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## Care Choreographies and the Making of the Psychosocial in Genetic Counseling - NCT ID: NCT06280833 - Study ID: 10001884 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-10-01 - Lead Sponsor: National Human Genome Research Institute (NHGRI) ### Study Description Background:Genetic counselors play a new and evolving role in medical care. Recent advances in genetic testing are changing many health care treatments, and genetic counselors play a key role in teaching people how their genes may affect both health and treatments. Genetic counselors may also help guide people through complex talks about their treatment risks; their chances for recovery; and their social and emotional health and wellbeing. Researchers want to learn more about the role genetic counselors play in health care.Objective:To observe how genetic counselors at NIH manage the social and psychological aspects of patient care.Eligibility:Genetic counselors who work at NIH. People aged 18 years or older who are scheduled to meet with one of these counselors are also needed.Design:An investigator will sit in on the session between the counselor and the participant. The investigator will take notes. The session will not be recorded. The investigator will leave at any point if asked.The investigator will focus on talk about social and psychological care. That person will also listen to talk about risk; diagnosis; odds of recovery; and hope, grief, and loss. That person will note strategies that help the participant manage their emotions and how they perceive their risks.Counselors may later have a 1-hour interview with the investigator. They will answer questions about their experiences as a care provider at NIH.Participants will have only 1 session with the investigator. Counselors may have 4 to 10 sessions with an investigator over 8 months. ### Conditions - Genetic Counselor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Care Secondary Outcomes ### Location - Facility: National Human Genome Research Institute (NHGRI), Bethesda, Maryland, 20892, United States @@
## Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART) - NCT ID: NCT06280820 - Study ID: 10001889 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2034-04-30 - Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI) ### Study Description Background:More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF.Objective:To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time.Eligibility:People aged 18 years and older with heart failure.Design:Participants will be asked to join the study based on a review of their medical records.They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein.Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA.Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation.Researchers will follow the participants health by monitoring their medical records for up to 5 years. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To study the association between multi-omics signatures with all-cause mortality Secondary Outcomes - Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2) - To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure ### Location - Facility: National Heart, Lung and Blood Institute (NHLBI), Bethesda, Maryland, 20892, United States @@
## Observation of Environment and Reproductive-Endocrine Effects - NCT ID: NCT06280807 - Study ID: 10001617 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2039-03-31 - Lead Sponsor: National Institute of Environmental Health Sciences (NIEHS) ### Study Description Background:Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems.Objective:To learn how environmental factors may affect the endocrine and reproductive systems.Eligibility:Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.Design:Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours.Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis.Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume.Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest.... ### Conditions - Hypogonadism - Hypergonadism - Precocious Puberty - Late Puberty - Amenorrhea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology. Secondary Outcomes - the relationship between nutrition, diet and reproduction - the impact of stress on reproductive dysfunction - the influence of behavioral and psychological factors on reproductive function ### Location - Facility: NIEHS Clinical Research Unit (CRU), Research Triangle Park, North Carolina, 27709, United States @@
## Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy - NCT ID: NCT06280794 - Study ID: Laser-Bell-2024 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2024-02-01 - Lead Sponsor: Beijing Tongren Hospital ### Study Description Objective:Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.Methods:This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Betahistine Mesylate tablet, Vitamin B1 tablet and Prednisolone.Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24. ### Conditions - Bell's Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laser acupuncture - Steroids ### Outcomes Primary Outcomes - House Brackmann Grading System (HB) Secondary Outcomes - Sunnybrook Facial Grading Scale (SB Grading) - Facial Disability Index (FDI) - Facial Clinimetric Evaluation Scale (FaCE Scale) ### Location - Facility: Beijing TongRen Hospital, Capital Medical University, Beijing, N/A, N/A, China @@
## Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance) - NCT ID: NCT06280781 - Study ID: 22CX7971 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2032-06 - Lead Sponsor: Imperial College Healthcare NHS Trust ### Study Description The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \[ no visible lesion, diffuse changes, discrete visible lesion\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: OTHER ### Interventions - MRI Scans ### Outcomes Primary Outcomes - Biopsy - Staging Secondary Outcomes - Cost-effectiveness - Biopsy Measurement - MRI & biopsy-related adverse events - Treatment - Compliance - EPIC Questionnaires - HADS Questionnaires - EQ-5D-5L Questionnaires ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation - NCT ID: NCT06280768 - Study ID: SHR-2004-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd ### Study Description This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SHR-2004 injection ### Outcomes Primary Outcomes - Incidence and severity of adverse events (including bleeding events) Secondary Outcomes - Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax) - Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC) - Pharmacokinetics of Dupilumab: Elimination half life (t1/2) - PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity - PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT) - Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study. - NCT ID: NCT06280755 - Study ID: ICO-S-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-04 - Lead Sponsor: icometrix ### Study Description The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression. ### Conditions - Multiple Sclerosis - NMO Spectrum Disorder - Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease - Radiologically Isolated Syndrome - Clinically Isolated Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The number of patients from each institution who have contributed data to the database. - The number of patients from each institution whose data was mapped to the common data model of the harmonised database. - The number of patients from the control arms of clinical trials who have contributed data to the database. - The data completeness of each variable in the harmonised database. Secondary Outcomes - The representativeness of the harmonised dataset for the MS patient population as evaluated by age range, gender balance, the distribution of country of residence, the distribution of race/ethnicity and the distribution of educational level - The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable. - The temporal uniformity of each institution's data over time as assessed by the number of changes to variables over time (addition of new variables or variables no longer being captured, alterations to how variables are captured). - The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable. - The presence of contextual information on standard data gathering and analysis processes of each institution - The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient. - The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient. - The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines. - The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis. - The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day. - The percentage of patients with a complete disease history available, from the date of diagnosis to the current day. - The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET) - NCT ID: NCT06280742 - Study ID: APHP221366 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-03-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The Service Hospitalier Frédéric-Joliot (SHFJ) and Paris Brain Institute (ICM) groups have identified \[18F\]-DPA-714 as a promising second-generation TSPO tracer, a macromolecule overexpressed in neuroinflammatory conditions, for PET imaging. They have also developed a non-invasive quantification methodology, enabling the generation of individual neuroinflammation maps in MS patients. Recent findings from \[18F\]-DPA-714 PET imaging in MS patients revealed that most of the white matter lesions contained a smoldering component, even when considered inactive on MRI, and that their neuroinflammatory profiles were associated with longitudinal disability worsening. The Inflanet project aims to leverage a unique consortium comprising French radiochemists, radiopharmacists, nuclear medicine/neuroimaging experts, and MS neurologists to establish the first national network dedicated to \[18F\]-DPA-714 PET imaging in MS, so far limited to monocentric studies.The objectives of the INFLANET project are (1) to conduct the first multicenter study assessing neuroinflammation in patients with active MS using \[18F\]DPA-714 PET tracer, and (2) to establish a methodology suitable for the quantification of multicenter PET data obtained with \[18F\]DPA-714. The INFLANET initiative aims to disseminate TSPO PET within the French MS research community, thereby opening the unique perspective of future large-scale, multicenter studies. These endeavors are expected to enhance our capacity to predict diseases, stratify patients, and assess new therapeutic interventions. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - PET-MRI with [18F]-DPA-714 ### Outcomes Primary Outcomes - To quantify the smoldering component of white matter lesions in people with MS, as compared with [18F]-DPA-714 binding in the white matter of HC who underwent a PET a acquisition with the same camera camera than patients in each center. Secondary Outcomes - To quantify for each patient the regional neuroinflammatory load, measured as [18F]-DPA-714 DVR, in specific regions of interest: total brain, normal appearing white matter, cortex, thalami, deep grey matter. - The MRI signatures of each lesional subtypes, and correlation between MRI metrics and [18F]-DPA-714 DVR in each region of interest. ### Location - Facility: Département de Neurologie,Pierre Wertheimer Neurological Hospital, Lyon, N/A, 69500, France @@
## AI-Predicted Disease Trajectories in Diabetes: A Retrospective Study - NCT ID: NCT06280729 - Study ID: AI-TRYDIA - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: IRCCS San Raffaele ### Study Description The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights. ### Conditions - Diabetes Mellitus, Type 1 - Diabetes Mellitus, Type 2 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AI-Analyis ### Outcomes Primary Outcomes - Primary Endpoint - Primary Endpoint - Primary Endpoint Secondary Outcomes - Exploratory Objectives ### Location - Facility: Diabetes Research Institute-IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy @@
## A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis - NCT ID: NCT06280716 - Study ID: 18817 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2026-11-04 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - Lebrikizumab - Topical Corticosteroid ### Outcomes Primary Outcomes - Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono Cohort - Percentage of Participants Achieving EASI-75 at Week 16 for Combo Cohort Secondary Outcomes - Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort - Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo Cohort - Percentage of Participants With a Itch Numerical Rating Scale (NRS) Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Combo Cohort - Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort - Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort - Percentage of Participants Achieving EASI-90 at Week 16 for Mono Cohort - Percentage of Participants With a Itch NRS Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Mono Cohort - Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort ### Location - Facility: Wannan Medical College Yijishan Hospital, Wuhu, Anhui, 241001, China @@
## A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) - NCT ID: NCT06280703 - Study ID: 18792 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-02-17 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec.The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected.The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Deglude given via intravenous (IV) infusion.The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period. ### Conditions - Healthy - Type 1 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - LY3938577 - Placebo - Insulin Degludec - Insulin Lispro ### Outcomes Primary Outcomes - Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. - Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. - Part A: Number of Participants With Clinically Significant Changes in Vital Signs - Part B: Number of Participants With Clinically Significant Changes in Vital Signs - Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters - Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters - Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 - Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 - Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577 - Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577 - Part C: PK: Concentration of LY3938577 Secondary Outcomes - Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577 - Part C: PD: Glucose infusion rate (GIR) of LY3938577 ### Location - Facility: Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, 41460, Germany @@
## SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia - NCT ID: NCT06280690 - Study ID: NL83765.058.23 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2025-07-30 - Lead Sponsor: Leiden University Medical Center ### Study Description This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101. ### Conditions - Colorectal Cancer - Image - Low Grade Dysplasia of Colon ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - SGM-101 ### Outcomes Primary Outcomes - The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic). Secondary Outcomes - - Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective) - - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope. - - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo - -The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo - - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3) - - The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen. ### Location - Facility: Leiden University Medical Center, Leiden, N/A, 2333ZA, Netherlands @@
## Aurora Test for ART Donor Patients (AURORA-Donor) - NCT ID: NCT06280677 - Study ID: 2023.Aurora-Donor - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-09 - Lead Sponsor: Fertiga, Belgium ### Study Description This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger. ### Conditions - Infertility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AURORA-Donor ### Outcomes Primary Outcomes - Basic clinical donor patient and stimulation characteristics: P4 - Basic clinical donor patient and stimulation characteristics: E2 - Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose - Clinical evaluation: number of Follicles - Clinical evaluation: number of cumulus-oocyte complex - Clinical evaluation: Meiosis II oocytes - Clinical evaluation: Abnormal fertilization - Clinical evaluation: Normal Fertilization - Clinical evaluation: Day 3 embryo evaluation - Clinical evaluation: Day 5/6 embryo evaluation - Clinical evaluation: Day5/6 good quality blastocyst rate - Clinical evaluation: Embryo utilization - Expression profile: blastocyst formation Secondary Outcomes - Biochemical pregnancy - Clinical pregnancy with positive fetal heartbeat - Expression profile: pregnancy prediction - Normalized messenger ribonucleic acid (mRNA) expression ### Location - Facility: Fertilab, Barcelona, N/A, 08017, Spain @@
## Efficacy Of Hiatal Closure For GERD - NCT ID: NCT06280664 - Study ID: IRB20-1151 - Status: RECRUITING - Start Date: 2020-10-02 - Completion Date: 2024-10 - Lead Sponsor: University of Chicago ### Study Description The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD. ### Conditions - Gastro Esophageal Reflux ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Concentration of pH testing Secondary Outcomes ### Location - Facility: The University of Chicago, Chicago, Illinois, 60637, United States @@
## Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis - NCT ID: NCT06280651 - Study ID: RGP 2/348/44 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-05-15 - Lead Sponsor: King Khalid University ### Study Description The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism. ### Conditions - Dental Caries in Children - Autistic Disorder - Dietary Habits ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - dietary preferences and their implications for oral health in children with Autism Spectrum Disorder ### Outcomes Primary Outcomes - Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS) - NCT ID: NCT06280638 - Study ID: 2023-2095 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-12 - Lead Sponsor: China National Center for Cardiovascular Diseases ### Study Description A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique.Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90). ### Conditions - Percutaneous Coronary Intervention - Coronary Physiology - Computed Tomography ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual stent-guided incremental optimization strategy (VIOS) - Standard angiographic strategy ### Outcomes Primary Outcomes - The proportion of patients with a final post-PCI FFR result ≥0.90 Secondary Outcomes - The proportion of patients with final post-PCI FFR ≤0.80 - The rate of target vessel failure (TVF) and its component features at 6 months. - The rate of target vessel failure (TVF) and its component features at 1 year. - Change from baseline in self-reported Health-related quality of life evaluation at 6 months. - Change from baseline in self-reported Health-related quality of life evaluation at 1 year. - Change from baseline in self-reported Angina status evaluation at 6 months. - Change from baseline in self-reported Angina status evaluation at 1 year. - Procedure Duration - Fluoroscopy Dose - Contrast Material Dose ### Location - Facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, 100037, China @@
## The Effect of the Inclusion of Soybean Flour on Glycemic Responses - NCT ID: NCT06280625 - Study ID: 24388 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-25 - Lead Sponsor: University of Illinois at Urbana-Champaign ### Study Description Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Replacement of wheat flour by soyflour ### Outcomes Primary Outcomes - Plasma glucose - Plasma insulin Secondary Outcomes - Hunger-Satiety ### Location - Facility: University of Illinois at Urbana Champaign, Champaign, Illinois, 61820, United States @@
## The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients - NCT ID: NCT06280612 - Study ID: RCS10042023 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-09-01 - Lead Sponsor: Karadeniz Technical University ### Study Description It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined. ### Conditions - Therapy-Associated Cancer - Cancer Patient - Happiness - Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Pet therapy ### Outcomes Primary Outcomes - Edmonton Symptom Diagnostic Scale - Oxford Happiness Scale Short Form Secondary Outcomes ### Location - Facility: Gümüşhane University, Gümüşhane, N/A, 29600, Turkey @@
## Transitional Care Model for Patients With Stroke - NCT ID: NCT06280599 - Study ID: SON KMU - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-04-29 - Lead Sponsor: Kaohsiung Medical University ### Study Description Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Transitional care model ### Outcomes Primary Outcomes - Self-efficacy - Activities of daily living Secondary Outcomes - Instrumental activities of daily living - Depression symptoms - Quality of life in stroke patients ### Location - Facility: RSUD Prof. Dr. W Z Johannes Kupang, Kupang, N/A, 308, Indonesia @@
## Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly - NCT ID: NCT06280586 - Study ID: 44/21 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-11-15 - Completion Date: 2024-12-31 - Lead Sponsor: Consorci Sanitari del Maresme ### Study Description Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in. ### Conditions - Muscle Strengh - Frailty - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Multidisciplinary intervention ### Outcomes Primary Outcomes - Muscle Mass - Muscle strength and/or Muscle function - Sarcopenia - Frailty Secondary Outcomes - Functional Capacity 1 - Functional Capacity 2 - Functional Capacity 3 - Functional Capacity 4 - Functional Capacity 5 - Functional Capacity 6 ### Location - Facility: Consorci Sanitari del Maresme, Mataró, Barcelona, 08304, Spain @@
## COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS) - NCT ID: NCT06280573 - Study ID: MS1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-01 - Completion Date: 2025-12-01 - Lead Sponsor: Comenius University ### Study Description The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.Researchers will compare the effect to control groups of MS patients without intervention. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Wim Hoff method ### Outcomes Primary Outcomes - concentration of pro-inflammatory cytokines - concentration of markers of oxidative stress - concentration of NfL - concentration of GFAP - concentration of ecDNA Secondary Outcomes - Expanded Disability Status Scale - Timed 25-Foot Walk - Nine-Hole Peg Test - Symbol Digit Modalities Test - Fatigue Scale for Motor and Cognitive Functions - General Anxiety Disorder-7 - Patient Health Questionnaire-9 ### Location - Facility: Derer's University Hospital, Bratislava, N/A, 83305, Slovakia @@
## Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation - NCT ID: NCT06280560 - Study ID: 2109-FIVI-087-FD - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-30 - Lead Sponsor: Fundación IVI ### Study Description Both controlled ovarian stimulation (COS) and frozen embryo transfer has become an integral part of in vitro fertilization (IVF) treatment. Fresh embryo transfer is usually performed by providing Luteal Phase Support (LPS) with progesterone after COS. Frozen embryo transfer (FET) is usually performed in artificial cycles with hormone replacement treatment (HRT), in which exogenous progesterone is administered, although it can also be performed in a Natural Cycle (without hormone supplementation) (NC). There is evidence that the supraphysiologic levels of estradiol and progesterone during COS+LPS and HRT could lead to morphologic and biochemical endometrial modifications, altering endometrial receptivity and lowering implantation and pregnancy rates.We hypothesize that the supraphysiologic hormone levels required for both COS+LPS, and HRT may be inducing alterations in endometrial composition and function, specifically the chronic accumulation of senescent cells; either due to an excessive hormonal induction, a lack of clearance due to a deficit of uNKs, or a combination of both, ultimately affecting both endometrial receptivity and decidualization, worsening IVF outcomes.The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells (EnSC), which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients.The results derived from this project would have a direct impact on clinical practice. First, the results would allow us to evaluate, based on experimental data, potential endometrial side effects of stimulation protocols commonly used in IVF treatments. In addition, in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity, we will be able to in vitro evaluate the effectiveness of adjuvant senolytic (drugs designed to specifically remove senescent cells) compounds to in vitro improve the expression of endometrial receptivity markers, as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients. ### Conditions - Endometrial Receptivity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Controlled Ovarian Stimulation + Luteal Phase Support - Hormonal Replacement Therapy programmed artificial cycle - Natural Cycle (NC) - Endometrial receptivity reference group ### Outcomes Primary Outcomes - Endometrial receptivity Secondary Outcomes - Senescent Cell Pathological Accumulation ### Location - Facility: IVI-RMA Valencia Clinic, Valencia, N/A, 46015, Spain @@
## The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children - NCT ID: NCT06280547 - Study ID: CUP 13-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-04-02 - Lead Sponsor: Cairo University ### Study Description Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt. ### Conditions - Dental Caries in Children - Knowledge, Attitudes, Practice ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Oral health education ### Outcomes Primary Outcomes - Oral health related attitude Secondary Outcomes - Change in oral health related Knowledge, attitude and practice ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects - NCT ID: NCT06280534 - Study ID: XT1061-2022-01 - Status: RECRUITING - Start Date: 2023-07-18 - Completion Date: 2024-03-31 - Lead Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. ### Study Description A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects. ### Conditions - Chronic Hepatitis b ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Test drug XT1061 capsules and placebo,Single dose group - Test drug XT1061 capsules and placebo，Multiple dosing group - Test drug XT1061 capsules and placebo，Food Impact Group ### Outcomes Primary Outcomes - Treatment-related adverse events - Cmax - Tmax - t1/2 - AUC - CL/F - Vz/F - CLr/F Secondary Outcomes - Ae0-72 h - Fe0-72 h - bioavailability ### Location - Facility: The First Hospital of Jilin University, Jilin, Changchun, N/A, China @@
## Validation of the Girls Questionnaire for Autism Spectrum Condition in French Langage - NCT ID: NCT06280521 - Study ID: 38RC23.0331 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: University Hospital, Grenoble ### Study Description Autism spectrum disorders (ASD) are currently diagnosed at a rate of approximately 3 males per 1 female, while evidence suggests the rate may be 1.8 males per 1.2 females. It has been shown that affected women receive an autism diagnosis on average 5 years later than men. This delay is associated with deleterious consequences on the educational, psychological and physical health levels in these women. Currently, there are a number of obstacles that delay or prevent women with ASD from accessing diagnosis and specialized support. These include, in particular, gendered assumptions about how ASD manifests depending on the gender of the person concerned, a tendency for clinicians to attribute female autistic traits to causes other than ASD, measures of standardized ASD assessments that may not be sensitive enough to identify ASD females, and finally a demonstrated greater tendency among ASD females to camouflage or mask autistic traits in order to blend in in social situations. It is in this context that the Girl Questionnaire for Autism Spectrum Conditions (GQ-ASC) was developped and validated to address these fundamental gaps in the early identification and measurement of female ASD symptoms.The GQ-ASC is presented as a self-questionnaire with 29 items which assess clinical characteristics specific to the adult female presentation of ASD in the dimensions (five) of imagination and play, camouflage, sensoriality, social situations and interests. To date, several studies have relevantly used the GQ-ASC in populations of adult ASD women, but none in French.The main objective of this online study is therefore to measure the predictive validity of the French version of the Girl Questionnaire for Autism Spectrum Conditions (fGQ-ASC) for the diagnosis of ASD in adult women over 18 years of age and speaking French kindergarten. Subjects included in this online study will complete the protocol using any computer, tablet, or cell phone. We will include 400 participants (100 females-ASD, 100 females-nonASD, 100 males-ASD, 100 males-nonASD). This study will validate for the first time a screening tool for the diagnosis of ASD in women of French mother tongue over 18 years of age (the Girls Questionnaire for Autism Spectrum Condition French version - fGQ-ASC). This tool will have particularly significant benefits since it will help reduce the diagnostic delay among adult women with ASD in France and accelerate their access to specialized support. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - fGQ-ASC ### Outcomes Primary Outcomes - VP fGQ-ASC Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer - NCT ID: NCT06280508 - Study ID: SYSKY-2024-082-01 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-03-31 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer. ### Conditions - Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab, Apatinib, Gemcitabine, cisplatin ### Outcomes Primary Outcomes - 1-year EFS rate Secondary Outcomes - R0 Resection rate - EFS - RFS - OS ### Location - Facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, China/Guangdong, N/A, China @@
## Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients - NCT ID: NCT06280495 - Study ID: INTENSIFY-CRC - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2028-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone. ### Conditions - Colorectal Cancer - Liver Metastases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oxaliplatin - Fluorouracil - Serplulimab - Bevacizumab ### Outcomes Primary Outcomes - 3-year Progression-Free Survival Rate Secondary Outcomes - Median Overall Survival - Major Pathological Response (MPR) - Pathologic complete response (pCR) - Pathological Partial Response - Disease Free Survival - Treatment-related adverse events ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction Syndrome (SMDS) - NCT ID: NCT06280482 - Study ID: HSC-MS-23-0332 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2025-07-25 - Lead Sponsor: The University of Texas Health Science Center, Houston ### Study Description The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients. ### Conditions - Smooth Muscle Dysfunction Syndrome (SMDS) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nicotinamide riboside (NR) ### Outcomes Primary Outcomes - Change in Fluoro-18-Deoxyglucose (18F-FDG ) uptake in aortic wall as measured by positron emission tomography (PET)/computerized tomography (CT) imaging Secondary Outcomes - Change in Levels of Nicotinamide adenine dinucleotide (NAD+) in whole blood as measured by high-performance liquid chromatography (HPLC) - Change in Levels of NR in whole blood as measured by high-performance liquid chromatography (HPLC) - Change in aortic measurements as assessed by echocardiography - Safety as assessed by number of participants that show drug toxicity as shown in bloodwork - Safety as assessed by number of participants that show drug toxicity as shown in bloodwork - Tolerability as assessed by the number of patients who complete study ### Location - Facility: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States @@
## Single-operator Versus Double-operator in Single-Balloon Enteroscopy - NCT ID: NCT06280469 - Study ID: KY20232298-C-1 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12 - Lead Sponsor: Shuhui Liang ### Study Description Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy. ### Conditions - Single-balloon Enteroscopy - Operation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Single-Balloon Enteroscopy ### Outcomes Primary Outcomes - Maximum insertion depth Secondary Outcomes - Total enteroscopy rate - Positive findings - Advent events - procedural time ### Location - Facility: Xijing Hospital of Digestive Diseases, Xi'an, N/A, N/A, China @@
## Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction - NCT ID: NCT06280456 - Study ID: 2023-09-017A - Status: COMPLETED - Start Date: 2022-09-05 - Completion Date: 2023-02-05 - Lead Sponsor: Taipei Veterans General Hospital, Taiwan ### Study Description Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have been used in orthopedic surgeries to reduce postoperative bleeding. Moreover, TXA was proved effective to reduced the events of hemarthrosis and increased the post-operative functional outcomes of the patients in several studies. The purpose of this study is to evaluate the efficacy of intra-articular injection of TXA with different drainage clamping time in patients receiving arthroscopic ACLRs. Patients were randomized into four groups. An intra-articular suction drain was placed recorded 24 h postoperatively. Group 1 patients(TXA 4hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 4 hours. Group 2 patients(TXA 8hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 8 hours. Clinical evaluations using an IKDC functional score and a Visual Analogue Scale (VAS) pain score were performed during admission, at postoperative day 3 and week 4. ### Conditions - Anterior Cruciate Ligament Reconstruction - Tranexamic Acid - Hemarthrosis, Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tranexamic Acid Powder ### Outcomes Primary Outcomes - The volume of drainage Secondary Outcomes - Visual analog scale (VAS) - International Knee Documentation Committee (IKDC) functional score ### Location - Facility: Taipei Veterans General Hospital, Taipei, N/A, N/A, Taiwan @@
## Sarcopenia in Chronic Lung Diseases - NCT ID: NCT06280443 - Study ID: CE22407B - Status: RECRUITING - Start Date: 2022-11-25 - Completion Date: 2032-09-30 - Lead Sponsor: Taichung Veterans General Hospital ### Study Description Inclusion criteria A)Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.B) Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources ### Conditions - Sarcopenia - COPD - Asthma - ILD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - sarcopenia rate Secondary Outcomes ### Location - Facility: Taichung Veterans General Hospital, Taichung, N/A, 40705, Taiwan @@
## Vascular Affection in Behcet Disease - NCT ID: NCT06280430 - Study ID: Vascular affection in behcet - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assiut University ### Study Description To measure the level of serum elafin in patients with behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity ### Conditions - Behcet Disease and Vascular Involvement ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To measure the level of serum elafin in behcet patients and compare it with control group Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults - NCT ID: NCT06280417 - Study ID: Unreamed IMN In IIIa tibia - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-08-01 - Lead Sponsor: Assiut University ### Study Description To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome . ### Conditions - Tibia Fracture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Unreamed intramedullary tibial nail ### Outcomes Primary Outcomes - Incidence of non union Secondary Outcomes - Incidince of fracture related infection - The rate of reoperation for delayed union or non-union , infection and fasciotomy - functional evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle - NCT ID: NCT06280404 - Study ID: Body first in lap chole - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-08-08 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \& VBI in patients with obscure calot's triangle. ### Conditions - Cholecystitis, Chronic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lap cholecystectomy ### Outcomes Primary Outcomes - Safe laparoscopic cholecystectomy. Secondary Outcomes - Evaluation of the body first approach technique ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis - NCT ID: NCT06280391 - Study ID: ACT18018 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-08-11 - Lead Sponsor: Sanofi ### Study Description ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive).Study details include:* The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks.* The treatment duration will be up to 24-52 weeks.* The follow-up duration will be 20 weeks.* Site/phone visits are at a monthly interval. ### Conditions - Bronchiectasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Itepekimab (SAR440340) - Placebo ### Outcomes Primary Outcomes - Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period Secondary Outcomes - Time to first moderate or severe PE over the treatment period - Percentage of participants who are PE free over the treatment period - Annualized rate of severe PEs over the treatment period - Percentage of participants who are severe PE free over the treatment period - Time to first severe PE over the treatment period - Change From Baseline in FEV1 at Week 8 and Week 24 - Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use - Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24 - Change from baseline in SGRQ total score at Week 24 - Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24 - Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period - Serum concentrations of itepekimab from baseline to end of study - Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study ### Location - Facility: Allianz Research Institute Site Number : 8400013, Westminster, California, 92683, United States @@
## A Phase I/II Clinical Study of the KL003 Cell Injection in β-Thalassemia Major Participants - NCT ID: NCT06280378 - Study ID: CP-KL003-003/01 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2027-05 - Lead Sponsor: Kanglin Biotechnology (Hangzhou) Co., Ltd. ### Study Description This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with β-thalassemia major. ### Conditions - Transfusion-dependent Beta-Thalassemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - KL003 Cell Injection Drug Product ### Outcomes Primary Outcomes - KL003 engraftment - Engraftment time of neutrophil and platelet - Overall Survival - The number, frequency and severity of adverse events (AE) within 1 year after infusion of KL003 drug products - Clonal dominance or secondary tumors caused by lentiviral vector insertional-mutation - Numbers of Participants With Vector-Derived Replication-Competent Lentivirus (RCL) Secondary Outcomes - The proportion of participants achieved Transfusion Independence (TI)for at least 6 months - The proportion of participants achieved TI 12 - The start time of Transfusion Independence (TI) after KL003 infusion - Total Hb and the vector-derived HbA^T87Q ### Location - Facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, N/A, China @@
## MWM Technique in Patients With Knee OA - NCT ID: NCT06280365 - Study ID: 012 - Status: COMPLETED - Start Date: 2024-02-19 - Completion Date: 2024-03-15 - Lead Sponsor: Okan University ### Study Description The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (OA). ### Conditions - Mobilization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mulligan Mobilization with Movement Technique ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) - Short form-36 (SF-36) - Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) - Evaluation of proprioception - The range of motion Secondary Outcomes ### Location - Facility: Emine Atıcı, Tuzla, İstanbul, N/A, Turkey @@
## Robotic Assisted vs Custom Made Total Knee Arthroplasty - NCT ID: NCT06280352 - Study ID: AUVA_Knieathlon_2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12 - Lead Sponsor: Austrian Workers Compensation Board Styria ### Study Description The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:* Which implant/philosophy yields better clinical outcomes?* Which implant/philosophy yields better satisfaction?* Which system is more OR efficient? Participants will be followed for 2 years postoperatively. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Custom made Total Knee Arthroplasty - Functionally aligned robotically assisted total knee arthroplasty ### Outcomes Primary Outcomes - Clinical Outcome using the Forgotten Joint Score Secondary Outcomes - Clinical outcomes using the Kujala anterior knee pain Score - Patient satisfaction - Visual analog pain (VAS) scale - Surgical and total theatre time - Opioid use - Number of physiotherapy sessions - Range of motion measurements (in degrees) - Radiographic data including radiolucent lines - Revision rate ### Location - Facility: AUVA UKH Steiermark Standort Graz, Graz, Styria, 8020, Austria @@
## Food Cravings Strategies During Dietary Weight Loss - NCT ID: NCT06280339 - Study ID: IRB23-0190 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2024-08-01 - Lead Sponsor: University of Illinois at Urbana-Champaign ### Study Description The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management.The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings. ### Conditions - Obesity - Food Cravings - Weight Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Test two food cravings strategies during dietary weight loss - Dietary weight loss program +Food cravings strategies ### Outcomes Primary Outcomes - Body weight - Food Craving Strategies Compliance - Food Cravings - Food Cravings Secondary Outcomes - Dietary intake ### Location - Facility: Bevier HAll UIUC, Urbana, Illinois, 61801, United States @@
## Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies - NCT ID: NCT06280326 - Study ID: Orogastric Tube Removal - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-08-05 - Lead Sponsor: Ondokuz Mayıs University ### Study Description While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage. ### Conditions - Neonatal Skin Conditions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Sunflower oil - Slicone based spray ### Outcomes Primary Outcomes - Neonatal Skin Condition Score Secondary Outcomes ### Location - Facility: Hatice Uzşen, Samsun, Atakum, 55100, Turkey @@
## Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension - NCT ID: NCT06280313 - Study ID: uHCC-STI-TJ01 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2028-03-15 - Lead Sponsor: Zhiyong Huang ### Study Description Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population. ### Conditions - Unresectable Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Splenectomy+Targeted therapy+ Immunotherapy ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - Overall Survival (OS) - Progression Free Survival (PFS) ### Location - Facility: Tongji Hospital, Wuhan, Hubei, 430000, China @@
## Multi-disciplinary Care for Brain Metastases - NCT ID: NCT06280300 - Study ID: UVMMC2203 - Status: RECRUITING - Start Date: 2023-11-16 - Completion Date: 2025-11-01 - Lead Sponsor: University of Vermont Medical Center ### Study Description This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases. ### Conditions - Brain Metastases, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - health services intervention ### Outcomes Primary Outcomes - Patient reported outcomes Secondary Outcomes - Feasibility - Patient understanding of prognosis - survival ### Location - Facility: University of Vermont Medical Center, Burlington, Vermont, 05401, United States @@
## PET Imaging of Fibroblast Activation in Atherosclerosis - NCT ID: NCT06280287 - Study ID: FAPI-PLAQUE - Status: RECRUITING - Start Date: 2021-08-01 - Completion Date: 2025-12-31 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome. ### Conditions - Atherosclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - FAPI PET ### Outcomes Primary Outcomes - SUVmax of atherosclerotic plaque in carotid or coronary arteries - TBR of atherosclerotic plaque in carotid or coronary arteries Secondary Outcomes ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Metformin Use in Patients Undergoing Total Joint Replacement Surgery - NCT ID: NCT06280274 - Study ID: STUDY00025798 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2025-05-30 - Lead Sponsor: Oregon Health and Science University ### Study Description The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial. ### Conditions - Hyperglycemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metformin - Placebo ### Outcomes Primary Outcomes - Rate of participant enrollment - Rate of appropriate study drug administration - Rate of participant adherence to trial intervention per protocol - Rate of participant retention to 90-day follow up Secondary Outcomes - Perioperative glycemic variability - Sliding scale insulin utilization - Hospital length of stay - 90-day Rate of surgical site infection - 90-day Rate of periprosthetic joint infection - 90-day Rate of mortality - 90-day rate of readmission ### Location - Facility: Oregon Health & Science University, Portland, Oregon, 97239, United States @@
## The Struggle That Is Phenylketonuria : What Do The Patients and Caregivers Suffer From - NCT ID: NCT06280261 - Study ID: GO20/296 - Status: COMPLETED - Start Date: 2020-05-27 - Completion Date: 2020-09-01 - Lead Sponsor: Hacettepe University ### Study Description Objective: To assess the stress levels and life hardships of phenylketonuria patients and their parents. ### Conditions - Psychological Well-Being - Caregiver Burden - Life Stress ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - parenting stress index, Zarit burden scale, Rosenberg self esteem scale, stait trait anxiety inventory, struggles and difficulties questionnaire ### Outcomes Primary Outcomes - Rosenberg Self-Esteem Scale - Stait trait anxiety inventory - Strenghts and difficulties questionnaire - Zarit burden scale - Parenting stress index Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, Sihhiye, 06100, Turkey @@
## EUS Guided Drainage of Post Pancreatitis Pancreatic Fluid Collection - NCT ID: NCT06280248 - Study ID: EUS in pancreatic fluid - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: Assiut University ### Study Description The number as well as the caliber of plastic stents used for EUS-guided PFC drainage are controversial in current practice \[Lin et al., 2014\]. The timing of necrosectomy in WOPN drainage continues to be debated. To date, no comparative studies have been conducted to investigate the ideal timing for stent removal. Thus, the aim of our study is to:* Assess the technical success rates, clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type, caliber and number of plastic stents and ideal timing for stent removal.* Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates, clinical success rates, potential complications and number of sessions needed. ### Conditions - Pancreas Pseudocyst ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst ### Outcomes Primary Outcomes - Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine - NCT ID: NCT06280235 - Study ID: 1447-0005 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2025-10-03 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression.Participants continue their standard therapy throughout the study.Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks.Participants are in the study for about 2 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms.The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants. ### Conditions - Depressive Disorder, Major ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI 1569912 - Placebo ### Outcomes Primary Outcomes - Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8 Secondary Outcomes - Change from baseline in MADRS total score at Week 6 - Response defined as ≥50% MADRS reduction from baseline at Day 8 - Response defined as ≥50% MADRS reduction from baseline at Week 6 - Remission defined as MADRS total score ≤10 at Week 6 - Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8 - Change from baseline in SMDDS total score at Week 4 ### Location - Facility: Hassman Research Institute, Marlton, New Jersey, 08053, United States @@
## The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation. - NCT ID: NCT06280222 - Study ID: VR FOR ANXIETY-HMO-CTIL - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2025-02-01 - Lead Sponsor: Hadassah Medical Organization ### Study Description A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level . ### Conditions - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - The VR instrument - Oculus Quest 2 ### Outcomes Primary Outcomes - Vital signs - Vital signs - VAS (visual-analogue scale) - State and Trait Anxiety (STAI) Score Secondary Outcomes ### Location - Facility: Hadassah mound scopus IVF unit, Jerusalem, N/A, N/A, Israel @@
## A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy - NCT ID: NCT06280209 - Study ID: 351-201 - Status: RECRUITING - Start Date: 2024-01-03 - Completion Date: 2025-12 - Lead Sponsor: BioMarin Pharmaceutical ### Study Description The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping. ### Conditions - Duchenne Muscular Dystrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BMN 351 ### Outcomes Primary Outcomes - To evaluate and safety and tolerability of single and multiple doses of BMN 351 (incidence, severity, and dose-relationship of adverse effects and changes in laboratory parameters). Secondary Outcomes - Pharmacokinetics (PK) concentration of BMN 351 in plasma, urine and muscle approximately every 8 weeks for up to 48 weeks. ### Location - Facility: Hospital Sant Joan de Deu, Barcelona, N/A, 08950, Spain @@
## A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC - NCT ID: NCT06280196 - Study ID: BAT-3306-002-CR - Status: NOT_YET_RECRUITING - Start Date: 2024-08-15 - Completion Date: 2028-10-30 - Lead Sponsor: Bio-Thera Solutions ### Study Description To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin. ### Conditions - Carcinoma, Non-Small-Cell Lung ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BAT3306 - EU-Keytruda® - US-Keytruda® - Pemetrexed - Carboplatin ### Outcomes Primary Outcomes - clinical equivalence Secondary Outcomes - safety of BAT3306-AE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Functional Inspiratory Muscle Training in Obese Individuals - NCT ID: NCT06280183 - Study ID: 323132 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2025-06-30 - Lead Sponsor: Biruni University ### Study Description In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals.This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Functional Inspiratory Muscle Training - Aerobic+Resistive Exercise Traning ### Outcomes Primary Outcomes - Respiratory Muscle Strength - Incremental load test (Respiratory Muscle Endurance) - Forced expiratory volume 1st second (Respiratory Function) - Forced vital capacity (Respiratory Function) Secondary Outcomes - Comorbidity Assessment - Physical Activity Assessment - Edmonton Obesity Staging System (EOSS) - Functional Capacity - Peripheral Muscle Strength - Waist circumference - Hip circumference - Body fat-muscle ratios - Glucose profile - Lipid profile ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## AI to Support Mental Health Case Management Providers - NCT ID: NCT06280170 - Study ID: ST11480 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-19 - Completion Date: 2025-12-31 - Lead Sponsor: Eleos Health ### Study Description The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:1. Is the AI platform acceptable and feasible for case managers?2. Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation. ### Conditions - Depressive Disorder - Anxiety Disorders - Substance Use Disorders - Post Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Artificial Intelligence platform for case managers ### Outcomes Primary Outcomes - Case manager satisfaction - Case manager productivity - Case manager note completion time Secondary Outcomes - Clients' crisis services utilization ### Location - Facility: Centerstone, Alton, Illinois, 62002, United States @@
## A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers - NCT ID: NCT06280157 - Study ID: MVX0007 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-18 - Completion Date: 2028-01 - Lead Sponsor: Minervax ApS ### Study Description The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination. ### Conditions - Group B Streptococcus Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - GBS-NN/NN2 ### Outcomes Primary Outcomes - Antibody Concentration Specific for GBS-NN and GBS-NN2 - Antibody Responses Specific to AlpCN, RibN, Alp1N and Alp2-3N Secondary Outcomes ### Location - Facility: Simbec-Orion Clinical Pharmacology, Merthyr Tydfil, Pentrebach Merthyr Tydfil CF48 4DR, N/A, United Kingdom @@
## Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine - NCT ID: NCT06280144 - Study ID: PF20230428 - Status: RECRUITING - Start Date: 2023-09-22 - Completion Date: 2024-10-30 - Lead Sponsor: Changchun BCHT Biotechnology Co. ### Study Description To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine. ### Conditions - Influenza Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Influenza Vaccine, Live, Nasal, Freeze-dried - Sterile water for inhalation ### Outcomes Primary Outcomes - Primary influenza protective effect endpoint - Primary influenza protective effect endpoint Secondary Outcomes - Secondary protective efficacy endpoint - Secondary protective efficacy endpoint - Secondary protective efficacy endpoint - Safety - Study on detoxification ### Location - Facility: N/A, Chi Feng, Inner Mongolia Autonomous Region, 024000, China @@
## The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients: - NCT ID: NCT06280131 - Study ID: multiple sclerosis and pulse - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assiut University ### Study Description This work is aimed to assess the short term effect of pulse therapy on clinical and neurophysiological course before and after pulse therapy in order to understand the possible mechanism of action of steroid therapy on RRMS patients low-dose oral treatment should also be retained for patients in whom this approach seems appropriate ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - to evaluate efficacy of a pulse therapy on clinical outcome Secondary Outcomes - clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional - clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Fatigue on CPR - NCT ID: NCT06280118 - Study ID: EFCPR008 - Status: COMPLETED - Start Date: 2023-04-20 - Completion Date: 2023-10-25 - Lead Sponsor: Artvin Coruh University ### Study Description Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course.Methods: The study was designed as a randomized controlled trial. The sample, consisting of 84 paramedic students, was randomly assigned as 42 control and 42 experimental groups. Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. A personal information form and a CPR measurement form were used to obtain the data. The simulator was used to evaluate the accuracy of CPR. The collected data were analysed with the statistical program. ### Conditions - Resuscitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Fatigue ### Outcomes Primary Outcomes - Correct number of ventilations - Correct number of compression Secondary Outcomes - CPR duration ### Location - Facility: Resuscitation simulation laboratory of Artvin Çoruh University Health Services Vocational School, Artvin, N/A, 08000, Turkey @@
## A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib - NCT ID: NCT06280105 - Study ID: 2023_148_01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2027-03-31 - Lead Sponsor: Meng Chao Hepatobiliary Hospital of Fujian Medical University ### Study Description To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cadonilimab+regorafenib ### Outcomes Primary Outcomes - objective response rate (ORR) per RECIST1.1 Secondary Outcomes - Progression-free survival（PFS） - Overall survival（OS） - Duration of response (DOR) - Occurence of AE and SAE ### Location - Facility: Mengchao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, Fujian, N/A, China @@
## Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery - NCT ID: NCT06280092 - Study ID: 23-009133 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-03 - Lead Sponsor: Sanjeet S. Grewal ### Study Description This study is a non-randomized, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during standard of care DBS surgery for epilepsy.Subjects will be screened at our outpatient clinic and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients will undergo a standard preoperative evaluation which includes baseline laboratory values and a high-definition MRI. Patients will then undergo a stereotactic procedure for bilateral thalamic implantation of DBS leads through the ClearPoint® system. After the thalamic target for DBS is identified, cells will be infused directly into the anterior nucleus of the thalamus previous to lead implantation.Patients will be followed in the outpatient setting for up to a year after therapy application.Surgical, clinical, and radiographic data will be obtained during these visits ### Conditions - Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - AMSCs ### Outcomes Primary Outcomes - Primary Objective - Secondary Objective Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultra-high-caloric, Fatty Diet in ALS - NCT ID: NCT06280079 - Study ID: LIPCAL-ALS II 1.1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: University of Ulm ### Study Description This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS). ### Conditions - Amyotrophic Lateral Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ultra-high-caloric fatty diet - Placebo ### Outcomes Primary Outcomes - Survival Secondary Outcomes - Amyotrophic Lateral Sclerosis Functional Rating Scale Revised - Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale - Individual Quality of Life - Slow vital capacity - Survival - Survival - Time to death - Time to tracheostomy - Time to permanent continous ventilator dependence - Ventilation assistance-free survival - Body Mass Index - Council of Nutrition Appetite Questionnaire - Eating Habits - Neurofilament light chain - Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model - Neurofilament Assess Score ### Location - Facility: RWTH Aachen, Aachen, N/A, N/A, Germany @@
## An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers - NCT ID: NCT06280066 - Study ID: 2023/607 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Kirsehir Ahi Evran Universitesi ### Study Description Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers.In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months. ### Conditions - Cystic Fibrosis - Children - Resilience,Psychological - Laughter Yoga - Laughter Therapy - Mothers - Psychological Health - Lung Functions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers ### Outcomes Primary Outcomes - The Respiratory Function Test - The Revised Cystic Fibrosis Questionnaire Child Form - Psychological Resilience Attitude and Skills Scale Child Form - Functional Disability Inventory Child - The Revised Cystic Fibrosis Questionnaire Parent Form - Depression Anxiety and Stress Scale - Post-Traumatic Growth Scale - Brief Psychological Resilience Scale Secondary Outcomes ### Location - Facility: Erciyes University, Kayseri, N/A, 38000, Turkey @@
## HealiAid in the Treatment of Different Wounds - NCT ID: NCT06280053 - Study ID: 103-3024A3 - Status: COMPLETED - Start Date: 2016-03-02 - Completion Date: 2018-10-26 - Lead Sponsor: Maxigen Biotech Inc. ### Study Description The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds.The main questions it aims to answer are:1. The wound healing which was defined as the percentage of area change.2. The duration of wound healing.3. The granulation tissue growth of the wound.4. The wound exudate.5. Safety Indicators of which incidences after treatment.HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks. ### Conditions - Venous Ulcers - Bedsores - Diabetic Foot Wound - Burn Wound ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - HealiAid Collagen Wound Dressing ### Outcomes Primary Outcomes - Wound Healing Secondary Outcomes - Wound Healing - Duration of Wound Healing - Granulation Tissue Growth - Wound Exudate - Incidence of Safety Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma - NCT ID: NCT06280040 - Study ID: UM Longitudinal 1942/2022 - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2025-06-30 - Lead Sponsor: Medical University of Vienna ### Study Description The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry. ### Conditions - Uveal Melanoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinical examination and multimodal ocular imaging ### Outcomes Primary Outcomes - Incidence and Severity of Retinopathy Secondary Outcomes - Incidence and Severity of Opticopathy - Functional Outcome - Incidence and Severity of Retinopathy and Opticopathy in oximeter ### Location - Facility: Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, N/A, 1090, Austria @@
## Effect of Midline Discrepancy and Crown Width Disporportion on Esthetics - NCT ID: NCT06280027 - Study ID: MUDHF_BK1 - Status: COMPLETED - Start Date: 2023-06-05 - Completion Date: 2023-12-22 - Lead Sponsor: Marmara University ### Study Description In the web-based cross-sectional study 180 participants were included. Half of them (n = 90) were patients (laypeople) of the university clinic and the remaining half were restorative dentists and prosthodontists with similar levels of clinical experience (at least 3 years of academic training).A frontal view full-face portrait image of a 25-year-old female was selected as a model for the study, with a smile exhibiting good dental alignment, a quite good midline position, and tooth size symmetry.The original image was digitally modified by a single restorative instructor using Photoshop CC (Adobe, USA) software program. The modifications were divided into three parts. The first part was the generation of midline discrepancy at different levels. The midline was digitally moved to the right side of the patient 1 - 4 millimeters, gradually. The midline movement was performed together with the whole maxillary arch.The second part was the generation of individual crown width disproportions. Accordingly, the mesiodistal width of the left central, lateral, and canine was digitally decreased one by one, gradually, while the width of the symmetrical teeth on the right side was simultaneously increased.The third part was the generation of distributed crown width disproportions. Accordingly, the total mesiodistal width of the left central, lateral, and canine was equally decreased, gradually, while the total width of the symmetrical teeth on the right side was simultaneously increased.In total, 15 images were displayed in random order to the participants including the original image. An online survey was generated to quantitatively evaluate the level of esthetic perception. Subsequently, the participants were asked to evaluate the level of smile esthetics of the presented random images, without being informed about the digital manipulations of the images. The participants were even not informed about the original image. They were expected to answer the question "How esthetic do you consider this smile?" The evaluation of each image was performed via a Visual analog scale VAS, ranging from point 0 (extremely not esthetic) to point 100 (extremely esthetic). ### Conditions - Esthetics, Dental ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - survey ### Outcomes Primary Outcomes - survey on midline discrepancy at different levels - survey on individual crown width disproportions - survey on distributed crown width disproportions Secondary Outcomes ### Location - Facility: Marmara University Faculty of Dentistry, İstanbul, N/A, 34854, Turkey @@
## Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Wisdom Dental Surgery - NCT ID: NCT06280014 - Study ID: YYU-09/15.12.2021 - Status: COMPLETED - Start Date: 2022-01-20 - Completion Date: 2023-09-25 - Lead Sponsor: Yuzuncu Yıl University ### Study Description This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. The effects of these two materials on patient comfort were investigated. ### Conditions - Tooth, Impacted - Tooth Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Surgery of impacted mandibular wisdom teeth - Surgery of impacted mandibular wisdom teeth ### Outcomes Primary Outcomes - Mouth opening measurements - Facial edema - Visual Analog Scale Secondary Outcomes ### Location - Facility: Serap Keskin Tunc, Van, N/A, 65100, Turkey @@
## A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection - NCT ID: NCT06280001 - Study ID: 2023YFC2308802-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-11 - Lead Sponsor: Zhejiang University ### Study Description The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are:* Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression.* Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies.* Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection. ### Conditions - Acquired Immunodeficiency Syndrome - HIV Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Secondary infections in patients with HIV/AIDS at 4 weeks - quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks Secondary Outcomes - Survival rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## BRING-UP 3 Heart Failure - NCT ID: NCT06279988 - Study ID: K24 - Status: RECRUITING - Start Date: 2023-09-15 - Completion Date: 2026-07-30 - Lead Sponsor: Heart Care Foundation ### Study Description The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF). ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF Secondary Outcomes - Rate of patient achieving appropriate dosages of GDMTs - Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF) - Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF - All cause and specific causes of death and hospitalization (Exploratory endpoint) ### Location - Facility: Ospedale Santo Spirito - Sc Cardiologia, Casale Monferrato, AL, 15033, Italy @@
## Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study - NCT ID: NCT06279975 - Study ID: Req-2023-01275; am23Sutter2 - Status: RECRUITING - Start Date: 2023-12-18 - Completion Date: 2030-12 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination. ### Conditions - Brain Death - Adults ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - non-invasive device-supported, automated pupillometry ### Outcomes Primary Outcomes - Reliability of clinical examination of pupils in patients with suspected brain death Secondary Outcomes ### Location - Facility: Intensive care unit at the University Hospital Basel, Basel, Basel-Stadt, 4031, Switzerland @@
## Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender - NCT ID: NCT06279962 - Study ID: 2000034620 - Status: COMPLETED - Start Date: 2023-06-15 - Completion Date: 2023-09-15 - Lead Sponsor: Yale University ### Study Description This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness. ### Conditions - Mental Illness - Stigma, Social ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Survey questionnaire ### Outcomes Primary Outcomes - Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE - Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE Secondary Outcomes ### Location - Facility: Empowerment to Heal - Uganda, Iganga, N/A, N/A, Uganda @@
## Confidential Care and Adolescent HIV Testing - NCT ID: NCT06279949 - Study ID: 2000036999 - Status: NOT_YET_RECRUITING - Start Date: 2026-04 - Completion Date: 2027-10 - Lead Sponsor: Yale University ### Study Description The purpose of this study is to assess the feasibility and acceptability of structural intervention components to increase adolescent HIV testing uptake by improving the implementation of confidential care as standard practice in pediatric primary care. ### Conditions - Hiv ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Provider training - Clinic protocols ### Outcomes Primary Outcomes - Feasibility, defined as the extent to which structural intervention components to improve confidential care implementation can be successfully carried out in pediatric primary care settings - Acceptability, defined as the perception among pediatric primary care clinic leadership and providers that structural intervention components to improve confidential care implementation are agreeable or satisfactory - Change in HIV testing uptake Secondary Outcomes - Reach, defined as the number of adolescent patients who receive confidential care - Adoption, defined as the proportion of pediatric primary care providers who have time alone with and/or provide confidentiality assurances to adolescent patients - Implementation, defined as pediatric primary care provider fidelity to confidential care provision - Maintenance, defined as the extent to which confidential care is provided and adolescent patients are screened for, accept, and receive results of HIV testing 6-months post-intervention ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID - NCT ID: NCT06279936 - Study ID: B3002021000171 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-11-01 - Completion Date: 2024-12-31 - Lead Sponsor: Universiteit Antwerpen ### Study Description Objectives:To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms.Study design:Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months.The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients. ### Conditions - Long COVID ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neuropsychological battery - Surveys and symptom severity questionnaires - Blood withdrawal - Saliva swabs ### Outcomes Primary Outcomes - Concentration of immunological and HPA-axis markers Secondary Outcomes - Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints - Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...) ### Location - Facility: SINAPS, Duffel, Antwerp, 2570, Belgium @@
## CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases - NCT ID: NCT06279923 - Study ID: TXB2023023 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-02-01 - Lead Sponsor: Zhejiang University ### Study Description Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases. ### Conditions - Autoimmune Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CD19-BAFF Targeted CAR T-cells ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) - Incidence of treatment-emergent adverse events (TEAEs) Secondary Outcomes - Multiple Myeloma (MM), Overall response rate (ORR) - Progression-free survival (PFS) - Duration of remission,DOR ### Location - Facility: The first affiliated hospital of medical college of zhejiang university, Hangzhou, Zhejiang, 310000, China @@
## Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19). - NCT ID: NCT06279910 - Study ID: 2021 36 (EOm) - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-04-25 - Lead Sponsor: Complejo Hospitalario Universitario de Albacete ### Study Description Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to "Gerencia de Atención Integrada (GAI) de Albacete". "Complejo Hospitalario Universitario de Albacete". Albacete (Spain)", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy. ### Conditions - SARS-CoV 2 Pneumonia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Calcifediol ### Outcomes Primary Outcomes - Measure mortality by differentiating groups: calcifediol yes/no. - Measure the need for ICU admission by differentiating the groups calcifediol yes/no. Secondary Outcomes - Measure mortality in relation to baseline 25(OH)D levels - To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency - Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no ### Location - Facility: Complejo Hospitalario Universitario de la Gerencia de Atención Integrada (GAI) de Albacete, Albacete, N/A, 02008, Spain @@
## LBNP Tolerance With Skin Warming After Exercise Cold Stress - NCT ID: NCT06279897 - Study ID: 2023-068 - Status: RECRUITING - Start Date: 2022-01-24 - Completion Date: 2025-09-30 - Lead Sponsor: University of Colorado, Colorado Springs ### Study Description Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold. ### Conditions - Blood Pressure - Blood Loss ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Skin Surface Rewarming - Skin Surface Warming - Skin Surface Heating - Skin Surface Cooling ### Outcomes Primary Outcomes - Arterial blood pressure - Tolerance to simulated blood loss Secondary Outcomes - Core temperature - Cutaneous Vascular Conductance ### Location - Facility: University of Colorado Colorado Springs, Colorado Springs, Colorado, 80918, United States @@
## A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection - NCT ID: NCT06279884 - Study ID: 2023YFC2308802-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-11 - Lead Sponsor: Zhejiang University ### Study Description The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are:* Characterize the distribution of pathogenic bacteria infecting liver transplant recipients.* Establish a monitoring and early warning system for secondary infections. ### Conditions - Liver Transplantation - Transplant Recipients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Secondary Infections in liver transplant recipients at 4 weeks - quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks Secondary Outcomes - Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection - Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection - qSOFA score at 8 weeks - qSOFA score at 12 weeks ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults - NCT ID: NCT06279871 - Study ID: ARCT-2303-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Arcturus Therapeutics, Inc. ### Study Description This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine. ### Conditions - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ARCT-2303 - Influenza vaccine - Influenza vaccine, adjuvanted - Placebo ### Outcomes Primary Outcomes - SARS-CoV-2 neutralizing antibody titers - SARS-CoV-2 neutralizing antibody seroconversion rates - Hemagglutination Inhibition (HI) titers - SARS-CoV-2 neutralizing antibody titers Secondary Outcomes - SARS-CoV-2 neutralizing antibody titers - SARS-CoV-2 neutralizing antibody seroconversion rates - SARS-CoV-2 neutralizing antibody response (Group 1a; Group 2a) - Hemagglutination Inhibition (HI) titers - SARS-CoV-2 neutralizing antibody responses - Hemagglutination Inhibition (HI) assay titers - Local and systemic adverse events (AEs) - Unsolicited AEs - SAE, Medically Attended Adverse Events (MAAE), Adverse Events of Special Interest (AESI), and AE leading to early termination ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome - NCT ID: NCT06279858 - Study ID: 1-2024 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Specila hospital for cerebral palsy and developmental neurology ### Study Description The primary objective of this clinical trial is to evaluate efficacy of probiotic mixture which contains Lactobacillus casei, Lactobacillus salivarius and Bifidobacterium breve, in children with Fragile X aged 3-18 years. Specifically, links between microbiome modifications by probiotic mixture and behavioral manifestations and brain processing (eye tracker, EEG analysis) will be assessed. Exploratory objects of this trial are analyses of microbiome composition and assessment of its alterations and modifications (by probiotic mixture) that may lead to clinical improvement and prediction which patients with FXS may be likely to benefit from probiotics treatment.This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. The study plans to enroll 15 participants with FXS, aged 3-18 years, both sexes, during 1-year period and complete all study-related activities by January 2025. During the 3-month study period, subjects will attend three visits (screening/baseline, 6-week, and 3-month visits) to the Fragile X Clinic at the Special Hospital for Cerebral Palsy and Developmental Neurology, Belgrade, Serbia. The primary outcome measureswill be Vineland Adaptive Behavior Scales-Third Edition (VABS-III) and eye tracking measures (social gaze and pupillometry). Exploratory endpoint will be microbiome analyses. Secondary outcome measures will be: CGI-S and CGI-I scores, ABC-CFX score, quality of life, sleep habits and EEG analyses. ### Conditions - Fragile X Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Probiotics ### Outcomes Primary Outcomes - 1. Vineland Adaptive Behavior Scales-Third Edition (VABS-III) - Eye tracking Secondary Outcomes - Clinical Global Impression Scales of Severity (CGI-S) and Improvement (CGI-I) - - The Aberrant Behavior Checklist - Community Edition (ABC-C), scored using the FXS-specific factoring system (ABC-CFX) - Pediatric Quality of Life Questionnaire (PedsQL) Parent Proxy - Child Sleep Habits Questionnaire (CSHQ) - EEG analyses ### Location - Facility: Special Hospital for Cerebral Palsy and Developmental Neurology, Belgrade, N/A, 11000, Serbia @@
## A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection - NCT ID: NCT06279845 - Study ID: 2023YFC2308802-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-11 - Lead Sponsor: Zhejiang University ### Study Description The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:* Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.* Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression. ### Conditions - Liver Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Secondary infection in patients at 4 weeks - quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks Secondary Outcomes - Survival rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer. - NCT ID: NCT06279832 - Study ID: 3994 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2025-10-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines. ### Conditions - Endometrial Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - trascriptomic profiling ### Outcomes Primary Outcomes - Predictive value of the model Secondary Outcomes - Validity of the model ### Location - Facility: Fondazione Policlinico Agostino Gemelli IRCSS, Rome, Lazio, 00118, Italy @@
## Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients - NCT ID: NCT06279819 - Study ID: 2024-008 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Fudan University ### Study Description The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:* Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.* Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.* Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months. ### Conditions - Hiv - Cardiovascular Diseases - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - gut microbiota-targeted dietary intervention ### Outcomes Primary Outcomes - ASCVD risk estimated by the PCE - The composition of gut microbiota Secondary Outcomes - fasting blood lipids - blood pressure - BMI - ASCVD symptoms ### Location - Facility: Fudan University, Shanghai, Shanghai, 200032, China @@
## The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer - NCT ID: NCT06279806 - Study ID: SerapAlkas - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-10-30 - Lead Sponsor: Gazi University ### Study Description Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses. ### Conditions - Posttraumatic Growth - Grief ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mobile health application use - Information of the breast cancer survivor period booklet ### Outcomes Primary Outcomes - Women's progression through the stages of grief Secondary Outcomes - Women's increased level of posttraumatic development ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients. - NCT ID: NCT06279793 - Study ID: MODIFYCSX - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-12-01 - Lead Sponsor: GCP-Service International West GmbH ### Study Description The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care. ### Conditions - Cardiac Surgery - High Risk Patients - Intensive Care Unit - Cardiopulmonary Bypass - Valve Surgeries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Long-chain n-3 fatty acids - Intravenous 0.9% Sodium Chloride ### Outcomes Primary Outcomes - Atrial fibrillation Secondary Outcomes - Weaning from cardiopulmonary bypass (CPB) - Time to discharge alive - Persistent Organ Dysfunction + Death - Days alive and out of hospital - Hospital length of stay - ICU length of stay - Simplified Acute Physiology Score - Therapeutic Intervention Scoring System - ICU and Hospital Readmission rates - Delta Sequential Organ Failure Assessment Score (SOFA) Score - Mechanical ventilation - Stroke - Acute Kidney Injury - Infections rate - Clinical frailty scale - Development of delirium - Survival status - Physical activity assessment - Quality of Life (SF-36) - Adverse Events - Postoperative bleeding ### Location - Facility: RWTH Aachen University, Aachen, N/A, N/A, Germany @@
## Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity - NCT ID: NCT06279780 - Study ID: PI18/00932 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-01-01 - Completion Date: 2024-08-31 - Lead Sponsor: Celia Bañuls ### Study Description It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \[total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry\], markers of mitochondrial dynamics \[Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot\], markers of inflammation \[Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers. ### Conditions - Obesity Adult Onset ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - very low-calorie diet ### Outcomes Primary Outcomes - Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention. - Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present metabolically healthy obesity (MHO) or metabolically unhealthy obesity (MUHO). Secondary Outcomes - Evaluate significant changes in body fat mass percentage after the dietetic intervention. - Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietetic intervention. - Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention. - Assess significant changes in plasmatic homocysteine as an inflammatory parameter after the dietetic intervention. - Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention. - Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention. - Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention. - Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention. - Analyze the significant differences between metabolomic profile before and after the dietetic intervention. - Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels. - Assess if there is a significant reduction after the dietetic intervention in glutathione levels. - Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels. - Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production. - Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential. - Analyze the proportion of subjects achieving at least 10% reduction in weight compared with baseline. ### Location - Facility: FISABIO, Valencia, N/A, 46020, Spain @@
## Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma - NCT ID: NCT06279767 - Study ID: 2022-SR-557 - Status: RECRUITING - Start Date: 2022-07-01 - Completion Date: 2025-07-31 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description Glioblastoma, the most prevalent malignant tumor in the central nervous system, is characterized by high invasiveness and a propensity to recur, contributing to a relatively elevated mortality rate. Patients diagnosed with high-grade glioblastomas typically experience a median survival period of less than 14 months. Presently, the standard treatment for glioblastoma involves surgical resection combined with postoperative radiotherapy and chemotherapy, with postoperative chemotherapy playing a pivotal role in enhancing patient prognosis. Temozolomide (TMZ), a cutting-edge oral alkylating agent known for its advantageous properties, including easy traversal of the blood-brain barrier, induces DNA alkylation in tumor cells, fostering apoptosis. Currently, it serves as a frontline medication for postoperative chemotherapy in glioblastoma. However, clinical resistance to TMZ chemotherapy significantly hampers its efficacy in later stages. We have recently discovered and validated that 5-aminoimidazole-4-carboxamide (AICA), derived from TMZ, can transform into 5-aminoimidazole-4-carboxamide ribonucleotide-5-phosphate (AICAR) in GBM cells. Hypoxanthine phosphoribosyltransferase 1 (HPRT1) has been identified as the catalyst for the AICA reaction, generating AICAR. AICAR acts as an endogenous activator of AMP-activated protein kinase (AMPK), fostering chemoresistance in glioblastoma through the activation of the AMPK signaling pathway. 6-mercaptopurine (6-MP) competes effectively to inhibit HPRT1 activity, thereby impeding TMZ-induced AMPK activation and significantly heightening glioblastoma cell sensitivity to TMZ. In this project, we propose an innovative strategy involving the combination of 6-MP with TMZ for the treatment of glioblastoma. ### Conditions - Glioblastoma - Cancer - Temozolomide ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 6-mercaptopurine ### Outcomes Primary Outcomes - PFS Secondary Outcomes - OS - Safety evaluation ### Location - Facility: Department of Neurosurgery of The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China @@
## Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy - NCT ID: NCT06279754 - Study ID: ZLXGBXKYXM-031-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-18 - Completion Date: 2025-12-18 - Lead Sponsor: The First Affiliated Hospital of Xinxiang Medical College ### Study Description This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III. ### Conditions - Locally Advanced Squamous Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Recombinant Human Endostatin Injection ### Outcomes Primary Outcomes - objective response rate Secondary Outcomes - Overall survival - Progression-free survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants - NCT ID: NCT06279741 - Study ID: EVENEW - Status: RECRUITING - Start Date: 2023-12-28 - Completion Date: 2029-12-31 - Lead Sponsor: EXO Biologics S.A. ### Study Description The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution).Infants will be followed up to 2 years of corrected age (end of study). ### Conditions - Bronchopulmonary Dysplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Endotracheopulmonary Instillation, Suspension ### Outcomes Primary Outcomes - Number of subjects with treatment-emergent adverse events (phase 1) - Number of subjects with BPD grade II-III incidence rate per groups (phase 2). Secondary Outcomes - Assessment of medium-term safety of EXOB-001 (phase 1/2) - Number of subjects with dose-limiting toxicity (DLT) (phase 1) - Number of subjects needing for oxygen and ventilation for BPD incidence (phase 1/2) - Assessment of immune markers (phase 2) - Assessment of BPD incidence and severity (phase 1/2) - Safety evaluation (phase 1/2) - Assessment of lung ultrasound score (phase 1/2) - Number of subjects with complications of prematurity (phase 1/2) - Assessment of the respiratory morbidity (phase 1/2) - Assessment of neurodevelopment (phase 1/2) ### Location - Facility: Cliniques Universitaires Saint-Luc (UCLouvain), Brussels, N/A, 1200, Belgium @@
## Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients - NCT ID: NCT06279728 - Study ID: DS1062-0003-EAP-MA - Status: AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: Daiichi Sankyo ### Study Description The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial. ### Conditions - Advanced Non-Small Cell Lung Cancer - Metastatic Non Small Cell Lung Cancer ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Datopotamab deruxtecan ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: Queen's Medical Center, Honolulu, Hawaii, 96813, United States @@
## DFI and Aneuploidies - NCT ID: NCT06279715 - Study ID: 3437 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-19 - Completion Date: 2025-02-01 - Lead Sponsor: Clinique Ovo ### Study Description IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure.Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes. ### Conditions - Embryo Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Preimplantation Genetic Testing for Aneuploidy ### Outcomes Primary Outcomes - DFI association and aneuploidy Secondary Outcomes ### Location - Facility: Clinique ovo, Montreal, Quebec, H4P 2S4, Canada @@
## Serious Game Simulation and Comics in School Students - NCT ID: NCT06279702 - Study ID: OCalisir - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-07-19 - Completion Date: 2025-07-19 - Lead Sponsor: TC Erciyes University ### Study Description The aim of the study is to determine the effect of first aid training for injuries given to secondary school students through serious game simulation and comic books on knowledge, skills and motivation.Hypotheses:H1: First aid training given through simulation applications affects the level of knowledge.H2: First aid training given through simulation applications affects the skill level.H3: First aid training given with simulation application affects motivation.H4: First aid training given with comics affects the level of knowledge.H5: First aid training given with comic books affects the skill level.H6: First aid training given with comics affects motivation.METHOD: The research will be conducted as a randomized controlled experimental study with a pre-test-post-test design with children studying in the 5th and 6th grades of schools in the central district of Aksaray. One group will be given first aid training for injuries prepared with serious games, the other group will be given first aid training for injuries prepared with comic books. No intervention will be made to the control group. Serious game scenario software prepared based on the literature will be integrated into the computer. Appropriate statistics will be made after the research by applying the prepared data collection tools. With this research, the gap in the literature will be filled, children's first aid knowledge and skills in injuries will be increased, and school health nurses will be provided with up-to-date teaching material. ### Conditions - First Aid ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - SERIOUS GAME - COMICS ### Outcomes Primary Outcomes - Motivation Scale for Teaching Materials - Student Knowledge Level Evaluation Form for First Aid Application in Injuries - Student Skill Level Evaluation Form for First Aid Application in Injuries Secondary Outcomes ### Location - Facility: Özlem Çalışır, Aksaray, Center, 68200, Turkey @@
## Echography Study_Anthropometric Measurements - NCT ID: NCT06279689 - Study ID: CJTCDZ2301 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-06 - Lead Sponsor: Crossject ### Study Description This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force.In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force.Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed. ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Ultrasound scans ### Outcomes Primary Outcomes - STBD : Skin To Bone Distance - STMD: Skin To Muscle Distance - Thickness of skin layers (dermis, hypodermis) - Thickness of muscle layers Secondary Outcomes - Circumferences measurements (thigh, upper arm, waist, hip) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improvement of Women's Health After Allogeneic Stem Cell Transplantation - NCT ID: NCT06279676 - Study ID: SaFeGreff - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2028-12 - Lead Sponsor: Ciusss de L'Est de l'Île de Montréal ### Study Description The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women. ### Conditions - GVHD, Chronic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice. Secondary Outcomes - Evaluate genital cGVHD treatment response - Evaluate the frequency of premature ovarian failure - Measure the incidence and prevalence of HPV infection - Evaluate the quality of life (QoL) of allografted women - Evaluate intimacy within relationships of allografted women - Evaluate sexual function of allografted women - Evaluate sexual distress of allografted women ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease - NCT ID: NCT06279663 - Study ID: NSTE-ACS Multivessel Trial - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2029-12-31 - Lead Sponsor: Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me ### Study Description The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG. ### Conditions - Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Revascularization ### Outcomes Primary Outcomes - Death from any cause - Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization) - target LDL level Secondary Outcomes - Myocardial infarction - Stroke - Repeated unplanned myocardial revascularization - Duration of the hospital period - Intra/perioperative complications - Significant hemorrhagic complications (grade 3 or more on the BARC scale) - Questionnaire ### Location - Facility: Anton, Novosibirsk, Novosibirsk Obl, 630055, Russian Federation @@
## Self-hypnosis Training for Chronic Pain Management - NCT ID: NCT06279650 - Study ID: 2022-2741 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-12 - Lead Sponsor: Ciusss de L'Est de l'Île de Montréal ### Study Description Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.Adverse events: none expected. ### Conditions - Hypnosis, Chronic Pain Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Self-hypnosis - Psycho-education and cognitive Bahavioral therapy (CBT) ### Outcomes Primary Outcomes - Time 1 : Numerical Rating Scale (NRS) from 0 to 10 - Time 1 : Questionnaire Brief Pain Inventory (BPI) - Time 1 : Hospital anxiety and depression scale (HADS) - Time 1 : SF-36 (36-Item Short Form Survey) - Time 1 : Questionnaire socio-demographic and clinical Secondary Outcomes - Time 2 : Numerical Rating Scale (NRS) from 0 to 10 - Time 2 : Questionnaire Brief Pain Inventory (BPI) - Time 2 : Hospital anxiety and depression scale (HADS) - Time 2 : SF-36 (36-Item Short Form Survey) ### Location - Facility: 5415 Bd de l'Assomption, Montréal, Quebec, H1T 2M4, Canada @@
## Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes - NCT ID: NCT06279637 - Study ID: PRO00046457 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-07 - Lead Sponsor: Medical College of Wisconsin ### Study Description This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.The aims of the study are:Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Joint Home-DM-BAT Intervention - Usual Care ### Outcomes Primary Outcomes - Glycemic Control (Hemoglobin A1C [HbA1C]) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of the PCV13 in Older Thai Adults - NCT ID: NCT06279624 - Study ID: NRCT9-4 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-06 - Lead Sponsor: Mahidol University ### Study Description This is the matched 1:2 case-control study, prospectively collect case and control who are diagnosed with pneumococcal or non-pneumococcal community acquired pneumonia (CAP), accordingly from November 2023 through October 2024. The investigators define a CASE as a person aged ≥60 years due to pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge. While a CONTROL is defined as a person aged ≥60 years due to non-pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge.The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal CAP in Thai adults aged ≥ 60 years with or without any medical conditions.The main questions it aims to answer is:• What are the effectiveness of PCV13 for preventing all typed, vaccine typed, or non-vaccine typed of pneumococcal CAP among Thai older adults?The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023. The investigators define case and control the same as prospective method, but all data were retrieved from archive database.-The investigators select a 1:2 matched control with criteria as follows; 10-year-interval of age, ward (the same patient care such as out or in-patient, or admitted in the same level ward).Participants will be* collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition.* explored their vaccine status by either vaccine book checking or hospital database.Researcher will compare the effectiveness of PCV13 to prevent all typed, vaccine typed and non-vaccine typed pneumococcal pneumonia. ### Conditions - Community-acquired Pneumonia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Vaccine effectiveness of PCV13 on all types of pneumococcal CAP Secondary Outcomes - Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Evaluation of LY007 Cell Injection for r/r B-NHL - NCT ID: NCT06279611 - Study ID: LY007C1101 - Status: RECRUITING - Start Date: 2021-12-25 - Completion Date: 2026-05-31 - Lead Sponsor: Shanghai Longyao Biotechnology Inc., Ltd. ### Study Description An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research ### Conditions - B-NHL ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - LY007 ### Outcomes Primary Outcomes - Maximum tolerated dose or clinically recommended dose - Dose limiting toxicity - Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern Secondary Outcomes - PK aspect - PK aspect - PD aspect - therapeutic effect - Anti LY007 antibody - The titer of human anti mouse antibody ### Location - Facility: Ruijin hospital, Shanghai, Shanghai, N/A, China @@
## PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD - NCT ID: NCT06279598 - Study ID: UniversityGroningen - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2032-08-31 - Lead Sponsor: University of Groningen ### Study Description The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized.Key questions:1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?Secondary goals:* Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;* Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;* Investigating how much the quality of the therapeutic alliance influences outcomes.Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom. ### Conditions - Stress Disorders, Post-Traumatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prolonged Exposure therapy - Eye Movement Desensitization Reprocessing (EMDR) - Interpersonal Psychotherapy (IPT) ### Outcomes Primary Outcomes - PTSD Checklist for DSM-5 (PCL-5) Secondary Outcomes - Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) - International Trauma Questionnaire (ITQ) - Hospital Anxiety and Depression Scale (HADS) - Mental Health Continuum Short Form (MHC-SF) - Positive and Negative Experiences of Psychotherapy questionnaire (PNEP) ### Location - Facility: Dimence, Deventer, N/A, N/A, Netherlands @@
## Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD - NCT ID: NCT06279585 - Study ID: ECA GVHD - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-09 - Lead Sponsor: University of Seville ### Study Description Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD. ### Conditions - Graft-versus-host-disease - Graft Versus Host Disease, Chronic - Stem Cell Transplant Complications - Hematological Malignancy - Hematologic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical therapy ### Outcomes Primary Outcomes - Health-related quality of life - Chronic Graft-Versus-Host Disease (cGVHD) symptom burden Secondary Outcomes - Muscular strength - Cardiorespiratory fitness - Functional status - Distress - Mood - Anxiety - Biological markers - Responses to medical treatment ### Location - Facility: University of Seville; Manuel Siurot Avenue, no number, Seville, N/A, 41013, Spain @@
## Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy - NCT ID: NCT06279572 - Study ID: 20-011624 - Status: RECRUITING - Start Date: 2021-04-22 - Completion Date: 2026-12-31 - Lead Sponsor: Mayo Clinic ### Study Description This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biospecimen Collection - Bone Marrow Aspirate - Electronic Health Record Review ### Outcomes Primary Outcomes - Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy Secondary Outcomes ### Location - Facility: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States @@
## Music Therapy and High-risk Pregnancy - NCT ID: NCT06279559 - Study ID: MTinHRP_v1_10/01/2023 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-12-01 - Lead Sponsor: Istituto Giannina Gaslini ### Study Description The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?3. How does the risk of preterm birth modulate the future attachment bond between mother and child?Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question. ### Conditions - High Risk Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Music-therapy ### Outcomes Primary Outcomes - Depressive symptoms - State anxiety and trait anxiety - Perceived stress - Perceived positive and negative feelings - Mother-fetus attachment bond - Mother-child attachment bond Secondary Outcomes ### Location - Facility: Istituto Giannina Gaslini, Genova, N/A, 16147, Italy @@
## Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy - NCT ID: NCT06279546 - Study ID: IECED-12345 - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2024-01-26 - Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas ### Study Description Endoscopic ultrasound (EUS) visual impression is operator-dependant and can hinder diagnostic accuracy, especially in less experienced endoscopists. The implementation of artificial intelligence can potentially mitigate operator dependency and interpretation variability, helping or improving the overall accuracy.The investigators therefore aim to compare diagnostic accuracy between artificial intelligence (AI)-based model and the endoscopists when identifying normal anatomical structures in EUS-procedures. ### Conditions - Gastrointestinal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Detection of structures ### Outcomes Primary Outcomes - Diagnostic accuracy Secondary Outcomes - Interobserver agreement ### Location - Facility: IECED, Guayaquil, Guayas, 090505, Ecuador @@