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## Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients - NCT ID: NCT06314646 - Study ID: 3747 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2027-12-31 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis. ### Conditions - Rectal Cancer - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transanal Transection and Single-Stapled anastomosis (TTSS) - Double-stapled Total Mesorectal Excision (TME) ### Outcomes Primary Outcomes - Rate of anastomotic leak Secondary Outcomes - Rate of postoperative complications - Postoperative Recovery Profile (PRP) score - Proportion of patients fit for stoma closure - Healthcare costs - Low Anterior Resection Syndrome (LARS) score - Low Anterior Resection Syndrome (LARS) score - Low Anterior Resection Syndrome (LARS) score - Cancer recurrence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children - NCT ID: NCT06314633 - Study ID: ICO-2023-13 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2026-06 - Lead Sponsor: Institut Cancerologie de l'Ouest ### Study Description PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences. ### Conditions - Healthy Volunteer Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Hair cut - Socio-economic questionnaires ### Outcomes Primary Outcomes - Describe DNA damage - Describe DNA damage - Describe socio-economic characteristics. - Describe socio-economic characteristics. Secondary Outcomes - Characterize chemical exposome variations - Characterize chemical exposome variations - Characterize socio-economic indicators - Characterize socio-economic indicators, geographical area, seasons - Characterize socio-economic indicators, geographical area, seasons - Characterize socio-economic indicators, geographical area, seasons - Describe DNA damage - Describe DNA damage ### Location - Facility: Institut de Cancérologie de l'ouest, Saint-Herblain, N/A, 44800, France @@
## Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency - NCT ID: NCT06314620 - Study ID: FF-2024-043 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-06-01 - Lead Sponsor: National University of Malaysia ### Study Description Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results.Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently , in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures.British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions.The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement.There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion. ### Conditions - Pleural Effusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Heparin saline lock - Without heparin saline lock ### Outcomes Primary Outcomes - To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock Secondary Outcomes - To determine the onset of intercostal chest catheter occlusions (in hours) - To determine the change of hemoglobin (in g/dL) post ICC insertion - To determine the change of platelet (in 10 9/L) post ICC insertion - To determine the adverse effects of heparin saline lock - To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots ### Location - Facility: National University of Malaysia, Kuala Lumpur, Wilayah Persekutuan, 53300, Malaysia @@
## Genetic and Molecular Characterization of Nervous System Lesions - NCT ID: NCT06314607 - Study ID: APHP220498 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2034-03 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets.Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies).In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile.This project aims to make a decisive contribution to these objectives. ### Conditions - Brain Tumor - Brain Lesion (General) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Prospective Biological Collection - Retrospective Biological Collection ### Outcomes Primary Outcomes - Study the clinical markers with the evolution of brain lesions. - Study the biological markers with the evolution of brain lesions. - Study the anatomopathological markers with the evolution of brain lesions. Secondary Outcomes ### Location - Facility: Service de Neurochirurgie - Hôpital de la Pitié Salpêtrière, Paris, N/A, 75013, France @@
## the Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis - NCT ID: NCT06314594 - Study ID: 2024KY920 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2026-12-01 - Lead Sponsor: Hangzhou Medical College ### Study Description Based on the risk factors affecting adolescent scoliosis found in the previous social survey, this project adopts the paradigm based on transfer learning and semi-supervised learning, and uses mathematical methods such as multiple learning methods and Transformer image classification algorithms to develop and verify the early warning model and stepped treatment model of adolescent scoliosis, and conducts cost-effect analysis. ### Conditions - Adolescent Scoliosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional treatment - intervention treatment ### Outcomes Primary Outcomes - Number of Cobb angles - Accuracy of new screening modalities - Hamilton Depression Volume Secondary Outcomes ### Location - Facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College., Hangzhou, Zhejiang, 311000, China @@
## Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department - NCT ID: NCT06314581 - Study ID: 673_BPPV-Teaching - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-12-01 - Lead Sponsor: Fondation Hôpital Saint-Joseph ### Study Description Acute vertigo accounts for around 4% of emergency room visits. Triggered episodic vestibular syndrome is the most commonly encountered symptomatic context. BPPV (Benign Paroxysmal Positional Vertigo) is the main cause, representing 40-50% of the vertigo cases assessed in emergency departments. It results from the migration of calcium carbonate particles (otoliths), from the sticky membrane of the utricle and saccule of the inner ear, to one of the 3 semicircular canals (SCC), posterior, horizontal or lateral, and anterior. It occurs idiopathically with head movement, through degeneration, or following head trauma. The otolith impulse causes the endolymph to move, temporarily and aberrantly displacing the cup of the affected canal, resulting in the transmission of erroneous information to the vestibular nuclei. This leads to the sudden onset of vertigo and eye deviation, resulting in transient nystagmus. The location of the displaced otoliths determines the variant of BPPV: BPPV of the posterior semicircular canal is the most common (around 65% of BPPVs), followed by BPPV of the horizontal canal, while BPPV of the anterior canal is rare, as it resolves spontaneously and rapidly. Although a benign condition, BPPV leads 9 times out of 10 to a medical consultation, interruption of daily activities, or sick leave. Untreated, it will usually recur, and can impact on patients' quality of life. ### Conditions - Benign Paroxysmal Positional Vertigo ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - accurate BPPV diagnostics Secondary Outcomes - therapeutic maneuvers performed - Satisfaction of clinicians who received the educational interventio ### Location - Facility: Groupe Hospitalier Paris Saint-Joseph, Paris, N/A, 75014, France @@
## Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer - NCT ID: NCT06314568 - Study ID: 6350 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2028-12-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer ### Conditions - Vaginal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radiochemotherapy plus interventional radiotherapy ### Outcomes Primary Outcomes - Local Control Secondary Outcomes - Cancer specific overall survival - Toxicities - Overall survivall - Disease free survivall - Metastasis free survival - Changes in quality of life over time ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia - NCT ID: NCT06314555 - Study ID: CEROG2023 - Status: COMPLETED - Start Date: 2019-10-01 - Completion Date: 2021-01-27 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia. ### Conditions - Preeclampsia Possible ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample - Vascular-renal sample ### Outcomes Primary Outcomes - Doctor's medical care decisions on Hospitalization Secondary Outcomes - Intensive monitoring - Corticosteroid administration for lung maturation - Birth induction ### Location - Facility: Chu Saint Etienne, St Etienne, N/A, 42100, France @@
## Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria for Lung Cancer Based on Real-world Data - NCT ID: NCT06314542 - Study ID: REC-001 - Status: RECRUITING - Start Date: 2013-01-01 - Completion Date: 2026-06-30 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description Eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. In order to evaluate the REC of NSCLC drug trials, this study will use deep learning methods to construct a structured real-world database of NSCLC across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety. ### Conditions - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - relaxing eligibility criteria ### Outcomes Primary Outcomes - Scale of eligibility criteria Secondary Outcomes ### Location - Facility: Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, N/A, N/A, China @@
## Long-term Follow-up Study of BHC001 for TDT - NCT ID: NCT06314529 - Study ID: 2022-LTF-BHC001 - Status: RECRUITING - Start Date: 2022-12-14 - Completion Date: 2037-05-10 - Lead Sponsor: Bioray Laboratories ### Study Description Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects. ### Conditions - Thalassemia, Beta ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Assessments ### Outcomes Primary Outcomes - Incidence of hematologic malignancies - Frequency, grade, and relationship of SAEs Secondary Outcomes ### Location - Facility: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, Nanning, Guangxi, 530021, China @@
## Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes - NCT ID: NCT06314516 - Study ID: CRP17122 - Status: COMPLETED - Start Date: 2017-12-27 - Completion Date: 2024-02-28 - Lead Sponsor: Benaroya Research Institute ### Study Description Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study. ### Conditions - Esophageal Cancer - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Longitudinal variation in body composition Secondary Outcomes - Patient and disease-specific factors ### Location - Facility: Virginia Mason Medical Center, Seattle, Washington, 98101, United States @@
## First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients - NCT ID: NCT06314503 - Study ID: 23-075_CORDIAL_FIH - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2024-12-31 - Lead Sponsor: UMC Utrecht ### Study Description The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid.The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment.The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions.Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber.Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane). ### Conditions - Renal Insufficiency, Chronic - Kidney Failure, Chronic - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - WEAKID ### Outcomes Primary Outcomes - Serious adverse device effects (SADEs) and device deficiencies (DDs) - Critical changes in blood pressure - Critical changes in heart rate - Critical changes in body temperature - Critical changes in oxygen saturation - Critical changes in plasma potassium - Critical changes in plasma calcium - Critical changes in plasma bicarbonate - Critical changes in intra-abdominal dialysate volume - Critical changes in intra-abdominal pressure Secondary Outcomes - Adverse events (AEs) and device deficiencies (DDs) - Number of WEAKID treatments - Duration of WEAKID treatments - Dialysate flow rates during WEAKID treatment - Evolution of blood pressure - Evolution of heart rate - Evolution of body temperature - Evolution of oxygen saturation - Ultrafiltration volume - Peak glucose concentration in the device effluent - Ultrafiltration efficiency - Removal of urea by the WEAKID system - Removal of creatinine by the WEAKID system - Removal of phosphate by the WEAKID system - Removal of potassium by the WEAKID system - Removal of uric acid by the WEAKID system - Removal of beta-2 microglobulin by the WEAKID system - Removal of vitamin B12 by the WEAKID system - Mass transfer area coefficient of urea - Mass transfer area coefficient of creatinine - Mass transfer area coefficient of phosphate - Mass transfer area coefficient of potassium - Mass transfer area coefficient of uric acid - Mass transfer area coefficient of beta-2 microglobulin - Mass transfer area coefficient of vitamin B12 - Plasma clearance of urea - Plasma clearance of creatinine - Plasma clearance of phosphate - Plasma clearance of potassium - Plasma clearance of uric acid - Plasma clearance of beta-2 microglobulin - Plasma clearance of vitamin B12 - The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate - The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide - The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid - The plasma reduction ratio of the protein-bound uremic toxin kynurenine - The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid - The plasma reduction ratio of the protein-bound uremic toxin hippuric acid - The release of base - Evolution of plasma levels of urea - Evolution of plasma levels of creatinine - Evolution of plasma levels of uric acid - Evolution of plasma levels of beta-2 microglobulin - Evolution of plasma levels of phosphate - Evolution of plasma levels of potassium - Evolution of plasma levels of bicarbonate - Evolution of plasma levels of lactate - Evolution of plasma levels of sodium - Evolution of plasma levels of chloride - Evolution of plasma levels of calcium - Evolution of plasma levels of magnesium - Evolution of plasma levels of glucose - Evolution of plasma levels of lactate dehydrogenase - Evolution of plasma levels of vitamin B12 - Evolution of plasma levels of albumin - Evolution of plasma leucocyte count - Evolution of plasma thrombocyte count - Evolution of plasma levels of C-reactive protein (CRP) - Evolution of plasma levels of bilirubin - Evolution of plasma levels of aspartate transaminase (ASAT) - Evolution of plasma levels of alanine aminotransferase (ALAT) - Evolution of sodium levels in dialysate effluent - Evolution of chloride levels in dialysate effluent - Evolution of calcium levels in dialysate effluent - Evolution of magnesium levels in dialysate effluent - Evolution of bicarbonate levels in dialysate effluent - Evolution of lactate levels in dialysate effluent - Evolution of pH of dialysate effluent - Total number of device deficiencies and adverse device effects - Evolution of delta intraperitoneal pressure during WEAKID treatment - Patient tolerance (abdominal discomfort) - Evolution of uremic symptoms - Usability ### Location - Facility: Università degli studi di Modena e Reggio Emilia (UNIMORE), Modena, N/A, 41121, Italy @@
## Personalized Antisense Oligonucleotide Therapy for Rare Pediatric Genetic Disease: SCN2A - NCT ID: NCT06314490 - Study ID: ASOSCN2A - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-16 - Completion Date: 2026-02-16 - Lead Sponsor: University of California, San Diego ### Study Description This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with SCN2A associated developmental epileptic encephalopathy ### Conditions - Genetic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - nL-SCN2A-002 ### Outcomes Primary Outcomes - Seizure frequency - Motor function as measured by Dyskinetic Cerebral Palsy Functional Impact Scale - Motor function as measured by the motor skills domain of Vineland Adaptive Behavior Scales - Motor function as measured by the motor skills domain of Bayley Scales of Infant and Toddler Development - Gastrointestinal assessment as measured by the Bristol Stool Chart Secondary Outcomes - Neurodevelopmental Function as measured by Aberrant Behavior Checklist - Neurodevelopmental Function as measured by Observer-Reported Communication Ability Measure - Neurodevelopmental Function as measured by the Vineland Adaptive Behavior Scales - Neurodevelopmental Function as measured by the Bayley Scales of Infant and Toddler Development ### Location - Facility: Rady Children's Hospital, San Diego, California, 92123, United States @@
## Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial - NCT ID: NCT06314477 - Study ID: HCB/2022/1204 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Hospital Clinic of Barcelona ### Study Description The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA) ### Conditions - Obstructive Sleep Apnea - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CPAP treatment - Hygienic and dietary advice ### Outcomes Primary Outcomes - Asthma control questionnaire - Asthma control test Secondary Outcomes - Lung function- forced expiratory volume in the first second (FEV1) in spirometry - Lung function-forced vital capacity (FVC) in spriometry - Prevalence of OSA in severe uncontrolled asthma - Inflammatory profile - Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI - NCT ID: NCT06314464 - Study ID: C2023.055 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-12 - Completion Date: 2025-09-30 - Lead Sponsor: BlueHalo ### Study Description The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI).The main questions this comparative pilot study aims to answer are:* Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?* Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery?Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including:* gaze stabilization* dual-task balance training* spatial navigation* agility trainingData from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group.Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation. ### Conditions - Brain Concussion - Vestibular Disorder - Cognition Disorder - Mild Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Praxis - Supervised cardiovascular exercise ### Outcomes Primary Outcomes - Perceived usability of the Praxis system measured by the System Usability Scale (SUS) Secondary Outcomes - Change in Dizziness Handicap Inventory (DHI) score - Change in Pittsburgh Sleep Quality Index (PSQI) score - Change in Generalized Anxiety Disorder scale (GAD-7) score - Change in Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) score - Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score - Change in Headache Impact Test-6 (HIT-6) score - Change in Santa Barbara Sense of Direction Scale (SBSOD) score - Change in time required to perform 300-yard shuttle run (single- and dual-task) - Change in perceived fogginess - Change in time required to perform 5-10-5 shuttle run - Change in score for 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI) - Change in time required to perform POrtable WARrior Test Of Tactical AgiLity (POWAR-TOTAL) (single- and dual-task) - Change in Vestibular/Ocular Motor Screening (VOMS) total symptom score - Compliance with 20-minute daily dose of gaze stability exercises ### Location - Facility: Brooke Army Medical Center, Fort Sam Houston, Texas, 78234, United States @@
## Cross-condition Validation of the Steroid PRO - NCT ID: NCT06314451 - Study ID: HAS.22.11.035 - Status: RECRUITING - Start Date: 2022-06-01 - Completion Date: 2024-05-31 - Lead Sponsor: University of the West of England ### Study Description Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions ### Conditions - Inflammatory Disease - Immune System Disorder - Gastrointestinal Diseases - Dermatologic Disease - Respiratory Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cognitive Interview ### Outcomes Primary Outcomes - Steroid PRO Secondary Outcomes ### Location - Facility: University of the West of England, Bristol, N/A, BS2 8HW, United Kingdom @@
## Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood - NCT ID: NCT06314438 - Study ID: STUDY00017189 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-15 - Completion Date: 2024-03-15 - Lead Sponsor: University of Washington ### Study Description The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are:* Is the Family Care Project workbook useful for families?* Is the Family Care Project workbook easy to use?* Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds?Participants will complete surveys that elicit their feedback on their use of the workbook. ### Conditions - Autism - Development Delay ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Family Care Project ### Outcomes Primary Outcomes - Staff Training Feedback Survey of Implementation Properties (self-report) - Staff Competence in Assisting Families with Children at-autism Likelihood Survey (self-report) - The Maternal Self-Efficacy Scale Questionnaire - Caregiver Knowledge and Use of Behaviors that Support Children at autism-likelihood Survey - Current Services Utilized by Families to Support Children at autism-likelihood Survey - Family Care Project Feedback Survey of Implementation Properties Secondary Outcomes ### Location - Facility: Mother Africa, Kent, Washington, 98032, United States @@
## Zirconia Implants: Practice-based Evidence - NCT ID: NCT06314425 - Study ID: IRB_20240714 - Status: RECRUITING - Start Date: 2024-04-28 - Completion Date: 2025-12 - Lead Sponsor: Swiss Dental Solutions ### Study Description This study is a prospective case series clinical study to examine the effectiveness of Ceramic dental implants manufactured by Swiss Dental Solutions (SDS). Participants with an indication from the dentist for teeth extraction and replacement are invited to participate in this study. Participating in this study will involve the use of dental implants manufactured by Swiss Dental Solutions (SDS zirconia dental implants), submission of the case data, including pre-operative information, intra-operative details, and post-operative follow-up data, to the study site and its collaborating partners.The SDS zirconia dental implants used in this research are FDA cleared devices that are available for dental treatments. ### Conditions - Dental Implants - Ceramic Implant ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Immediate dental implants placements on fresh sockets after tooth extraction ### Outcomes Primary Outcomes - Cumulative Survival Rate (CSR) Secondary Outcomes - Marginal Bone Loss (MBL) ### Location - Facility: Brighton Periodontal & Implant Dental Group, Woodland Hills, California, 91367, United States @@
## Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence - NCT ID: NCT06314412 - Study ID: 24C211 - Status: RECRUITING - Start Date: 2023-02-13 - Completion Date: 2025-07 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Recently, several studies have investigated the safety and efficacy of the Stoller afferent nerve stimulation (SANS) treatment in Multiple Sclerosis (MS) patients. However, because of the differences among the published protocols (percutaneous versus transcutaneous stimulation, stimulation site, total number of sessions), and the absence of data on the duration of the effect, this treatment is not yet currently included in the rehabilitation programs. The present study aims at evaluating the efficacy of a protocol of SANS in the short- and medium-term follow-up.The efficacy of the proposed stimulation protocol on the physiological parameters of bladder function will be also investigated. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Stoller's Afferent Nerve Stimulation (SANS) ### Outcomes Primary Outcomes - Measure of variation of incontinence. - Measure of variation of urinary urgency Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano, Milan, N/A, 20122, Italy @@
## Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients With Laparoscopic Cholecystectomy - NCT ID: NCT06314399 - Study ID: 2023-18 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06 - Lead Sponsor: Hospital Universitario Mayor Méderi ### Study Description The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations. ### Conditions - Biliary Infection - Antibiotic Resistant Strain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bile culture and phenotypic antibiogram resistance test ### Outcomes Primary Outcomes - Bile culture positivity - Phenotypical antibiogram resistance Secondary Outcomes - Microbial characteristics - Bile culture and antibiotic resistance relationship - Demographical and clinical characteristics - Surgical characteristics and outcomes - Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Systems Analysis and Improvement Approach to Prevent TB - NCT ID: NCT06314386 - Study ID: 23.139.01 - Status: NOT_YET_RECRUITING - Start Date: 2025-01-06 - Completion Date: 2029-02-28 - Lead Sponsor: Boston College ### Study Description This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to:* Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts* Determine the drivers of SAIA-TB implementation success or failure across clinicsThe investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. ### Conditions - Tuberculosis - TPT - TB - Tuberculosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Systems Analysis and Improvement Approach for TB (SAIA-TB) ### Outcomes Primary Outcomes - TB Screening - Linkage to care for TB disease treatment - TB Evaluation - TB Diagnosis Secondary Outcomes - Successful TB Prevention Treatment (TPT) Outcome - Successful TB Outcome ### Location - Facility: Addo Clinic, Addo, N/A, N/A, South Africa @@
## A Study for HSK39775 in Participants With Solid Tumors - NCT ID: NCT06314373 - Study ID: HSK39775-101/201 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2028-09-01 - Lead Sponsor: Xizang Haisco Pharmaceutical Co., Ltd ### Study Description This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HSK39775 Monotherapy ### Outcomes Primary Outcomes - AE/SAE - DLT - MTD/MAD Secondary Outcomes - Maximum Plasma Concentration [Cmax] - Area Under Curve[AUC] - Time to maximum observed concentration [Tmax] - Elimination half-life [t1/2] - Overall Response Rate (ORR) per RECIST V1.1 - Progression Free Survival - Time To Response - Disease Control Rate - Best percentage change in target lesion ### Location - Facility: Fundan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## Comparison of Foot Posture, Plantar Pressure, and Postural Balance in Patellofemoral Pain Patients and Healthy Subjects - NCT ID: NCT06314360 - Study ID: BAP_PFS - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: Hacettepe University ### Study Description Patellofemoral pain syndrome (PFS) is a musculoskeletal problem characterized by pain felt in the front of the knee or behind the patella, commonly affecting individuals in adolescence or young adulthood, especially those engaged in sports such as cycling and running. It is one of the most encountered knee injuries and can have a poor prognosis. The intensity of knee pain increases during functional activities such as stair climbing, squatting, running, and jumping due to the increased patellofemoral joint reaction force.A disturbance in postural stability is observed in individuals with PFS due to pain during functional activities. Studies examining changes in foot posture, plantar pressure, and postural balance in individuals with PFS are quite limited and controversial. Moreover, research that simultaneously investigates these parameters and interprets the results is scarce. Some studies have utilized detailed technical systems such as medical imaging or motion analysis, while practical methods incorporating foot posture and plantar pressure analyses are available and easy to use in clinical settings.There is a lack of literature on the easy assessment and interpretation of plantar pressure, postural balance, and functional activities in individuals with PFS. Within the scope of this project, the plan is to assess plantar pressure, postural balance, and functional activities in individuals with PFS. The aim is to quickly interpret the biomechanical changes occurring in these individuals and guide rehabilitation programs based on the obtained data.The use of practical and fast assessment methods in planning treatments for PFS is crucial for early rehabilitation planning. Practical methods such as foot posture, plantar pressure, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The objective of this study is to compare the foot posture, plantar pressure, and postural stability of individuals with PFS with healthy individuals. Additionally, the investigators aim to investigate the relationship between foot posture, plantar pressure parameters, postural balance, and functional level in individuals with PFS. Through these objectives, it will be possible to identify potential parameters that could be effective in rehabilitation processes and contribute to determining treatment programs by revealing biomechanical changes in individuals with PFS. ### Conditions - Patellofemoral Pain Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention. ### Outcomes Primary Outcomes - Plantar Pressure - Postural Stability - Foot posture - Functionality Secondary Outcomes - Pain Assessment - Limb dominance ### Location - Facility: Hacettepe University, Ankara, Ankara/Sıhhıye, 06100, Turkey @@
## Reference Value of Figure of 8 Walk Test - NCT ID: NCT06314347 - Study ID: gibtuipekkirmaci - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-30 - Lead Sponsor: Gaziantep Islam Science and Technology University ### Study Description The aim of the study is to determine the reference values of the Figure 8 Walking Test in healthy adults. ### Conditions - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Figure of 8 walk test ### Outcomes Primary Outcomes - Figure of 8 walk test Secondary Outcomes - Age - gender - height - weight ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma - NCT ID: NCT06314334 - Study ID: SHCA-NKT-202301 - Status: RECRUITING - Start Date: 2023-03-04 - Completion Date: 2028-12-30 - Lead Sponsor: Fudan University ### Study Description Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival. ### Conditions - Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sintilimab+Pegaspargase - P-GemOx - GELAD - IMRT ### Outcomes Primary Outcomes - PFS24 Secondary Outcomes - ORR - OS - EFS - TRAE ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients - NCT ID: NCT06314321 - Study ID: 2021-K151-01 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2024-02-20 - Lead Sponsor: Affiliated Hospital of Nantong University ### Study Description The aim of this study is to examine the effect of 18-month Baduanjin exercise on shoulder joint function in maintenance hemodialysis (MHD) patients. 60 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities. ### Conditions - Hemodialysis Complication - Shoulder Joint Disorder - CKD-MBD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Baduanjin exercise ### Outcomes Primary Outcomes - Shoulder joint function score - Shoulder joint internal rotation function - Muscle strength measurement - Area of biceps brachii muscle Secondary Outcomes - Changes in the Short Form-36 (SF-36) and European Quality of Life Five Dimension（EQ-5D-5L） - Changes in the Hospital Anxiety and Depression Scale （HADS） ### Location - Facility: Affiliated Hospital of Nantong University, Nantong, Jiangsu, 226000, China @@
## Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke - NCT ID: NCT06314308 - Study ID: AAAU8161 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Columbia University ### Study Description CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) guided by telehealth based Cognitive Behavioral Therapy (CBT) to reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies and facilitate engagement in physical activity.1. To integrate and establish feasibility of CATCHES intervention. Hypothesis: A multidisciplinary team providing home based TST with exposure therapy tailored to an underserved urban setting will inform a patient-centered behavioral intervention to reduce fear of falling (FOF) among post-acute stroke patients returning home. Feasibility outcomes will include recruitment, retention, and fidelity of implementation.2. Test effects of the intervention on hypothesized treatment mechanism of fear of falling. Hypothesis: Therapy will reduce task specific fear of falling Primary outcome will be change in Activities-specific Balance Confidence Scale.3. Explore physical activity measures subjectively and objectively. Exploratory outcomes include pre and post Timed Up and Go test, patient reported outcome surveys and activity as measured by wearable devices. ### Conditions - Stroke, Acute Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - CATCHES ### Outcomes Primary Outcomes - Percentage of intervention completers to demonstrate feasibility Secondary Outcomes - Change in Activities-specific Balance Confidence Scale Score ### Location - Facility: The Neurological Institute of New York, Columbia University, New York, New York, 10032, United States @@
## Automated Echocardiographic Detection of Coronary Artery Disease Using Artificial Intelligence Methods - NCT ID: NCT06314295 - Study ID: BeijingH-WF - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2026-04-11 - Lead Sponsor: Beijing Hospital ### Study Description The incidence rate and mortality of coronary artery disease are increasing year by year. Exploring non-invasive, accurate, and widely applicable methods to screen and diagnosis is of great significance. New ultrasound techniques, such as non-invasive myocardial work, have been proven to be superior to traditional ultrasound techniques in screening and diagnosis. However, diagnostic analysis based on ultrasound video images is time-consuming and subjective. The progress of artificial intelligence technology in fully automated quantitative evaluation of video images provides the possibility for computer-aided design screening and diagnosis. At present, the application of artificial intelligence in computer-aided design is a cutting-edge issue in the field of cardiovascular disease research. The application of artificial intelligence technology in the construction of computer-aided diagnostic models based on ultrasound video images is still in its early stages. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Different coronary angiography results Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use - NCT ID: NCT06314282 - Study ID: D3461R00072 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2027-08-31 - Lead Sponsor: AstraZeneca ### Study Description INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study. ### Conditions - Systemic Lupus Erythematosus (SLE) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - PGA - SLEDAI-2K - CLASI - FACIT-Fatigue - LupusQoL - EQ-5D-5L Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Incidence of Perioperative Cerebrovascular Stroke in Assuit University Hospitals , Hospital Based Study - NCT ID: NCT06314269 - Study ID: 246810121416 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-09-30 - Lead Sponsor: Assiut University ### Study Description Stroke is the most common cause of disability in elderly people (over 65years of age) and the third most common cause of death in the world . The World Health Organization estimates that one in six people globally will suffer from stroke in their lifetime.Perioperative stroke is the most unwanted complication for patients, as well as for surgeons and anesthesiologists . The reported risk of perioperative stroke varies with the type of surgery. Its incidence is generally not high (approximate 0.1-1.9%) in non-cardiac, non-neurologic, and non-major surgery However, it may occur in up to 10% of patients undergoing high-risk cardiac or brain surgery . Patients with perioperative stroke are less likely to have a good functional outcome and have an eight-fold higher mortality compared with those without perioperative stroke ### Conditions - Perioperative Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 1- To determine incidence and prevalence of perioperative cerebrvosacular stroke in General surgery, cardiothorasic surgery and vascular surgery departments , Assuit university hospitalis , Egypt. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction - NCT ID: NCT06314256 - Study ID: 2023/218 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-11-10 - Lead Sponsor: Altinbas University ### Study Description The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstruction of interdental papilla loss. The main questions it aims to answer are:* How compareable are above mentioned two interventions (i-PRF\&HA) in reconstruction of interdental papilla loss?* Which treatment option is better accepted by patients? Which treatment option would patients be more satisfied with? Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design. Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes, for how long do they last. ### Conditions - Interdental Papilla Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Injection - Injection ### Outcomes Primary Outcomes - Reduction in Black Triangle Area - Reduction in Black Triangle Height - Reduction in Black Triangle Width Secondary Outcomes - Volume Gain of Interdental Papilla - Patient Satisfaction Score ### Location - Facility: Altinbas University, Istanbul, N/A, N/A, Turkey @@
## The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients - NCT ID: NCT06314243 - Study ID: RHDIRB2020110301 REC #241 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Ain Shams University ### Study Description The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients.The main question it aims to answer is:• Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients?Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile. ### Conditions - Hemodialysis Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. " ### Outcomes Primary Outcomes - To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients. - To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients. Secondary Outcomes - To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Australian Genomics Of Chronic Allograft Dysfunction Study - NCT ID: NCT06314230 - Study ID: AUSCAD - Status: RECRUITING - Start Date: 2012-04-26 - Completion Date: 2040-01-01 - Lead Sponsor: Western Sydney Local Health District ### Study Description The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles. ### Conditions - Kidney Transplant Rejection - Kidney Transplant; Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Graft failure - Allograft rejection - Gene profile Secondary Outcomes - Death - Major infectious adverse outcomes - Major malignancy related adverse outcomes - Major cardiovascular adverse outcomes - Chronic allograft dysfunction - BK virus associated nephropathy - Albuminuria - Surrogate end-points - Delayed graft function (DGF) - Death censored graft loss (DCGL) - Treatment resistant rejection ### Location - Facility: Westmead Hospital, Westmead, New South Wales, 2145, Australia @@
## Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME - NCT ID: NCT06314217 - Study ID: CL-00002 - Status: RECRUITING - Start Date: 2024-02-18 - Completion Date: 2025-03-30 - Lead Sponsor: Everads Therapy ### Study Description This is an open-label pilot device study. The aim of the study is to evaluate the safety and performance of Everads Injector following single injection of suspension approved for ocular use into the suprachoroidal space.The study population is patients diagnosed with diabetic macular edema (DME) that were previously treated. 10 adult subjects are expected to be enrolled based on the inclusion-exclusion criteria.The study will involve 6 visits during a period of 6 weeks ### Conditions - Diabetic Macular Edema ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Everads Injector ### Outcomes Primary Outcomes - Frequency of treatment-emergent adverse events - Frequency of adverse device effects Secondary Outcomes - Confirmation of TA delivery into the suprachoroidal space - Change from baseline in central macular thickness ### Location - Facility: Rambam MC, Haifa, N/A, N/A, Israel @@
## Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms - NCT ID: NCT06314204 - Study ID: 2015-A01222-47 - Status: RECRUITING - Start Date: 2016-09-20 - Completion Date: 2026-09-06 - Lead Sponsor: Centre hospitalier de Ville-Evrard, France ### Study Description Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of patients with psychotic symptoms and cannabis use. We hypothesize that these patients (in comparison with patients with psychotic symptomatology and not using cannabis) would be hospitalized more long, exposed to a higher risk of resistance to the usual therapeutics, would have a lack of therapeutic alliance and insight, relapses and hospitalizations more frequent, more marked negative symptoms and lower quality remission. They would also be more prone to impulsive and aggressive behaviour. ### Conditions - Psychotic; Disorder, Cannabis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - PANSS: Positive and Negative Syndrom Scale - PANSS: Positive and Negative Syndrom Scale - PANSS: Positive and Negative Syndrom Scale - PANSS: Positive and Negative Syndrom Scale - MCQ-SF :Marijuana Craving Questionnaire- Short Form - MCQ-SF :Marijuana Craving Questionnaire- Short Form) - MCQ-SF :Marijuana Craving Questionnaire- Short Form) - MCQ-SF :Marijuana Craving Questionnaire- Short Form) - CGI: Clinical Global Impression - CGI: Clinical Global Impression - CGI: Clinical Global Impression - CGI: Clinical Global Impression - MADRS: Montgomery Åsberg Depression Rating Scale - MADRS: Montgomery Åsberg Depression Rating Scale - MADRS: Montgomery Åsberg Depression Rating Scale - MADRS: Montgomery Åsberg Depression Rating Scale - PDS: Psychotic Depression Scale - PDS: Psychotic Depression Scale - PDS: Psychotic Depression Scale - PDS: Psychotic Depression Scale - YMRS: Young Mania Rating Scale - YMRS: Young Mania Rating Scale - YMRS: Young Mania Rating Scale - YMRS: Young Mania Rating Scale - CDS: Self-Consciousness Revised Scale - CTQ: Childhood Trauma Questionnaire - BFI: Big Five Inventory Secondary Outcomes ### Location - Facility: unité de recherche clinique de l'E.P.S de Ville Evrard, Neuilly Sur Marne, N/A, 93332, France @@
## Adipose Tissue and Symptomatic Gonarthrosis - NCT ID: NCT06314191 - Study ID: 23-AOIP-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-09-15 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description 1. Prevalence of osteoarthritis in France Osteoarthritis (OA) is a very common disease, affecting almost 15% of the population. It is responsible for a significant socio-economic cost in connection with the chronic and disabling pain it causes . Gonarthrosis is the most frequently encountered arthritic localization . In a large 2010 meta-analysis, the main risk factors for developing knee OA were shown to be obesity, previous knee trauma, hand OA, female gender and advanced age. Smoking appeared to have a moderate protective effect . The risk of developing gonarthrosis in obese patients is 2.6 times higher than in the general population. Hypercholesterolemia itself is a risk factor for osteoarthritis, as are increased plasma levels of specific fatty acids and lipoproteins Inflammatory mechanism in osteoarthritis. Studies have shown that plasma levels of C-reactive protein, can be used to estimate individual susceptibility to developing osteoarthritis over a lifetime . In osteoarthritis patients, plasma concentrations of TNF-α, IL-6 and IL-1 are abnormally high, which appears to contribute to cartilage loss in these subjects .3. Inflammatory mechanism in obesity. Obesity induces systemic and local joint mechanical stresses that increase the risk of developing gonarthrosis in obese or overweight individuals . Beyond the simple mechanical aspect, a body of evidence supports the assertion that obesity is responsible for a systemic inflammatory state, deleterious to joints. 1) Obesity is associated with radiographic and symptomatic osteoarthritis in non-weight-bearing joints, such as the hand In overweight and obese adults, plasma levels of tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6) are significantly increased .3)Weight loss in obese subjects with osteoarthritis alleviates joint symptoms through reduced mechanical stress but also through reduced production and response of inflammatory products .4. Common inflammatory mechanisms between adipose tissue and obesity. The relationship between adipose tissue and inflammation is complex given the different types of adipose tissue and the action of cells derived from it. Adipose tissue is an active endocrine organ composed of mature and developing adipocytes, as well as fibroblasts, endothelial cells and a wide range of immune cells, namely adipose tissue macrophages, neutrophils, eosinophils, mast cells, T cells and B cells. Adipose tissue is recognized as an endocrine organ that secretes a large number of inflammatory mediators, including cytokines (IL-1, IL-6, IL-8, TNF-α) and adipokines (leptin, adiponectin, resistin, visfatin). Communication between adipocytes and immune cells maintains tissue homeostasis. Obesity, however, can upset this balance.Lipid metabolism and joint disorders have been shown to be linked . A high-fat diet may contribute to the development of osteoarthritis .White and brown adipose tissue appear to play a complementary role in the development of osteoarthritis. Increased white adipose tissue in obesity is thought to create a systemic environment of increased inflammation through the release of pro-inflammatory cytokines and adipokines such as leptin and visfatin, all of which have been associated with osteoarthritis . Locally, white adipocytes in infra patellar adipose tissue are architecturally different in patients without gonarthrosis compared with those with knee osteoarthritis. This difference suggests that adipocyte gene expression is directly influenced by inflammation . In obese individuals, there is elevated IL-6 production in brown adipose tissue . Furthermore, it would appear that brown adipose tissue, unlike white, down-regulates the inflammatory profile of macrophages . ### Conditions - Gonarthrosis - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - blood sampling - knee radiography ### Outcomes Primary Outcomes - lipolytic activity - lipolysis measurement Secondary Outcomes ### Location - Facility: Nice University Hospital, Nice, N/A, 06000, France @@
## Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice. Patients Eligible for Inclusion Are Women With a Gestational Age Between 24-42 Weeks Undergoing a Third-trimester Growth Scan. The Image Data From the Scan Are Used to Calculate Fetal Weight. - NCT ID: NCT06314178 - Study ID: p-2024-15469 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-07-30 - Lead Sponsor: Copenhagen Academy for Medical Education and Simulation ### Study Description The goal of this observational study is to compare a new artificial intelligence (AI) feedback tool with the traditional method for estimating fetal weight during ultrasound scans on pregnant women between 24-42 weeks of gestation. The study aims to investigate the presence of demographic bias in the AI model. The demographic factors examined in the study include Body Mass Index (BMI), the number of births, fetal age, mother\'s age, fetal sex, and the presence of preeclampsia. Moreover, the study will compare the accuracy of the AI model and the Hadlock model, a fetal growth formula, in estimating fetal weight. Participants will have their ultrasound scans pseudonymized and securely stored on password-protected removable drives, ensuring their identity and privacy are maintained. Afterward, the ultrasound data will be sent to the Technical University of Denmark (DTU), where the AI model will analyze the images to estimate fetal weight. ### Conditions - Pregnancy Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Demographic biases Secondary Outcomes - Comparing the accuracy of the Hadlock formula and the AI model ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms - NCT ID: NCT06314165 - Study ID: PamukkaleU-SBE-RND-01 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-02 - Lead Sponsor: Pamukkale University ### Study Description In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period. ### Conditions - Menstruation; Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - music medicine practice ### Outcomes Primary Outcomes - menstruation symptom scale Secondary Outcomes - Visual Analogue Scale ### Location - Facility: Pamukkale University Faculty of Health Sciences, Denizli, N/A, 20180, Turkey @@
## 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia - NCT ID: NCT06314152 - Study ID: 2023032 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-10-10 - Lead Sponsor: Nanchong Central Hospital ### Study Description This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al. ### Conditions - Inguinal Hernia - Chronic Pain - Seroma - Recurrent - Infections - Hematoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lightweight mesh fixation in 3 points or 1 point ### Outcomes Primary Outcomes - Rate of recurrence - Rate of postoperative pain Secondary Outcomes - Rate of postoperative complications ### Location - Facility: Yunhong Tian, Nanchong, Sichuan, 637000, China @@
## Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study. - NCT ID: NCT06314139 - Study ID: YanmingXu001 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-06-01 - Lead Sponsor: West China Hospital ### Study Description Essential tremor (ET) is one of the most common movement disorders in adults. The prevalence rate among the elderly over 65 years old is about 4.6%. Tremor usually worsens with age, leading to disability and loss of independence, which has an adverse impact on the quality of life of patients. However, the traditional first-line treatment drugs are neither effective enough nor completely safe for ET patients. Although surgical procedures such as deep brain stimulation (DBS) and thalamotomy can be used to better control unilateral limb tremor, many patients are reluctant to choose surgical treatment because it's invasive. Therefore, there is an urgent need to develop new drugs or non-invasive therapies as a better treatment option for ET.The pathology of the disease is not yet clear, it is generally believed that genetic, aging and environmental factors are related to ET. Hyperactivity of cerebellar function and changes of cerebello-thalamo- cortical (CTC) pathways are currently considered to be the most important pathophysiological mechanisms of ET. Therefore, the cerebellum and cortex may be the best targets for the treatment of tremor.Continuous theta burst stimulation (cTBS) is one of the non-invasive electrophysiological techniques characterized by plexus stimulation, which is similar to low-frequency repetitive transcranial magnetic stimulation (rTMS) but closer to the physiological state of neural activity, and may inhibit the excitability of the stimulated cortex. The stimulation duration is greatly shortened, which is simpler and easier than the low-frequency rTMS of 20-30 minutes. In addition, functional near infrared spectroscopy (fNIRS) is a new non-invasive functional neuroimaging technique. It mainly uses the difference characteristics of oxyhemoglobin and deoxyhemoglobin in brain tissue for near-infrared light absorption at different wavelengths of 600-900nm. The efficacy, safety, and mechanisms involved in non-invasive stimulation therapy for ET patients are still unclear. There are few studies on the treatment of ET with cTBS, and the sample size is small (the largest sample includes only 23 ET patients). Additionally, there was a lack of exploration on the therapeutic mechanism of cTBS for ET patients. Therefore, the investigators conducted a double-blind, randomized, sham-controlled clinical trial to evaluate the safety and efficacy of cTBS in the treatment of ET patients over both cerebellar and cortical area. ### Conditions - Essential Tremor - Continuous Theta Burst Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - continuous theta-burst stimulation (cTBS) ### Outcomes Primary Outcomes - Tremor assessment using Fahn-Tolosa-Marin (FTM) tremor-rating scales Secondary Outcomes - Clinical global impression-improvement (CGI-I) rating scores - Electrophysiological evaluation of cortical excitability and inhibition measured by TMS. ### Location - Facility: Department of Neurology, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, Sichuan Province 610041, P.R. China., Chengdu, Sichuan Sheng, 610041, China @@
## Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis - NCT ID: NCT06314126 - Study ID: ENDO-DCI - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-04 - Lead Sponsor: University of Palermo ### Study Description To date, the treatment for endometriosis is represented by the surgical removal of the lesions. Nonetheless, in the years following surgery, the lesions can recur, often due to excessive estrogen production. To balance estrogen, progestin- or estrogen-progestin-based medications are generally prescribed. On the other hand, progestins and estrogen-progestins act as contraceptives, preventing the onset of a pregnancy. At the same time, these can have side effects that can affect up to 30% of patients. For these and other reasons, some women refuse therapy with progestins or estrogen-progestins, preferring to resort to no treatment.Considering the need to research effective molecules in the prevention of relapses that can maintain fertility and avoid unwanted effects, the research focuses on natural molecules, well tolerated by the body.D-Chiro-Inositol (DCI) is a polyol normally present in human cell membranes, where, from a metabolic point of view, it acts as a second messenger of insulin, while from a hormonal point of view, it exerts an on the biosynthesis of androgens. This effect on steroidogenesis can be attributed to more than one mechanism. In the ovary, DCI stimulates direct testosterone production. Furthermore, it stimulates the accumulation of testosterone by reducing the activity of the aromatase enzyme, responsible for the conversion of androgens into estrogens. Considering the responsiveness of endometriosis to estrogens, and that these constitute a risk factor for recurrences following surgical removal, the use of DCI could be interesting from a clinical point of view.The study plans to verify whether D-Chiro-Inositol dietary supplementation can be effective in reducing systemic estrogen levels in women with endometriosis, thus also reducing the risk of relapses and associated symptoms. ### Conditions - Endometriosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - D-Chiro-Inositol - Placebo ### Outcomes Primary Outcomes - Estradiol Secondary Outcomes - Pelvic pain ### Location - Facility: "Paolo Giaccone" Hospital, Palermo, N/A, 90127, Italy @@
## Evaluation of Oral EGCG Treatment for L-SIL Associated With HPV Infection - NCT ID: NCT06314113 - Study ID: EGCG-HPV - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-09-01 - Lead Sponsor: University of Palermo ### Study Description The study aims to evaluate the effectiveness of the synergy of oral Epigallocatechin Gallate as a treatment for Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) infection. ### Conditions - Low-Grade Intraepithelial Neoplasia of Cervix ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Epigallocatechin Gallate ### Outcomes Primary Outcomes - Persistence Secondary Outcomes ### Location - Facility: "Paolo Giaccone" Hospital, Palermo, N/A, 90127, Italy @@
## The Effect of Aerosol Formed From Tobacco Heating Systems on the Microbiome of Supragingival Dental Biofilm - NCT ID: NCT06314100 - Study ID: IP-2020-02-4027-EB - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2023-10-25 - Lead Sponsor: University of Rijeka ### Study Description Dental caries is a multifactorial disease primarily caused by supragingival dental biofilm. Its progression is influenced by many environmental factors, which include smoking. Tobacco heating systems (THS) are a novel tobacco product whose effect on the microbiome of the supragingival dental biofilm has not yet been investigated.The aim of the proposed research is to determine and compare the composition of the microbiomes of the supragingival dental biofilm of THS smokers, cigarette smokers, and nonsmokers using the Next Generation Sequencing method and to assess and compare the risk of new caries lesion formation between the test groups using the Cariogram method.The results of this research will provide insight into changes in the microbiome of the supragingival dental biofilm resulting from exposure to aerosols from tobacco combustion and tobacco heating. ### Conditions - Dental Caries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tobacco heating systems - cigarette smoking - non smoking ### Outcomes Primary Outcomes - diversity of bacterial species - abundance of bacterial species - caries risk Secondary Outcomes ### Location - Facility: Faculty of dental medicine, University of Rijeka, Rijeka, N/A, N/A, Croatia @@
## iTAPVR Study - Phase II Randomized Study - NCT ID: NCT06314087 - Study ID: Neoantigen Radiotherapy - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-08 - Lead Sponsor: The University of Hong Kong-Shenzhen Hospital ### Study Description In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy ### Conditions - Advanced Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Placebo + conventional treatment including radiotherapy - Radiation: Radiation Therapy；Biological: Personalized tumor peptide vaccine ### Outcomes Primary Outcomes - Progression free survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 2.5 Versus 5 Minutes Trial - NCT ID: NCT06314074 - Study ID: 2023-101143-BO-ff - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-04 - Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf ### Study Description This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery. ### Conditions - Hypotension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Oscillometric blood pressure monitoring at 2.5-minute intervals - Oscillometric blood pressure monitoring at 5-minute intervals ### Outcomes Primary Outcomes - Time-weighted average mean arterial pressure <65 mmHg Secondary Outcomes - Episodes of a mean arterial pressure <50 mmHg - Norepinephrine dose ### Location - Facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, N/A, 20246, Germany @@
## The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes. - NCT ID: NCT06314061 - Study ID: WARD-glucose RCT v.2.2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-01 - Lead Sponsor: Christian S. Meyhoff ### Study Description The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.The main question it aims to answer is:• Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes?Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge. ### Conditions - Diabetes Mellitus - Dysglycemia - Perioperative Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) ### Outcomes Primary Outcomes - Time in range (TIR) of CGM glucose levels Secondary Outcomes - Duration of hypoglycaemia - Duration of hyperglycaemia - Number of hypoglycaemia events - Number of hyperglycaemia events - Complications ### Location - Facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Copenhagen, The Capital Region Of Denmark, 2100, Denmark @@
## 4T Sustainability Program - NCT ID: NCT06314048 - Study ID: 74212 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-01 - Lead Sponsor: Stanford University ### Study Description The goal of the 4T program is to implement proven methods and emerging diabetes technology into clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities. ### Conditions - Type1diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - CGM and RPM ### Outcomes Primary Outcomes - HbA1c trajectory observed 4-12 months post-diagnosis - Diabetes distress measured at baseline and 12 months post-diagnosis. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Decision Support on End-of-life Care Planning in Older Adults - NCT ID: NCT06314035 - Study ID: CIC2023003 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-01-31 - Lead Sponsor: National Taipei University of Nursing and Health Sciences ### Study Description This study aims to test the effects of a patient decision aid (PDA) on planning for end-of-life (EOL) care among older adults with COPD. The main questions it aims to answer are:1. Does a PDA improve the process of a person to make decisions on EOL care?2. Does a PDA improve the readiness of a person to join advance care planning (ACP) communication?3. Does a person make an advance directive after using a PDA?Participants in this study will:1. Be randomly assigned to one of two groups.2. In the experimental group, participants will receive two 60-minute interactive consultations over four weeks, using a PDA to help clarify values and preferences for future medical care. A guidebook summarising these future care options will be provided.3. In the control group, participants will receive two 60-minute sessions on lifestyle modification and self-care management over four weeks using a guidebook with coaching. A guidebook summarising general health information will be provided.Researchers will compare the intervention group to the control group to see if the PDA is better at improving the decision-making process on EOL care, the readiness of a person to join ACP communication and the chance to make an advance directive. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - COPD Patient Decision Aid - General Health Coaching Intervention ### Outcomes Primary Outcomes - Patients' decisional conflict regarding EOL care Secondary Outcomes - Patients' confidence level regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and medical doctors. - Patients' readiness for ACP - Participant's completion of an Advance Directive (AD) - Participants' understanding of the PDA - Participant's subjective clarity of content, comfort during reading and viewing, and the usefulness of the information of the PDA. - Semi-structured Interviews ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP) - NCT ID: NCT06314022 - Study ID: 22-PI113 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2025-12-30 - Lead Sponsor: Hospital del Río Hortega ### Study Description Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake. ### Conditions - Colorectal Cancer - Premalignant Colon Lesions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mobile application for colonoscopy preparation instructions ### Outcomes Primary Outcomes - Compliance with the diet and intake of laxatives with the use of a mobile application - Evaluate the quality of colon cleansing with mobile application as an experimental factor - Assessment of the usability of the APP - Compliance with the laxative intake with the use of the mobile application Secondary Outcomes - Assessment of the difficulty of the preparation instructions - Evaluate colonoscopy quality indicators: - Evaluate attendance at the scheduled colonoscopy appointment - Evaluate colonoscopy quality indicators ### Location - Facility: Hospital Universitario Rio Hortega, Valladolid, N/A, 47012, Spain @@
## Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy - NCT ID: NCT06314009 - Study ID: EH23-302 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: NorthShore University HealthSystem ### Study Description The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy. This study will evaluate blood flow across the placenta by functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL). The investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight. Participants will be asked to complete Magnetic Resonance Imaging scans (MRIs), the first in the second trimester at 20-24 weeks and the second in the third trimester at 30-34 weeks. ### Conditions - Placenta Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - functional Magnetic Resonance Imaging (fMRI) ### Outcomes Primary Outcomes - Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL) - Mean placental perfusion in second and third trimester - Mean R2* relaxation rates in second and third trimester Secondary Outcomes - Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma - NCT ID: NCT06313996 - Study ID: CA082-011 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2031-10-16 - Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company ### Study Description The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma. ### Conditions - Relapsed or Refractory Follicular Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cyclophosphamide - Doxorubicin - Vincristine - Rituximab - Prednisone - Bendamustine - Lenalidomide - Fludarabine - Liso-cel ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Complete response (CR) - Overall survival (OS) - Overall response (OR) - Duration of response (DOR) - Event-free survival (EFS) - Time to next anti-cancer therapy (TTNLT) - PFS rate - EFS rate - OS rate - Progression-free survival on the next line of treatment (PFS-2) - Number of participants with adverse events (AEs) - Number of participants with adverse event of special interest (AESIs) - Number of participants with serious adverse events (SAEs) - Number of participants with laboratory abnormalities - Frequency and length of hospitalizations - Number of participants with intensive care unit (ICU) inpatient days - Number of participants with non-ICU inpatient days - Mean change from baseline in key health-related quality of life (HRQoL) domains. - Time to meaningful improvement/deterioration in key HRQoL domains. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer - NCT ID: NCT06313983 - Study ID: HM022BC3C01 - Status: RECRUITING - Start Date: 2022-01-08 - Completion Date: 2026-06 - Lead Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd ### Study Description The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI.The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hemay022+AI - Lapatinib+Capecitabine ### Outcomes Primary Outcomes - Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1 Secondary Outcomes - Overall Survival (OS) of the two group according to RECIST v1.1 - Objective response rate ( ORR, partial response rate+ complete response rate) according to RECIST v1.1 - Clinical benefit rate (CBR) according to RECIST v1.1 - Duration of Response (DOR) according to RECIST v1.1 - Time to Response (TTR) ### Location - Facility: Beijing Cancer Hospital, Beijing, N/A, N/A, China @@
## First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients - NCT ID: NCT06313970 - Study ID: QLMA-PC-IIT-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-04-15 - Lead Sponsor: Fudan University ### Study Description This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - QL1706 - Nab-paclitaxel - Gemcitabine - Bevacizumab ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Disease control rate (DCR) - Duration of Response (DoR) - Time to response(TTR) - Progression-free survival (PFS) - Overall survival（OS） - Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma - NCT ID: NCT06313957 - Study ID: LB2302-0001 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2028-09 - Lead Sponsor: Peking University Cancer Hospital & Institute ### Study Description This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. ### Conditions - Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - LUCAR-20SP cells ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) rate - Incidence, severity, and type of treatment-emergent adverse events (TEAEs) - Recommended Phase 2 Dose (RP2D) regimen finding - Pharmacokinetics in peripheral blood - Pharmacokinetics in bone marrow Secondary Outcomes - Objective Response Rate (ORR) after administration - Time to Response (TTR) after administration - Duration of Remission (DoR) after administration - Progression-free Survival (PFS) after administration - Overall Survival (OS) after administration - Incidence of anti-LUCAR-20SP antibody ### Location - Facility: Peking University Cancer Hospital & Institute, Beijing, Beijing, 100142, China @@
## German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation - NCT ID: NCT06313944 - Study ID: GE-R-A-TPS - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-01 - Lead Sponsor: Heinrich-Heine University, Duesseldorf ### Study Description This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores. ### Conditions - Alzheimer Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Registry ### Outcomes Primary Outcomes - Number of (Serious) Adverse Events - Number of adverse device effects Secondary Outcomes - ADAS - Mini Mental State Examination (MMSE) baseline and follow- up - BDI-II - Clinical Dementia Rating Sum of Boxes Score (CDR-SB) - Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI) - NCT ID: NCT06313931 - Study ID: UTI-IIDI-074-2023 - Status: COMPLETED - Start Date: 2023-07-03 - Completion Date: 2023-09-14 - Lead Sponsor: Universidad de Zaragoza ### Study Description This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - cognitive training via immersive virtual reality - cognitive training via paper and pencil - motor stimulation ### Outcomes Primary Outcomes - Spanish version of the Montreal Cognitive Assessment (MoCA-S) - Short Geriatric Depression Scale (SGDS-S) - Instrumental Activities of Daily Living Scale (IADL-S) Secondary Outcomes ### Location - Facility: University of Zaragoza, Teruel, N/A, 44003, Spain @@
## Exercise Therapy in Mental Disorders-study - NCT ID: NCT06313918 - Study ID: REK nr. 428096 - Status: RECRUITING - Start Date: 2023-09-27 - Completion Date: 2026-09-26 - Lead Sponsor: Haukeland University Hospital ### Study Description The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective. ### Conditions - Schizophrenia and Related Disorders - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High intensity training (HIT) ### Outcomes Primary Outcomes - Adherence Secondary Outcomes - Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score - Change of the Calgary Depression Scale in Schizophrenia score - Change of the Clinical Global Impression (CGI) score - Change of the Global Assessment of Funtioning (GAF) score - Change of quality of life (QOL10) score - Change of the International Physical Activity Questionaire (IPAQ) score - Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score - Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score - Change of the Difficulties in Emotion Regulation (DERS) score - Change in heart rate (beats per minute) - Change of maximal oxygene extraction (VO2max) - Change of level of inflammatory markers in blood - Change of body weight (kilograms) - Change of hip- and waist circumference (centimetres) - Change of serum glucose (mmol/L) - Change of serum cholesterols (mmol/L) - Change of serum triglyceride (mmol/L) - Change of gene expression - Change of methylation of DNA - Change of the Young Mania Rating Scale (YMRS) score ### Location - Facility: Haukeland University Hospital, Bergen, N/A, 5020, Norway @@
## EVADRY® in the Treatment of Xerostomia in Sjögren's Syndrome - NCT ID: NCT06313905 - Study ID: DRYLESS1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-31 - Lead Sponsor: University Tunis El Manar ### Study Description Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test. ### Conditions - Sjogren's Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EVADRY - Placebo ### Outcomes Primary Outcomes - salivary flow rate (SFR) Secondary Outcomes - Xerostomia Inventory in French version - Oral Health-related quality of life (OHIP-14) questionnaire - Hospital anxiety and depression (HAD) scale - Buccal Schirmer test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Home Based Tel-Exercise on Dialysis Patients - NCT ID: NCT06313892 - Study ID: PA24HD-2-05 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06 - Lead Sponsor: Pardis Specialized Wellness Institute ### Study Description The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy. ### Conditions - End Stage Renal Disease - Hemodialysis Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Home based Exercise ### Outcomes Primary Outcomes - Recruitment rate - Retention rates - Adherence rate Secondary Outcomes - Rate of changes of daily physical activity level - Rate of changes of Frailty level - Rate of changes of physical function level ### Location - Facility: Khorshid Dialysis Center, Isfahan, N/A, N/A, Iran, Islamic Republic of @@
## The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy - NCT ID: NCT06313879 - Study ID: PamukkaleU-SBE-SA-01 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-02 - Lead Sponsor: Pamukkale University ### Study Description This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy. ### Conditions - Hydrocephalus in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - online education ### Outcomes Primary Outcomes - State and Trait Anxiety Scale Secondary Outcomes - General Self-Efficacy Scale ### Location - Facility: Pamukkale University Hospital, Denizli, N/A, 20180, Turkey @@
## the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI - NCT ID: NCT06313866 - Study ID: 2024ZL368 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2025-02-01 - Lead Sponsor: Hangzhou Medical College ### Study Description The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, with 35 people in each group. After the end of the treatment, the clinical efficacy was evaluated. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - control - Electronuchal acupuncture group treatment - Smell therapy group treatment - Electronuchal acupuncture combined with smell and inhalation therapy group treatment ### Outcomes Primary Outcomes - MMSE - MoCA - MBI Secondary Outcomes - TCD - Near-infrared functional imaging of the brain - Magnetic resonance scanning ### Location - Facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College., Hangzhou, Zhejiang, 311000, China @@
## Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision - NCT ID: NCT06313853 - Study ID: STUDY00007068 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-09 - Lead Sponsor: University of Rochester ### Study Description Building upon prior work, the investigator team developed a communication intervention for older adults with ADRD who are considering a decision about cancer management (adapted intervention: COACH-Cog). The investigators hypothesize that for patients with dual diagnoses of ADRD and cancer, COACH-Cog will increase autonomy support of care partners and patients in the decision-making process, leading to greater acknowledgement and support of cognitive concerns and cognitive-related goals, thereby improving goal concordant care. The investigators are conducting a pilot randomized controlled trial (RCT; cluster randomized by physician) including approximately 45 oncology clinicians and 130 patient/care partner dyads evaluating the effect of COACH-Cog on care partner and patient autonomy support, care partner well-being, goal-concordance, and communication. ### Conditions - Cancer - Dementia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - COACH-Cog ### Outcomes Primary Outcomes - Care Partner: Health Care Climate Questionnaire (HCCQ) Secondary Outcomes - Montgomery Borgatta Caregiving Burden Scale - World Health Organization Quality of Life Brief Version (WHOQOL-BREF) - Care Partner PROMIS Depression - Care partner PROMIS Anxiety - Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca) - Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age) - Care partner: Qualitative assessment of goal concordance - Care partner: Decision Regret Scale ### Location - Facility: University of Rochester Wilmot Cancer Institute, Rochester, New York, 14620, United States @@
## Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients With Heart Failure With Reduced or Mildly Reduced Left Ventricular Ejection Fraction - NCT ID: NCT06313840 - Study ID: CIP3125 - Status: RECRUITING - Start Date: 2023-08-21 - Completion Date: 2024-11-30 - Lead Sponsor: Zoll Medical Corporation ### Study Description Study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) followed by case-control study to assess the link between central sleep apnea and cognitive function ### Conditions - Heart Failure - Central Sleep Apnea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of CSA in tested HFrEF/HFmrEF patients Secondary Outcomes - Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment. ### Location - Facility: Przychodnia na Teczowej, Wrocław, N/A, N/A, Poland @@
## e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population - NCT ID: NCT06313827 - Study ID: UV-INV_3165929 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: University of Valencia ### Study Description The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life.Participants will be assigned to one of 3 study groups:Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist. ### Conditions - Cystic Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Exercise plus Monitoring Group (TG-2) - Exercise plus monitoring and follow-up group (TGF-3) - Exercise Group (CG-1) ### Outcomes Primary Outcomes - Clinical exacerbation Secondary Outcomes - Dyspnea - Spirometric function - Oxigenation - Functional capacity - Quality of life (QoL) ### Location - Facility: Universitat de Valencia, Valencia, N/A, 46010, Spain @@
## The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia - NCT ID: NCT06313814 - Study ID: DE RKEB/IKEB 5622-2020 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-06-01 - Completion Date: 2025-12 - Lead Sponsor: University of Debrecen ### Study Description The goal of this clinical trial is to assess ginger's effect on patients with functional dyspepsia.The main question\[s\] it aims to answer are:1. Does ginger intake improve functional dyspepsia symptoms?2. Does ginger intake decrease the body fat content among patients with functional dyspepsia? Dyspepsia patients will be asked to take 540 mg of ginger capsule twice a day. Researchers will assess if there is an improvement in the symptoms of the disease and the fat content. \[ to see if gingers effect. ### Conditions - Functional Dyspepsia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Swanson ginger capsule ### Outcomes Primary Outcomes - Functional Dyspepsia Symptom Severity - Body Fat Content Analysis Secondary Outcomes - Improvement in Quality of Life ### Location - Facility: University of Debrecen, Debrecen, N/A, 4032, Hungary @@
## Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions - NCT ID: NCT06313801 - Study ID: DPNCD-2309 - Status: RECRUITING - Start Date: 2023-01-19 - Completion Date: 2026-01-19 - Lead Sponsor: Nizhny Novgorod Regional Clinical Oncology Center ### Study Description After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Docetaxel - Oxaliplatin - Calcium folinate - Fluorouracil - Diagnostic laparoscopy - dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)). ### Outcomes Primary Outcomes - The progression-free survival. - Complications from polychemotherapy. Secondary Outcomes - The overall survival. - The completeness of the planned therapy. - Percentage of patient conversions to Су- and PCI- rate. - Surgical complications of operated patients - Аssessment of the quality of life ### Location - Facility: Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", Nizhny Novgorod, N/A, 603126, Russian Federation @@
## Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain Experiences in Child Patients - NCT ID: NCT06313788 - Study ID: EC007-2324 - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Lingnan University ### Study Description Pain is common among children. Given that children are not as mature and independent in assessing or treating their pain as adults, they are a relatively vulnerable group in terms of pain management and are in need of additional attention. However, there is still insufficient recognition and treatment of pain in children. Taken the procedure of injection/vaccination in children as an example, child patients usually wait for their turn to take the injection from the nurse/doctor, during which anxiety and fear of pain develop. As children are less able to manage their pain than adults, the fear they develop during the waiting time, together with the pain they actually felt after the treatment, can bring negative experiences to them. In this proposed project, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection / vaccination) to help managing pediatric pain. ### Conditions - Pediatric Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Possession of a customized placebo analgesic band-aid prior to vaccination or injection ### Outcomes Primary Outcomes - Pain intensity Rating (rating how much pain participants feel) - Pain intensity Measurement (measure how much pain participants feel) - Pain Threshold (record the first-time participants feel the pain) - Pain unpleasantness (rating how unpleasant participants feel about the pain) Secondary Outcomes - Mood (rating the positive and negative emotions of the participants) - State-anxiety (Rating the participants' current anxiety level) - Fear of pain Rating - Magical thinking Rating - Pain Self-Efficacy - Self-efficacy to tackle pain - Expectation of Pain Severity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy - NCT ID: NCT06313775 - Study ID: SPS005 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: Sanpasitthiprasong Hospital ### Study Description The goal of this randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. The main question it aims to answer are:• Is there a difference in the level of pain during bilateral orchiectomy between spinal anesthesia and spermatic cord block?Participants will undergo bilateral orchidectomy. They will be randomly assigned to two groups: the group receiving spinal anesthesia and the group receiving spermatic cord block If there is a comparison group: Researchers will compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications in both groups of patients. ### Conditions - Orchiectomy - Spermatic Cord Block - Spinal Anesthesia - Pain Score - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - bilateral orchiectomy ### Outcomes Primary Outcomes - intraoperative pain score Secondary Outcomes - post-operative pain score - morphine consumption - post-operative complications ### Location - Facility: Sanpasitthiprasong hospital, Ubon Ratchathani, N/A, 33000, Thailand @@
## Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers. - NCT ID: NCT06313762 - Study ID: Codi CEIm: 21/132-P - Status: COMPLETED - Start Date: 2022-01-18 - Completion Date: 2024-02-08 - Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina ### Study Description The objective of this randomized, multicenter, open-label, parallel, controlled clinical trial is to evaluate pain reduction during the administration of two vaccines in children aged 3 and 6 years through virtual reality.The main question\[s\] it aims to answer are:1. To evaluate the reduction in pain during the administration of two vaccines in children aged 3 and 6 years.2. To evaluate the reduction in anxiety during and after the administration of two vaccines in children aged 3 and 6 years.3. Improve the satisfaction of parents or legal guardians after the administration of two vaccines in children aged 3 and 6 years.4. Evaluate the Safety of the use of virtual reality glasses in children aged 3 and 6 years during the administration of vaccines.The study population will include children aged 3 and 6 years who are included in the patient registry and are being seen in a primary care center of the Catalan Institute of Health in Central Catalonia.The clinical trial has two assigned groups: a control group and an intervention group.The intervention group will use the Pico G2 VR goggles (Pico Interactive Inc) during the administration of the two vaccines, together with an Android AOYODKG tablet, which will be connected to the goggles as a controller.The control group participants will receive traditional distractors, such as being held by the parent or guardian who accompanies them to the appointment, receiving stickers at the end of the appointment, or receiving rewards that the parent or guardian has prepared from home.International Registered Report Identifier (IRRID): PRR1-10.2196/35910 ### Conditions - Pain - Pediatrics - Vaccination - Virtual Reality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet - Traditional Distractors - Triple Viral + Varicella Vaccine at 3 years of age - Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age. ### Outcomes Primary Outcomes - Evaluation of pain perception during the administration of two vaccines in children aged 3 and 6 years, through the Wong-Baker Pain Scale. Secondary Outcomes - Evaluation of anxiety during the administration of two vaccines in children aged 3 and 6 years, through heart rate and the Children's Fear Scale. - Degree of satisfaction of parents/legal guardians of minors after the administration of two vaccines, using the CSAT scale. - Number of patients who experienced adverse effects during the administration of vaccines and who used virtual reality glasses, through the registration of the effects presented. ### Location - Facility: Catalan Institute of Health. Territorial Management of Central Catalonia., Manresa, Barcelona, 08260, Spain @@
## Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy - NCT ID: NCT06313749 - Study ID: MMS-US-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Sanoculis Ltd ### Study Description The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C. ### Conditions - Primary Open Angle Glaucoma - Open Angle Glaucoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Minimally Invasive Micro Sclerostomy Device ### Outcomes Primary Outcomes - Surgical success rate of the MIMS® device/procedure at 12 months after surgery Secondary Outcomes - Exploratory Effectiveness Endpoint 1 - Exploratory Effectiveness Endpoint 2 - Exploratory Effectiveness Endpoint 3 - Exploratory Effectiveness Endpoint 4 - Safety Outcome 1 - Safety Outcome 2 - Safety Outcome 3 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## What SSI Duration is Most Effective? An Online Experiment With American Adults - NCT ID: NCT06313736 - Study ID: STU00220591_shortening - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-05 - Lead Sponsor: Northwestern University ### Study Description In a previous study (https://osf.io/qdznc), the research team found that an 8-minute version of a single-session intervention for loneliness was more effective than a 23-minute version of it. The present work aims to further explore the relationship between intervention duration and effectiveness.In this online trial, participants will be randomized to a 15-minute single-session depression intervention called the Action Brings Change (ABC) Program, a 10-minute version of it, a 6-minute version of it, or a 2-minute version of it. The main analysis will evaluate how change in depressive symptoms over eight weeks differs across conditions. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Action Brings Change Project (15-minute adult version) - Action Brings Change Project (10-minute adult version) - Action Brings Change Project (6-minute adult version) - Action Brings Change Project (2-minute adult version) ### Outcomes Primary Outcomes - Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009) Secondary Outcomes - Change in Beck Hopelessness Scale at 8 weeks (BHS-4; Perczel Forintos et al., 2013) - Change in Beck Hopelessness Scale - 4-item at post-intervention - Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004) - Presence of an "Aha! moment" at post-intervention - Presence of an "Aha! moment" at 8 weeks post-intervention - Significance of the "Aha! moment" at immediately post-intervention - Significance of the "Aha! moment" at 8 weeks post-intervention - Change in Frequency of actions and thoughts scale at post-test at 8 weeks post-intervention (FATS; Terides et al., 2016) - Expected improvement at post-intervention (from the Credibility / Expectancy Questionnaire; Devilly, 2004) - Self-reported improvement at 8-weeks post-intervention (adapted from the Credibility/ Expectancy Questionnaire; Devilly, 2004) - Intervention satisfaction star rating at post-intervention - Intervention satisfaction star rating at 8 week follow-up ### Location - Facility: Northwestern University Medical Social Sciences, Chicago, Illinois, 60611, United States @@
## The Effect of Mother's Anxiety, Fear and Prenatal Connection in the Prenatal Education Given to Pregnant Women Via Podcast During the Non-stress Test - NCT ID: NCT06313723 - Study ID: SBÜ-AYDINKARTAL-030 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-31 - Lead Sponsor: YASEMİN AYDIN KARTAL ### Study Description This study was planned to determine the effect of prenatal education given via podcast to nulliparous pregnant women who applied to the Non-Stress Test Polyclinic of the University of Health Sciences, Istanbul Bagcilar Training and Research Hospital, on maternal anxiety, fear and fetal attachment. The research, planned in a randomized controlled quasi-experimental design, will be carried out with nulliparous pregnant women (n:104) who apply to the Non-Stress Test polyclinic of the University of Health Sciences Istanbul Bağcılar Training and Research Hospital. Pregnant women who voluntarily participate in the research will be divided into intervention (n: 52) and control (n: 52) groups according to the computer-assisted simple random sampling technique. The intervention group, nulliparous pregnant women, will listen to 3 podcasts of 5-6 minutes. Pregnant women in the control group will be given a booklet on the pregnancy and birth process from the Ministry of Health as part of routine care. "Personal Information Form", "State-Trait Anxiety Inventory", "Wijma Birth Expectation/Experience Scale Version A" and "Prenatal Attachment Inventory" will be applied to all pregnant women included in the study. ### Conditions - Prenatal Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Prenatal education management delivered via podcast ### Outcomes Primary Outcomes - Introductory Information Form - State-Trait Anxiety Inventory(D-SKE) - Wijma Birth Expectation/Experience Scale Version A (W-DEQ A) - Prenatal Attachment Inventory (PBI) Secondary Outcomes - State-Trait Anxiety Inventory(D-SKE) - Wijma Birth Expectation/Experience Scale Version A (W-DEQ A) - Prenatal Attachment Inventory (PBI) ### Location - Facility: University of Health Sciences, Istanbul, N/A, 34668, Turkey @@
## Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4) - NCT ID: NCT06313710 - Study ID: Y (2024) 058 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2026-12-01 - Lead Sponsor: General Hospital of Shenyang Military Region ### Study Description This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment. ### Conditions - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - head down position ### Outcomes Primary Outcomes - Changes in National Institute of Health stroke scale (NIHSS) Secondary Outcomes - proportion of excellent functional outcome - proportion of favorable functional outcome - ordinal distribution of modified Rankin Score (mRS) - early neurological improvement (ENI) - changes in infarct volume - changes in cerebral edema - Changes in National Institute of Health stroke scale (NIHSS) - new stroke or other vascular event(s) - proportion of sympomatic intracranial hemorrhage - proportion of intraparenchymal hemorrhage (PH) - percentage of severe adverse events - all-cause mortality ### Location - Facility: Department of Neurology, General Hospital of Northern Theater Command, Shenyang, N/A, 110016, China @@
## A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult - NCT ID: NCT06313697 - Study ID: GR2102-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-24 - Completion Date: 2025-12-06 - Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. ### Study Description the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。 ### Conditions - Respiratory Syncytial Virus Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GR2102 injection - placebo ### Outcomes Primary Outcomes - Adverse events Secondary Outcomes - Maximum Observed Serum Concentration - Terminal Elimination Half Life - anti-respiratory syncytial virus neutralizing antibodies titer levels ### Location - Facility: The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, 250102, China @@
## Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure - NCT ID: NCT06313684 - Study ID: Fondecyt 1230787 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-03 - Lead Sponsor: Universidad de La Frontera ### Study Description CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone. ### Conditions - Heart Failure NYHA Class II - Heart Failure NYHA Class III ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comprehensive Initial Assessment - Continuous evaluation - Interval Exercise - Psychosocial support - Diet management - Resistance exercise - Continuous exercise - Initial Assessment ### Outcomes Primary Outcomes - Cardiorespiratory fitness - Functional capacity - Health Related Quality of Life Secondary Outcomes - Program adherence and completion - Concentration of Pro-B-type Natriuretic Peptide - Functioning - Mortality and Hospital admission - Upper-body muscle strength - Lower-body muscle strength - Cost ### Location - Facility: Complejo Hospitalario San José, Santiago, N/A, N/A, Chile @@
## Plethysmographic Perfusion Index and Fluid Responsiveness - NCT ID: NCT06313671 - Study ID: Perfusion Index - FR study - Status: RECRUITING - Start Date: 2024-02-10 - Completion Date: 2024-09 - Lead Sponsor: Avicenna Military Hospital ### Study Description The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care. ### Conditions - Fluid Responsiveness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Perfusion index ### Outcomes Primary Outcomes - Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness. Secondary Outcomes ### Location - Facility: Avicenna Military Hospital, Marrakesh, Marrakesh Tensift El Haouz, 40000, Morocco @@
## Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury - NCT ID: NCT06313658 - Study ID: Total BPBI - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: Assiut University ### Study Description Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. ### Conditions - Brachial Plexus Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Total brachial plexus exploration and reconstruction ### Outcomes Primary Outcomes - Active Movement Scale (AMS) Secondary Outcomes - Al-Qattan pronation/Supination score - Raimondi hand score ### Location - Facility: Assiut University Hospitals, Assiut, N/A, 71526, Egypt @@
## Vascular Senescence and Atherosclerotic Plaque Vulnerability - NCT ID: NCT06313645 - Study ID: B83C22004880006 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2025-12-31 - Lead Sponsor: Niguarda Hospital ### Study Description Chronological aging significantly contributes to structural and functional alterations in the vasculature, making it a major risk factor for atherosclerotic disease and its acute thrombotic events. DNA damage, including telomeric, non-telomeric, and mitochondrial damage, is recognized as a key initiator of vascular aging and atherogenesis. There is abundant evidence indicating the presence of oxidative DNA lesions, telomere erosion, and mitochondrial DNA damage in both experimental and human plaques, as well as in the peripheral cells of atherosclerotic patients.It is increasingly evident that genomic instability activates signaling pathways that lead to a multitude of pathophysiological cellular and molecular changes. These changes promote inflammation, apoptosis, autophagy, and ultimately, cellular senescence, accompanied by the "senescence-associated secretory phenotype" (SASP). However, the precise mechanisms linking the DNA damage response (DDR) to senescence, SASP in vascular cells, and the pathogenesis of atherosclerosis and vulnerable atheroma are yet to be fully understood. Additional research is needed to delineate the underlying mechanisms through which mitochondrial dysfunction influences telomere length and vice versa, and how their interaction contributes to the vascular aging process. Progress in this area has the potential to uncover therapeutic targets and novel, more precise diagnostic, and prognostic indicators.The objectives of the VICTORIA study are to examine the levels of aging-related non-coding RNA deregulation (specifically lncRNA TERRA and mitomiR) and peripheral markers of cell aging (including telomere length and mitochondrial DNA content) across the various spectra of angina pectoris (stable angina, unstable angina, NSTEMI, and STEMI). Additionally, the study aims to determine whether these markers are correlated with vulnerable plaque characteristics and major adverse cardiovascular events. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Several biomarkers ### Outcomes Primary Outcomes - Telomere length Secondary Outcomes - Mitochondrial DNA copy number (mtDNAcn) - MitomiR - Long non-coding (lnc) RNA TERRA - pro-oxidant cytokines ### Location - Facility: ASST GOM Niguarda, Milano, Lombardia, 20162, Italy @@
## Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy - NCT ID: NCT06313632 - Study ID: STUDY-23-01105 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2025-03 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone. ### Conditions - Pleural Disease - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bupivacaine injection - Placebo - Monitored Anesthesia Care ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) for Pain Secondary Outcomes - Change in the Numerical Rating Scale - Type of Analgesic use - Number of Analgesic use - Dosage of Analgesic use - Quality of Recovery-15 (QoR-15) Survey Score ### Location - Facility: Mount Sinai West Hospital, New York, New York, 10019, United States @@
## Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program - NCT ID: NCT06313619 - Study ID: BSMMU/20236831 - Status: RECRUITING - Start Date: 2023-10-23 - Completion Date: 2024-03-31 - Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh ### Study Description The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial resistance (AMR) is a global threat to human health. Even though the awareness of the potential threat from AMR is widespread, studies and monitoring programs describing the present situation are lacking. The presence of a 'pluralistic' health system and a large informal sector involving unqualified drug dispenser/providers/practitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country. An estimated 63% of antibiotic prescriptions are from unqualified providers. Besides, misconception about antibiotics is very common in Bangladesh. Meanwhile, the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain. Without adherence to national regulations, unnecessary and inappropriate prescriptions become common practice, particularly in rural areas. Domestic drug industries contribute to easily accessible and affordable drugs. To tackle this problem, prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS. Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices. Therefore, this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh, which were grouped into four interlinked areas - lack of awareness among patients/ consumers (demand side), perverse incentives and lack of knowledge among providers (supply side), poorly regulated pharmaceutical marketing and retail sales (regulatory side) and lack of data and research evidence to support awareness raising and policymaking (enabler).A before-after designed quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted among the same participants with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample alongside a total of anticipated 6240 community dwellers. For qualitative part, the sample will be selected purposively until data saturation and a total of 20 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding acceptability, adoption, feasibility, and cost of the intervention.The study is expected to bring light upon a comprehensive understanding of the current level of knowledge, perception and practice of irrational use of anti-microbials among target population. Furthermore, a digital intervention design will be produced to reduce irrational use of anti-microbials after considering its effectiveness. The wide range of the study findings will aid in assessing the acceptability, adoption, feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs. ### Conditions - Resistance Bacterial - Increased Drug Resistance - Drug Resistance, Microbial ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - SmartAMR ### Outcomes Primary Outcomes - Irrational usage of anti-microbials - Acceptance rate - Completion rate Secondary Outcomes ### Location - Facility: Medicine Shop, Dhaka, N/A, 1212, Bangladesh @@
## Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ - NCT ID: NCT06313606 - Study ID: 2047436 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-05-31 - Lead Sponsor: University of California, Davis ### Study Description Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool. ### Conditions - Dietary Fat Metabolism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Dietary fat positive control - Dietary fat negative control ### Outcomes Primary Outcomes - Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool Secondary Outcomes ### Location - Facility: University of California, Davis School of Medicine, Sacramento, California, 95817, United States @@
## A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms - NCT ID: NCT06313593 - Study ID: INCB160058-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-14 - Completion Date: 2027-09-04 - Lead Sponsor: Incyte Corporation ### Study Description This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms. ### Conditions - Myeloproliferative Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - INCB160058 ### Outcomes Primary Outcomes - Number of participants with Dose Limiting Toxicities (DLTs) - Number of participants with Treatment-emergent Adverse Events (TEAEs) - Number of participants with TEAEs leading to dose modification or discontinuation Secondary Outcomes - INCB160058 pharmacokinetic (PK) in Plasma - Response using the revised IWG-MRT and ELN response criteria for MF - Percentage of participants achieving spleen volume reduction as defined in the protocol - Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS) - Participants with MF with symptomatic anemia: Anemia Response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile - NCT ID: NCT06313580 - Study ID: 22-1055 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-06 - Lead Sponsor: University of Alabama, Tuscaloosa ### Study Description Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites. ### Conditions - Cardiometabolic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Yogurt with added Spices - Yogurt without added Spices ### Outcomes Primary Outcomes - Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate - Concentration of serum leptin - Concentration of serum ghrelin (pg/mL) - Concentration of serum peptide tyrosine tyrosine (PYY) Secondary Outcomes ### Location - Facility: The University of Alabama, Tuscaloosa, Alabama, 35487, United States @@
## Metronomic Capecitabine in Stage III Gastric Cancer - NCT ID: NCT06313567 - Study ID: Meca-GC - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2029-03-10 - Lead Sponsor: Fudan University ### Study Description The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metronomic capecitabine - Observation ### Outcomes Primary Outcomes - Disease-free survival Secondary Outcomes - Overall survival - Side effects ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200000, China @@
## Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma - NCT ID: NCT06313554 - Study ID: HMPL-012-SH-ICC101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2027-05-20 - Lead Sponsor: Fudan University ### Study Description This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes. ### Conditions - Intrahepatic Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin ### Outcomes Primary Outcomes - ORR objective response rate Secondary Outcomes - Progression-Free Survival(PFS) - OS overall survival - DCR disease control rate - Adverse events as assessed by NCI CTCAE v5.0 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy - NCT ID: NCT06313541 - Study ID: 2024-Lung-LDRT/SBRT - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-12-31 - Lead Sponsor: Fudan University ### Study Description This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC ### Conditions - NSCLC Stage IV ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SBRT or LDRT - PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy ### Outcomes Primary Outcomes - Progression Free Survival Secondary Outcomes - Overall Survival - Objective response rate - Progression free survival 2 - Treatment-related adverse event ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, N/A, N/A, China @@
## A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943 - NCT ID: NCT06313528 - Study ID: 18726 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-07 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LY3437943 - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined) Secondary Outcomes - Change from Baseline in Sleep Metabolic Rate (SMR) - Change from Baseline in SMR - Change from Baseline in 24-hour Energy Expenditure (EE) - Change from Baseline in 24-hour EE - Change from Baseline in Total Calorie Intake at Lunch - Change from Baseline in Total Calorie Intake at Dinner - Change from Baseline in Fasting Appetite Visual Analog Score (VAS) ### Location - Facility: AdventHealth Orlando, Orlando, Florida, 32804, United States @@
## Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI - NCT ID: NCT06313515 - Study ID: STUDY00019529 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-02-01 - Lead Sponsor: University of Washington ### Study Description Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).The main questions the study aims to answer are:* Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6.* Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6.* Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6.* Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.Participants will:* Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks.* Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise.* During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning.Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI. ### Conditions - Spinal Cord Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcutaneous Spinal Cord Stimulation - Arm-crank bike exercise - Sham Stimulation ### Outcomes Primary Outcomes - Change in systolic Blood Pressure (BP) from baseline. - Change in systolic Blood Pressure during a sit-up test or head-up tilt test. - Heart rate variability recorded by electrocardiogram (ECG). Secondary Outcomes - Peak oxygen uptake (VO2peak) - Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure - International Standards for Neurological Classification of Spinal Cord Injury - International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) - Blood Pressure variability - Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2 - Change from baseline- Capabilities of Upper Extremity Test - International Spinal Cord Injury Pain Basic Dataset version 2.0 - International Spinal Cord Injury Lower Urinary Tract Function Dataset - International Spinal Cord Injury Bowel Function Dataset ### Location - Facility: University of Washington, Seattle, Washington, 98195, United States @@
## High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders - NCT ID: NCT06313502 - Study ID: 274271 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: University of Arkansas ### Study Description The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current standard myeloablative dose (200 mg/m2). Based on our preclinical data, the investigator hypothesize that the combination of reduced dose melphalan with IV HDAA will have high efficacy and tolerabilityPrimary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B).Secondary ObjectivesObjectives:1. Determine the safety and tolerability of HDAA in combination with reduced dose melphalan conditioning and autologous stem cell transplantation (ASCT) in relapsed refractory multiple myeloma subjects.2. Determine the rate of Minimal Residual Disease (MRD) negativity at time point of response assessment using 8 color flow cytometry on BM sample. Functional imaging, such as positron emission tomography (PET) scan and magnetic resonance imaging (MRI), will also be performed to assess the disease status.3. Categorize and quantify adverse events compared to historical control.4. Determine quality of life parameters using standardized health-related quality of life measures5. Determine oxidative stress parameters in plasma during treatment. ### Conditions - Plasma Cell Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - 75gm HDAA - 100gm HDAA - 125gm HDAA ### Outcomes Primary Outcomes - Tumor Response measured by IMWG criteria Secondary Outcomes - Safety and Tolerability of HDAA with reduced dose melphalan measured using number and severity of AEs - Rate of Minimal Residual Disease (MRD) negativity using 8 color flow cytometry - Determine quality of life parameter using QLQ-C30 - Determine quality of life parameter using EQ-5D-5L ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology - NCT ID: NCT06313489 - Study ID: 282151 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-01 - Completion Date: 2024-06-30 - Lead Sponsor: Sahlgrenska University Hospital, Sweden ### Study Description Fractures of the wrist (fractures of the distal radius) are one of the most common fractures with almost 60 000 injuries per year in Sweden. One known complication following these fractures is that the long extensor tendon of the thumb ruptures (extensor pollicis longus tendon, EPL tendon). This leads to disability to stretch the thumb in order to grip bigger objects. Earlier studies show that the tendon ruptures in about 3-5% of all wrist fractures. These ruptures occur some weeks to months after the fracture.There are different theories about the cause of the rupture. One theory is that the fracture creates a bleeding in the tight area that the tendon lies, leading to high pressure and therefore low blood supply to the tendon. Another theory is that the tendon comes in contact with some sharp bonny fragments in this area that injures the tendon when it moves.Such tendon ruptures need almost always some type of surgical intervention in order to reconstruct the function of the thumb. A common problem is that the quality of the tendon is insufficient for just suturing it. Another problem is that the muscle becomes stiff after the rupture. However, there is no objective method to determine how stiff the muscle is.The most common treatment option is the transfer of one of the two extensor tendons of the index finger to the thumb, a so-called extensor indicis proprius to extensor pollicis longus transfer. The motivation behind this operation is that the muscle of EPL is so stiff that cannot be used to lift the thumb. However, there is no consensus about the time period after which the EPL muscle can be used to reconstruct the function of thumb.The study aims to investigate the microscopical changes in the muscle and tendon of EPL after such a rupture. Better knowledge of these factors could lead to better understanding of the treatment options.The investigators plan to include in the study all patients that would get operated for an EPL tendon rupture after a fracture of the distal radius at the institution the study is conducted. After oral and written information to the patient and written consent the investigators will take some samples from the ruptured tendon and muscle for microscopical analysis. ### Conditions - Distal Radius Fractures - Tendon Injury - Hand - Pathology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biopsy of EPL tendon and muscle during the operation ### Outcomes Primary Outcomes - Histopathological analysis of the EPL muscle Secondary Outcomes - Histopathological analysis of the EPL tendon ### Location - Facility: Sahlgrenska University Hospital, Gothenburg, Västra Götaland, 43180, Sweden @@
## AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients - NCT ID: NCT06313476 - Study ID: SYSKY-2024-030-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-04-30 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Anti-Mullerian Hormone Secondary Outcomes - Estradiol - Follicle Stimulating Hormone - Menstruation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy - NCT ID: NCT06313463 - Study ID: SYSKY-2023-1282-02 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2035-12 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients.The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy. ### Conditions - Breast Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Carrellizumab + Capecitabine - Placebo + Capecitabine ### Outcomes Primary Outcomes - Disease-Free Survival Secondary Outcomes - Invasive Disease-Free Survival - Overall Survival - Distant Recurrence-Free Interval - Patient-reported outcomes-Proportion of patients in each group experiencing clinically meaningful deterioration - Patient-reported outcomes-EORTC QLQ-C30 scores after treatment - Patient-reported outcomes-EORTC QLQ-C30 scores changes ### Location - Facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China @@
## De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma - NCT ID: NCT06313450 - Study ID: B2023-110-X02 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2028-02-01 - Lead Sponsor: Sun Yat-sen University ### Study Description In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy. ### Conditions - Nasopharyngeal Carcinoma - Radiotherapy; Complications - IMMUNOTHERAPY ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - de-escalated radiotherapy - conventional radiotherapy ### Outcomes Primary Outcomes - local recurrence rate(LRR) Secondary Outcomes - primary tumor volume regression≥75% rate - 3-year overall survival - acute and late radiation-induced toxicities - complete response rate of primary tumor ### Location - Facility: Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Revumenib in Combination With 7+3 + Midostaurin in AML - NCT ID: NCT06313437 - Study ID: 24-021 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-03-02 - Lead Sponsor: Maximilian Stahl, MD ### Study Description This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML).The names of the study drugs involved in this study are:* Revumenib (SNDX-5613) (a type of menin inhibitor)* Midostaurin (a type of multi-kinase including FLT3 inhibitor)* Cytarabine (a type of antineoplastic agent)* Daunorubicin (a type of antineoplastic agent) ### Conditions - Acute Myeloid Leukemia - AML, Adult - AML With Gene Mutations - AML - Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Revumenib - Midostaurin - Cytarabine - Daunorubicin ### Outcomes Primary Outcomes - Number of Participants Experiencing Dose Limiting Toxicity (DLT) - Maximum Tolerated Dose (MTD) - Recommended phase II dose (RP2D) Secondary Outcomes - Complete Remission (CR) rate with induction chemotherapy - Complete Remission (CR) rate with consolidation chemotherapy - Flow Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy - Flow Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy - Molecular Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy - Molecular Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy - Relapse-Free Survival at 1 year (RFS1) - Overall Survival at 1 year (OS1) ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States @@
## Arthroscopic Treatment of Meniscal Lesions on Healthy Meniscus in Children and Adolescents - NCT ID: NCT06313424 - Study ID: 9029 - Status: RECRUITING - Start Date: 2023-08-29 - Completion Date: 2024-04-29 - Lead Sponsor: University Hospital, Strasbourg, France ### Study Description Meniscal lesions are common in pediatrics and mainly affect adolescents. These lesions can jeopardize the functional prognosis of the knee in the short, medium or long term if they are not well managed.More precisely, it is a question of determining whether arthroscopic repair of isolated meniscal lesions in children gives good results and what factors influence them, with the aim of improving the care of children suffering from meniscal lesions.The treatment of meniscal lesions comes down to either conservative or restorative treatment or non-conservative treatment by meniscectomy. For most authors, the treatment of meniscal lesions must remain restorative through meniscal suture, leaving no room for meniscectomy. The open approach has given way to the arthroscopic approach which, according to the literature, is the gold standard. Meniscal lesions are varied and therefore there are numerous therapeutic procedures. Therapeutic indications are precise but the results of the treatments remain differently assessed depending on the studies; studies evaluating the results of treatment in the pediatric population are few in number.Based on this observation, the present study aims to describe the results of repairs of meniscal lesions in pediatric traumatology. ### Conditions - Knee Injuries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - description of the results of repairs of meniscal lesions in pediatric traumatology Secondary Outcomes ### Location - Facility: Service de Chirurgie Pédiatrique - CHU de Strasbourg - France, Strasbourg, N/A, 67091, France @@
## How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma - NCT ID: NCT06313411 - Study ID: 8778 - Status: RECRUITING - Start Date: 2022-11-23 - Completion Date: 2024-04 - Lead Sponsor: University Hospital, Strasbourg, France ### Study Description Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care. ### Conditions - Endometriosis Pelvic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - laparoscopic removal of a retroperitoneal pelvic schwannoma Secondary Outcomes ### Location - Facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France, Strasbourg, N/A, 67091, France @@
## Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling - NCT ID: NCT06313398 - Study ID: 10001883 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-06-15 - Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI) ### Study Description Background:Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant.Objective:To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant.Eligibility:People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed.Design:Participants will be screened. They will have a physical exam with blood and urine tests.Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream.Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected.... ### Conditions - Sickle Cell Disease - Thalassemia - Hemoglobinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Biotin-labeled red blood cells ### Outcomes Primary Outcomes - To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies. Secondary Outcomes - Validate the association of RBC survival with known markers of increased survival. ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators - NCT ID: NCT06313385 - Study ID: 22-10-1180 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-03-29 - Lead Sponsor: Indonesia University ### Study Description This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses. ### Conditions - Free Flap - Indocyanine Green - Microsurgery - Temperature Change, Body ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - Indocyanine Green Fluorescence (ICG) - Temperature - Transcutaneous oxygen and carbon dioxide pressure - Histopathology - Hypoxia inducible factor-1 (HIF-1) alpha ### Outcomes Primary Outcomes - The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion Secondary Outcomes - The ICG fluorescence intensity in different titration dose with flap surface Temperature - Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure - Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count - Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume - Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue - Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha ### Location - Facility: Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta Pusat, Jakarta, 10430, Indonesia @@
## Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study - NCT ID: NCT06313372 - Study ID: CA2085 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-01 - Lead Sponsor: Scius Healthcare Solutions Pty Ltd ### Study Description This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD).The primary objective of the Delphi study is to aid the interpretation of respiratory oscillometry in clinical practice amongst adult patients with asthma or COPD. This will be achieved by obtaining expert consensus on:* Which parameters are used in clinical practice for impulse oscillometry (IOS) and for forced oscillation technique (FOT) devices.* What cut-offs can be used for each parameter to guide clinical practice in the management of adult patients with asthma and COPD.This study is based on the Delphi methodology. The Delphi study will comprise of four rounds, one brainstorming round, to formulate the consensus survey, and three rounds to attempt to obtain consensus.In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to participants in the Delphi study electronically using SurveyLet, an online survey platform. Participants will respond anonymously to the survey questions, indicating their level of agreement or disagreement with each statement or question. Participants will be given 4 weeks to complete each round of the Delphi study.Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds). Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds. ### Conditions - Asthma - Chronic Obstructive Pulmonary Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Respiratory oscillometry ### Outcomes Primary Outcomes - Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale. - Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, AX, R5-R20) to define an abnormal test result as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly) Secondary Outcomes - Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, and AX) to define a bronchodilator response as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly) - Identification of cut-off values used for oscillometry parameters (R5, X5, AX, R5-R20) to define a significant clinical change between visits as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fall Risk and Quality of Life: in Individuals With Cancer Treatment Related Peripheral Neuropathy. - NCT ID: NCT06313359 - Study ID: FY2024-125 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-06 - Lead Sponsor: Texas Woman's University ### Study Description The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer. Specifically, we are interested to find out if you have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. We are also interested to see if you have any difficulty with doing two activities at the same time, such as walking and texting. ### Conditions - Peripheral Neuropathy Due to Chemotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Fall risk - Quality of life- in cancer patients Secondary Outcomes - Trail Making Test (TMT) Parts A & B - Single Task- Working Memory - Single Task- Visual Attention Cognitive Task - Protective Sensation - Grip Strength - LE strength assessment- HHD - Dynamic Balance - Single Task- Gait Speed - Dual Task- Working Memory & Gait Speed - Composite measure - Dual Task- Visual Attention Cognitive Task & Gait Speed - Composite measure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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