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## Implementation of Contemporary Coronary CT Angiography in Clinical Practice - NCT ID: NCT06273033 - Study ID: CONCORDE - Status: RECRUITING - Start Date: 2023-10-10 - Completion Date: 2025-01 - Lead Sponsor: Humanitas Hospital, Italy ### Study Description Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary angiography. It is therefore pivotal to understand instances of discrepancies that are encountered in clinical practice. Moreover, most of the literature on this topic relies on obsolete machines or definitions of coronary artery stenosis that cannot be defined as severe.The investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive coronary artery disease (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies. ### Conditions - Coronary Artery Disease of Significant Bypass Graft - Coronary Syndrome - Coronary Arteriosclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD. Secondary Outcomes - Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD. - Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD - Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD ### Location - Facility: IRCCS Humanitas Research Hospital, Rozzano, Milano, 20089, Italy @@
## Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke - NCT ID: NCT06273020 - Study ID: MI22-00013 - Status: RECRUITING - Start Date: 2022-11-17 - Completion Date: 2024-12 - Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez ### Study Description A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes ### Conditions - Ischemic Stroke, Acute - Diabetes Mellitus, Type 2 - Blood Brain Barrier ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cerebrolysin - Brain-MRI with contrast after 10-14 days of cerebrolysin ### Outcomes Primary Outcomes - Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery Secondary Outcomes - Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin - Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin - Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin ### Location - Facility: Servicio de Neurología del Hospital Universitario "Dr.José E. González", Nuevo León, Monterrey, 64020, Mexico @@
## Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach - NCT ID: NCT06273007 - Study ID: EFP_2023_02_19 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2027-12-31 - Lead Sponsor: Haramaya Unversity ### Study Description Overall ObjectiveTo introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.Interventions1. Locally agreed and achievable intrapartum guidelines2. Low dose high frequency trainings (LDHF)3. Partograph Overall DesignA quasi-experimental pre-post study (PartoMa study)SettingDepartment of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.PopulationLaboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge.EndpointsThe primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.Study TimeData collection from June 2023 to May 2025.Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.SettingPartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000. ### Conditions - Stillbirth - Obstetric Complication - Maternal Death - Perinatal Death - Perinatal Morbidity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings ### Outcomes Primary Outcomes - stillbirth - Birth Asphyxia Secondary Outcomes - Maternal death - Cesarean sections and vacuum extractions - Process indicators of quality of intrapartum care - Birth attendant's perception of their work condition in the labour and delivery rooms - The women's experience of care received during delivery. ### Location - Facility: Haramaya Hospital, Harar, Oromia, N/A, Ethiopia @@
## Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin - NCT ID: NCT06272994 - Study ID: 231724 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-03 - Completion Date: 2027-12-31 - Lead Sponsor: Vanderbilt University Medical Center ### Study Description This is a single center, pragmatic, randomized clinical trial (pRCT) examining whether reporting the results of a negative rapid PCR back to the provider via a pager alert results in decreased vancomycin utilization for critically ill adults with community-acquired pneumonia when compared with usual care. ### Conditions - Community-acquired Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MRSA Nasal Swab PCR ### Outcomes Primary Outcomes - Vancomycin-free hours alive Secondary Outcomes - Time Alive off Vancomycin - 30-day all-cause mortality ### Location - Facility: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States @@
## A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS - NCT ID: NCT06272981 - Study ID: BWI202308 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2025-08-29 - Lead Sponsor: Biosense Webster, Inc. ### Study Description The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation ### Outcomes Primary Outcomes - Number of Participants with Primary Adverse Events (PAEs) - Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure Secondary Outcomes - Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score ### Location - Facility: Royal Prince Alfred Hospital, Camperdown, N/A, 2050, Australia @@
## Predicting Cognition After DBS for Parkinson's Disease 2 - NCT ID: NCT06272968 - Study ID: EA2/252/23 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-25 - Completion Date: 2030-12-01 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit.The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures. ### Conditions - Cognitive Impairment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neuropsychological Testing ### Outcomes Primary Outcomes - Change in cognitive performance after STN-DBS - Incidence of postoperative neurocognitive disorder Secondary Outcomes ### Location - Facility: Charité - Universitätsmedizin Berlin, Berlin, N/A, 13351, Germany @@
## LONG TERM EFFECTS OF SPINAL CORD STIMULATION - NCT ID: NCT06272955 - Study ID: H-54417 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-04 - Completion Date: 2025-06-30 - Lead Sponsor: Nora Vanegas ### Study Description Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.1. Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.2. Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Spinal Cord Stimulator (SCS) ### Outcomes Primary Outcomes - Safety and Tolerability Secondary Outcomes - New Freezing of Gait Questionnaire (NFOG-Q) score - Gait and Falls Questionnaire (GFQ) - MDS-UPDRS score - Timed Up and Go test (TUG) - Timed 10-meter walk (T10MW) - Mini-Mental State Examination (MMSE) - Montreal Cognitive Assessment Scale (MoCA) - Beck Depression Inventory (BDI-2) - Beck Anxiety Inventory (BAI) - Parkinson's Disease Questionnaire - 39 (PDQ39) - Non-Motor Symptoms Scale (NMSS) ### Location - Facility: Baylor College of Medicine, Houston, Texas, 77005, United States @@
## An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States - NCT ID: NCT06272942 - Study ID: 22722 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-31 - Completion Date: 2025-08-30 - Lead Sponsor: Bayer ### Study Description This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.In observational studies, only observations are made without participants receiving any advice or any changes to health care.People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay. ### Conditions - Acute Respiratory Distress Syndrome (ARDS) - Post Intensive Care Syndrome (PICS) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - An ICU admission and a temporally related ARDS diagnosis ### Outcomes Primary Outcomes - Morbidity - Post ICU Syndrome-related morbidity - Incident morbidity - Post ICU Syndrome-related incident morbidity - Difference in prevalence rates pre versus post index hospitalization - Average total healthcare costs based on healthcare billing data in the one year post index ICU admission Secondary Outcomes ### Location - Facility: Bayer, Whippany, New Jersey, 07981, United States @@
## Serum Elafin and Vascular Affection in Behcet Disease - NCT ID: NCT06272929 - Study ID: behcet and vascular - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assiut University ### Study Description To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.To assess the correlation between serum elafin and vascular affection and their relation with disease activity. ### Conditions - Behcet Disease and Vascular Affection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - doppler ultrasound ### Outcomes Primary Outcomes - Measuring the level of serum Elafin in patients with BD in comparison to healthy participants. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section. - NCT ID: NCT06272916 - Study ID: Effect drugs on headache inCS - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: Assiut University ### Study Description This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH. ### Conditions - Post-Dural Puncture Headache ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Aminophylline , magnesium sulphate and placebo ### Outcomes Primary Outcomes - Effect of the study drugs on the incidence and severity of PDPH Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns - NCT ID: NCT06272903 - Study ID: MBRU IRB-2023-228 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences ### Study Description The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE). ### Conditions - Effect of Benzocaine on Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 20% benzocaine, topical anesthetic - Children's Toothpaste ### Outcomes Primary Outcomes - Immediate Pain Levels Secondary Outcomes - Patient Satisfaction During Procedure ### Location - Facility: Mohammed Bin Rashid University Of Medicine and Health Sciences, Dubai, N/A, N/A, United Arab Emirates @@
## THE EFFECT OF MOTIVATIONAL INTERVIEWING ON NURSING STUDENTS WITH SOCIAL ANXIETY - NCT ID: NCT06272890 - Study ID: GiresunU - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-07-20 - Lead Sponsor: Gazi University ### Study Description Studies support the idea that people diagnosed with social anxiety disorder score significantly lower on self-acceptance than healthy controls, and that self-compassion is inversely related to anxiety. Motivational interviewing has been shown to improve treatment outcomes as well as predict higher self-compassion and reduced resistance among participants.It also has the ability to increase the effectiveness of motivational interviewing as an intervention with perpetrators of intimate partner violence, promoting readiness for change and progression through stages of change. In this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety. ### Conditions - Motivation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - motivational interviewing ### Outcomes Primary Outcomes - Motivational interviewing has an effect on nursing students' social anxiety. Secondary Outcomes - Motivational interviewing has an effect on nursing students' dating violence. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fluidotherapy in Patients With Distal Radius Fractures - NCT ID: NCT06272877 - Study ID: 129944-54 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-07-20 - Lead Sponsor: Ahi Evran University Education and Research Hospital ### Study Description Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase. ### Conditions - Distal Radius Fractures - Edema Arm - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fluidotherapy - conventional rehabilitation program ### Outcomes Primary Outcomes - Visual analog scale - Visual analog scale - Visual analog scale - Wrist joint range of motion - Wrist joint range of motion - Wrist joint range of motion - Circumference (mm) - Circumference (mm) - Circumference (mm) Secondary Outcomes - Gross Grip Strength: - Gross Grip Strength: - Gross Grip Strength: - Patient-Rated Wrist Evaluation (PRWE) questionnaire - Patient-Rated Wrist Evaluation (PRWE) questionnaire - Patient-Rated Wrist Evaluation (PRWE) questionnaire ### Location - Facility: Kirsehir Research and Training Hospital, Kirsehir, Kişrsehşr, 40100, Turkey @@
## BostonGene and Exigent Genomic INsight Study - NCT ID: NCT06272864 - Study ID: BEGIN study - Status: NOT_YET_RECRUITING - Start Date: 2024-03-08 - Completion Date: 2028-01-08 - Lead Sponsor: BostonGene ### Study Description The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings. ### Conditions - Breast Cancer - Non-small Cell Lung Cancer - Melanoma - Sarcoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Frequency of actionable findings - Test turn-around time Secondary Outcomes - Frequency of patients who receive molecularly matched therapy - Frequency of patients who receive molecularly matched therapy ### Location - Facility: Northwest Medical Specialities, Puyallup, Washington, 98373, United States @@
## Measuring Choroidal Thickness Using Optical Coherence Tomography - NCT ID: NCT06272851 - Study ID: Choroidal thickness by OCT - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2029-05-15 - Lead Sponsor: Assiut University ### Study Description To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography. ### Conditions - Choroid Disease - Diabetes Mellitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - optical coherence tomography ### Outcomes Primary Outcomes - comparison between choroidal thickness Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Biodex Balance System in Patients With Parkinson's Disease - NCT ID: NCT06272838 - Study ID: 2023-19/145 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-10-14 - Lead Sponsor: Kirsehir Ahi Evran Universitesi ### Study Description Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biodex balance system - The conventional balance exercise program ### Outcomes Primary Outcomes - Berg Balance Scale - Berg Balance Scale - Berg Balance Scale - Biodex dynamic balance score - Biodex dynamic balance score - Biodex dynamic balance score - The fall efficacy scale - The fall efficacy scale - The fall efficacy scale - Time up and go test - Time up and go test - Time up and go test Secondary Outcomes - The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) - The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) - The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) - The Five Times Sit to Stand Test - The Five Times Sit to Stand Test - The Five Times Sit to Stand Test - Beck Depression Inventory - Beck Depression Inventory - Beck Depression Inventory ### Location - Facility: Kırşehir Ahi Evran University Faculty of Medicine, Kırşehir, City Center, 40100, Turkey @@
## Virtual Reality in Patients With Knee Osteoarthritis - NCT ID: NCT06272825 - Study ID: 2023-19/140 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-08-14 - Lead Sponsor: Kirsehir Ahi Evran Universitesi ### Study Description One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation. ### Conditions - Knee Osteoarthritis - Pain - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual reality - conventional rehabilitation ### Outcomes Primary Outcomes - Visual Analog Scale - Visual Analog Scale - Visual Analog Scale - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Biodex Balance System - Biodex Balance System - Biodex Balance System Secondary Outcomes - Short Form 36 (SF36) - Short Form 36 (SF36) - Short Form 36 (SF36) ### Location - Facility: Kırşehir Ahi Evran University Faculty of Medicine, Kırşehir, City Center, 40100, Turkey @@
## A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region. - NCT ID: NCT06272812 - Study ID: IAVI C113 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-03 - Lead Sponsor: International AIDS Vaccine Initiative ### Study Description A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region. ### Conditions - Tuberculosis (TB) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MTBVAC - Placebo ### Outcomes Primary Outcomes - To evaluate the protective efficacy of of MTBVAC against bacteriologically confirmed pulmonary TB disease, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment as compared to placebo. Secondary Outcomes - To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. - To evaluate the protective efficacy of MTBVAC candidate vaccine against definite Xpert MTB/RIF Ultra positive pulmonary TB disease diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. - To evaluate the protective efficacy of one dose of MTBVAC candidate vaccine against clinical TB, as compared to placebo - To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. - To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. - To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. - To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. - To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. - To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. - To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. - To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tolerability and Efficacy of Adjuvant T-DM1 in Patients With HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study - NCT ID: NCT06272799 - Study ID: RS1480/21 - Status: RECRUITING - Start Date: 2022-09-20 - Completion Date: 2024-09-20 - Lead Sponsor: Regina Elena Cancer Institute ### Study Description Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - T-DM1 adjuvant ### Outcomes Primary Outcomes - Evaluate the tolerability. Secondary Outcomes - Evaluate the effectiveness of treatment. ### Location - Facility: "Regina Elena" National Cancer Institute, Rome, N/A, 00144, Italy @@
## Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair - NCT ID: NCT06272786 - Study ID: 2023-18/128 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-10-01 - Lead Sponsor: Kirsehir Ahi Evran Universitesi ### Study Description Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .. Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications. ### Conditions - Rotator Cuff Tears - Pain - Nerve Block ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - conventional physiotherapy program. - Suprascapular nerve block ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) - Visual Analog Scale (VAS) - Visual Analog Scale (VAS) - Shoulder joint range of motion (ROM) - Shoulder joint range of motion (ROM) - Shoulder joint range of motion (ROM) Secondary Outcomes - Shoulder Pain and Disability İndex (SPADİ) - Shoulder Pain and Disability İndex (SPADİ) - Shoulder Pain and Disability İndex (SPADİ) - Modified Constant-Murley Scoring - Modified Constant-Murley Scoring - Modified Constant-Murley Scoring ### Location - Facility: Ahi Evran University, Kirşehir, City Centre, 40100, Turkey @@
## Forced Oscillation and Breathing Pattern in Asthma - NCT ID: NCT06272773 - Study ID: IRAS Ref: 333663 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Karl Sylvester ### Study Description Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT.Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality. ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Forced Oscillation Test ### Outcomes Primary Outcomes - Change in airway resistance at 5 Hertz (Hz) and 19Hz Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy - NCT ID: NCT06272760 - Study ID: 2024-02-060 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-02-28 - Lead Sponsor: Samsung Medical Center ### Study Description The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Home-based hand-arm bimanual intensive training (Tele-HABIT) - Hand-arm bimanual intensive training (In-clinic-HABIT) ### Outcomes Primary Outcomes - Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0). Secondary Outcomes - Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0). - Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0). - Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0). - Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0). - Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0). - Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase I Study of XH-S003 in Healthy Volunteers - NCT ID: NCT06272747 - Study ID: XH-S003-I-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-10-30 - Lead Sponsor: S-Infinity Pharmaceuticals Co., Ltd ### Study Description The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S003 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S003. ### Conditions - Healthy Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - XH-S003 - Placebo ### Outcomes Primary Outcomes - Number of participants with adverse events (AEs) - Number of participants with adverse events (AEs) Secondary Outcomes ### Location - Facility: Beijing Friendship Hospital,Capital Medical University, Beijing, N/A, N/A, China @@
## Reprieve System Pilot Study - NCT ID: NCT06272734 - Study ID: RCV-0007 - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2025-01-31 - Lead Sponsor: Reprieve Cardiovascular, Inc ### Study Description The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure. ### Conditions - Acute Decompensated Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Reprieve System ### Outcomes Primary Outcomes - Functional Device Success Secondary Outcomes ### Location - Facility: Tbilisi Heart and Vascular Clinic, Tbilisi, N/A, 0159, Georgia @@
## Hypothyroidism in Pregnancy and Neuropsychological Development in Children - NCT ID: NCT06272721 - Study ID: 6272 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-05-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Thyroid dysfunction, particularly hypothyroidism and thyroid autoimmunity, impacts a significant proportion of pregnant women, affecting 3% and 17% respectively. The management of thyroid-stimulating hormone (TSH) levels is crucial, with subclinical hypothyroidism often defined by a TSH upper reference limit of 4 mU/L, and overt hypothyroidism by TSH levels above 10 mU/L and potentially low free thyroxine (FT4) levels. Levothyroxine (LT4) treatment is strongly advised for TSH levels above 10 mU/L, with the timing of intervention being critical during the first trimester for optimal fetal brain development.Research shows that untreated maternal hypothyroidism can significantly impact the neuropsychological development of the child, affecting cognitive, verbal, and motor skills. Even subclinical maternal hypothyroidism has been associated with lower IQ and motor scores in children. Early pregnancy intervention is key, as treatment after the first trimester may not improve children's neurocognitive outcomes.Regarding sensory and linguistic development, evidence is mixed, but recent studies suggest that maternal hypothyroidism can lead to expressive language delays. The Development Quotient (DQ) is used to assess cognitive and motor development in children, with the Griffiths Mental Development Scales II being a common tool.This study aims to explore the effects of treated maternal hypothyroidism during pregnancy on children's neurodevelopment, focusing on learning and language. It includes 31 women diagnosed with hypothyroidism and a control group of 21 euthyroid women, along with their children. The study emphasizes the importance of early detection and treatment of maternal hypothyroidism for preventing adverse neurodevelopmental outcomes in offspring. Statistical analysis will be conducted using SPSS, with a focus on maternal-fetal outcomes and cognitive-neuropsychological outcomes, highlighting the significance of early intervention. ### Conditions - Thyroid Dysfunction - Pregnancy Related - Language Development ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Griffiths Scale ### Outcomes Primary Outcomes - total development quotient measured using the Griffiths scale Secondary Outcomes ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients - NCT ID: NCT06272708 - Study ID: IIT-2023-0356 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2024-05-31 - Lead Sponsor: RenJi Hospital ### Study Description Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer. ### Conditions - Thromboelastography - Hemodialysis - Anticoagulation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - thromboelastography parameter R value Secondary Outcomes - thromboelastography parameter K value - thromboelastography parameter Angle - thromboelastography parameter MA ### Location - Facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, 200127, China @@
## Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab - NCT ID: NCT06272695 - Study ID: R477-203 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-06-15 - Lead Sponsor: REMD Biotherapeutics, Inc. ### Study Description This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline. ### Conditions - Type 1 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Volagidemab ### Outcomes Primary Outcomes - Change in Time to glucagon treatment success at Week 6. Secondary Outcomes - Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia. - Treatment emergent adverse events (AEs) - Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale - Hypoglycemia symptoms - Clarke Survey - Hypoglycemia symptoms - Gold Questionnaire - Change from baseline in hemoglobin A1c (HbA1c) at Week 6. ### Location - Facility: Altman Clinical and Translational Research Institute, San Diego, California, 92037, United States @@
## Corticosteroids in Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study - NCT ID: NCT06272682 - Study ID: 6669 - Status: RECRUITING - Start Date: 2023-07-17 - Completion Date: 2025-10-11 - Lead Sponsor: Hospital Italiano de Buenos Aires ### Study Description The goal of this prospective, randomised, controlled, non-inferiority analytical study is to compare the Boston score in patients treated with systemic (intramuscular) versus local infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18 years of age with mild or moderate carpal tunnel syndrome.The main questions it aims to answer are:* What is the effectiveness of intramuscular injection of corticosteroids compared to local infiltration in the treatment of mild/moderate carpal tunnel syndrome?* What are the adverse effects and application site pain associated with each route of administration?Patients who meet the inclusion criteria will be asked to participate in the study and sign an informed consent form.The Redcap randomizer will be used to assign the patient to one of the branches.Researchers will compare* Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under ultrasound* Branch B: patients treated with intramuscular corticosteroid injection.Researchers will:* Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and 12 months post-procedure.* Describe adverse reactions associated with the route of administration.* Compare the pain at the site of application associated with the route of administration. ### Conditions - Carpal Tunnel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Systemic bethametasone injection - Local bethametasone injection ### Outcomes Primary Outcomes - Compare the Boston Carpal Tunnel Syndrome Questionnaire Secondary Outcomes - Adverse reactions - Pain at the site of application ### Location - Facility: Hospital Italiano de Buenos Aires, Buenos Aires, N/A, C1199, Argentina @@
## Cumulative and Booster Effects of Multisession Prefrontal tDCS in Adolescents With ASD - NCT ID: NCT06272669 - Study ID: HSEARS20220216004 - Status: RECRUITING - Start Date: 2022-06-02 - Completion Date: 2025-12 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD. ### Conditions - Transcranial Direct Current Stimulation - Autistic Spectrum Disorder - Electroencephalography ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Active-tDCS - Sham-tDCS ### Outcomes Primary Outcomes - Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) Secondary Outcomes - Clinical response in tDCS outcome - Change in neuropsychological measures - CANTAB® cognitive tests ### Location - Facility: The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, Hong Kong @@
## Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma - NCT ID: NCT06272656 - Study ID: AKR-TACE-001 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-30 - Lead Sponsor: Hebei Medical University Third Hospital ### Study Description Primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in China, posing a serious threat to the lives and health of the Chinese people . At present, non-surgical treatment methods are often used, such as radiofrequency ablation (RFA), Transcatheter arterial chemoembolization (TACE), radiation therapy, and systemic anti-tumor therapy. However, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include AFP, AFP-L3%, DCP, etc. , but there are no reports on whether AKR1B10 can be used for the efficacy evaluation of these treatment methods.Therefore, this project aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE Secondary Outcomes - long-term survival (1-year, 3-year, 5-year) - progression- free - time ### Location - Facility: HebeiMUTH, Shijia Zhuang, Hebei, 050000, China @@
## Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions - NCT ID: NCT06272643 - Study ID: EPIC36-EMPERATRIZ - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2026-01-20 - Lead Sponsor: Fundación EPIC ### Study Description Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT. ### Conditions - Coronary Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) ### Outcomes Primary Outcomes - To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions Secondary Outcomes - Cardiac Death - Cardiovascular Death - Acute myocardial infarction of treated/functionally assessed lesion - Acute myocardial infarction of any lesion - Need for revascularisation of lesion treated/functionally assessed - Need for revascularisation of any lesion - Secondary efficacy endpoint: Clear Image Length - Extend of detectable EEL in LM - Correlation between contrast volume used and results, as well as the average contrast volume used in the study. ### Location - Facility: Hospital Universitario Juan Ramon Jimenez, Huelva, N/A, 21005, Spain @@
## Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease - NCT ID: NCT06272630 - Study ID: DW_DWJ1464401 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-02-06 - Completion Date: 2024-08-31 - Lead Sponsor: Daewoong Pharmaceutical Co. LTD. ### Study Description This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded. ### Conditions - Chronic Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DWJ1464 - Placebo of DWJ1464 ### Outcomes Primary Outcomes - At 8 weeks, the change of ALT level compared to baseline Secondary Outcomes - At 4 weeks, the change of ALT level compared to baseline - At 4, 8 weeks, the change of AST level compared to baseline - At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline - At 8 weeks, the change of liver function comparator Fibrotest compared to baseline - At 8 weeks, the change of liver function comparator Fibroscan compared to baseline - At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline ### Location - Facility: SoonChunHyang University Seoul Hospital, Seoul, N/A, 04401, Korea, Republic of @@
## Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer - NCT ID: NCT06272617 - Study ID: 2023-960 - Status: RECRUITING - Start Date: 2023-07-25 - Completion Date: 2025-07-24 - Lead Sponsor: West China Hospital ### Study Description A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors ### Conditions - Malignant Tumor of Head and/or Neck - Radiotherapy; Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - verum acupuncture - sham acupuncture ### Outcomes Primary Outcomes - Xerostomia questionnaire scores Secondary Outcomes - Salivary flow rate - Taste function assessed by patients - Taste function assessed by electrogustometer test - Taste function assessed by taste strips test - Oral mucositis - Dysphagia - Quality of Life assessed by EORTC QLQ-C30 - Quality of Life assessed by QLQ-H&N35 - Adverse effects - Changes of oral flora - Tongue range of motion - Neck Fibrosis ### Location - Facility: West China Hospital, Sichuan University, Chengdu, Sichuan, N/A, China @@
## Exercise Rehabilitation for Children With Asthma - NCT ID: NCT06272604 - Study ID: 2024-IRB-0015-P-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-10-01 - Lead Sponsor: The Children's Hospital of Zhejiang University School of Medicine ### Study Description Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients. ### Conditions - Asthma in Children - Rehabilitation - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Personalized Exercise Rehabilitation ### Outcomes Primary Outcomes - Lung Function - Daily Physical Activity Level Secondary Outcomes - Asthma Control Status - Fractional Exhaled Nitric Oxide (FeNO) - Body Composition - Sleep - Health Related Quality of Life - Anxiety and Depression - Inflammatory Mediators ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Patient Satisfaction With Home Induction and In-patient Induction. - NCT ID: NCT06272591 - Study ID: IRBN1192023/CHUSTE - Status: RECRUITING - Start Date: 2023-11-20 - Completion Date: 2024-05 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital. ### Conditions - Induced; Birth - Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Preliminary search in the patient's file - A posteriori research in the patient's file - First questionnaire : choice of induction method reason for choice - Second questionnaire : experience of induction ### Outcomes Primary Outcomes - Questionnaire on patients' experience of induction in hospital and at home. - Questionnaire on patients' satisfaction of induction in hospital and at home. Secondary Outcomes - Questionnaire on patients' choice of induction method - Questionnaire on reasons for choosing home induction. - Maternal morbidity - Maternal mortality - Neonatal morbidity - Neonatal mortality ### Location - Facility: Chu Saint Etienne, St Etienne, N/A, 42100, France @@
## Screen CardRen - A Cross-sectional Observational Cohort Study - NCT ID: NCT06272578 - Study ID: 20021405 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-30 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure. ### Conditions - Heart Failure - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography ### Outcomes Primary Outcomes - prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction - Proteomic analysis Secondary Outcomes - Duration of echocardiographic examination - Time saved by portable echocardiography and automated image analysis - Image quality of cart-based vs. portable echo images ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage - NCT ID: NCT06272565 - Study ID: 2023KYPJ292 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-30 - Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University ### Study Description Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group. ### Conditions - Diabetic Retinopathy - Diabetic Macular Edema - Anti-vascular Endothelial Growth Factor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Untargeted metabolomics for metabolic profile using UHPLC/MS Secondary Outcomes - Best-corrected visual acuity - Central subfield thickness ### Location - Facility: Zhongshan Ophthalmic Center of Sun Yat-sen University, Guangzhou, Guangdong, 510623, China @@
## Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact - NCT ID: NCT06272552 - Study ID: PI21-00026 - Status: RECRUITING - Start Date: 2023-10-25 - Completion Date: 2027-10 - Lead Sponsor: Parc de Salut Mar ### Study Description There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\' and health professionals\' experiences on health care, as well as improve patients\' health. ### Conditions - PROMs - PREMs - Implementation Research - Impact Evaluation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - PROMs and PREMs - PREMs - Control - Healthcare professionals ### Outcomes Primary Outcomes - Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals - Health-related quality of life Secondary Outcomes ### Location - Facility: Hospital del Mar Reseach Institute, Barcelona, Catalonia, 08003, Spain @@
## Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome - NCT ID: NCT06272539 - Study ID: 2023 101435 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-01 - Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir ### Study Description Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception. ### Conditions - Failed Back Surgery Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise - Spinal Cord Stimulation ### Outcomes Primary Outcomes - Disability (Oswestry Disability Index) - Perception Pain (Visual analogue scale) Secondary Outcomes - Quality of life (Short Form 36 Health Survey, SF36) - Patient's satisfaction - Strength (Sorensen Test) - Fear of Movement (Tampa Scale of Kinesiophobia, TSK) - Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale) - Catastrophic thinking (Pain Catastrophizing Scale) ### Location - Facility: Juan Vicente-Mampel, Torrent, Valencia, 46900, Spain @@
## Internet-Based Self-Help Intervention for Social Anxiety Symptoms - NCT ID: NCT06272526 - Study ID: SOCIALANX_1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Anadolu University ### Study Description This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Internet Based Intervention - GUIDED ### Outcomes Primary Outcomes - Liebowitz Social Anxiety Scale (LSAS) Turkish Form Secondary Outcomes - Social Appearance Anxiety Scale (SAAS) Turkish Form - Patient Health Questionnaire-9 (PHQ-9) Turkish Form - Generalized Anxiety Disorder-7 (GAD-7) Turkish Form ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Influencing Factors for Physical Activity in People With Head and Neck Cancer - NCT ID: NCT06272513 - Study ID: ProAct-HNC-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06-30 - Lead Sponsor: Kantonsspital Winterthur KSW ### Study Description The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:* What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?* What motivates people with advanced head and neck cancer to be physically active?* How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?The interviews will be transcribed verbatim and analysed with a structuring content analysis approach. ### Conditions - Advanced Head and Neck Squamous Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - interview transcripts Secondary Outcomes - personal information of participants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring Methods for Treating Hypergastrinemia in Patients With Autoimmune Gastritis - NCT ID: NCT06272500 - Study ID: 2024-KY-0146-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-31 - Lead Sponsor: Jianning Yao ### Study Description Autoimmune atrophic gastritis (AAG) is an organ-specific autoimmune disease that primarily affects the gastric body and fundus while sparing the antrum. Its characteristics include destruction of gastric wall cells, loss of intrinsic factors, and atrophy of the gastric mucosa. Endoscopic examination reveals features of reverse atrophy, with significant atrophy in the gastric body and fundus, appearing as a mosaic of red and white patches. Currently, AAG is believed to result from a pathological CD4+ T-cell-mediated autoimmune response against the gastric H+/K+-ATPase. CD4+ T lymphocytes target the parietal cells' H+/K+-ATPase, stimulating plasma cells to secrete autoantibodies, including parietal cell antibodies (PCA) and intrinsic factor antibodies (IFA). The former plays a key role in parietal cell destruction and glandular atrophy. AAG is considered a premalignant condition, with the potential development of gastric dysplasia, cancer, and type 1 gastric neuroendocrine tumours (type 1 g-NET).Gastric neuroendocrine tumors (g-NETs), also known as gastric carcinoids, account for approximately 23% of gastrointestinal and pancreatic neuroendocrine tumors. Clinically, g-NETs are mainly classified into three types. Type III is typically sporadic tumors associated with normal gastrin levels and poor prognosis. Although type 1 g-NETs caused by AAG are usually well-differentiated, studies have reported that 8%-23% of type 1 g-NETs extending into the deep submucosal layer may metastasize to regional lymph nodes or even to the liver. Furthermore, 3% of patients may develop neuroendocrine carcinoma, highlighting the need for appropriate attention.Due to the destruction of gastric glands (including parietal and chief cells) in AAG patients, there is a deficiency in intrinsic factor, gastric acid, and a decrease in pepsinogen I (PG-I) levels. Insufficient gastric acid secretion leads to a compensatory increase in gastrin secretion by G cells in the gastric antrum, which acts on receptors present in enterochromaffin-like cells (ECL) in the gastric body and fundus, promoting ECL cell proliferation. Prolonged stimulation by hypergastrinemia can result in the development of ECL cell tumors, namely type 1 g-NETs. Considering the close association between type 1 g-NETs and AAG, primarily related to hypergastrinemia resulting from reduced gastric acid secretion, it is hypothesized that supplementation with gastric acid could provide negative feedback regulation of gastrin, reducing the risk of type 1 g-NET development in AAG patients. This study aims to investigate the impact of oral apple cider vinegar on gastrin levels in AAG patients, thus exploring a simple and cost-effective method to reduce the risk of type 1 g-NETs in AAG patients. ### Conditions - Autoimmune Gastritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - oral administration of a compound digestive enzyme capsule - oral administration of apple cider vinegar - oral administration of both the compound digestive enzyme capsule and apple cider vinegar ### Outcomes Primary Outcomes - serum gastrin levels - serum gastrin levels Secondary Outcomes - the adverse reaction rates ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) - NCT ID: NCT06272487 - Study ID: ALN-AGT01-007 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-12-19 - Lead Sponsor: Alnylam Pharmaceuticals ### Study Description The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications. ### Conditions - High Cardiovascular Risk - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Zilebesiran - Placebo ### Outcomes Primary Outcomes - Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) Secondary Outcomes - Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) - Change from Baseline at Month 6 in Mean Seated Office SBP - Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM - Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 - Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 - Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM - Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP - Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM - Change from Baseline Over Time in Serum Angiotensinogen (AGT) ### Location - Facility: Clinical Trial Site, Flint, Michigan, 48504, United States @@
## Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments - NCT ID: NCT06272474 - Study ID: 0266-07/2021 - 18/07/2021 - Status: COMPLETED - Start Date: 2022-09-11 - Completion Date: 2023-12-09 - Lead Sponsor: Hams Hamed Abdelrahman ### Study Description Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained. ### Conditions - Dental Occlusion ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - CAD-CAM zirconia crowns using buccal interocclusal record. - CAD-CAM zirconia crowns using lateral interocclusal records. ### Outcomes Primary Outcomes - Static occlusal interference - Dynamic occlusal interference Secondary Outcomes ### Location - Facility: Alexandria Faculty of Dentistry, Alexandria, N/A, N/A, Egypt @@
## Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery - NCT ID: NCT06272461 - Study ID: UTEM ELKI - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-06-30 - Lead Sponsor: University Tunis El Manar ### Study Description Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. ### Conditions - Colorectal (Colon or Rectal) Cancer - Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lidocaine IV - Ketamine Injectable Solution ### Outcomes Primary Outcomes - The variation of Interleukin-6 levels Secondary Outcomes - Pain assessed by Numerical Rating Scale (NRS) - Post-operative nausea and vomiting - Bowel function. - Hospital length of stay. - Post-operative complications. ### Location - Facility: Tunisia, Nabeul, N/A, 8000, Tunisia @@
## teleRehabilitation for pAtients With ParkInson's Disease at Any mOment - NCT ID: NCT06272448 - Study ID: CERM2022-27 21042022 - Status: RECRUITING - Start Date: 2022-11-15 - Completion Date: 2024-05-31 - Lead Sponsor: Università Politecnica delle Marche ### Study Description The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • Will this training be safe and impact the patient's well-being perception? Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.They will be requested to perform the motor tasks per a predetermined protocol over 3 months. Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Telerehabilitation ### Outcomes Primary Outcomes - Compliance with the telerehabilitation system - Perceived usability of system - Incidence of treatment-emergent adverse events Secondary Outcomes - User satisfaction - Compliance with the monitoring system - Feasibility of telemonitoring approach - Motor symptom and disability progression - Non motor symptom progression - Patients' Quality of life - Caregiver's burden ### Location - Facility: Neurorehabilitation Clinic, Ancona, N/A, 60126, Italy @@
## Beverage Hydration Index: Assessment of Four Rehydration Solutions - NCT ID: NCT06272435 - Study ID: PRO-FY2024-64 - Status: RECRUITING - Start Date: 2023-12-23 - Completion Date: 2024-05-31 - Lead Sponsor: University of Memphis ### Study Description No studies to date to evaluate the effects of the three different liquid IV electrolyte products on the beverage hydration index (BHI). Therefore, the purpose of this study is to determine the impact of three different LIV products (Hydration multiplier, Sugar Free formulation with Amino Acids, and Sugar Free with allulose) on hydration status in young and active men and women compared to a control (water). The study will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and BHI (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance, as well as determining electrolyte concentrations, osmolality, specific gravity, and sodium and potassium in urine. ### Conditions - Hydration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Multiplier - Sugar Free - Sugar Free with Amino Acids - Water ### Outcomes Primary Outcomes - Beverage Hydration Index - Beverage Hydration Index - Beverage Hydration Index - Beverage Hydration Index - Beverage Hydration Index Secondary Outcomes - Net Fluid Balance - Net Fluid Balance - Net Fluid Balance - Net Fluid Balance - Net Fluid Balance - Urine Osmolality - Urine Osmolality - Urine Osmolality - Urine Osmolality - Urine Osmolality - Urine Osmolality - Urine Sodium - Urine Sodium - Urine Sodium - Urine Sodium - Urine Sodium - Urine Sodium - Urine Potassium - Urine Potassium - Urine Potassium - Urine Potassium - Urine Potassium - Urine Potassium - Urine Specific Gravity - Urine Specific Gravity - Urine Specific Gravity - Urine Specific Gravity - Urine Specific Gravity - Urine Specific Gravity - Urine Specific Gravity - Sodium balance - Sodium balance - Sodium balance - Sodium balance - Sodium balance - Potassium balance - Potassium balance - Potassium balance - Potassium balance - Potassium balance - Body Mass - Body Mass - Mood and Digestive Questionnaire - Mood and Digestive Questionnaire - Mood and Digestive Questionnaire - Mood and Digestive Questionnaire - Mood and Digestive Questionnaire - Mood and Digestive Questionnaire ### Location - Facility: Center for Nutraceutical and Dietary Supplement Research, Memphis, Tennessee, 38152, United States @@
## Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning - NCT ID: NCT06272422 - Study ID: 2022/0472 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: University Hospital, Lille ### Study Description The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery.To this end, two types of examination are carried out, both of which are used in current practice:* Pre-operatively: EOS radiography* Post-operatively: EOS radiograph and CT scanInclusion (m-3; m-1) :* Patient information at pre-operative visit* Non-opposition of patient, family member or legal guardian, if applicable* Questionnaires and clinical examination (standard management)* EOS during anesthetic consultationFollow-up visit (m+3):- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examinationFollow-up visit (m+12):- Post-operative check-up, questionnaire and clinical examination ### Conditions - Coxarthrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - hip arthroplasty ### Outcomes Primary Outcomes - Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty. Secondary Outcomes - Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA). - Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA). - Correlate restoration of hip femoral offset and patient functional outcome at 3 months. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children. - NCT ID: NCT06272409 - Study ID: DEP114-III-0123 - Status: NOT_YET_RECRUITING - Start Date: 2025-02-15 - Completion Date: 2027-04-15 - Lead Sponsor: EMS ### Study Description The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years. ### Conditions - Allergic Rhinitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DEP114 - Desloratadine 0.5 MG/ML ### Outcomes Primary Outcomes - To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment. Secondary Outcomes - To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment. - Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment. - Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. - Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. - Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment. - Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant. - Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch - NCT ID: NCT06272396 - Study ID: CHUBX 2023/64 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2028-03-20 - Lead Sponsor: University Hospital, Bordeaux ### Study Description Over the past few years, various systems have been developed to record ECG traces on an ambulatory basis. The latest connected watch models feature 2-electrode ECG recording. This single or six derivations can be used to derive a wealth of information about the heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ simple differentiation between atrial fibrillation and sinus rhythm. In contrast, in various clinical situations, a tracing restricted to an ICD may prove falsely normal, wrongly reassuring a patient and delaying management. The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters, compared with a standard ECG-12D, also to obtain a bank of tracings, to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children. ### Conditions - Arrhythmias, Cardiac ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Smart watch ### Outcomes Primary Outcomes - Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude - Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration - Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude - Comparison of electrical parameters measured using the 2 ECG methods: QRS duration - Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc Secondary Outcomes - Creation of bank of anormal ECG trace - Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG - Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home - Validate the feasibility of recording an ECG trace with a connected watch for a child - Validate the sensibility of an ECG trace with a connected watch for a child ### Location - Facility: Hôpital Haut-Lévèque, Pessac, N/A, 33604, France @@
## Croup Dosing Study - NCT ID: NCT06272383 - Study ID: HS26166 (B2023:092) - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: University of Manitoba ### Study Description Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup. ### Conditions - Croup ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 0.15 mg/kg dexamethasone ### Outcomes Primary Outcomes - Return visits or readmissions to the hospital Secondary Outcomes - Adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Individualizing Treatment for Asthma in Primary Care - NCT ID: NCT06272370 - Study ID: PLACER-2021C3-24737-IC - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-09-30 - Lead Sponsor: DARTNet Institute ### Study Description This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system. ### Conditions - Asthma - Bronchial Diseases - Respiratory Tract Infections - Lung Diseases, Obstructive - Lung Diseases - Respiratory Hypersensitivity - Immune System Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Asthma Symptom Monitoring online tools - Inhaled Steroids - Azithromycin Pill ### Outcomes Primary Outcomes - The annualized rate of major asthma exacerbations (a hospitalization for asthma or 72+ hours of oral/parenteral steroids). Secondary Outcomes - Asthma control as measured by the Asthma Control Test - Asthma Quality of Life as measured by the Juniper Mini Asthma Quality of Life Questionnaire - Days Per Year Lost from Work or School/Days Unable to Carry Out Usual Activities Due to Asthma. ### Location - Facility: DARTNet Insitute, Aurora, Colorado, 80045, United States @@
## The Use of Antiarrhythmic Drugs in Pediatrics - NCT ID: NCT06272357 - Study ID: Antiarrhythmic drugs - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-31 - Lead Sponsor: Assiut University ### Study Description A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit ### Conditions - Antiarrhythmic Drug Adverse Reaction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Antiarrhythmic drugs ### Outcomes Primary Outcomes - Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remote Programming of Cardiac Implantable Electronic Devices 2 - NCT ID: NCT06272344 - Study ID: CHUBX 2022/38 - Status: RECRUITING - Start Date: 2023-04-24 - Completion Date: 2024-10-24 - Lead Sponsor: University Hospital, Bordeaux ### Study Description Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. In this study we aim to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert. ### Conditions - Pacemaker - Defibrillator - Telemedecine ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Teleconsultation ### Outcomes Primary Outcomes - assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital Secondary Outcomes - Time saving for patient - Savings on medical transport - Costs associated with teleconsultation - safety of teleconsultation ### Location - Facility: Bordeaux University Hospital, Pessac, N/A, 33604, France @@
## Milk and Plant Protein Digestion - NCT ID: NCT06272331 - Study ID: NL83162.091.22 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-07-01 - Lead Sponsor: Wageningen University ### Study Description The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study.The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks.Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior. ### Conditions - Food Digestion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Low-protein plant-based drink - High-protein plant-based drink - Cow's milk ### Outcomes Primary Outcomes - Postprandial plasma amino acid profile as characterized by the peak height and iAUC Secondary Outcomes - Gastric behavior - Postprandial plasma response ### Location - Facility: Human Research Unit - Division of Human Nutrition and Health, Wageningen, N/A, 6708WE, Netherlands @@
## Vital Signs Blood Pressure Trial - NCT ID: NCT06272318 - Study ID: 74131 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-12-31 - Lead Sponsor: Stanford University ### Study Description The purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ECG), and photoplethysmogram (PPG). This data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device. ### Conditions - Cardiovascular Diseases - Hypertension - Blood Pressure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood Pressure Cuff, EKG, PPG ### Outcomes Primary Outcomes - Collection of Subject Name (optional) - Collection of Subject Height - Collection of Subject Weight - Collection of Subject Age - Collection of Subject Medical Comorbidities - Blood Pressure Measurement - Collection of ECG Waveforms - Collection of PPG Waveforms Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis - NCT ID: NCT06272305 - Study ID: 49RC21_0301 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-01 - Lead Sponsor: University Hospital, Angers ### Study Description Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year.Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis. ### Conditions - Hyperplasia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - This research does not require any specific investigation and does not imply any modification of treatment. ### Outcomes Primary Outcomes - Rate of restenosis Secondary Outcomes - Morbidity and mortality rate - Major cardiological event - Minor neurological events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls - NCT ID: NCT06272292 - Study ID: S66441 - Status: RECRUITING - Start Date: 2022-07-28 - Completion Date: 2024-03-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Femoroacetabular impingement (FAI) is an orthopaedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Moreover, another important aspect that has been consistently overlooked in past FAI movement studies is the influence muscle strength and activation can have on movement pattern and symptom presentation. The diagnosis and management of FAI needs to be addressed through a more wholesome investigation of the biomechanical influence on the manifestation of symptoms.This project aims to further unravel the link between spinopelvic anatomy, its biomechanical contribution to femoro-pelvic motion and the manifestation of femoroacetabular impingement in adult male population. By, for the first time, integrating three-dimensional (3D) instrumented motion analysis with state-of-the-art full-body biplanar X-ray imaging (EOS imaging, Paris France), we will more specifically investigate the presence of an association between spinopelvic kinematics and the link to symptomatic FAI morphology, as well as investigate the presence of differences in these measures between symptomatic and asymptomatic subjects with comparable femoral morphology. ### Conditions - Femoroacetabular Impingement ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - EOS - 3D motion lab analysis ### Outcomes Primary Outcomes - The presence of CAM morphology in combination with symptoms Secondary Outcomes - The Copenhagen Hip and Groin Outcome Score (HAGOS) - Radiographic spinopelvic parameters - 3D motion analysis parameters ### Location - Facility: University Hospitals of Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Neuromodulation With Spinal Stimulation Methods - NCT ID: NCT06272279 - Study ID: HS23666(B2020:015) - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: University of Manitoba ### Study Description This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed. ### Conditions - Spinal Cord Injuries - Spinal Cord Injury at C5-C7 Level - Paraplegia, Spinal - Paraplegia, Incomplete ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - spinal stimulation-DCS - spinal stimulation-sham DCS - spinal stimulation-EPS - sham spinal stimulation-EPS ### Outcomes Primary Outcomes - Motor response - Motor evoked potentials Secondary Outcomes - Blood pressure ### Location - Facility: University of Manitoba, Winnipeg, Manitoba, R3E 0J9, Canada @@
## The Aerobic Exercise Capacity and Muscle Strenght in Individuals With COVID-19 - NCT ID: NCT06272266 - Study ID: 2021/03-26 - Status: COMPLETED - Start Date: 2022-04-20 - Completion Date: 2023-02-15 - Lead Sponsor: Selda Sarıkaya ### Study Description The subject of the project is the impact of COVID-19 on the exercise capacity of patients. The long-term sequelae of COVID-19 infection are still unknown. It is not yet clear whether pulmonary sequelae, which may be a consequence of the disease, are associated with a measurable functional deficit. In this project, the aerobic capacity of healthy people will be compared with individuals who have experienced Covid-19, and the amount of increase in aerobic capacity will be determined at the end of 15 sessions by applying a rehabilitation program including bicycle ergometry to individuals who have experienced Covid-19 Detailed description : In December 2020, in the pneumonia epidemic in which the city of Wuhan, China is the center, pneumonia developed due to the newly defined SARS-CoV-2 factor was defined as Coronavirus disease 2019 (COVID-19). It has been observed that clinical findings of SARS-CoV-2 infection in patients hospitalized in Wuhan range from mild manifestations such as asymptomatic disease and mild upper respiratory tract infection to severe viral pneumonia accompanied by respiratory failure and may result in death.The long-term sequelae of COVID19 are still unknown. Pulmonary sequelae that impair physical fitness have been predominantly defined for hospitalized patients with COVID-19. Although lung lesions have been identified as asymptomatically in infected individuals, it is not yet clear whether these observations are related to a measurable functional deficit in physical fitness. They measured the change in the predicted maximum aerobic capacity (VO2 max) of non-infected,asymptomatically infected, and recovering COVID-19 individuals with a well-established and validated physical fitness test before and after the COVID-19 outbreak among young Swiss adults.They demonstrated decreased aerobic capacity in young adults 1 to 2 months after symptomatic COVID-19 without physical strength being affected. In their study, 19% of young adults who recovered after COVID-19 had a VO2 max decrease of more than 10% compared to baseline before infection. It has been identified that decreased VO2 max value is the hallmark of interstitial lung disease. SARS-CoV-2 infection causes lung damage even in asymptomatic cases.A total of 64 people, including 32 people in 2 groups between the ages of 18-55, who have or have not had corona virus infection, who applied to Bülent Ecevit University Faculty of Medicine Physical Therapy and Rehabilitation or Infectious Diseases outpatient clinics for different reasons, will be included in our project. The research start date is February 2021 and the end date is February 2023. At the beginning of the study, demographic information of the individuals such as gender, age,height, weight, occupation, education, body mass index, physical activity level (international physical activity index-IPAQ), the most used hand (dominant hand) in daily life activities will be recorded. In the control group, resting heart rate, blood pressure, saturation measurement, ECG will be performed before exercise. In addition, in order to evaluate their muscle strength, microFET3 manual muscle measurement device will be used to measure the triceps muscle strength in the upper extremity they actively use, and the quadriceps muscle strength of the same side will be measured, and their grip strength will be measured with the JAMAR hydraulic hand dynamometer. Using the international physical activity index(IPAQ), activity status in daily life will be assessed. The exercise capacity of all individuals will be measured with the aid of the COSMED Quark CPET device using the bicycle ergometry test recommended by the American Society of Cardiovascular and Pulmonary Rehabilitation. In this test, submaximal exercise test will be performed by providing 25 W increase in 2 minutes periods after the warm-up period at 0 load (W) for 2 minutes. In addition, the borg scale obtained at the end of the test, metabolic equivalent of task (MET) and maximum work (W), test duration, maximum heart rate parameters will also be recorded in order to evaluate the exercise capacity.Individuals who have been confirmed by the previous SARS-COV 2 real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to have coronovirus infection after the test will be included in a treatment program of 15 sessions, at least 3 sessions per week, with bicycle ergometry. After 15 sessions, exercise capacity will be re-evaluated using the cycling test, the aforementioned triceps and grip muscle strengths, V02 max, maximum conjugate (MET), maximum work (w), borg scale, maximum heart rate, test time parameters will be saved again after treatment. ### Conditions - COVID-19 Pneumonia - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system) - Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). - Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) - Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) ### Outcomes Primary Outcomes - Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device - Assessment of Maximum work (watts) ın the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. - Assessment of Metabolic Equivalent (MET) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. - Assessment of VO2peak (ml/kg/min) in the exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. - Assessment of VO2peakpredictive (%) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. - Assessment of Hand grip strength (kg) by using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). - Assessment of Exchange Ratio(RER ) by using cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, - Assessment of Anaerobik Treshold (VAT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, - Assessment of Maximum Oxygen Capacity (VO2peak) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, - Assessment of Maximum Oxygen Capacity at Ventilatory Anaerobic Threshold (VO2AT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, - Assessment of Carbon Dioxide Ventilatory Equivalent (VE/CO2) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, - Assessment of Heart Rate Recovery (HRR) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, - Assessment of Heart Rate Recovery at first minute (HRR1) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, - Assessment of quadriceps muscle strength by using the Micro FET3 muscle strength device Secondary Outcomes - Assessment of Physical activity by using the International Physical Activity Questionnaire (IPAQ) - Assessment of Test Duration (min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. - Assessment of Perceived Difficulty by using the Borg Scale - Assessment of Maximum heart rate (beats/min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. - Assessment of Systolic and diastolic blood pressure (mmHg) by using a blood pressure monitor - Assessment of resting heart rate (beats/min) by using a a pulse oximeter ### Location - Facility: Zonguldak Bülent Ecevit University, Zonguldak, N/A, 67100, Turkey @@
## UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects - NCT ID: NCT06272253 - Study ID: UNAIR-MP-INAKTIF-R-010 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-19 - Completion Date: 2024-07-19 - Lead Sponsor: Dr. Soetomo General Hospital ### Study Description This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports. ### Conditions - COVID-19 Pandemic - COVID-19 Vaccines ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg ### Outcomes Primary Outcomes - Humoral Immune Response (Neutralizing antibody) Secondary Outcomes - Incidence of Adverse Events - Humoral Immune Response - The neutralizing antibody - Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA ### Location - Facility: Dr. Soetomo General Hospital, Surabaya, Jawa Timur, 67161, Indonesia @@
## Tumor Microenvironment in Ovarian Cancer - NCT ID: NCT06272240 - Study ID: 17380 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2027-01 - Lead Sponsor: University of Udine ### Study Description A detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies. The new frontier in biomedical research is represented by organoids, a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro, which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy. With this research project, we expect to generate ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules). ### Conditions - Ovarian Cancer Stage III - Ovarian Cancer Stage IV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ovarian Cancer Organoids ### Outcomes Primary Outcomes - • Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids Secondary Outcomes ### Location - Facility: Università degli Studi di Udine, Udine, UD, 33100, Italy @@
## Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients - NCT ID: NCT06272227 - Study ID: 4-2023-0986 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-13 - Completion Date: 2025-09-01 - Lead Sponsor: Yonsei University ### Study Description This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group. ### Conditions - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - alfacalcidol - placebo - Denosumab ### Outcomes Primary Outcomes - Improvement in SPPB score of 0.5 or more compared to the control group Secondary Outcomes ### Location - Facility: Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, N/A, 03722, Korea, Republic of @@
## Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy - NCT ID: NCT06272214 - Study ID: ZJCCRT005 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-03-01 - Lead Sponsor: Zhejiang Cancer Hospital ### Study Description This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and were defined as preoperative clinical stage at T3-4N+M0.Eligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1/PDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg/m2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients. ### Conditions - Adjuvant Radiotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adjuvant radiotherapy - Observation ### Outcomes Primary Outcomes - 2-year DFS Secondary Outcomes - OS - LRFS - DMFS - HRQoL - Adverse effects recorded during radiotherapy and PD1/PDL1 inhibitors maintaince period - Incidence of Recurrence ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, N/A, China @@
## Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study - NCT ID: NCT06272201 - Study ID: 50620 TPR - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2026-08 - Lead Sponsor: USGI Medical ### Study Description This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP). ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors ### Outcomes Primary Outcomes - Percentage of total body weight loss (%TBWL) following randomization - Responder rate of at least 50% in the POSE2.0 treatment group - Safety- Incidence of device and procedure related adverse events through 12 months Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preconception Care for Couples Planning Pregnancy - NCT ID: NCT06272188 - Study ID: 09.2023.1435 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-08-15 - Lead Sponsor: Yuzuncu Yıl University ### Study Description Preconception care is to optimize health, address modifiable risk factors, and eliminate or reduce health-threatening factors for the woman, fetus, and newborn by working with couples to achieve a healthy pregnancy. Preconception care is the best way to protect against risks in pregnancy and plan risk management. Preconception care offers women and their partners the opportunity to gain healthy lifestyle behaviors, make conscious choices, and gain awareness of factors that threaten health before, during and after pregnancy. However, the rate of receiving preconception care is only 12.3% in our country.The aim of this project is to examine the effect of online preconception counseling on information and care practices for couples planning pregnancy for healthy starts.Materials and Methods:The randomized controlled experimental study will be conducted between February 1, 2024 and February 1, 2026 in the provinces of Istanbul, Izmir, Kastamonu, Ankara and Van. The population of the research will consist of all couples who applied to the marriage offices in the above provinces between February 1, 2024 and February 1, 2026. In the sample calculation, it was calculated that at least 80 couples (experimental group: 40 couples, control group: 40 couples) should be included in the study. Couples that meet the sampling criteria will be assigned to the experimental or control group according to the random numbers table. Online preconception care counseling will be provided to couples in the experimental group 1 month after their wedding date. Preconception care counseling, consisting of 17 titles, was prepared in line with the relevant literature and standardized by the researchers. After the counseling, the couples will be introduced to the preconception care website, which they can use if they need it, and will be given login information.Data will be obtained before and in the 3rd month after counseling with the Introductory Information Form (TBF), Preconceptional Period Risk Assessment Form, Preconceptional Care Health Literacy Scale and Preconceptional Period Health Behavior Scale. The data will be transferred to the SPSS 22 program and evaluated by the researchers. Chi-square test, t-test, Mann Whitney-U Test, Wilcoxon test and paired simple t test will be used to analyze the data. ### Conditions - Preconception Care, Preconception Risk ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - web-based online preconceptional counselling ### Outcomes Primary Outcomes - Identifying Information Form Secondary Outcomes - Preconceptional Period Risk Assessment Form ### Location - Facility: Van Yuzuncu Yil University, Van, N/A, N/A, Turkey @@
## Immediate Effects of Open and Closed Kinetic Chain Exercises on Upper Extremity in Stroke Patients. - NCT ID: NCT06272175 - Study ID: 10102023 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-12-30 - Lead Sponsor: Istinye University ### Study Description Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Open Kinetic Chain Activity - Closed Kinetic Chain Activity ### Outcomes Primary Outcomes - MyotonPRO digital palpation device - Box and Block Test Secondary Outcomes - Modified Ashworth Scale - Goniometer - PhysioMaster ### Location - Facility: Istinye University Hospital Medical Park Gaziosmanpasa, Istanbul, N/A, N/A, Turkey @@
## Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy - NCT ID: NCT06272162 - Study ID: NL85622.041.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2030-01 - Lead Sponsor: UMC Utrecht ### Study Description A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC). ### Conditions - Locally Advanced Pancreatic Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MR guided radiotherapy ### Outcomes Primary Outcomes - HRQoL deterioration-free survival Secondary Outcomes - Overall survival - Patient reported Quality of Life EORTC QLQ-PAN26 - Patient reported Quality of Life EORTC QLQ-C30 - Patient reported Quality of Life EQ5D-5L - The need of subsequent treatments - Treatment response assessed on CT-imaging (graded according to RECIST guidelines) - CA 19.9 response - Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch - Trial@home monitoring related outcome: feasibility Body+ scale - Trial@home monitoring related outcome: feasibility Whitings Sleep - Trial@home monitoring related outcome: feasibility ePRO application - Trial@home monitoring related outcome: digital biomarkers - Intervention arm related outcome toxicity - Intervention arm related outcome, completion of therapy - Intervention arm related outcome diffusion weighted images ### Location - Facility: Catharina Hospital, Eindhoven, Noord- Brabant, 5623 EJ, Netherlands @@
## An Exploratory Clinical Trial of VGN-R08b in Patients With Type II Gaucher Disease - NCT ID: NCT06272149 - Study ID: VGN-R08b-001 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2029-02-28 - Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description This exploratory trial is to prove the tolerability and safety of VGN-R08b to treat infants with type II Gaucher disease. ### Conditions - Type II Gaucher Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - VGN-R08b ### Outcomes Primary Outcomes - Number of Adverse Events (AEs), Serious Adverse Events (SAEs) Secondary Outcomes - Long-term safety follow-up - Survival ratio at age of 24 months - Changes in the activity of glucose cerebroside lipase (GCase) - Changes in the activity of glucose cerebroside (GC) levels - Changes in the activity of glucose sphingosine (Lyso GL1) levels in peripheral blood and CSF after medication - Immunogenicity - Changes in the genomic level of VGN-R08b vector in peripheral blood after medication ### Location - Facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200097, China @@
## Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM) - NCT ID: NCT06272136 - Study ID: SPN-007 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-12-31 - Lead Sponsor: Spiden AG ### Study Description This is a single-centre, multiple sequential-cohort, open study. ### Conditions - Type 1 Diabetes - Type2diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Clinical Demo 2.0 ### Outcomes Primary Outcomes - Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia Secondary Outcomes ### Location - Facility: Profil for Stoffwechselforschung GmbH, Neuss, Nordrhein-Westfallen, 41460, Germany @@
## Endotypic Stability in CRS - NCT ID: NCT06272123 - Study ID: 20D.776 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-31 - Lead Sponsor: Thomas Jefferson University ### Study Description A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients ### Conditions - Chronic Sinusitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Endotypic markers Secondary Outcomes - SF-36 - SNOT-22 ### Location - Facility: Thomas Jefferson University Department of Otolaryngology, Philadelphia, Pennsylvania, 19107, United States @@
## Promoting Equitable Access to Language Services in Health and Human Services - NCT ID: NCT06272110 - Study ID: 22-01303 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-08 - Lead Sponsor: NYU Langone Health ### Study Description This is a community-based study that will engage community and health care stakeholders to develop, implement, and evaluate a Health Literacy (HL)-informed, culturally- and linguistically- sensitive approach to improving language access services for patients with limited English proficiency (LEP) to promote health equity and reduce disparities in preventive health services use and health outcomes in New York City (NYC). This study will have a total of 4 phases that include a preparatory work phase (Non-Human Subjects Research), a pre-implementation phase, an implementation phase, and a post-implementation phase.Findings from the preparatory work and pre-implementation phase and discussions with key partners will inform the co-design of intervention strategies and endpoints for the later phases (implementation and post-implementation phase). ### Conditions - Appropriate Use of Language Across Services ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - System level Language Access (LA) intervention ### Outcomes Primary Outcomes - Percentage of appropriate interpreter use - Percentage of appropriate interpreter use Secondary Outcomes - Percentage of patients up to date with preventive screenings and vaccinations - Percentage of patients up to date with preventive screenings and vaccinations - Percentage of patients with knowledge of federal rights related to LA services - Percentage of patients with knowledge of federal rights related to LA services - Percentage using untrained interpreters - Percentage using untrained interpreters - Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) - Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) - Percentage of patients with satisfaction with LA services preventive health services utilization - Percentage of patients with satisfaction with LA services preventive health services utilization ### Location - Facility: Health + Hospitals Diagnostic/Treatment Centers, New York, New York, 10016, United States @@
## Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration - NCT ID: NCT06272097 - Study ID: 201328 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-11-15 - Lead Sponsor: Danni Feng ### Study Description This study aims to investigate the effectiveness of an optimized care management protocol for refractory postoperative wounds based on the TIME CDST tool. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of refractory postoperative wounds in clinical practice, thereby improving patient outcomes and quality of life. ### Conditions - Wound Heal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intervention program based on TIME-CDST tool led by wound specialist nurses - A routine wound care program ### Outcomes Primary Outcomes - Wound healing time Secondary Outcomes - The wound healing rate - The rate of wound area reduction - The Pressure Ulcer Scale for Healing (PUSH) - The positive rate of bacterial culture - The pain intensity - Patient comfort score - Patient satisfaction score - The levels of albumin - The number of dressing changes - Medical costs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Analysis of TPE Treatments With multiFiltratePRO - NCT ID: NCT06272084 - Study ID: CRRT-TPE-01-DE - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Fresenius Medical Care Deutschland GmbH ### Study Description Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments. ### Conditions - Autoimmune Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO ### Outcomes Primary Outcomes - Total amount of exchange plasma (prescribed vs achieved exchange volume) Secondary Outcomes ### Location - Facility: Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Bavaria, 63739, Germany @@
## A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection - NCT ID: NCT06272071 - Study ID: 2023YFC2308802-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-11 - Lead Sponsor: Zhejiang University ### Study Description The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with severe hepatitis (liver failure). The main questions it aims to answer are:* Mapping of infectious agents in patients with severe hepatitis (liver failure)* Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function. ### Conditions - Liver Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 4 weeks, including site of infection and pathogen of infection. - quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks Secondary Outcomes - Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 8 weeks, including site of infection and pathogen of infection. - Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 12 weeks, including site of infection and pathogen of infection. - qSOFA score at 8 weeks - qSOFA score at 12 weeks ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems - NCT ID: NCT06272058 - Study ID: 1366-0034 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-10-01 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2.Avenciguat (BI 685509) is a medicine that is being developed to treat high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether having liver problems influences how Avenciguat (BI 685509) is taken up in the body. All participants take Avenciguat (BI 685509) once as a tablet.Participants are in the study for slightly longer than 1 month. Following the screening period of about 4 weeks, they stay at the study site for 4 nights. Afterwards, there are 2 visits to the study site. The site staff measures the amount of Avenciguat (BI 685509) in the blood. The doctors also regularly check participants' health and take note of any unwanted effects. ### Conditions - Healthy - Liver Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Avenciguat (BI 685509) ### Outcomes Primary Outcomes - Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) - Maximum measured concentration of the analyte in plasma (Cmax) Secondary Outcomes - Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) - Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator ### Location - Facility: Orlando Clinical Research Center, Orlando, Florida, 32809, United States @@
## Early Intervention to Promote Cardiovascular Health of Mothers and Children - NCT ID: NCT06272045 - Study ID: IRB00398712 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-07 - Lead Sponsor: JHSPH Center for Clinical Trials ### Study Description Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors. ### Conditions - Cardiovascular Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Enriched home visiting - Routine home visiting ### Outcomes Primary Outcomes - Parent physical activity - Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale - Parent body mass index - Parent blood pressure Secondary Outcomes - Child body mass index ### Location - Facility: California Polytechnic Institute, San Luis Obispo, California, 93407, United States @@
## Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis - NCT ID: NCT06272032 - Study ID: 2023KFKT001 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-07-31 - Lead Sponsor: Chongqing Medical University ### Study Description Allergic rhinitis (AR) is a common condition, with nearly 300 million affected individuals in China, significantly impacting the quality of life. Despite standardized drug treatments, approximately 20% of AR patients experience inadequate control and require surgical intervention. AR manifests as nasal itching, sneezing, clear nasal discharge, nasal congestion, primarily associated with inflammation-induced hypertrophy of nasal turbinates and a heightened neurogenic state of the nasal mucosa. Surgical treatment focuses on "reducing hypertrophy" of nasal turbinates and "desensitizing" neurogenic hyperreactivity.High-intensity focused ultrasound (HIFU), as a minimally invasive therapeutic modality in AR, is still in its early stages of application and requires further multicenter clinical studies and widespread adoption. This project collaborates with six established institutions proficient in ultrasound treatment for AR. It aims to conduct a prospective multicenter observational study and subsequent dissemination, emphasizing the application of "reduction of hypertrophy" and "desensitization" in AR.Through standardized case selection, subjective and objective measures such as subjective symptom scores, quality of life assessments, nasal reflex, and nasal resistance tests before and after treatment will be employed to evaluate the effectiveness and safety of HIFU in "reducing hypertrophy" and "desensitizing" aspects of AR. Simultaneously, building on our established Otolaryngology Head and Neck Surgery Alliance and Southwest Allergy Alliance, the research results will be promoted through lectures, hands-on guidance, training sessions, academic conferences, and other means to facilitate the application of HIFU in AR and benefit a larger population of AR patients. ### Conditions - Allergic Rhinitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-intensity focused ultrasound (HIFU) - intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines ### Outcomes Primary Outcomes - Nasal Symptom Score - daily medication score Secondary Outcomes ### Location - Facility: Chongqing Medical University, Chongqing, Chongqing, N/A, China @@
## Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse - NCT ID: NCT06272019 - Study ID: HREC-DCU 2023-074 - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2024-04-20 - Lead Sponsor: Chulalongkorn University ### Study Description To compare the iodine remaining in saliva between gargle method and swab method ### Conditions - The Retention of Iodine in Saliva Over the Time - The Comparison of Iodine in Saliva Between Gargle and Swab ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Iodine gargle ### Outcomes Primary Outcomes - The rate of retention of iodine in saliva - The comparison of the retention of iodine between gargle and swab Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Chulalongkorn University, Bangkok, N/A, N/A, Thailand @@
## The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach - NCT ID: NCT06272006 - Study ID: Anatomical recession - Status: NOT_YET_RECRUITING - Start Date: 2024-02-24 - Completion Date: 2025-04-05 - Lead Sponsor: Hacettepe University ### Study Description The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are:Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments?The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate. ### Conditions - Gingival Recession ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Coronally Positioned Flap with Connective Tissue Graft - Modified Coronally Advanced Tunnel with Connective Tissue Graft ### Outcomes Primary Outcomes - Anatomical Recession Rate (ARR) Secondary Outcomes - Clinical Attachment Level (CAL) - Gingival Thickness (GT) - Keratinized Tissue Thickness (KTT) - Wound healing index (WHI) - Tissue appearance - Aesthetic evaluation - Dentin hypersensitivity ### Location - Facility: Hacettepe University, Ankara, N/A, 06100, Turkey @@
## SPT for Sensitization of Collagen Dressing - NCT ID: NCT06271993 - Study ID: 23-233 - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2024-03-15 - Lead Sponsor: Covalon Technologies Inc. ### Study Description The goal of this clinical trial is to determine the sensitization (contact allergy) potential of the test product ColActive Plus Collagen Matrix Dressing after a skin prick test on the skin of healthy human subjects. The main question it aims to answer is:• Does the product induce any sensitization (contact allergy) after a skin prick using a UniTest PC (pain control) device in healthy human subjects? Participants will have the test product and both positive and negative controls applied, and skin response will be evaluated by an allergist at 15 minutes, 6 hours, and 24-48 hours post-application to see if sensitization occurs. ### Conditions - Allergy Skin - Allergic Skin Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ColActivePlus Collagen Matrix Dressing ### Outcomes Primary Outcomes - Wheal measurement - Wheal measurement - Wheal measurement Secondary Outcomes ### Location - Facility: ALS Beauty and Personal Care, Torrance, California, 90501, United States @@
## Early-Onset Colorectal Cancer Recurrence - NCT ID: NCT06271980 - Study ID: 23228/ENCORE - Status: COMPLETED - Start Date: 2023-04-15 - Completion Date: 2024-02-01 - Lead Sponsor: City of Hope Medical Center ### Study Description Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance.This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid) ### Conditions - Colorectal Cancer Recurrent - Colorectal Cancer - Colorectal Neoplasms - Colorectal Adenocarcinoma - Colorectal Cancer Stage I - Colorectal Cancer Stage II - Colorectal Cancer Stage III ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ENCORE ### Outcomes Primary Outcomes - Recurrence Free Survival Secondary Outcomes - Overall Survival ### Location - Facility: City of Hope Medical Center, Duarte, California, 91010, United States @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06271967 - Study ID: ABT-CIP-10518 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Relationship Between Emotion Regulation and Psychiatric Disorder in Youth - NCT ID: NCT06271954 - Study ID: 202300096A3 - Status: RECRUITING - Start Date: 2023-03-27 - Completion Date: 2025-03-26 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description According to the increasing worldwide prevalence rate of psychiatric disorders in youth, the mental health of youth is becoming more and more important.Taiwan's Ministry of Health and Welfare reported the clibing suicide rate of youth in past five years and showed the prevention work and related intervention for youth's mental health was noteable. The definition of emotion regulation was "consists of the extrinsic and intrinsic processes responsible for monitoring, evaluating, and modifying emotional reactions, especially their intensive and temporal features, to accomplish one's goals." Emotion regulation strategies including "rumination", "avoidance", "suppression", "Problem-solving", "reappraisal", "acceptance", "social support", and "distraction".Previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. Carstensen proposed social emotion theory in 1995 Selectivity theory (SST) refers to the need for emotion regulation, which activates Social participation in late adulthood. SST assumes that young people are more interested in social interaction behaviors related to information seeking and building self-concept. characteristics of youth affected by many normative challenges such as adolescence, school transitions, and more complex social Landscape; Adaptive emotion regulation will reduce risk of clinical emotion attacks of illness, especially depression and anxiety.To explore the relationship between emotion regulation and mental health from a psychosocial developmental aspect, we focused on the interaction between individual and environment. Compared with the previous generation, most youths of this generation were participating in social activities and building up interpersonal relationships through the internet, suggesting the internet was an important social context. ### Conditions - Major Depressive Disorder - Anxiety Disorder - Attention Deficit Hyperactivity Disorder (ADHD) - Adjustment Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The Difference and Similarity in Emotional Regulation Strategy Patterns between Western and Eastern Countries. Secondary Outcomes ### Location - Facility: Chang-Geng Medical Foundation Chang-Geng Memorial Hospital, Keelung, N/A, 204, Taiwan @@
## Prophylactic Double Thermal Ablation and Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial - NCT ID: NCT06271941 - Study ID: HAPC-RCT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-04-01 - Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) ### Study Description Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. Recent studies have found that the use of hybrid argon plasma coagulation (h-APC) for the ablation of the margin and base of resection post-EMR could significantly reduce the recurrence rate, and complete closure of the post-EMR defect can prevent other adverse pre- and post-procedure outcomes such as bleeding.We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation post-EMR for large (≥20mm) colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation (STSC) margin ablation. We also hypothesize that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed. ### Conditions - Colorectal Cancer - Polyp of Colon ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Hybrid Argon Plasma Coagulation (h-APC) - Snare tip soft coagulation (STSC) ### Outcomes Primary Outcomes - To compare the recurrence rates after EMR colorectal between the h-APC and SSTC methods Secondary Outcomes - To assess the potential advantages associated with a complete defect closure ### Location - Facility: Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, N/A, Canada @@
## A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging - NCT ID: NCT06271928 - Study ID: TJ-IRB20220634-yijingkeli - Status: RECRUITING - Start Date: 2021-10-01 - Completion Date: 2025-01-01 - Lead Sponsor: Tongji Hospital ### Study Description Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA. ### Conditions - Ovarian Aging ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Yijing Keli ### Outcomes Primary Outcomes - the recovery rate of ovarian function Secondary Outcomes ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, N/A, N/A, China @@
## Role of Cervical Spine Mobilization on Lateral Epicondylitis - NCT ID: NCT06271915 - Study ID: cervical spine mobilization - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-06-15 - Lead Sponsor: Cairo University ### Study Description The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis. ### Conditions - Lateral Epicondylitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SNAGs - eccentric exercise ### Outcomes Primary Outcomes - Leeds assessment of neuropathic symptoms and sign (LANSS) scale - Pain-free hand grip test Secondary Outcomes - The Numeric Rating Scale (NRS) ### Location - Facility: Outpatient physical therapy, Faculty of physical therapy, Giza, N/A, 2334, Egypt @@
## Effects of the Singapore Youth Shoulder Overuse Injury Prevention Program Among Youth Volleyball Athletes in Singapore - NCT ID: NCT06271902 - Study ID: IRB-2023-531 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Nanyang Technological University ### Study Description The Singapore Youth Shoulder Overuse Injury Prevention Program (YoSO-IPP) includes an exercise segment and an education segment. This study will (1) assess the effects of the exercise segment, and (2) assess the effects of the education segment among youth volleyball athletes using a randomized controlled trial over 12 weeks. Performance outcome measures of shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion will be used to assess the effects of the exercise segment. Knowledge scores via an online questionnaire will be used to assess the effects of the education segment.Hypothesis: The YoSO-IPP will have an effect on shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion and on knowledge scores. ### Conditions - Sport Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Singapore Youth Shoulder Overuse Injury Prevention Program - Lower body stretching program ### Outcomes Primary Outcomes - Shoulder external rotation strength - Internal rotation range of motion - Thoracic rotation range of motion - Knowledge of overuse injuries Secondary Outcomes - Shoulder overuse injury prevalence - Elbow overuse injury prevalence - Shoulder overuse injury severity - Elbow overuse injury severity ### Location - Facility: Nanyang Technological University, Singapore, N/A, N/A, Singapore @@
## The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery - NCT ID: NCT06271889 - Study ID: B.10.1.TKH.4.34.H.GP.0.01/330 - Status: RECRUITING - Start Date: 2021-11-24 - Completion Date: 2024-11-20 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped; fetal heart sounds of pregnant women, anxiety, pain and the birth in order to determine the effect of connecting the end of the level will be conducted. The study will guide midwives in reducing the anxiety or pain of pregnant women. ### Conditions - Delivery Fear - Labor Pain - Maternal-Fetal Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Non-stress test ### Outcomes Primary Outcomes - VİSUAL ANALOG SCALE - STATUS AND CONTINUOUS ANXIETY SCALE Secondary Outcomes ### Location - Facility: Saglık Bilimleri Universitesi, Istanbul, N/A, N/A, Turkey @@
## Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength, Vertical Jump Performance and Muscle Oxygen Saturation - NCT ID: NCT06271876 - Study ID: 0011 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-03 - Completion Date: 2024-03-19 - Lead Sponsor: Sierra Varona SL ### Study Description Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and muscular strength in lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure and muscle tissue oxygen levels.According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence muscular strength, exercise capacity and muscle tissue oxygenation.In this study, subjects will be divided into three groups: experimental group , activation group and control group.Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and vertical jump performance, will be conducted. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inspiratory muscle training ### Outcomes Primary Outcomes - Respiratory muscle strength - Diaphragmatic thickness and thickening fraction - Diaphragm movement curve - Vertical jump performance Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Outcome of Conservative Management in Cases of Pre Mature Rupture of Membranes (PROM) Between 20 and 28 Weeks of Pregnancy in Sohag City Hospitals - NCT ID: NCT06271863 - Study ID: Soh-Med-23-11-08MS - Status: ENROLLING_BY_INVITATION - Start Date: 2023-06-01 - Completion Date: 2024-07-01 - Lead Sponsor: Sohag University ### Study Description Prospective observational study ### Conditions - PROM, Preterm (Pregnancy) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Conservation vs termination in cases of PROM 20 to 28 weeks of pregnancy Secondary Outcomes ### Location - Facility: Sohag university hospital, Sohag, N/A, N/A, Egypt @@
## Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women - NCT ID: NCT06271850 - Study ID: P.T.REC/012/004949 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-07-20 - Lead Sponsor: Cairo University ### Study Description Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head posture (FHP), ultimately contributing to physical disability over the long term.so, The purpose of this study is to determine the effect of Pilates exercises on FHP in breastfeeding women. ### Conditions - Breastfeeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ergonomics breastfeeding training - Pilates exercises ### Outcomes Primary Outcomes - Measurement of craniovertebral angle (CVA) - Assessment of neck pain intensity - Measurement of cervical range of motion Secondary Outcomes - Evaluation of disability due to neck pain - Assessment of neck muscle fatigue - Assessment of breastfeeding self-efficacy - Measurement of weight and height of baby - Assessment of Health-Related Quality of Life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors - NCT ID: NCT06271837 - Study ID: D781AC00001 - Status: RECRUITING - Start Date: 2024-02-18 - Completion Date: 2026-04-17 - Lead Sponsor: AstraZeneca ### Study Description This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressingsolid tumors which are not eligible for curative therapy. ### Conditions - Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Trastuzumab deruxtecan ### Outcomes Primary Outcomes - Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) Secondary Outcomes - Confirmed Objective Response Rate (ORR) by investigator assessment - Duration of Response (DoR) by Independent Central Review (ICR) - Duration of Response (DoR) by investigator assessment - Disease control rate (DCR) by Independent Central Review (ICR) - Disease control rate (DCR) by investigator assessment - Confirmed best objective response (BOR) by Independent Central Review (ICR) - Confirmed best objective response (BOR) by investigator assessment - Progression-free survival (PFS) by Independent Central Review (ICR) - Progression-free survival (PFS) by investigator assessment - Overall survival (OS) - Occurrence of adverse events (AEs) and serious adverse events (SAEs) - Pharmacokinetics (PK) of T-DXd - Immunogenicity of T-DXd ### Location - Facility: Research Site, Beijing, N/A, 100142, China @@
## Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities - NCT ID: NCT06271824 - Study ID: 23-1519 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2024-06 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are:1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience?Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session. ### Conditions - Stress - Caregiver Burden - Anxiety - Depressive Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Self-Compassion Based Resilient Caregiving Course ### Outcomes Primary Outcomes - Percentage of participants who withdraw from course - Percentage of participants who attend at least 4 of 6 intervention sessions - Percentage of participants who rate the course as "acceptable" or "completely acceptable" - Percentage of intervention topics covered Secondary Outcomes - Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks - Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks - Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks - Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks - Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks - Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks - Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks - Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale ### Location - Facility: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States @@
## Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome - NCT ID: NCT06271811 - Study ID: UJAPFPS - Status: COMPLETED - Start Date: 2023-01-09 - Completion Date: 2023-11-20 - Lead Sponsor: University of Jaén ### Study Description The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). The main questions it aims to answer are:* Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone?* What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group will undergo sessions where a flossing band is applied around the knee joint to provide moderate compression. Researchers will compare the two groups to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS. ### Conditions - Anterior Knee Pain Syndrome - Patellofemoral Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Flossing band - Conventional physiotherapy ### Outcomes Primary Outcomes - Disability related to patellofemoral pain - Knee extensor muscle strength - Pain report Secondary Outcomes - Self-reported function - Short Form-36 (SF-36) - Berg Balance Scale (BBS) - Pittsburgh Sleep Quality Index - Brief Pain Questionnaire - Perceived Stress Scale ### Location - Facility: University of Jaen, Jaen, N/A, 23009, Spain @@
## Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women - NCT ID: NCT06271798 - Study ID: P.T.REC/012/004867 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-04-19 - Lead Sponsor: Cairo University ### Study Description The purpose of this study will be to determine the effect of resistive exercises on varicose veins in postmenopausal women, the effect of aerobic exercise on varicose veins in postmenopausal women and to compare between the effect of resistive exercise versus aerobic exercise on varicose veins in post menopausal women. ### Conditions - Varicose Veins ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Life style modification advice - Resistive exercise - Aerobic exercises ### Outcomes Primary Outcomes - Peak popliteal vein velocity Secondary Outcomes - Visual analogue scale - Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) - 6-minute. walk test ### Location - Facility: Cairo University, Giza, N/A, N/A, Egypt @@
## Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery - NCT ID: NCT06271785 - Study ID: 49RC22_0354 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-01 - Lead Sponsor: University Hospital, Angers ### Study Description This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.Electrical sources are then fused on structural magnetic resonance imaging (MRI).Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure. ### Conditions - Epilepsy in Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HR-EEG recording ### Outcomes Primary Outcomes - Prediction accuracy index Secondary Outcomes - Localization of the epileptogenic zone (Baseline) - Localization of the epileptogenic zone (After Surgery) - preoperative accuracy of epileptogenic source localization - prognostic value of HFO - Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate - health-economic modeling ### Location - Facility: Angers university hospital, Pédiatric department, Angers, N/A, 49000, France @@
## Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II - NCT ID: NCT06271772 - Study ID: 18-26045-RII - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-07-31 - Lead Sponsor: University of California, San Francisco ### Study Description Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:* Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT* Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT ### Conditions - Bacterial Keratitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Difluprednate Ophthalmic - Rose Bengal - Moxifloxacin Ophthalmic ### Outcomes Primary Outcomes - Best Spectacle-Corrected Visual Acuity Secondary Outcomes - Best Spectacle-Corrected Visual Acuity - Scar size - Scar depth - Adverse Events ### Location - Facility: Federal University of São Paulo, São Paulo, N/A, N/A, Brazil @@
## Psychological Effects of a Set of Functional Fragrances - NCT ID: NCT06271759 - Study ID: PSYFRAG - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-08-15 - Lead Sponsor: University of Bucharest ### Study Description The goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. The main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being.Participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart. ### Conditions - Stress - Anxiety - Well-Being, Psychological - Mood ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Fragrance inhalation ### Outcomes Primary Outcomes - Affective states - relaxation - Affective states - contentment - Affective states - happiness - Affective states - stress - Affective states - motivation - Affective states - tension - Emotional changes Secondary Outcomes - General mental health - Depression - General mental health - Anxiety - General mental health - Stress ### Location - Facility: University of Bucharest, Bucharest, N/A, 050663, Romania @@
## Treatment of Fibromyalgia With the FibroNova Neuromodulation Device - NCT ID: NCT06271746 - Study ID: TCH101 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-06-01 - Lead Sponsor: Theranica ### Study Description Fibromyalgia (FM) is a chronic disorder that affects the musculoskeletal system, causing widespread pain, tenderness, and fatigue. It is estimated to affect 1-5% of the population. The primary symptom of fibromyalgia is widespread pain throughout the body, accompanied by tenderness and sensitivity to pressure.Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers. Another treatment option for fibromyalgia is the use of devices such as Quell. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniques.Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents, as well as migraine prevention.The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms. ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FibroNova (Active mode) - FibroNova (Sham mode) ### Outcomes Primary Outcomes - Mean reduction in pain level during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4) - Device safety (rate of adverse events and device related adverse events) Secondary Outcomes - Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score - Mean change in FIQR functionality sub-scale score - Mean change in FIQR pain item score - Mean change in Brief Pain Inventory (BPI) score - Improvement in patient global impression according to PGIC score - Mean reduction in functional disability during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4) ### Location - Facility: Clinical Research Professionals, Chesterfield, Missouri, 63005, United States @@