques in Difficult CBD Cannulation - NCT ID: NCT06315647 - Study ID: Difficult CBD cannulation - Status: COMPLETED - Start Date: 2019-12-01 - Completion Date: 2023-11-20 - Lead Sponsor: Menoufia University ### Study Description This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation. ### Conditions - ERCP, Difficult CBD Cannulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation ### Outcomes Primary Outcomes - Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography Secondary Outcomes ### Location - Facility: National liver Institute, Shibīn Al Kawm, Menofia, 32951, Egypt @@
## Intrathecal Dexmedetomidine vs Midazolame - NCT ID: NCT06315634 - Study ID: AP210330102 - Status: COMPLETED - Start Date: 2021-03-15 - Completion Date: 2022-03-10 - Lead Sponsor: National Cancer Institute, Egypt ### Study Description Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine - Midazolam - Bupivacain ### Outcomes Primary Outcomes - Duration of sensory block Secondary Outcomes - Incidence of vomiting occurrence - Sedation - Change in mean arterial blood pressure - Duration of motor block - Change in heart rate ### Location - Facility: National cancer institute, Cairo, N/A, 11796, Egypt @@
## Accuracy of Conventional Impression Versus Intraoral Scanner in Capturing Three Different Nasal Defects - NCT ID: NCT06315621 - Study ID: 36124 - Status: COMPLETED - Start Date: 2024-02-01 - Completion Date: 2024-02-20 - Lead Sponsor: Cairo University ### Study Description For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1).Group 2, involves nasal defects which will be optically scanned using IOS(medit 700 wireless) without facial markers Group 3 involves nasal defects which will be optically scanned using IOS(medit 700 wireless) with facial markers.STL files of the facial scans and scanned cast obtained from the impression will be exported and saved to be used later for outcome assessment. ### Conditions - Nasal Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Scanning using intraoral scanner with markers - Scanning using intraoral scanner without markers - Physical Impression ### Outcomes Primary Outcomes - Dimensional accuracy of intraoral scanners Secondary Outcomes ### Location - Facility: Cairo University, Cairo, N/A, 11865, Egypt @@
## MRG-001 in Patients With Amyotrophic Lateral Sclerosis - NCT ID: NCT06315608 - Study ID: MRG24ALS - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2024-12-01 - Lead Sponsor: MedRegen LLC ### Study Description The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months. ### Conditions - Amyotrophic Lateral Sclerosis - Lou Gehrig Disease - Motor Neuron Disease - Motor Neuron Atrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MRG-001 ### Outcomes Primary Outcomes - Assessment of Treatment-Emergent Adverse Events Secondary Outcomes - Stem Cell Mobilization - Regulatory T-cell Mobilization - Change in Disease Progression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion - NCT ID: NCT06315595 - Study ID: 15-003511 - Status: RECRUITING - Start Date: 2015-09-30 - Completion Date: 2030-09-30 - Lead Sponsor: Mayo Clinic ### Study Description This study evaluates contrast-enhanced MR angiography and contrast-enhanced MR perfusion imaging for the visualization of blood vessels and enhancing tissues with better spatial detail and improved temporal fidelity compared to current methods. ### Conditions - Prostate Neoplasm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Improved performance in contrast-enhanced magnetic resonance imaging (MRI) as used for angiography and perfusion Secondary Outcomes ### Location - Facility: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States @@
## Surgical Approach to Uterine Septum - NCT ID: NCT06315582 - Study ID: STU00220487 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2026-02-26 - Lead Sponsor: Northwestern University ### Study Description The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures. ### Conditions - Uterine Septum - Surgical Complication - Septum; Uterus - Treatment Side Effects - Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Removal of uterine septum with hysteroscopic scissors without electrosurgery. - Hysteroscopic septoplasty utilizing bipolar electrosurgery ### Outcomes Primary Outcomes - Procedure-level variables: operative time hysteroscopic septoplasty - Procedure-level variables: Surgical Cost - Procedure-level variables: Fluid deficit - Resolution of uterine septum Secondary Outcomes - Compare adverse events - Comparing patient recovery and satisfaction ### Location - Facility: Northwestern Medicine Prentice Women's Hospital, Chicago, Illinois, 60611, United States @@
## A Multicentre Clinical Study on the Correlation Between Exercise and Hyperuricemia - NCT ID: NCT06315569 - Study ID: KY20242030-C-1 - Status: RECRUITING - Start Date: 2024-01-17 - Completion Date: 2024-11-01 - Lead Sponsor: Xijing Hospital ### Study Description This project is a multi-center clinical study on the correlation between exercise and hyperuricemia. The purpose is to explore the correlation between exercise and hyperuricemia, find out the metabolic rule of uric acid after exercise, and provide scientific evidence and clinical guidance for how to exercise scientifically and reasonably in patients with hyperuricemia. This trial is a multicenter, prospective, randomized controlled clinical trial with 100 participants. Inclusion criteria: 1. Patients with hyperuricemia (fasting uric acid \> 420μmol/L twice on different days); 2. Men aged between 18 and 35; 3. Able to complete baseline fitness test (3000m run time less than 14 minutes); 4. Fully informed consent, signed informed consent exclusion criteria: 1. Heart, liver and kidney insufficiency; 2. Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, diabetes mellitus; 3. Patients with secondary hyperuricemia caused by medicine or other diseases; 4. People who take uric acid lowering drugs; 5. People with related motor dysfunction or other factors that can easily cause discomfort after exercise 6. Those with mental disorders or communication disorders, and those who do not cooperate during the experiment A total of 100 subjects were included according to the scheduling criteria. SPSS23.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. According to the contents of the envelopes, the subjects were divided into group A, which exercised for 24 hours after 3000m exercise, and group B, which exercised for 48 hours after 3000m exercise. During the 48-hour observation period after each exercise, the changes of uric acid after exercise were explored. To provide scientific evidence and clinical guidance for patients with hyperuricemia how to exercise scientifically and rationally.Patients must meet all inclusion and exclusion criteria to be eligible to participate in the study. After determining patients' eligibility for the study, the researcher should fully explain the nature, purpose, risks and benefits of the study to the subjects before the study, and assure the patients that they have the right to withdraw at any time after agreeing to participate in the study, and the subjects should sign a written informed consent after fully considering and agreeing to participate in the study. The process of obtaining informed consent should be correctly recorded in all case report forms in this study.Baseline data such as blood uric acid, blood biochemistry, blood routine, urine routine, uric acid and demographic characteristics were collected after the patients were enrolled.The patients were randomly divided into two groups: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A.Within 48 hours after each 3000m exercise, the subjects' blood uric acid was detected immediately after exercise (within 5 minutes), 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, 36 hours, 48 hours. Blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid and other information were collected again 24 hours after intervention.From January 2024 to February 2024, we plan to draft clinical study protocols, investigator manuals, case reports, informed consent forms and other documents, and submit them to the Ethics Committee of the research sponsor for review and approval; February 2024 - March 2024: Complete the training of all researchers and officially start the research; March 2024 - August 2024: Participants were enrolled for the experiment; August 2024 - November 2024: collate and collect data, conduct statistical analysis, and confirm research results ### Conditions - Hyperuricemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Run 3000 meters ### Outcomes Primary Outcomes - Uric acid metabolism in patients with hyperuricemia after exercise Secondary Outcomes ### Location - Facility: Xijing Hospital, Xi'an, Shanxi, 710032, China @@
## An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK) - NCT ID: NCT06315556 - Study ID: 22539 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2027-04-30 - Lead Sponsor: Bayer ### Study Description This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied.ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth.Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina.Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner.Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown.The main purpose of this study is to:* find the number of preterm babies who are treated with aflibercept using a PDD in the UK* inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROPAn additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD.The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027.In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study. ### Conditions - Retinopathy of Prematurity - Preterm Infants ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Aflibercept (Eylea) ### Outcomes Primary Outcomes - Number of participants treated with Eylea PFS+PDD upon completion of 1- or 3-years following market introduction Secondary Outcomes - Summary of patient characteristics reported as number of participants with different categories - Summary of maternal factors reported as number of participants with different categories - Summary of comorbidities reported as number of participants with different categories - Summary of clinical condition and resource utilization reported as number of participants with different categories - Summary of clinical condition and resource utilization reported as days - Summary of outcomes of the premature infants reported as number of participants with different categories - Summary of ocular disease and treatment reported as number of participants with different categories ### Location - Facility: Many locations, Multiple Locations, N/A, N/A, United Kingdom @@
## A Multicentre Clinical Study on the Correlation Between Drinking Water and Hyperuricemia - NCT ID: NCT06315543 - Study ID: KY20222255-F-1 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-11-01 - Lead Sponsor: Xijing Hospital ### Study Description The name of this study is a multicentre clinical study on the correlation between drinking water and hyperuricemia. The purpose of this study is to clarify the correlation between drinking water and hyperuricemia. To explore the clinical effect of reducing uric acid by drinking water, and provide scientific evidence and clinical guidance for reducing uric acid by drinking water. The study design was a multicenter, prospective, randomized controlled clinical trial with a total of 88 participants. 1. Inclusion criteria: patients with hyperuricemia (fasting uric acid between 420-540μmol/L twice on different days and no drug treatment); Aged 18-65 years; Less than 1500mL of daily water intake recommended by the minimum dietary guidelines (assessed by dietary review combined with water diaries); Fully informed consent. Sign informed consent. 2. Exclusion criteria: patients with heart, liver and renal insufficiency; Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, polycystic ovary syndrome, diabetes mellitus; Patients with secondary hyperuricemia caused by medicine or other diseases; People who have gastrointestinal discomfort or have a history of gastrointestinal surgery, or other people who are not suitable for drinking more water; Patients with mental disorders or communication disorders, and those who did not cooperate during the experiment. A total of 88 subjects were included according to the exclusion criteria. SPSS26.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. The subjects were divided into two groups according to the contents of the envelopes: A constant drinking water observation group (maintaining the original drinking water volume) and B adequate drinking water intervention group (drinking an additional 1650mL of water per day (3 bottles of 550mL bottled water) on the basis of the original drinking water volume). During the 2-week observation period, the effects of constant drinking water and sufficient drinking water on blood uric acid, 24 h uric acid determination, urine osmotic pressure and other indicators were evaluated, and the effectiveness of sufficient drinking water in reducing blood uric acid was determined, and the applicable population was explored.Observation items and detection time: 1. During the screening period, the following data were collected: age, nationality, place of residence, education, occupation, height, weight, waist circumference, disease history, drug use history, drinking, smoking, normal water intake, urine volume, urine color and uric acid value. 2. Pre-test data: drinking water, urination, diet, psychological investigation, blood uric acid, blood biochemistry, routine blood routine, urine routine, uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure, heart rate, frequency of gout attack, whether to take urico-lowering drugs, whether to take other drugs that affect uric acid. 3. After the test: Fasting blood uric acid was monitored on the 2nd, 4th, 6th, 8th, 10th and 14th day respectively; Urge patients to record water diary and urination diary every day. At the end of the experiment, blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure and heart rate were tested again. Safety assessment indicators: edema, gastrointestinal discomfort, electrolytes, blood pressure, heart rate. ### Conditions - Hyperuricemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Drink water ### Outcomes Primary Outcomes - Blood uric acid change Secondary Outcomes ### Location - Facility: Xijing Hospital, Xi'an, Shanxi, 710032, China @@
## Effect of Telitacicept on Antibody Titers in Primary APS Patients - NCT ID: NCT06315530 - Study ID: sh12053 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Ruijin Hospital ### Study Description The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles. ### Conditions - Antiphospholipid Syndrome (APS) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Telitacicept - SOC ### Outcomes Primary Outcomes - The proportion of patients with decreased aPL titer at week 48 of treatment Secondary Outcomes - new thrombotic event - Effects of Telitacicept on the genotype, phenotype, and functional heterogeneity of T and B cells ### Location - Facility: Ruijin Hospital, Shanghai, Shanghai, 200025, China @@
## Double Crossover Casein Type Tolerance Trial - NCT ID: NCT06315517 - Study ID: AU24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Auburn University ### Study Description The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind, double-crossover study in which the physiological responses to increasing doses of lactose-free (A1-rich milk), A2 milk, and lactose-free A2 milk will be explored. ### Conditions - Dairy Intolerance - Healthy Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Conventional lactose-free cow's milk - Nonconventional (A2) cow's milk - Nonconventional (A2) lactose-free cow's milk ### Outcomes Primary Outcomes - Gastrointestinal Distress Scores Secondary Outcomes - Breath Hydrogen (ppm) - Breath Methane (ppm) - Blood Glucose (mg/dl) - Stool microbiome composition - Stool Beta-casomorphin-7 (BCM-7) - Stool intestinal fatty acid binding protein (I-FABP) ### Location - Facility: Auburn University, Auburn, Alabama, 36849, United States @@
## Circulating Factors in Nephrotic Syndrome - NCT ID: NCT06315504 - Study ID: Nephrotic Syndrome Cohort - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2034-04-01 - Lead Sponsor: Iain Bressendorff ### Study Description A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy. ### Conditions - Nephrotic Syndrome - Membranous Nephropathy - Minimal Change Disease - Primary Focal Segmental Glomerulosclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation ### Outcomes Primary Outcomes - levels of anti-nephrin in blood by ELISA Secondary Outcomes - changes in auto-antibodies in blood associated with membranous nephropathy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer - NCT ID: NCT06315491 - Study ID: CBX-12-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-04 - Lead Sponsor: Cybrexa Therapeutics ### Study Description The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days. ### Conditions - Platinum-resistant Ovarian Cancer - Refractory Ovarian Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CBX-12 ### Outcomes Primary Outcomes - Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] Secondary Outcomes - Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs) - Median Duration of Response (DoR) - Progression-Free Survival (PFS) - Plasma levels of CBX-12 (AUC0-24hr) - Plasma levels of CBX-12 (Cmax) - Plasma levels of CBX-12 (Tmax) - Plasma levels of CBX-12 (T1/2) - Plasma levels of Exatecan (AUC0-24hr) - Plasma levels of Exatecan (Cmax) - Plasma levels of Exatecan (Tmax) - Plasma levels of Exatecan (T1/2) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians - NCT ID: NCT06315478 - Study ID: Hybrid regimen for H.pylori - Status: COMPLETED - Start Date: 2021-02-01 - Completion Date: 2021-11-01 - Lead Sponsor: Helwan University ### Study Description Our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H. pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance ### Conditions - H.Pylori Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Omeprazole 20 MG Oral Tablet - Amoxicillin 500Mg Tab - Clarithromycin 500Mg Tab ### Outcomes Primary Outcomes - stool antigen retest Secondary Outcomes ### Location - Facility: Badr hospital, Cairo, N/A, N/A, Egypt @@
## Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD - NCT ID: NCT06315465 - Study ID: AIIMSA00647 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-01-01 - Lead Sponsor: All India Institute of Medical Sciences, New Delhi ### Study Description In general ketogenic diet is a recognized as an efficient non pharmacological treatment for children with refractory epilepsy. However, in the last decade, it has been tried for many neurological disorders in children including ASD, neurodegenerative disorders.Studies have shown that KD also helps in improvement of cognition, social skills, language function, and stereotypies. There is a limited number of reports of improvements after KD treatment, was insufficient evidence to attest the practicability of the KD as a treatment for ASD, but it is still a good indicator that this diet is a promising therapeutic option for this disorder. There are no major RCT's, hence raises concerns about the reliability and generalizability of findings. Majority of studies have used combined ketogenic diet therapy rather than single diet therapy and not many studies have compared add-on dietary intervention with standard of care. When compared to classic KD diet Modified Atkin's Diet is less restrictive, more palatable, more feasible and early response can be achieved. In summary, the rationale for conducting this study lies in the importance of add on dietary therapy in form of Modified Atkin's Diet along with standard of care for improvement of behavioral symptoms in children with ASD aged 3-8 years.This study aims to provide valuable insights that it can improve behavioral symptoms in ASD, early and ultimately improve the developmental outcomes in these children. ### Conditions - Modified Atkins Diet - Autism Spectrum Disorder - Standard of Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Modified Atkin's Diet with standard of care - Standard of Care ### Outcomes Primary Outcomes - To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years Secondary Outcomes - To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years - To compare the change in the cognitive ability as measured by Developmental Quotient(DQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years. - To compare the change in the cognitive ability as measured by Social Quotient(SQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years. - To compare the change in the cognitive ability as measured by Intelligence Quotient(IQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years. - To compare the quantitative reduction in behavioral problems using Child Behavior Checklist (CBCL) in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder aged 3-8 years. - To compare the change in sleep related problems using Children's Sleep Habit Questionnaire (CSHQ)children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder age - To compare the resting state fMRI findings in a subset of patients in the two arms - To assess the compliance in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care - To assess the adverse effect profile in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g - NCT ID: NCT06315452 - Study ID: PremaVitaD - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-02-01 - Completion Date: 2024-06-01 - Lead Sponsor: Fondation Hôpital Saint-Joseph ### Study Description Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month.The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns. ### Conditions - Vitamin D Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Vitamine D deficiency frequency Secondary Outcomes - vitamine D deficiency and maternal or feotal caracteristics - vitamine D deficiency and premature newborn comorbidities - effect of supplementation ### Location - Facility: Hôpital Saint Joseph, Paris, N/A, 75014, France @@
## Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion - NCT ID: NCT06315439 - Study ID: Multi-RELAMI - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-11-30 - Lead Sponsor: Campus Bio-Medico University ### Study Description Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results.Ex-vivo fluorescence confocal laser microscopy (FCM) with MAVIG VivaScope® 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample. ### Conditions - Pancreas Adenocarcinoma - Endoscopic Ultrasound - Digital Pathology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Endoscopic ultrasound fine needle biopsy ### Outcomes Primary Outcomes - Diagnostic accuracy Secondary Outcomes ### Location - Facility: Fondazione Policlinico Campus Bio Medico, Rome, Roma, 00191, Italy @@
## A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR). - NCT ID: NCT06315426 - Study ID: GR1802-011 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. ### Study Description Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease. ### Conditions - Allergic Rhinitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GR1802 injection - Placebo ### Outcomes Primary Outcomes - Change from Baseline in rTNSS( reflective total nasal symptom scores) Secondary Outcomes - Change from Baseline in rTOSS( reflective total ocular symptom scores) - Change from Baseline in rTNSS - Mean change from baseline in iTNSS(instantaneous total nasal symptom scores) - Mean change from baseline in iTOSS(instantaneous total ocular symptom scores) - Change from baseline in VAS(Visual Analog Scale) score - Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores - Adverse events (AEs) - Immunogenicity characteristics ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Composite Plug vs d-PTFE Membrane in Socket Preservation - NCT ID: NCT06315413 - Study ID: Composite plug vs d-PTFE - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-01 - Lead Sponsor: Cairo University ### Study Description The aim of the current study is to compare the effect socket sealing with flowable resin composite compared to dense polytetrafluoroethylene membrane after filling the extraction site with xenograft particles in terms of soft and hard tissue changes, procedural time, post operative pain, patients' satisfaction, and cost effectiveness. ### Conditions - Alveolar Bone Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Socket preservation using xenograft and composite plug - Socket preservation using xenograft and intentionally exposed d-PTFE ### Outcomes Primary Outcomes - Change in horizontal bone dimension Secondary Outcomes - Change in Vertical bone dimension - Keratinized tissue thickness - Procedural time - Post-operative pain - Patient Satisfaction - Incidence of complications ### Location - Facility: Faculty of oral and dental medicine, Cairo university, Cairo, N/A, 4240310, Egypt @@
## Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections - NCT ID: NCT06315400 - Study ID: ING-07-2023 - Status: RECRUITING - Start Date: 2023-12-19 - Completion Date: 2025-12-31 - Lead Sponsor: Valenta Pharm JSC ### Study Description The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo. ### Conditions - Influenza, Human - Acute Respiratory Infection - Common Cold ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ingavirin® - Placebo ### Outcomes Primary Outcomes - Percentage of patients with normalization of body temperature at Visit 3 (Day 3) Secondary Outcomes - Timeframe for normalization of body temperature from the start of treatment, measured in hours - Time of cough disappearance from the moment of treatment initiation - Percentage of patients with absence of catarrhal syndrome - Percentage of patients with absence of intoxication syndrome - Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy - Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration - Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration - Assessment of vital signs: blood pressure - Assessment of vital signs: heart rate - Assessment of vital signs: respiratory rate - Assessment of vital signs: body temperature - Evaluation of concomitant therapy - Laboratory evaluation: leukocyte formula - Laboratory evaluation: hemoglobin - Laboratory evaluation: leukocyte count - Laboratory evaluation: platelet count - Laboratory evaluation: red blood cell count - Laboratory evaluation: hematocrit - Laboratory evaluation: erythrocyte sedimentation rate - Laboratory evaluation: blood glucose - Laboratory evaluation: total protein - Laboratory evaluation: total bilirubin - Laboratory evaluation: AST - Laboratory evaluation: ALT - Laboratory evaluation: creatinine - Laboratory evaluation: urea - Laboratory evaluation: triglycerides - Laboratory evaluation: urinalysis - Frequency of adverse events (AEs) and serious adverse events (SAEs) - Percentage of patients who discontinued study due to AE/SAE ### Location - Facility: GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation, Rostov-na-Donu, N/A, N/A, Russian Federation @@
## Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers - NCT ID: NCT06315387 - Study ID: GIB-01-01-2023 - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2024-12-31 - Lead Sponsor: Valenta Pharm JSC ### Study Description Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers ### Conditions - Cholecystitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - 4-MUST, 1 tablet - 4-MUST, 2 tablets - 4-MUST, 3 tablets ### Outcomes Primary Outcomes - Pharmacokinetics - Cmax - Pharmacokinetics - tmax - Pharmacokinetics - AUC0-t - Pharmacokinetics - AUC0-inf - Pharmacokinetics - AUCextr - Pharmacokinetics - t1/2 - Pharmacokinetics - kel - Pharmacokinetics - MRT - Pharmacokinetics - Vd - Pharmacokinetics - CL - Pharmacokinetics - number of terminal timepoints Secondary Outcomes - Adverse event type - Adverse event frequency - Adverse event severety - Drop-outs associated with adverse events ### Location - Facility: Limited Liability Company "Medical Center Eco-Safety", St. Petersburg, N/A, 19119, Russian Federation @@
## 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases - NCT ID: NCT06315374 - Study ID: FJUH112267 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-07-31 - Lead Sponsor: Fu Jen Catholic University ### Study Description The purpose of this study is to investigate the auxiliary benefits of three-dimensional printed activating assistive devices for soft-mist inhaler on patients' utilization habit. ### Conditions - Chronic Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Use soft mist inhaler - Use soft mist inhaler with a 3D assistive device ### Outcomes Primary Outcomes - satisfaction survey Secondary Outcomes ### Location - Facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University, New Taipei City, N/A, 24352, Taiwan @@
## DIAbetes and NAFLD - NCT ID: NCT06315361 - Study ID: 2445 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-05-20 - Completion Date: 2035-12-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Non-alcoholic hepatic steatosis (NAFLD) is characterised by the excessive accumulation of triglycerides in the liver and is often associated, in the absence of significant alcohol consumption, with insulin resistance and metabolic syndrome with which it shares the most frequent clinical manifestations (hypertension, dyslipidaemia, visceral adiposity, glucose intolerance). Due to the pandemic spread of obesity and diabetes and by virtue of better control of viral hepatitis, NAFLD is the most common cause of liver damage in Western countries with a prevalence of around 20-30% of the general population.The clinical impact of NAFLD in diabetes is considerable and represents a real driver of the major clinical outcomes that impact on the health of the individual, consequently creating a real 'burden of disease' especially in those populations considered to be at higher risk of disease severity.Individuals with diabetes are, in fact, those at greatest risk of developing the clinical sequelae of NAFLD and often do not receive adequate hepatological support and a correct hepatic pathology. In fact, it has been documented in the literature that the presence of diabetes increases the severity of liver damage, bringing the risk of NASH up to 80% and increasing the risk of significant fibrosis to 30-40% of subjects with hepatic steatosis as well as representing an independent predictor for significant fibrosis. Lastly, the increased risk of hepatocarcinoma in subjects with diabetes and NAFLD should not be overlooked, as documented by our group and confirmed in a large Italian case series.In subjects with diabetes, moreover, the presence of NAFLD is not only associated with worse glycaemic control, but also with micro- and macro-vascular complications as well as nephrological and neuropathic complications and increased mortality.Therefore, the possibility of applying the non-invasive fibrosis scores currently available for NAFLD on a large scale, in a population at high risk of progressive liver disease, would make it possible to characterise (a) the true epidemiology of significant fibrosis (F3 or higher); (b) allow primary prevention actions to be carried out by optimising the use of resources or by identifying subjects at greater risk of damage progression; (c) understand, in cases with a long history of disease the true prevalence of clinical outcomes; (d) understand the epidemiology of comorbidities and polypharmacy as a function of significant fibrosis. ### Conditions - NAFLD - Diabetes - NASH - Fibrosis, Liver - Cirrhosis, Liver - Liver Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of significant fibrosis by non invasive tests Secondary Outcomes - Identification of MALO (major liver outcomes) - Identification of MACE ### Location - Facility: UOSD Diabetologia, Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS, Roma, Rome/lazio/italy, 00168, Italy @@
## Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment - NCT ID: NCT06315348 - Study ID: URI_116301123 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Universidad Complutense de Madrid ### Study Description Research QuestionWhile the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials.Aims of the ProjectThe aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups. ### Conditions - Dental Malocclusion - Maxillary Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - flapless alveolar decortication with augmentation ### Outcomes Primary Outcomes - Soft tissue contour changes pre- and post- orthodontic therapy - Plaque index (PlI) - Bleeding on probbing (BoP) - Probing depth (PD) - External apical root resorption (EARR) - Orthodontic tooth movement Secondary Outcomes - Percentage of residual pockets (PD>4 mm). - Soft tissue thickness by PIROP ultrasound scanner - Gingival microvasculature - PROMs - Adverse events (AEs) ### Location - Facility: Faculty of Odontology, University Complutense Madrid, Madrid, N/A, 28040, Spain @@
## A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants - NCT ID: NCT06315335 - Study ID: UP0118 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-07-29 - Lead Sponsor: UCB Biopharma SRL ### Study Description The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - UCB9741 - Placebo ### Outcomes Primary Outcomes - Occurrence of TEAEs - Occurrence of treatment-emergent SAEs Secondary Outcomes - Cmax - AUC0-t - AUCinf ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy - NCT ID: NCT06315322 - Study ID: EP0224 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-02-28 - Lead Sponsor: UCB Biopharma SRL ### Study Description The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy. ### Conditions - Childhood Absence Epilepsy - Juvenile Absence Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Brivaracetam Film-coated tablet - Brivaracetam oral solution ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) during the study - Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study Secondary Outcomes - Incidence of serious adverse events (SAEs) during the study - Incidence of IMP related TEAEs during the study ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant - NCT ID: NCT06315309 - Study ID: IRB-300012281 (UAB 23146) - Status: NOT_YET_RECRUITING - Start Date: 2024-06-29 - Completion Date: 2027-02 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD. ### Conditions - GVHD,Acute - Acute Leukemia - Myelodysplastic Syndromes - Myeloproliferative Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ATG Combined with Tacrolimus and Mini Methotrexate ### Outcomes Primary Outcomes - To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances Secondary Outcomes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer - NCT ID: NCT06315296 - Study ID: iRISID-2023-1985 - Status: RECRUITING - Start Date: 2023-12-13 - Completion Date: 2028-12 - Lead Sponsor: Thomas Jefferson University ### Study Description This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and improving survival outcomes after stereotactic radiosurgery in patients with breast or lung cancer that has spread to the brain (brain metastases). Lung cancer and breast cancer are the two most frequent causes of brain metastases. The diagnosis of brain metastases is associated with poorer survival and tumor-induced and treatment-related side effects. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. Patients who receive stereotactic radiosurgery for brain metastases may experience less neurocognitive side effects than with other types of brain radiation, but may still be at risk for their brain metastases growing, spreading, or getting worse. Patients with obesity and diabetes have been shown to have worse survival and increased radiation-related side effects. Evidence demonstrates that simply changing meal timing can have a positive impact on multiple health outcomes. Time-restricted eating, or prolonged nighttime fasting, has been proven to have positive effects on heart disease risk reduction, weight control management and chemotherapy side effect reduction. Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain metastases from breast or lung cancer. ### Conditions - Anatomic Stage IV Breast Cancer AJCC v8 - Metastatic Breast Carcinoma - Metastatic Lung Carcinoma - Metastatic Malignant Neoplasm in the Brain - Stage IV Lung Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Behavioral Dietary Intervention - Text Message-Based Navigation Intervention - Internet-Based Intervention - Dietary Counseling and Surveillance - Stereotactic Radiosurgery - Biospecimen Collection - Magnetic Resonance Imaging - Neurocognitive Assessment - Questionnaire Administration - Interview - Internet-Based Intervention - Stereotactic Radiosurgery - Text Message-Based Navigation Intervention - Biospecimen Collection - Magnetic Resonance Imaging - Neurocognitive Assessment - Questionnaire Administration - Interview ### Outcomes Primary Outcomes - Accrual rate - Attrition rate - Time-restricted eating (TRE) compliance rate - Incidence of adverse effects (AEs) - Patient satisfaction Secondary Outcomes - Neurocognitive function decline - Neurocognitive function decline - Neurocognitive function decline - Neurocognitive function decline - Intracranial progression free survival (PFS) ### Location - Facility: Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States @@
## An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia - NCT ID: NCT06315283 - Study ID: TV44749-BA-10196 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-04-15 - Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. ### Study Description The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia.Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.The total duration of participation in the trial for each participant is planned to be approximately 21 weeks. ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - TV-44749 - Oral olanzapine ### Outcomes Primary Outcomes - Area under the curve (AUC) of TV-44749 - AUC of oral olanzapine Secondary Outcomes - Number of participants with at least one treatment-emergent adverse event during treatment with TV-44749 - Number of participants with at least one treatment-emergent serious adverse event during treatment with TV-44749 - Number of participants with at least one injection site adverse event during treatment with TV-44749 - Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749 - Minimum observed plasma drug concentration at steady state (Cmin,ss) of TV-44749 - Cmax,ss of oral olanzapine - Cmin,ss of oral olanzapine ### Location - Facility: Teva Investigational Site 15739, Los Alamitos, California, 90720, United States @@
## To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer - NCT ID: NCT06315270 - Study ID: 24K040-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2029-03-20 - Lead Sponsor: The First Hospital of Jilin University ### Study Description This project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of TCR diversity with clinical outcomes and the potential role of TCR profiling in cancer prognosis. ### Conditions - Epithelial Ovarian Cancer - Stage III Ovarian Cancer - Stage IV Ovarian Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Analysis of TCR genealogy data Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients - NCT ID: NCT06315257 - Study ID: J23105sIRB - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2027-03 - Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ### Study Description A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy. ### Conditions - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PVX7 ### Outcomes Primary Outcomes - Safety of PVX7 as assessed by adverse events - Feasibility of PVX7 Secondary Outcomes - Cellular Immune Response - Immune Response - Presence of circulating HPV DNA ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study - NCT ID: NCT06315244 - Study ID: 2558 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital ### Study Description Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome. ### Conditions - Coccyx Disorder - Coccyx Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - US Guided Perineural Injection and Neuroprolotherapy ### Outcomes Primary Outcomes - Effectiveness of Perforating Cutaneous Nerve Injection Secondary Outcomes - Change in Pressure Pain Threshold - Change in Quality of Life ### Location - Facility: Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, N/A, 34371, Turkey @@
## Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients - NCT ID: NCT06315231 - Study ID: SIM0308-02-Y-2-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2025-05-30 - Lead Sponsor: Simcere Pharmaceutical Co., Ltd ### Study Description This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial.The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke.Participants will be required to receive 12 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo. ### Conditions - Post-stroke Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Edaravone dexborneol sublingual tablet - Placebo ### Outcomes Primary Outcomes - Adverse Events - Number of discontinuation/withdrawal patients - The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores. Secondary Outcomes - The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group - The changes of Mini-Mental State Examination (MMSE) score - The changes of Montreal Cognitive Assessment (MoCA) scale - The changes of MoCA subscales - Modified Rankin Scale (mRS) scores - The changes of National Institutes of Health Stroke Scale ### Location - Facility: The First Affiliated Hospital of USTC Anhui Provincial Hospital, Hefei, Anhui, N/A, China @@
## Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men - NCT ID: NCT06315218 - Study ID: Pro2023000968 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-04 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description This research study aims to test the effectiveness, reach, and maintenance over time of the iTHRIVE 365 intervention for Black same gender loving men (SGLM) living with HIV. iTHRIVE 365 is a SGLM community-developed multicomponent mHealth intervention that aims to: 1) Support daily health promotion via HIV and psychological health education and health maintenance reminders; 2) Foster positive social connections among SGLM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to SGLM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. ### Conditions - Sexual and Gender Minorities - Social Stigma - Medication Adherence - Depressive Symptoms - Anxiety Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - iTHRIVE 365 HIV care intervention ### Outcomes Primary Outcomes - Antiretroviral (ART) Medication Use - ART adherence-Long Lag Assessments Secondary Outcomes - Daily Diary Substance Use - Substance Use-Long Lag Assessments - Depressive Symptoms - Depressive Symptoms-Long Lag - Anxiety Symptoms - Anxiety Symptoms-Long Lag - Emotion Regulation Emotion Regulation - Emotion Regulation-Long Lag Assessments - COPE - COPE-Long Lag Assessments ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women - NCT ID: NCT06315205 - Study ID: ROV-LEBE-2023-01 - Status: RECRUITING - Start Date: 2023-07-26 - Completion Date: 2025-01 - Lead Sponsor: Rovi Pharmaceuticals Laboratories ### Study Description This is a Phase I, open label, sequential, single ascending dose (SAD) study to evaluate the pharmacokinetic (PK), safety, and tolerability of Letrozole LEBE in healthy post-menopausal women. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Letrozole LEBE 75 mg - Letrozole LEBE 150 mg - Letrozole LEBE 225 mg ### Outcomes Primary Outcomes - λz - Cmax - Clast - tmax - tlag - t1/2 - AUC∞ - AUClast Secondary Outcomes - E1 - SE1 - E2 - λz - Cav - Cmin, ss - Cmax,ss - tmax - t1/2 - AUCτ ### Location - Facility: Investigational Site number CZ-01, Praha, N/A, N/A, Czechia @@
## Stroke Alarm Efficacy Trial - NCT ID: NCT06315192 - Study ID: CIV-22-10-041006 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: Region Skane ### Study Description The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset.This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population.A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size.Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study.Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by:1. recent TIA, OR2. recent stroke without persisting arm motor deficit, OR3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard. ### Conditions - Stroke Acute - Atrial Fibrillation - TIA ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Stroke Alarm ### Outcomes Primary Outcomes - Time from onset of stroke with unilateral arm motor deficit until alarm by the device. Secondary Outcomes ### Location - Facility: Skane University hospital, Lund, N/A, 22185, Sweden @@
## Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE) - NCT ID: NCT06315179 - Study ID: STUDY00004616 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2030-01 - Lead Sponsor: Seattle Children's Hospital ### Study Description This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation. ### Conditions - Inflammatory Bowel Diseases - Crohn Disease - Ulcerative Colitis - Indeterminate Colitis - Functional Abdominal Pain Syndrome - Functional Bowel Disorder - Esophageal Diseases - Gastroduodenal Disorder - Bowel Dysfunction - Gallbladder Diseases - Sphincter of Oddi Dysfunction - Anorectal Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Esophagogastroduodenoscopy (EGD) with biopsy - Colonoscopy w/ biopsy ### Outcomes Primary Outcomes - Bio-repository sample collection for spatial transcriptomics Secondary Outcomes - Paris Classification of Crohn's Disease - Montreal Classification of Crohn's disease - Paris Classification of Ulcerative Colitis/Indeterminate Colitis - Montreal Classification of Ulcerative Colitis/Indeterminate Colitis - Disorder of Gut-Brain Interaction classification - Physician's Global Assessment (PGA) ### Location - Facility: Seattle Children's Hospital, Seattle, Washington, 98105, United States @@
## Study on Using Radiofrequency to Treat Moderate to Severe Acne - NCT ID: NCT06315166 - Study ID: CIP-PLG_CLINICAL-22-04 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-12 - Lead Sponsor: Pollogen ### Study Description Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris. ### Conditions - Moderate to Severe Acne Vulgaris ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - triLift/Legend Pro+ Fractional RF System ### Outcomes Primary Outcomes - Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris Secondary Outcomes - Overall Improvement of Acne - Subjective Satisfaction with the Treatment Results ### Location - Facility: Cosmedic Dermatology (CosmedicDerm), Grosse Pointe, Michigan, 48230, United States @@
## Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model - NCT ID: NCT06315153 - Study ID: KS2023077-1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-01-03 - Completion Date: 2026-04-01 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke.The objectives of the study were as follows: first, to integrate the degree of carotid stenosis and plaque characteristics assessed by vascular ultrasound for a comprehensive assessment of plaque vulnerability; second, to develop an assessment tool for the risk of future ischemic stroke in patients with asymptomatic carotid stenosis by combining vascular risk factors, serologic markers, carotid ultrasound characteristics, and contrast-enhanced ultrasonographic parameters; and third, to incorporate vascular ultrasound parameters into existing predictive models of ischemic stroke recurrence risk to develop a risk assessment tool for atherosclerotic ischemic stroke.The main questions it aims to answer are:* How to screen high-risk patients and those eligible for revascularization from asymptomatic carotid stenosis patients for primary prevention of stroke.* How to improve the prediction accuracy of atherosclerotic ischemic stroke based on existing prediction models for secondary prevention of stroke. ### Conditions - Carotid Stenosis - Ischemic Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The occurrence of ischemic stroke - The recurrence of ischemic stroke Secondary Outcomes ### Location - Facility: The first hospital of Jilin university, Changchun, Jilin, 130021, China @@
## Assessing and Addressing Community Exposures to Environmental Contaminants - NCT ID: NCT06315140 - Study ID: 22-00248 - Status: RECRUITING - Start Date: 2023-02-16 - Completion Date: 2027-04 - Lead Sponsor: NYU Langone Health ### Study Description The purpose of this study is to build on our equitable, eight-year Tribal-academic partnership with the Ramapough Nation of northern NJ to advance tradition-centered farming practices and management strategies supporting sustainable food systems to relieve local food insecurity and nutritional deficiency, prevent disease and promote health. Furthermore, assessing the extent of environmental contamination, individual toxicant burdens and micronutrient levels and health disorders in Ramapough Tribal members of both sexes as outlined in the following:* Collect in-person/online survey information on demographics, health and food intake, nutrition, food security, and psychosocial stressors, and perform core anthropometric measurements (i.e., height, weight, body mass index, body circumference and blood pressure) at enrollment on Tribal members to inform health promotion strategies and community actions.* Determine individual-level contaminant burdens and micronutrient concentrations (e.g., iron, calcium, folate, vitamins) in urine and blood from surveyed (sub-aim 1a) Ramapough Turtle Clan volunteers.* Test soil, plants and surface water where Turtle Clan residents live, recreate and attend church in Ringwood, NJ using a community-based, citizen scientist approach. ### Conditions - Environmental Exposure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Proportion of individuals with heavy metal contaminants in home water samples - Proportion of individuals with heavy metal and metalloid contaminations in blood biospecimens - Proportion of individuals with heavy metal and metalloid contaminations in urine biospecimens - Proportion of individuals with insufficient blood serum micronutrient levels - Proportion of individuals with health disorders Secondary Outcomes ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## The CanDo (Canadian Donor Milk) Trial - NCT ID: NCT06315127 - Study ID: 23-0119-A - Status: RECRUITING - Start Date: 2023-11-28 - Completion Date: 2025-03-31 - Lead Sponsor: Mount Sinai Hospital, Canada ### Study Description The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units. It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months. The Investigators will also explore whether the type of supplementation will positively affect measures of newborns' health, growth, behavior, feeding efficacy, and parental stress. Each participating infant born to a diabetic mother OR born small for his/her gestational age (\<2500 grams) is assigned at random to 2 groups. The groups are: 1) Donor milk: all babies in this group will receive pasteurized donor milk from a trusted milk bank. 2) Formula: all babies in this group will receive formula as a standard of care. ### Conditions - Small for Gestational Age at Delivery - Gestational Diabetes - type1diabetes - Type2diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Human donor milk - Formula ### Outcomes Primary Outcomes - Donor milk supplementation and exclusive breastfeeding rate at 4 months Secondary Outcomes - Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 months - Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 4 months - Exploring donor milk supplementation and glucose concentrations during hospital stay - Exploring donor milk supplementation and percent weight loss during hospital stay - Exploring donor milk supplementation and the length of hospital stay - Exploring donor milk supplementation and weight measurements - Exploring donor milk supplementation and length measurements - Exploring donor milk supplementation and head circumference measurements ### Location - Facility: Labour and Delivery at Mount Sinai Hospital, Toronto, Ontario, M5G 1X5, Canada @@
## A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders - NCT ID: NCT06315114 - Study ID: p-2023-15049 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2028-04-01 - Lead Sponsor: Mental Health Services in the Capital Region, Denmark ### Study Description The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service. ### Conditions - Mental Disorder - Behavior Disorders - Diagnosis, Psychiatric - Diagnosis Dual - Severe Mental Disorder - Mental Illness - Psychiatric Disorder - Psychiatric Disease - Psychiatric Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lighthouse MBT Parenting Program (LPP) - Care as usual (CAU) ### Outcomes Primary Outcomes - Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF) Secondary Outcomes - Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ) - Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF) - Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF). - Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW) - Parenting competence assessed with the Parenting Sense of Competence (PSOC) - Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI) - Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D) ### Location - Facility: Psychotherapeutic Centre Stolpegaard, Gentofte, Capital Region, 2820, Denmark @@
## Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China - NCT ID: NCT06315101 - Study ID: K-2023-092 - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2023-12-31 - Lead Sponsor: Guangzhou University of Chinese Medicine ### Study Description This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China. ### Conditions - Unresectable Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Chinese Herbal Medicine ### Outcomes Primary Outcomes - Efficacy outcomes - Survival analysis - Survival analysis Secondary Outcomes - Adverse Events assessment ### Location - Facility: the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, 510407, China @@
## Food Biodiversity and Human Health - NCT ID: NCT06315088 - Study ID: 69HCL24_0144 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2025-03-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description In Western countries, one of the major nutritional challenges requires reducing the proportion of animal proteins and increasing the proportion of vegetable proteins in the daily plate. Added to this nutritional challenge is an environmental challenge, with plant proteins being much less expensive to produce. However, plant proteins are mainly provided by cereals and legumes, a large diversity of which is necessary to cover the recommended daily intake of amino acids. However, given the collapse of cultivated biodiversity (loss of 75% in 100 years, FAO), the diversity of the supply is very reduced.Furthermore, for several years, public health studies have indicated a chronic deficit in micronutrients (minerals/trace elements, vitamins, antioxidants) as well as fiber in the diet of the French population. This comes in particular from the impoverishment of the nutritional quality of the fruits/vegetables/cereals/legumes consumed. In general, diet plays a major role in the primary prevention of chronic diseases (cardiovascular, diabetes, cancer) including periodontal disease. Thus, a diet low in sugars, saturated fats and rich in fiber would reduce the appearance of periodontal disease by strengthening salivary capacity. However, certain pathogenic periodontal bacteria (such as Porphyromonas gingivalis) can migrate (blood, digestive or respiratory routes) to reach other organs and represent a risk factor for other chronic diseases. Thus, the prevention of periodontal diseases through diet control would also contribute to the prevention of other chronic diseases.The benefit of plant-based diets to reduce the risk of cancer is now established. In addition, certain cereals such as spelled have superior nutritional qualities to common wheat, notably their protein content and they also contain higher quantities of certain bioactive compounds with anti-cancer properties (such as phytosterols).Furthermore, the potential impact of the oral microbiota on chronic diseases is now being studied: in healthy adults, a dysbiotic periodontal microbiota may be likely to lead to systemic para-inflammation. It has also been shown that a dietary change (Mediterranean diet) could lead to a reduction in pathogenic bacteria in the oral microbiota (including P. gingivalis). However, the link between the introduction of cereals into the diet and the evolution of cancer risk factor bacteria in the oral microbiota has never been demonstrated.This pilot clinical study plans to focus on the oral microbiota, with the aim of objectivizing a possible link between a modification of the diet by the introduction of cereals (einkorn type) and the evolution of certain bacteria of this microbiota. , notably P. gingivalis (but also T. forsythia, S. anginosus, A. actinomycetemcomitans, T. denticola and F. nucleatum), considered as cancer risk factors and thus observe an improvement in health status oral and general. ### Conditions - Oral Microbiota - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Einkorn Diet - Intermediate oral microbiota - Periodontal health status - General health status ### Outcomes Primary Outcomes - Total periodontal bacteria count Secondary Outcomes - Intermediate periodontal bacteria count - Periodontal health analysis:plaque index - Periodontal health analysis: gingival index - Periodontal health analysis : pocket depth and loss of clinical attachment - Periodontal health analysis : interdental inflammation - Periodontal health analysis : salivary pH - General health analysis : body mass index - General health analysis : measurement of abdominal circumference - General health analysis : blood pressure - General health analysis : MOS SF-36 quality of life questionnaire - General health analysis : eating habits ### Location - Facility: Maison des professionnels, Lyon, N/A, 69000, France @@
## Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial - NCT ID: NCT06315075 - Study ID: 657876 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2029-12-31 - Lead Sponsor: Haukeland University Hospital ### Study Description The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:* to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.* to investigate how well DBT-A works at 12 months follow-up* to investigate whether pre-treatment factors can predict who will benefit from treatment ### Conditions - Self-harm - Suicidal Ideation - Suicide and Self-harm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dialectical behavior therapy for adolescents (DBT-A) ### Outcomes Primary Outcomes - Lifetime Parasuicide Count Interview - Number of participants in need of emergency department visits caused by suicidal behavior Secondary Outcomes - Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ) - Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10) - Barriers to Treatment Participation Scale (BTPS) score - Perceived benefit of skills training in DBT-A measured by a study specific questionnaire. ### Location - Facility: Dept. of child and adolescent psychiatry, Haukeland University Hospital, Bergen, N/A, 5021, Norway @@
## Efficacy of Rezum® in Reducing Prostate Volume - NCT ID: NCT06315062 - Study ID: CEC-UNIBE-07-2023 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Urología Costa Rica ### Study Description This study aimed to assess the efficacy of Rezum® water vapor therapy in reducing prostate volume in patients aged 40 years or older with Benign Prostate Hyperplasia (BPH) at UNIBE Hospital in Costa Rica. A retrospective analysis will be conducted on 289 patient records, focusing on prostate volume, International Prostate Symptom Score (IPSS), and urinary flow rate. Statistical analyses included two-sample mean comparisons, effect size estimation, and linear regression. ### Conditions - Benign Hyperplasia of Prostate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prostate volume Secondary Outcomes - International Prostate Symptome Score - Urinary flow rate ### Location - Facility: Hospital UNIBE, San José, N/A, 11301, Costa Rica @@
## Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness - NCT ID: NCT06315049 - Study ID: 2023-ENFPOD-2621979 - Status: COMPLETED - Start Date: 2023-06-26 - Completion Date: 2023-07-31 - Lead Sponsor: Universitat Politècnica de València ### Study Description This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session. ### Conditions - Severe Mental Disorder - Schizophrenia - Bipolar Disorder - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Music therapy ### Outcomes Primary Outcomes - IDARE test - SBP - DBP - HR - RR Secondary Outcomes ### Location - Facility: Universitat Politècnica de València, Valencia, N/A, 46022, Spain @@
## Effects of Developmental Gymnastics on Preschoolers' Motor Skills - NCT ID: NCT06315036 - Study ID: 32/2021 - Status: COMPLETED - Start Date: 2021-09-05 - Completion Date: 2022-05-10 - Lead Sponsor: University of Novi Sad ### Study Description Background: During childhood, physical activity (PA) is considered indispensable for developing motor skills through movement in the early stages of human development. Being active helps individuals develop fine and gross motor skills (GMS) by promoting an active lifestyle. Notably, this phase, characterized by regular PA and attaining motor competence, is associated with many health-related benefits. Early motor intervention programs have garnered attention for their positive influence on children's motor skills, as evidenced by various studies. A spectrum of more specialized methods is available alongside these general approaches, including programs designed to augment the time dedicated to general PA within school environments. Previous research has demonstrated the efficacy of incorporating experimental exercise interventions, grounded in enjoyable activities and game drills, into the curriculum, significantly improving children's basic motor skills. Many research articles have explored the impact of developmental gymnastics (DG) on children's fitness, indicating that gymnastics training can produce numerous beneficial outcomes for children's physical fitness.Method and Materials: Three hundred preschool children were assigned to either a gender-balanced group participating in a DG exercise program (EG; n=99) or a control group (CG; n=121). While individuals in the CG followed three structured extracurricular physical activities per week in kindergarten, the EG participants received 60 minutes of the DG exercise program two days a week. The Test of Gross Motor Development-2 (TGMD-2) was used to assess GMS.Aim: The study aimed to determine if participation in a structured DG program could improve GMS among preschool children compared to those in a group that attended extracurricular physical activities in a kindergarten. ### Conditions - Motor Activity - Child Development - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Developmental gymnastics ### Outcomes Primary Outcomes - Test of gross motor development (tgmd-2): Locomotor Skills - Run - Test of gross motor development (tgmd-2): Locomotor skills - Gallop - Test of gross motor development (tgmd-2): Locomotor skills - Hop - Test of gross motor development (tgmd-2): Locomotor skills - Leap - Test of gross motor development (tgmd-2): Locomotor skills - Horizontal jump - Test of gross motor development (tgmd-2): Locomotor skills - skip - Test of gross motor development (tgmd-2): Locomotor skills - slide - Test of gross motor development (tgmd-2): Object control skill- two-hand strike - Test of gross motor development (tgmd-2): Object control skill- stationary bounce - Test of gross motor development (tgmd-2): Object control skill- catch - Test of gross motor development (tgmd-2): Object control skill- kick - Test of gross motor development (tgmd-2): Object control skill- overhand throw - Test of gross motor development (tgmd-2): Object control skill- underhand roll Secondary Outcomes - Sex - Date of birth - Weight - Height - Body Mass Index (BMI) - Adherence ### Location - Facility: Faculty of sport and Physical Education, University of Novi Sad, Novi Sad, Vojvodina, 21000, Serbia @@
## The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) - NCT ID: NCT06315023 - Study ID: CP-0029 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-10-06 - Completion Date: 2032-06-07 - Lead Sponsor: Endologix ### Study Description The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. ### Conditions - Peripheral Arterial Disease - Symptomatic Femoropopliteal Lesions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - DETOUR System ### Outcomes Primary Outcomes - Freedom from CD-TLR - Freedom from MAE Secondary Outcomes ### Location - Facility: NYU Langone Medical Center, New York, New York, 10016, United States @@
## REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis - NCT ID: NCT06315010 - Study ID: MedOPP662 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2028-04 - Lead Sponsor: MedSIR ### Study Description REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene. ### Conditions - NSCLC - Brain Metastases - ROS1 Gene Rearrangement ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Repotrectinib ### Outcomes Primary Outcomes - Intracranial Objective Response Rate (IC-ORR) Secondary Outcomes - Clinical Benefit Rate (CBR) for intracranial (IC) lesions - Disease Control Rate (DCR) for IC lesions - Time to Response (TTR) for IC lesions - Duration of Response (DoR) for IC lesions - Objective Response Rate for extracranial (EC) and overall lesions (EC-ORR) - CBR for EC and overall lesions - DCR for EC and overall lesions - TTR for EC and overall lesions - DoR for EC and overall lesions - Best percentage of change in tumor burden - Progression-Free Survival (PFS) - Overall Survival (OS) - Neurologic function - Quality of life (QoL) with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) - QoL with the brain cancer specific questionnaire (QLQ-C20). - Safety and tolerability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dynamic Changes in Circulating Tumour Cells Protein Expression - NCT ID: NCT06314997 - Study ID: 2013.34 - Status: RECRUITING - Start Date: 2019-01-14 - Completion Date: 2027-12-18 - Lead Sponsor: Matteo's Friends ### Study Description This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4). ### Conditions - Recurrence Free Survival ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - panitumumab (EGFR inhibitors) ### Outcomes Primary Outcomes - The primary efficacy end point was recurrence- free survival at 12 months. Secondary Outcomes ### Location - Facility: Natalia Malara, Germaneto, N/A, 88100, Italy @@
## Jet Injectors Versus Conventional Anesthetic Technique in Children - NCT ID: NCT06314984 - Study ID: A10040521 - Status: COMPLETED - Start Date: 2021-07-21 - Completion Date: 2023-03-21 - Lead Sponsor: Mansoura University ### Study Description This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of1. Pain level during the administration of local anesthesia in children.2. Their effectiveness during pulpotomy procedures in primary molars.Whether comfort-in jet injector device will achieve sufficient anesthesia for the procedures undertaken during pulpotomy or not when compared to the conventional technique and the pain levels of both techniques during the anesthesia step. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Group I A (Conventional needle syringe) - Group I B (Conventional needle syringe) - Group II A (Comfort-in Jet Injector) - Group II B (Comfort-in Jet Injector) ### Outcomes Primary Outcomes - Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale - Pain levels during pulpotomy procedures steps by Wong-Baker faces pain rating scale - Pain level during administration of local anesthesia in children by FLACC scale. - Pain levels during pulpotomy procedures steps by FLACC scale. Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Mansoura University., Mansoura, Dakahlia, 35516, Egypt @@
## Predicting Local and Distant Recurrence in T1 Colorectal Cancer - NCT ID: NCT06314971 - Study ID: 23228/T1CR - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: City of Hope Medical Center ### Study Description Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC. ### Conditions - Colorectal Cancer - Colorectal Neoplasms - Colorectal Adenocarcinoma - Colorectal Cancer Stage I - Colorectal Neoplasms Malignant - Colorectal Cancer Recurrent ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tw1CE ### Outcomes Primary Outcomes - Recurrence-free Survival Secondary Outcomes ### Location - Facility: City of Hope Medical Center, Duarte, California, 91010, United States @@
## Stage II/III Colorectal Cancer Recurrence - NCT ID: NCT06314958 - Study ID: 23228/CENSURE - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: City of Hope Medical Center ### Study Description This study will develop an assay to predict disease recurrence in patients with stage II/III CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation. ### Conditions - Colorectal Cancer - Colorectal Adenocarcinoma - Colorectal Cancer Stage II - Colorectal Cancer Stage III - Colorectal Cancer Recurrent ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CENSURE ### Outcomes Primary Outcomes - Recurrence-Free Survival Secondary Outcomes - Overall Survival ### Location - Facility: City of Hope Medical Center, Monrovia, California, 91016, United States @@
## Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula - NCT ID: NCT06314945 - Study ID: #11280-4\12-2023 - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2024-03-01 - Lead Sponsor: Zagazig University ### Study Description Perianal fistula is a common anal problem. It needs only surgery. MRI is the best preoperative diagnostic tool, but it is demanding as it is expensive, time consuming and needs an experienced radiologist. So, we tried to find an alternative diagnostic tool which is cheaper, time saving and accurate and comparing its preoperative reports with intraoperative findings.study was held in surgery department in Zagazig University Hospitals from September 2023 to March 2024. It included 93 patients with perianal fistula who were diagnosed clinically and radiological by trans recto-perineal ultrasound and comparing pre-operative ultrasound findings with intra-operative surgical findings. ### Conditions - Perianal Fistula ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - age - sex - body mass index - history of abscess drainage - Internal opening - fistula branches - type fistulous tract - abscess cavity Secondary Outcomes - other anal disease - external openings - anal discharge ### Location - Facility: Zagazig University Hospitals, Zagazig, N/A, 44519, Egypt @@
## Role of Ultra-processed Foods in Modulating the Effect of Mediterranean Diet - NCT ID: NCT06314932 - Study ID: spe123.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: University of Milan ### Study Description Mediterranean diet is worldwide promoted as one of the healthiest and most sustainable dietary patterns. One of the main pillars of Mediterranean diet is the abundant consumption of plant-based ingredients typically consumed as raw or minimally processed. However, even in the Mediterranean countries, these fresh foods are increasingly replaced by ultra-processed foods (UPF). Epidemiological evidence suggests that consumption of UPF may be detrimental to human health, but there is only one clinical trial on this topic which is largely debated in the scientific community due to limitations related to the short duration of the trial and the composition of dietary interventions.The present study aims at exploring whether the inclusion of UPF within a Mediterranean-based dietary pattern can impact on cardiometabolic markers, gut microbiota and other health markers in a dietary intervention performed in Italian subjects. For this purpose, 50 clinically healthy subjects will be recruited for a 7-month randomized, open, cross-over dietary trial. Eligible participants will be randomly assigned to consume a 3-month Mediterranean diet high in UPF (intervention group) or a low-UPF Mediterranean diet (control group), spaced by a 1-month wash-out period. The two diets will have the same composition in terms of food groups. However, in the high-UPF Mediterranean diet group, 5 servings/day of UPF, as defined by the NOVA system, will be consumed (e.g., flavored yogurt, breakfast cereals with added sugar, processed meat). In the control group, these foods will be replaced by products from the same food group, but not UPF (e.g., plain yogurt, breakfast cereals with no added sugar, unprocessed meat). The inflammatory potential of pairs of food products, both UPF and non UPF, will be evaluated using an in vitro cell model testing the modulation of inflammatory markers. Before and after each intervention blood, urine and fecal samples will be collected. The primary endpoint is change in low-density lipoprotein (LDL) cholesterol levels from baseline. Among the other markers, blood pressure and anthropometric parameters will be measured; biochemical parameters, adipokines, inflammatory and oxidative stress markers, fecal microbiota composition and short chain fatty acids (SCFAs) will be analyzed. Adherence to the study, dietary intake and food waste production will be evaluated through specific food diaries, useful also for estimating the metabolic food waste. ### Conditions - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - MD high in UPF - MD low in UPF ### Outcomes Primary Outcomes - Low-density lipoprotein (LDL) cholesterol levels Secondary Outcomes - Total cholesterol levels - High-density lipoprotein (HDL) cholesterol levels - Triglycerides levels - Fasting blood glucose levels - Insulin levels - Aspartate aminotransferase (AST) levels - Alanine aminotransferase (ALT) levels - Gamma-glutamyl transferase (GGT) levels - Folates levels - Vitamin B12 levels - Urea levels - Creatinine levels - Body weight - Body mass index (BMI) - Fat mass - Concentration of ghrelin in plasma - Concentration of leptin in plasma - Concentration of adiponectin in plasma - Concentration of resistin in plasma - Concentration of visfatin in plasma - Concentration of interleukin (IL)-4 in plasma - Concentration of interleukin (IL)-6 in plasma - Concentration of interleukin (IL)-10 in plasma - Concentration of Protein C-reactive (PCR) in plasma - Concentration of interferon gamma (IFN-γ) in plasma - Concentration of tumor necrosis factor -alpha (TNF-α) in plasma - DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2) - Concentration of F2-isoprostanes in urine - Gut microbiota composition and function changes ### Location - Facility: University of Florence, Florence, N/A, 54141, Italy @@
## A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib - NCT ID: NCT06314919 - Study ID: BR-PEC-OS-401 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-03 - Lead Sponsor: Boryung Pharmaceutical Co., Ltd ### Study Description The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition ### Conditions - Primary Hypercholesterolemia - Mixed Dyslipidemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of reaching the target LDL Cholesterol level Secondary Outcomes ### Location - Facility: Ewha Womans University Seoul Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer - NCT ID: NCT06314906 - Study ID: SHLU-2024001 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2027-03-31 - Lead Sponsor: Feixue Song ### Study Description This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment. ### Conditions - Electroacupuncture - Olanzapine-contained Four-drug Antiemetic - Nausea and Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Electroacupuncture - Antiemetic Therapy - Sham electroacupuncture - Antiemetic Therapy ### Outcomes Primary Outcomes - Proportion of Patients Free from Nausea Throughout Treatment Secondary Outcomes ### Location - Facility: Second Hospital of Lanzhou University, Lanzhou, Gansu, 730000, China @@
## Establishing a Correlation Between HRM and UGI MM Studies - NCT ID: NCT06314893 - Study ID: LMCII2022-001 - Status: RECRUITING - Start Date: 2022-08-24 - Completion Date: 2025-07 - Lead Sponsor: Lexington Health Incorporated ### Study Description A retrospective and prospective cohort, quantitative data collection with the goal of comparing preoperative High Resolution Manometry(HRM) results to Upper Gastrointestinal Marshmallow(UGI MM) results, in patients undergoing preoperative esophageal motility assessments. The aim of this study is to establish a correlation between HRM and UGI MM in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment. ### Conditions - Esophageal Motility Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Determining the correlation between HRM and UGI MM assessments among preoperative candidates will provide an evidenced based evaluation strategy for establishing procedural candidacy and predicting postoperative outcomes. Secondary Outcomes ### Location - Facility: Lexington Health Incorporated, West Columbia, South Carolina, 29169, United States @@
## Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli) - NCT ID: NCT06314880 - Study ID: 2022112701 - Status: RECRUITING - Start Date: 2023-07-22 - Completion Date: 2024-12-30 - Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd ### Study Description The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose) - Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose) - Placebo control ### Outcomes Primary Outcomes - The incidence rate of all AEs within 0-30 days after each dose of vaccination - The incidence rate of solicited AEs within 30 minutes after each dose of vaccination - The incidence rate of solicited AEs within 0-14 days after each dose of vaccination - The incidence rate of unsolicited AEs within 0-30 days after each dose of vaccination - The incidence rate of grade 3 and higher AEs within 0-30 days after each dose of vaccination Secondary Outcomes ### Location - Facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, Guangxi, 530028, China @@
## Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23 - NCT ID: NCT06314867 - Study ID: 20220231 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-30 - Completion Date: 2028-06-30 - Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd ### Study Description The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) - 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) - 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) ### Outcomes Primary Outcomes - Geometric mean concentration (GMC) levels Secondary Outcomes ### Location - Facility: Sichuan Center for Disease Control and Prevention, Chengdu, Sichuan, 610041, China @@
## The Effect of Running Water Sound Listened to Patients During Hemodialysis - NCT ID: NCT06314854 - Study ID: P202300046 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2024-03-15 - Lead Sponsor: Kırklareli University ### Study Description It is known that being in nature and the visual perception of nature positively affects an individual's mood and self-confidence (Bratman et al., 2012). Studies have reported that natural sounds have a positive effect in situations such as pain, anxiety, and stress (Arai et al., 2008; Thoma et al., 2018). This finding means that listening to natural sounds may be a simple and easily accessible intervention that can positively impact key human stress systems.Although many non-pharmacological methods are used in the literature to reduce the invasive pain and anxiety experienced by hemodialysis (HD) patients during cannulation, the most popular recently; However, we aimed to determine the effect of the sound of running water, which we have not yet encountered in dialysis patients, on invasive pain and anxiety experienced during fistula access. ### Conditions - Hemodialysis Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Running water sound ### Outcomes Primary Outcomes - Pain Assessment Secondary Outcomes - State and Trait Anxiety Assessment ### Location - Facility: Aas, Kırklareli, Center, 39000, Turkey @@
## Polytrauma and Resuscitation Impact on Innate Immunity - NCT ID: NCT06314841 - Study ID: LBG-AUVA - Status: TERMINATED - Start Date: 2017-06-01 - Completion Date: 2022-01-01 - Lead Sponsor: Ludwig Boltzmann Gesellschaft ### Study Description Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression. ### Conditions - Wounds and Injuries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Immunocompetence Secondary Outcomes - Changes in cellular immuno-status - Release of extracellular vesicles and associated content - Platelet-leukocyte aggregates - Immunocompetence clusters ### Location - Facility: Trauma Center Vienna, Meidling, Vienna, N/A, 1120, Austria @@
## A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL - NCT ID: NCT06314828 - Study ID: RJMty19-B-NHL002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2027-05-20 - Lead Sponsor: Guangdong Ruishun Biotech Co., Ltd ### Study Description This is a Phase 1, open-label, single-arm study to evaluate tolerability, safety and efficacy of RJMty19 in adult subjects with r/r B-NHL. ### Conditions - B-cell Non-Hodgkin's Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RJMty19 (CD19-CAR-DNT cells) ### Outcomes Primary Outcomes - Dose-Limiting Toxicity (DLT) - Maximum Tolerated Dose (MTD) - Incidence of abnormalities Secondary Outcomes - Pharmacokinetics (PK) indicator (Cmax) - Pharmacokinetics (PK) indicator (AUC) - Pharmacokinetics (PK) indicator (Tmax) - Pharmacokinetics (PK) indicator (T1/2) - Overall Response Rate - Disease Control Rate - Duration of Response - Progression Free Survival - Overall Survival - Overall Response Rate at 3 months ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ilioinguinal-iliohypogastric Nerve Block Prior to Shouldice Inguinal Hernia Repair - NCT ID: NCT06314815 - Study ID: Shouldice hospital - Status: COMPLETED - Start Date: 2023-01-11 - Completion Date: 2024-03-15 - Lead Sponsor: Shouldice Hospital ### Study Description The introduction of ilioinguinal-iliohypogastric nerve blocks into the preoperative care regimen at Shouldice Hospital for inguinal hernia repair marks a significant shift in pain management strategies. While Shouldice Hospital has traditionally not employed this technique, recent literature highlighting its potential benefits has prompted its trial within their patient population.Research in this area, although limited, suggests promising outcomes. Studies such as those by Beaussier et al. (2005) and Nehra et al. (1995) have demonstrated decreased postoperative pain and opioid use, as well as increased mobility associated with the use of ilioinguinal-iliohypogastric nerve blocks. However, concerns such as orthostatic hypotension and rebound pain have also been noted, indicating the need for careful consideration and monitoring of potential adverse effects.More recent studies, particularly those focusing on the Lichtenstein repair, have further supported the potential benefits of ilioinguinal-iliohypogastric nerve blocks. Kacmaz and Bolat (2020) found improved patient satisfaction, reduced opioid consumption, and shorter hospital stays associated with nerve block techniques. Additionally, the use of adjuncts such as dexamethasone has shown promise in reducing rebound pain and opioid requirements postoperatively.The purpose of evaluating the use of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital is multifaceted. Not only does it aim to enhance patient care and satisfaction by improving pain management strategies, but it also provides valuable insights for anesthetists and surgeons regarding the utility and efficacy of this technique within the context of inguinal hernia repair. Furthermore, the trial may facilitate the refinement of current practices, potentially leading to standardized protocols that optimize patient outcomes while minimizing adverse effects.In summary, the introduction of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital represents a proactive approach toward enhancing perioperative care for inguinal hernia patients. By leveraging emerging evidence and adapting to evolving clinical practices, the hospital stands to benefit from improved patient outcomes and potentially contribute to the advancement of pain management strategies in hernia surgery. ### Conditions - Inguinal Hernia - Pain, Postoperative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Compare pain and pain medication use between patients receiving an ilioinguinal-iliohypogastric nerve block prior to hernia surgery with those who do not. Secondary Outcomes - Evaluate the impact of the ilioinguinal-iliohypogastric nerve block on patients with pain conditions, mental health conditions, and substance use histories. - Determine sample size for future prospective trial. ### Location - Facility: Shouldice hospital, Thornhill, Ontario, L3T 4A3, Canada @@
## Learning Curve of the Shouldice Procedure - NCT ID: NCT06314802 - Study ID: LCSR - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-06-10 - Lead Sponsor: Shouldice Hospital ### Study Description Hernia repair surgery is common, especially the Shouldice repair for primary inguinal hernias, which is considered a top-notch nonmesh technique. However, outcomes can vary, possibly due to differences in surgical skill and experience. Many surgeons are trained more in mesh repairs like the Lichtenstein technique, rather than nonmesh repairs like Shouldice.Understanding a surgeon's learning curve-how many surgeries they need to do to become proficient-is crucial. Yet, there's not much research on this for the Shouldice repair. This project aims to fill that gap and improve surgeon education.The study's goal is to find out how the learning curve affects Shouldice repair for primary inguinal hernias. They'll look at how operative time changes over a surgeon's first 300 repairs compared to their 900-1000th. They'll also check for complications and recurrence rates.The study objectives are:1. Explore the learning curve and factors affecting Shouldice repair.2. Compare operative times between a surgeon's early and later surgeries.3. Look at complications during the learning curve.4. Determine how long training takes at Shouldice Hospital and the surgeons' previous experience.5. Review recurrence rates between the first 300 and 900-1000 surgeries.This research aims to give surgeons and the hernia community valuable insights into improving surgical techniques and patient outcomes. ### Conditions - Groin Hernia - Shouldice Procedure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Operating time I Secondary Outcomes - Operating time II - Operating time III ### Location - Facility: Shouldice hospital, Thornhill, Ontario, L3T 4A3, Canada @@
## The Use of Lung Ultrasonography in the Delivery Room in Neonates - NCT ID: NCT06314789 - Study ID: G1201 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Kırıkkale University ### Study Description Lung ultrasonography has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. (1, 2) In our clinic, lung ultrasonography imaging is performed in infants hospitalized with respiratory distress.Lung ultrasonography is widely used especially in conditions that mainly cause respiratory distress such as respiratory distress syndrome (RDS), pneumonia, neonatal transient tachypnea (NTRT), congenital pneumonia, meconium aspiration syndrome and pneumothorax. (1, 2) The reliability and specificity of AUS imaging especially in the diagnosis of NTRT have been proven in many studies.AUS imaging has become an objective value by scoring today. Images will be obtained using the linear probe of the device to be used for lung ultrasound and transferred to a cell phone, both lungs will be evaluated as three areas on the right and left (anterior upper, anterior lower and lateral) and scored separately. Anteriorly, the region between the anterior axillary line and the parasternal line is divided into two by the line passing through the nipple. Above is considered as the upper anterior region and below as the lower anterior region. The area in the middle of the anterior and posterior axillary line is evaluated as the lateral region. Each area is scored from 0 to 3 points. If A lines are present, 0 points are given, if there are more than 3 B lines in an area, 1 point is given, if B lines are very dense and there are no A lines, it is considered as white lung and 2 points are given. If there is a consolidation image on AUS, 3 points were given. The maximum total score was 18 (8,9) (Figure 1).In this study, both AUS imaging and scoring will be performed in the delivery room within the first 30 minutes and AUS score evaluation will be performed at postnatal 2nd, 6th and 24th hours in the intensive care unit for inpatients and in the maternal ward for maternal patients. The hypothesis of this study is that newborns with high AUS scores will have high rates of respiratory morbidities and respiratory support in the neonatal unit. The primary aim of the study was to determine the role and importance of AUS scores measured in the delivery room in predicting respiratory morbidities of infants. The secondary aim was to investigate the value of the course of AUS scores at postnatal 2, 6 and 24 hours in predicting the respiratory prognosis of the newborn infant. ### Conditions - Suspected Damage to Fetus From Other Disease in the Mother, Affecting Management of Mother, With Delivery - Patient Death or Serious Disability Associated With A Haemolytic Reaction Due to the Administration of ABO-Incompatible Blood or Blood Products ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - doing lung ultrasonography ### Outcomes Primary Outcomes - LUS in delivery room Secondary Outcomes - LUS in NICU or room ### Location - Facility: Kirikkale University, Kirikkale, N/A, N/A, Turkey @@
## Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy - NCT ID: NCT06314776 - Study ID: NEURO24 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-06-30 - Lead Sponsor: Universidad de Almeria ### Study Description Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution ### Conditions - Cerebral Palsy - Neurologic Disorder - Gait Disorders in Children - Hemiplegia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Usual physiotherapy without Whole-Body Vibration - Pre-Usual physiotherapy - Post-Usual physiotherapy ### Outcomes Primary Outcomes - Test Time Up and Go - Timed 10-Meter Walk Test - Gross Motor Function Measure Secondary Outcomes ### Location - Facility: María del Mar Sánchez-Joya, Almería, N/A, 04120, Spain @@
## Rivaroxaban Sotorasib Interaction Study - NCT ID: NCT06314763 - Study ID: ROSIE - Status: RECRUITING - Start Date: 2023-11-09 - Completion Date: 2024-11 - Lead Sponsor: Radboud University Medical Center ### Study Description Venous thromboembolic Events (VTEs) are common in lung cancer patients with an incidence of \>15%, requiring anticoagulant treatment or prophylaxis. Although direct acting oral anticoagulants (DOACs) are the agents of first choice due to ease and patient friendliness, these drugs are often avoided in cancer patients due to suspected pharmacokinetic drug-drug interactions with oncolytic drugs. Sotorasib is the first KRASG12C inhibitor that has been approved by the US \[FDA\] and EU \[EMA\] for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Sotorasib has a potential to cause CYP3A-mediated drug-drug interactions due to induction of CYP3A and inhibition of P-GP. Rivaroxaban is the most frequently prescribed DOAC in the Netherlands. As rivaroxaban is a substrate for this enzyme and efflux pump, sotorasib may increase or decrease the exposure to rivaroxaban and, thus, impact its benefit-to-risk ratio. To enable safe combination of sotorasib and rivaroxaban, it is pivotal to investigate the magnitude of the pharmacokinetic interaction between these drugs. ### Conditions - Drug Drug Interaction Study ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Rivaroxaban 20mg - Sotorasib 960mg ### Outcomes Primary Outcomes - The pharmacokinetics (AUC) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state. - The pharmacokinetics (Cmax) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state. Secondary Outcomes - The pharmacokinetics (AUC) of sotorasib in healthy volunteers. - The pharmacokinetics (Cmax) of sotorasib in healthy volunteers. - Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 - Pharmacokinetic variability in AUC of rivaroxaban. - Pharmacokinetic variability in Cmax of rivaroxaban. - Pharmacokinetic variability in AUC of sotorasib. - Pharmacokinetic variability in Cmax of sotorasib. ### Location - Facility: Radboud university medical centre, Nijmegen, N/A, N/A, Netherlands @@
## Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer - NCT ID: NCT06314750 - Study ID: 2023ZSLYEC-680 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2010-01-01 - Completion Date: 2027-09-30 - Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University ### Study Description Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment. ### Conditions - Locally Advanced Rectal Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - OS Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer - NCT ID: NCT06314737 - Study ID: 2021ZSLYEC-192 - Status: COMPLETED - Start Date: 2010-10-02 - Completion Date: 2024-01-01 - Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University ### Study Description This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally advanced rectal cancer, explore the population benefiting most from neoadjuvant therapy, and provide evidence-based medicine for the benefits of neoadjuvant therapy in patients with colorectal cancer in the real world. ### Conditions - Locally Advanced Rectal Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall Survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines - NCT ID: NCT06314724 - Study ID: PRO-VZV-4006 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2024-06-15 - Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. ### Study Description This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac"). ### Conditions - Varicella ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Varicella Vaccine - Varivax ### Outcomes Primary Outcomes - Seroresponse rate of varicella-zoster virus (VZV) antibody Secondary Outcomes - Geometric mean concentrations (GMCs) of VZV antibody - GMC of VZV antibody - seropositive rate - Geometric mean fold rise (GMFR) from before vaccination of VZV antibody - Incidence of adverse reactions within 0~42 days after vaccination - Incidence of adverse reactions within 0~14 days after vaccination - Incidence of serious adverse events (SAE) within 0~42 days after vaccination ### Location - Facility: San Juan de Dios Educational Foundation, lnc., Pasay, N/A, 1300, Philippines @@
## Ex Vivo 3D-ultrasound for Oropharyngeal Cancer - NCT ID: NCT06314711 - Study ID: Ex Vivo US for OPC - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2024-02-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description Patients with biopsy-verified oropharyngeal squamous cell carcinoma or Human Papillomavirus (HPV)-positive unknown primary treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment. ### Conditions - Oropharyngeal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Fresh ex vivo US Tumor detection (blinded to histopathology) - Margin assessment (blinded to histopathology) - Fresh ex vivo US tumor volume (blinded to histopathology) - Fresh ex vivo US margin distance (blinded to histopathology) - Fresh ex vivo tumor visible on specimen mecrophoto (blinded to histopathology) Secondary Outcomes - Fresh ex vivo US tumor volume (unblinded to histopathology) - Formalin-fixed ex vivo US tumor volume (unblinded to histopathology) - Fresh ex vivo US margin distance (unblinded to histopathology) - Formalin-fixed ex vivo US margin distance (unblinded to histopathology) ### Location - Facility: Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease - NCT ID: NCT06314698 - Study ID: IIT-2024-0011 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-30 - Lead Sponsor: RenJi Hospital ### Study Description The purpose of this study is to determine if narlumosbart is non-inferior to denosumab in the treatment of bone diseases from multiple myeloma (MM). ### Conditions - Multiple Myeloma - Bone Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Narlumosbart - Denosumab ### Outcomes Primary Outcomes - Percent change from baseline in urinary N-terminal telopeptide of type 1 collagen corrected for urinary creatinine (uNTx/uCr) at week 13 Secondary Outcomes - The proportion of subjects with a change in uNTx/uCr greater than 65% from baseline to week 13 - Time to first on-study skeletal related event - Percentage of participants with an on-study SRE at different time points - Time to first and subsequent on-study SRE - Percent changes of serum bone alkaline phosphatase (BALP) and serum C-terminal telopeptide of type 1 collagen (sCTX-I) - Overall Survival - Incidence and type of adverse events (AEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years - NCT ID: NCT06314685 - Study ID: 2020040C-2 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-12-10 - Completion Date: 2024-08-30 - Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd ### Study Description The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. ### Conditions - Healthy Population ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine - Group A and C Meningococcal Polysaccharide Vaccine - Group ACYW135 Meningococcal Polysaccharide Vaccine ### Outcomes Primary Outcomes - Antibody positive conversion rate Secondary Outcomes ### Location - Facility: Hunan Center for Disease Control and Prevention, Changsha, Hunan, 410005, China @@
## Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial - NCT ID: NCT06314672 - Study ID: OSU-22318 - Status: RECRUITING - Start Date: 2023-08-22 - Completion Date: 2025-12-31 - Lead Sponsor: Ohio State University Comprehensive Cancer Center ### Study Description This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials. ### Conditions - Hematopoietic and Lymphoid System Neoplasm - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Accrual - Discussion - Educational Activity - Interview - Review - Survey Administration ### Outcomes Primary Outcomes - Change in referral to clinical trials (CTs) (short-term outcomes) - Change in accrual of minorities to CTs (short-term outcomes) - CT accrual and retention due to patient navigation (short-term outcomes) - Identification of program gaps in trial accrual (long-term outcomes) - Uptake of program in other clinics (long-germ outcomes) Secondary Outcomes - Probability of trial enrollment and retention ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months - NCT ID: NCT06314659 - Study ID: 2020020C - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-09-17 - Completion Date: 2024-12-30 - Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd ### Study Description The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old. ### Conditions - Healthy Population ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu) - Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) - Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax) ### Outcomes Primary Outcomes - Analysis of antibody positivity conversion rate of serogroup A - Analysis of antibody positivity conversion rate of serogroup C Secondary Outcomes ### Location - Facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, Guangxi, 530028, China @@

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