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## Health Benefits of Writing Therapy Among Asian American Cancer Survivors - NCT ID: NCT06367959 - Study ID: 2021-0324 - Status: RECRUITING - Start Date: 2023-07-27 - Completion Date: 2026-08-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Esays - Questionnaires ### Outcomes Primary Outcomes - Primary Outcome Measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Mechanism Study of Ventilator-Induced Lung Injury in Elderly People. - NCT ID: NCT06367946 - Study ID: XH-24-0093 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2027-06-30 - Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description 1. We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age.2. We collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation. ### Conditions - Ventilator-Induced Lung Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - mechanical ventilation ### Outcomes Primary Outcomes - KLK8 concentration of lung tissue - Endothelial/epithelial damage index concentration in peripheral blood Secondary Outcomes ### Location - Facility: Shanghai Xinhua hospital, Shanghai, N/A, 200000, China @@
## Mini-invasive Spine Surgery for Neuromuscolar Scoliosis - NCT ID: NCT06367933 - Study ID: MISNM - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves. ### Conditions - Neuromuscular Scoliosis - Spine Deformity - Surgery - Vertebral Fusion ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - mini-invasive spine surgery ### Outcomes Primary Outcomes - Visual Analogue Scale - Visual Analogue Scale - Spine Correction - Spine Correction Secondary Outcomes ### Location - Facility: Istituto Ortopedico Rizzoli, Bologna, N/A, 40136, Italy @@
## Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development - NCT ID: NCT06367920 - Study ID: 2022-02-005 - Status: RECRUITING - Start Date: 2023-03-23 - Completion Date: 2024-12-31 - Lead Sponsor: Bundang CHA Hospital ### Study Description Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders ### Conditions - Pediatric ALL - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnetic Resonance Imaging, Behavioral assessments ### Outcomes Primary Outcomes - Brain magnetic resonance imaging Secondary Outcomes - Medical records ### Location - Facility: CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do, 463-712, Korea, Republic of @@
## Biological Effects of Schema Therapy - NCT ID: NCT06367907 - Study ID: SM 68/6-1 - Status: RECRUITING - Start Date: 2021-09-09 - Completion Date: 2025-06 - Lead Sponsor: Jena University Hospital ### Study Description Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared.Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed.The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations. ### Conditions - Personality Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - schema therapy ### Outcomes Primary Outcomes - Changes in emotion regulation capabilities Secondary Outcomes - Improvement of BPD specific symptomatology - Change of personality traits - Changes of the intensity of early maladaptive schemas. - Changes of the intensity of schema modes. ### Location - Facility: University Hospital Jena, Jena, N/A, 07743, Germany @@
## Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care - NCT ID: NCT06367894 - Study ID: STONECARE - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2024-12-31 - Lead Sponsor: Agnieszka Pozdzik ### Study Description Nearly 10% of the Belgian population suffer from kidney stone disease. Recent reviews reported that kidney stones represent an underestimated risk factor for further kidney function deterioration. Preventive measures are recommended in lithiases patients to prevent the formation of new stones. The individual effects of different medicated prosthetic interventions have been documented in clinical trials. However, there is little data on the effectiveness of combining these different preventive measures in routine clinical practice (real-world context).Patients with kidney stone disease require a complete metabolic assessment. The three main factors contributing to the stone's formation are the patient's metabolism, diet and lifestyle. Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hyperuricuria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes at minimum the 24h urine test, a blood test and spot urine test. Dietary habits and lifestyle are assessed by means of a questionnaire.The CHU Brugmann Hospital has a specialized multidisciplinary clinic for renal lithiases and mineral metabolism. Preventive personalized and interdisciplinary care in CHU Brugmann consists of a full metabolic work-up allowing the identification of lithogenic risk factors by nephrologists, dietary assessment by specialized dieticians and specific treatment protocol associated with regular follow-up.The aim of this study is to evaluate, in the context of a retrospective single-center cohort study, the effect of preventive personalized and interdisciplinary care on the evolution of all urinary lithogenic risk factors and the recurrence of kidney stones (rate of renal colics, emergency room admissions, and urological interventions). ### Conditions - Kidney Stone ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of acute renal colics - Number of emergency admissions - Number of surgeries - Number of hospitalizations - Identified genetics abnormalities - Wisconsin questionnaire - Kidney function outcome Secondary Outcomes ### Location - Facility: CHU Brugmann, Brussels, N/A, 1020, Belgium @@
## Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS - NCT ID: NCT06367881 - Study ID: MD 185/ 2022 - Status: RECRUITING - Start Date: 2022-08-18 - Completion Date: 2024-10 - Lead Sponsor: Ain Shams University ### Study Description An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide. ### Conditions - Neonatal Respiratory Distress Syndrome - Inflammatory Response - Premature Lungs - Neutrophil Extracellular Trap Formation - Preterm Birth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alveofact - Budesonide ### Outcomes Primary Outcomes - Assessment of Neutrophil Extracellular Trap (NET) Secondary Outcomes - comparison of Alveolar with whole blood NET formation - Clinical out come - Assessment of Reactive Oxygen Species (ROS) - oxygen needs - Hospital stay ### Location - Facility: Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517, Cairo, N/A, N/A, Egypt @@
## Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring - NCT ID: NCT06367868 - Study ID: E-83045809-604.01.02-179951 - Status: COMPLETED - Start Date: 2021-09-09 - Completion Date: 2022-12-01 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP. ### Conditions - ICP (Intracranial Pressure) Increase - Optic Nerve Sheath Diameter - Intracranial Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - After 5 ml CSF Drainage ### Outcomes Primary Outcomes - Intracranial Pressure-1 (ICP-1) - Optic Nerve Sheath Diameter-1 (ONSD-1) Secondary Outcomes - Intracranial Pressure-2 (ICP-2) - Optic Nerve Sheath Diameter-2 (ONSD-2) ### Location - Facility: Istanbul University-Cerrahpasa, Istanbul, Fatıh, 34098, Turkey @@
## Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial - NCT ID: NCT06367855 - Study ID: KSKC20222025 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-31 - Lead Sponsor: Potsawat Surabotsopon ### Study Description Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes. ### Conditions - Spinal Stenosis Lumbar - Disc Degeneration - Disc Disease - Fusion of Spine - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexamethasone - Normal saline ### Outcomes Primary Outcomes - effectiveness of dexamethasone Secondary Outcomes - Morphine consumption - Complication - Fusion rate - Length of hospital stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO) - NCT ID: NCT06367842 - Study ID: MED-02-2023 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-09 - Lead Sponsor: Institut Mutualiste Montsouris ### Study Description The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:1. What is the frequency of ATTR deposits in samples retrieved during surgery?2. What is the frequency of cardiac involvement in ATTR positive patients?3. What are the preoperative predictors of ATTR deposits? Participants will * have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples, * undergo a multimodal imaging search for cardiac involvement, if ATTR is identified, * undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis) * ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement.Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries ### Conditions - ATTR Amyloidosis - Cardiopathy - Carpal Tunnel Syndrome - Lumbar Spine Stenosis - Hip Prosthesis - Knee Prosthesis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - frequency of ATTR amyloidosis Secondary Outcomes - presence of ATTR cardiopathy - proportion of wild type and hereditary ATTR - Description of preoperative predictors of ATTR - Description of preoperative predictors of ATTR - preoperative predictors of ATTR ### Location - Facility: Mutualist Montsouris Institute, Paris, N/A, 75014, France @@
## Lubinus SPII Hip Stem Target Trial Emulation (LARGE) - NCT ID: NCT06367829 - Study ID: WO.24.025 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-08 - Completion Date: 2025-01-08 - Lead Sponsor: JointResearch ### Study Description The research questions this study aims to answer are as follows:Primary research question:"Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?"Secondary aims include:* How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques?* Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures?To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis. ### Conditions - Treatment Outcome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lubinus SPII hip stem 130mm - Lubinus SPII hip stem 150mm ### Outcomes Primary Outcomes - Mortality rate - Revision rate Secondary Outcomes - NRS pain score - Oxford hip score - EQ - 5D - HOOS - PS - Revision rate - Mortality rate ### Location - Facility: OLVG, Amsterdam, Noord Holland, 1090 HM, Netherlands @@
## Brain Recovery With Automated VEntilation - NCT ID: NCT06367816 - Study ID: 13509 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-12-31 - Lead Sponsor: University of Genova ### Study Description Thus far, the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ARDS), patients with ARDS, and patients with chronic obstructive pulmonary disease (COPD). Some of these studies included acute brain injury (ABI) patients, but the effectiveness, efficacy and safety of INTELLiVENT-ASV has never been thoroughly tested in these patients. The current study will investigate the effectiveness in providing both brain- and lung protective ventilation, the safety and the efficacy of a closed-loop ventilation mode (INTELLiVENT-ASV) in acute brain injury patients, using breath-by-breath data. ### Conditions - Brain Injuries, Acute - Respiration, Artificial - Automation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - INTELLiVENT - Conventional ventilation ### Outcomes Primary Outcomes - Proportion of breaths in predefined zones of ventilation - Proportion of time in predefined zones of ventilation Secondary Outcomes - Intracerebral changes assessed by multimodal neuromonitoring available - Changes on Electrical Impedence Tomography when available - Effectiveness in primary ABI patients vs non primary ABI patients - Episodes and time of high maximum airway pressure - Episodes and time of high respiratory rate - Incidence of severe hypoxemia - Incidence of severe hypercapnia - Discontinuation of ventilatory mode (yes or no) - Percentage of breaths in the predefined 'critical' ventilation zone - Incidence of pneumothorax - Efficacy on glascow coma scale - Duration of ventilation in survivors - Ventilator free days - Intensive care unit length of stay - Hospital length of stay - 28-day mortality - 90-day mortality - Number of alarms - Number of manual adjustments ### Location - Facility: UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino, Genova, GE, 16132, Italy @@
## Cost Analysis of Vascular Surgical Techniques - NCT ID: NCT06367803 - Study ID: DVS010 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-03-01 - Lead Sponsor: University Hospital of Limerick ### Study Description Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available. ### Conditions - Critical Limb Ischemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation. Secondary Outcomes ### Location - Facility: University Hospital Limerick, Limerick, Munster, N/A, Ireland @@
## Plyometry and Tapping in the Functional Improvement of Non-professional Basketball Players - NCT ID: NCT06367790 - Study ID: Bask-Pliomet - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-07-01 - Lead Sponsor: Universidad Católica San Antonio de Murcia ### Study Description Introduction. In basketball, the lower extremities have the highest prevalence of injury, regardless of gender and professional category.Objective. To analyse the efficacy of a physiotherapy intervention using a protocol of plyometric exercises and dry needling in non-professional basketball athletes.Methods. Randomised clinical study. 20 players will be randomised to an experimental group (plyometric exercises and dry needling of the gastrocnemius muscles) and a control group (plyometric exercises). The intervention will include 8 sessions over 4 weeks. The study variables will be: range of motion in dorsal flexion in loading (Leg Motion®) and unloading (goniometer) and vertical jump (MyJump2®).Expected results. An intervention of plyometric exercises and dry needling produces significant differences in range of motion and vertical jump in basketball players, compared to the isolated administration of plyometric exercises. ### Conditions - Basketball Players ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Experimental group - Control group ### Outcomes Primary Outcomes - Change from baseline range of motion in loaded dorsal flexion after treatment and at 4 weeks Secondary Outcomes - Change from baseline range of motion in unloaded dorsal flexion after treatment and at 4 weeks - Change from baseline vertical jump after treatment and at 4 weeks ### Location - Facility: Rubén Cuesta-Barriuso, Oviedo, Asturias, 33006, Spain @@
## Cervical/Thoracic Neuromodulation and Nociceptive Processing - NCT ID: NCT06367777 - Study ID: 2024/14MAR/132 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-10 - Lead Sponsor: Université Catholique de Louvain ### Study Description Several studies have demonstrated that direct currents delivered through the skin at the level of the low-thoracic spinal cord can influence spinal cord function. In human volunteers, anodal low-thoracic transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known. In this double-blinded, sham-controlled and cross-over trial, the investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS. ### Conditions - Nociceptive Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - cervical a-tsDCS - thoracic a-tsDCS - sham tsDCS ### Outcomes Primary Outcomes - Change in contact-heat evoked potentials amplitude Secondary Outcomes - Change in intensity of perception to contact-heat nociceptive stimuli - Change in skin temperature - Change in cutaneous blood flow ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations - NCT ID: NCT06367764 - Study ID: BPS-2022C3-30535 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-06 - Lead Sponsor: University of California, San Francisco ### Study Description The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are:* Do these treatments reduce PTSD symptoms in LGBTQIA+ patients?* Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients?* Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms?* Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community?* Do LGBTQIA+ patients complete these treatments?Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment. ### Conditions - PTSD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Processing Therapy - STAIR Narrative Therapy ### Outcomes Primary Outcomes - Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) Secondary Outcomes - Change in Depression Measured by Patient Health Questionnaire (PHQ-9) - Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales - Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) - Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions ### Location - Facility: UCSF Alliance Health Project, San Francisco, California, 94103, United States @@
## Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT) - NCT ID: NCT06367751 - Study ID: 2024-00358; th23Kasenda - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-10 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel.Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091).Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ctDNA measurement ### Outcomes Primary Outcomes - Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment - Patients in whom actionable alterations were identified in ctDNA analysis - Turn-around time of ctDNA analysis - ctDNA kinetics Secondary Outcomes - Number of ctDNA testing results that were successfully made available to the molecular tumor board - Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential - Quality of life and physical function - Overall survival - Survival rate 6 months - Survival rate 12 months - Time to next treatment line - Unplanned hospital admissions and emergency room visits - Progression free survival - Number of ctDNA analyses with a valid result ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults - NCT ID: NCT06367738 - Study ID: 2024-11-14799 - Status: NOT_YET_RECRUITING - Start Date: 2025-04-01 - Completion Date: 2027-12-30 - Lead Sponsor: University of California, Berkeley ### Study Description We will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. We will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. We will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect. ### Conditions - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Psilocybin ### Outcomes Primary Outcomes - MRI measurements of brain structure Secondary Outcomes - Amplitude and pattern of fMRI cortical responses - Peripheral psychophysiology - Perceptual measurements - Cognitive measurements ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density - NCT ID: NCT06367725 - Study ID: 1-10-72-122-23 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2030-12-30 - Lead Sponsor: University of Aarhus ### Study Description The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:* How does the intake of dexamethasone correlate with systemic exposure to dexamethason?* Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?Participants will:* Continue to receive the best available therapy for ALL in Western Europe.* Have blood samples taken from their central line to measure dexamethasone levels.* When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.* Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels. ### Conditions - Acute Lymphoblastic Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Area Under the Plasma Concentration Curve (AUC) of Dexamethasone Secondary Outcomes - Mineral bone density by DXA-scan - Vertebral fracture assessment (VFA) by DXA-scan - Dexamethasone in cerebrospinal fluid ### Location - Facility: Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, København Ø, 2100, Denmark @@
## Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol - NCT ID: NCT06367712 - Study ID: Ahmed Kassab - Status: COMPLETED - Start Date: 2022-11-10 - Completion Date: 2023-11-10 - Lead Sponsor: Egymedicalpedia ### Study Description Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor.Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure ### Conditions - PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Letrozole tablets ### Outcomes Primary Outcomes - Pregnancy test Secondary Outcomes ### Location - Facility: Ahmed Maher Teaching Hospital, Cairo, N/A, N/A, Egypt @@
## Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care (ECA-HPV) Clinical Trial - NCT ID: NCT06367699 - Study ID: H-44821 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-12 - Lead Sponsor: Tufts Medical Center ### Study Description The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors. ### Conditions - Human Papilloma Virus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Usual Care - ECA-HPV App with Clinic Notification and Adolescent Functions Disabled - ECA-HPV App with Clinic Notification Function Enabled - ECA-HPV App with Adolescent Function Enabled - ECA-HPV App with Clinic Notification and Adolescent Functions Enabled ### Outcomes Primary Outcomes - HPV vaccination series completion comparing the control group to the intervention groups - HPV vaccination series completion comparing the intervention groups Secondary Outcomes - HPV Knowledge - HPV Attitudes - General Vaccine Attitudes - ECA-HPV App Satisfaction - Clinic Notification Feature Satisfaction ### Location - Facility: Boston Medical Center, Boston, Massachusetts, 02118, United States @@
## Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor - NCT ID: NCT06367686 - Study ID: REK KULMU B 714179 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: The Hospital of Vestfold ### Study Description The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values. ### Conditions - Hypercapnic Respiratory Failure - Pulmonary Disease, Chronic Obstructive - Neuromuscular Diseases - Obesity Hypoventilation Syndrome (OHS) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - IscAlert sensor ### Outcomes Primary Outcomes - Partial pressure (level) of carbon dioxide at the nasal mucosa Secondary Outcomes - Bleeding - Infection - Sinusitis - Ulceration - Pain at sensor insertion site ### Location - Facility: Vestfold Hopsital Trust, Tønsberg, N/A, 3103, Norway @@
## Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia - NCT ID: NCT06367673 - Study ID: QH-ZYDC-01 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-08-31 - Lead Sponsor: Zhejiang University ### Study Description This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML ### Conditions - AML, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - iPSC-NK cells ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events Secondary Outcomes ### Location - Facility: the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 321000, China @@
## Comparison Between Hyperbaric Bupivacaine With Fentanyl vs. Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia - NCT ID: NCT06367660 - Study ID: 98-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine. ### Study Description In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale ### Conditions - Visceral Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine ### Outcomes Primary Outcomes - Primary outcome Secondary Outcomes - Secondary Outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigation on the Detection Rate of Pathogenic Viruses in Feces of Parenteral Infected Individuals - NCT ID: NCT06367647 - Study ID: zhujiangjy-20240229 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-31 - Lead Sponsor: Zhujiang Hospital ### Study Description This project is a cross-sectional study. Investigators plan to search and collect 1600 publicly published fecal metagenomic and metatranscriptome data through the Pubmed database, by summarizing and analyzing them to construct an enterovirus database. 200 apparently healthy individuals are planned to be enrolled. At the time of enrollment, fecal specimens of participants will be collected, and their demographic characteristics, disease and medication history, gastrointestinal status, dietary habits, lifestyle habits, and mental health information will be recorded. Another 200 specimens will be collected from patients with parenteral virus infection. The demographic characteristics and pathogen test results of the parenteral virus infected patients will be reviewed and recorded. By virus metagenomic sequencing on fecal specimens, investigators will identify which viruses can be detected in the intestinal tract of apparently healthy people, and to explore whether parenteral infection viruses can be detected in feces. ### Conditions - Virus Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - virus infection checklist Secondary Outcomes - general information of apparently healthy individuals by questionnaire - Self-Rating Anxiety Scale SAS - Self-rating depression scale SDS - Pittsburgh sleep quality index PSQI - demographic characteristics case information of parenteral virus infected patients ### Location - Facility: Zhujiang hospital of southern medical university, Guangzhou, Guangdong, 510280, China @@
## TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults - NCT ID: NCT06367634 - Study ID: TEO-TSUL-2301 - Status: RECRUITING - Start Date: 2024-01-19 - Completion Date: 2026-02 - Lead Sponsor: Teoxane SA ### Study Description This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable. ### Conditions - Nasolabial Folds ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - injection in NLF ### Outcomes Primary Outcomes - WSRS grading Secondary Outcomes ### Location - Facility: Guangdong Second Provincial General Hospital, Guangzhou, N/A, N/A, China @@
## Retrospective Study of iStatis Syphilis Ab Test (POC) - NCT ID: NCT06367621 - Study ID: CLS-015C - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-04-15 - Lead Sponsor: bioLytical Laboratories ### Study Description The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification. ### Conditions - Syphilis - Syphilis Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - iStatis Syphilis Antibody Test ### Outcomes Primary Outcomes - Sensitivity and specificity of the iStatis Syphilis Ab Test Secondary Outcomes ### Location - Facility: Epicentre Health Research, Hillcrest, KwaZulu Natal, 3650, South Africa @@
## MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD) - NCT ID: NCT06367608 - Study ID: HP-00104695 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-06 - Lead Sponsor: University of Maryland, Baltimore ### Study Description The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a type of dystonia that affects hand movements during specific tasks such as writing, playing instruments or typing, often causing involuntarily movements or cramping. ### Conditions - Task-Specific Focal Dystonia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - ExAblate Transcranial treatment ### Outcomes Primary Outcomes - Incidence of Treatment related adverse events Secondary Outcomes - Change in dystonia intensity - Change in patient's perception of quality of life - Change in patient's perception of the effect of the procedure ### Location - Facility: University of Maryland Medical Center, Baltimore, Maryland, 21201, United States @@
## Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy - NCT ID: NCT06367595 - Study ID: Intrathecal MgSO4 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-11 - Lead Sponsor: Assiut University ### Study Description The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications. ### Conditions - Abdominal Hysterectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Magnesium sulfate ### Outcomes Primary Outcomes - effect on postoperative pain after abdominal hysterectomy using visual analog score Secondary Outcomes - sedation by Ramsay sedation scale - time of the first opioid request - Mean arterial blood pressures (MAP) - Heart rate (HR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SPINE BONE CEMENTS OUTCOMES - NCT ID: NCT06367582 - Study ID: CV01-TK-SPINE - Status: RECRUITING - Start Date: 2019-09-04 - Completion Date: 2039-09-30 - Lead Sponsor: Teknimed ### Study Description A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites. ### Conditions - Vertebral Fracture - Compression Fracture - Osteoporotic Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vertebroplasty (VP) - Kyphoplasty (KP) - Pedicular Screw Augmentation (PSA) ### Outcomes Primary Outcomes - Alleviation of Pain Secondary Outcomes - Restoration of quality of life - Patient satisfaction - Stabilization of vertebrae - Adverse events - Antalgic Consumption ### Location - Facility: CHU HautePierre, Strasbourg, Bas-Rhin, 67200, France @@
## Evaluation of MRI of the Pineal Gland in Retinoblastoma - NCT ID: NCT06367569 - Study ID: 2012//375 - Status: COMPLETED - Start Date: 2012-10-01 - Completion Date: 2023-09-01 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description Rationale: Currently baseline brain MRI (magnetic resonance imaging) with extended follow-up of pineal cysts is systematically performed in all new retinoblastoma (Rb) patients, because children with hereditary retinoblastoma have an increased risk of primitive neuroectodermal tumors (PNET) that are histopathologically identical to the retinal tumors (1). The prevalence of developing a PNET in combination with unilateral or bilateral hereditary Rb is 5-15% (2). Treatment is difficult and the prognosis is poor as only few survivors are reported. Only patients with small asymptomatic PNETs (\<15 mm) are potentially curable.Objective: The main objective of this prospective multicenter study is to evaluate the current strategy of baseline MRI screening of the brain in newly diagnosed retinoblastoma patients, with extended follow-up of selected patients with simple and complicated pineal cysts.Study design: The investigators propose a prospective cohort study (part of a larger multicenter study) to investigate the diagnostic accuracy and survival of baseline MRI screening of the pineal gland in new patients with retinoblastoma, with extended follow-up of selected patients with pineal cysts for early detection of pineoblastoma.Study population: Within the European Retinoblastoma Imaging Collaboration (ERIC) about 150 new retinoblastoma patients are diagnosed every year. About 10 percent of all new retinoblastoma patients will be diagnosed at the VUmc. According to our sample size calculations the investigators will need 334 Rb patients.Main study parameters/endpoints: The primary endpoint of the study is pineoblastoma or supra- / parasellar PNET on MRI (index test). Because a gold standard will not be available, tumor cells in cerebrospinal fluid, histopathological confirmation, clinical disease progression during follow-up, and/or follow-up MRI diagnostics will be used as a composite reference standard in case of a positive index test and clinical diagnosis of pineoblastoma or supra- / parasellar PNET within one year of the last MRI will be used as a composite reference standard in case of a negative index test. ### Conditions - Retinoblastoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Screening for trilateral retinoblastoma with MRI ### Outcomes Primary Outcomes - Diagnostic accuracy of the screening Secondary Outcomes - Survival analysis of trilateral retinoblastoma patients ### Location - Facility: VU University Medical Center, Amsterdam, Noord-Holland, 1081 HV, Netherlands @@
## Emotion and Symptom-Focused Engagement (EASE) for Caregivers - NCT ID: NCT06367556 - Study ID: 4542 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-10-01 - Lead Sponsor: University Health Network, Toronto ### Study Description The goal of this two-site phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:- Does EASE reduce traumatic stress symptom severity (primary outcome)?To do so, researchers will compare parents receiving EASE to usual care. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience. ### Conditions - Trauma and Stressor Related Disorders - Pediatric Cancer - Caregiver Burden ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - EASE ### Outcomes Primary Outcomes - Posttraumatic Stress Disorder Checklist for DSM-5 [PCL-5] Secondary Outcomes - SF-36v2 Health Survey - Patient Health Questionnaire [PHQ-9] - Caregiving Health Engagement Scale [CHE-s] - Family Adaptability and Cohesion Evaluation Scales III [FACES-III] - Clinical Evaluation Questionnaire [CEQ] - Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10] ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients - NCT ID: NCT06367543 - Study ID: AZ 117/22 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-11-30 - Completion Date: 2024-12-31 - Lead Sponsor: University of Giessen ### Study Description The aim of the planned study project is to assess the current situation regarding the treatment of patients with severe stroke at the neuro-critical care unit. Specifically, determination of whether the target parameters recommended in the guidelines for temperature, systolic blood pressure, mean arterial blood pressure, blood glucose, arterial oxygen partial pressure and arterial carbon dioxide partial pressure had to be maintained. From the planned data analysis, the need for the introduction of cerebrovascular bundles can be derived and planned. ### Conditions - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Time in therapeutic range of vital parameters ### Outcomes Primary Outcomes - Time in Therapy range Secondary Outcomes - Acute measures - Invasive measures performed in the course of the Stay - Duration of ventilation - Deceased on Intensive Care. - NIHSS (National Institutes of Health Stroke Scale). ### Location - Facility: Universitätsklinikum Gießen, Gießen, Hessen, 35392, Germany @@
## Trilateral Retinoblastoma: Incidence and Outcomes - NCT ID: NCT06367530 - Study ID: GS-TRIO-2024 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2029-12-31 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description Patients with heritable retinoblastoma are at risk to develop an intracranial brain tumor, which is often fatal. The investigators intend to look at the incidence and survival of trilateral retinoblastoma (which is a brain tumor that can either be located in the pineal gland or elsewhere in the brain) in retinoblastoma patients globally. All retinoblastoma patients from participating centers will be included. The investigators hypothesize that the apparent incidence of trilateral retinoblastoma (especially the usually later diagnosed pineal trilateral retinoblastoma) in low-income countries will be lower because of low chances of surviving the ocular tumors at about 50% and also because of possible under-diagnosis. Therefore, as retinoblastoma care improves in low-income countries the incidence of (pineal) trilateral retinoblastoma might go up. Knowledge about incidence and survival can help improve health practices in parts of the world where this might be needed. Therefore this global study firstly aims 1) to evaluate survival after trilateral retinoblastoma and factors influencing survival and 2) to evaluate incidence of trilateral retinoblastoma by country income level. The study will run from 2024 through 2027. ### Conditions - Trilateral Retinoblastoma - Retinoblastoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Incidence and survival of trilateral retinoblastoma and the differences globally ### Outcomes Primary Outcomes - Number of participants (retinoblastoma patients) that will be diagnosed with trilateral retinoblastoma (incidence) - Overall and event-free survival after being diagnosed with trilateral retinoblastoma Secondary Outcomes ### Location - Facility: Amsterdam UMC, Amsterdam, Noord-Holland, 1082HV, Netherlands @@
## Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease) - NCT ID: NCT06367517 - Study ID: KB/114/2022 - Status: RECRUITING - Start Date: 2021-05-20 - Completion Date: 2026-05-20 - Lead Sponsor: Medical University of Warsaw ### Study Description The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease. ### Conditions - Orbitopathy, Graves - Thyroid Eye Disease - Ophthalmopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tocilizumab ### Outcomes Primary Outcomes - Disease improvement - Improvement of quality of life Secondary Outcomes - Disease inactivation - Proportion of patients achieving response in specific GO signs and symptoms - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 - Decrease in concentration of thyrotropin receptor antibodies - Decrease in levels of proinflammatory cytokines - Number of the rehabilitative surgeries performed after immunosuppressive therapy - The rate of disease relapse - Decrease in proptosis by at least 2 mm assessed using magnetic resonance imaging (MRI) ### Location - Facility: Department of Internal Medicine and Endocrinology, Medical University of Warsaw, Warsaw, N/A, 02-097, Poland @@
## A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection - NCT ID: NCT06367504 - Study ID: DB/230904/DBMF/CDI - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-30 - Lead Sponsor: Vedic Lifesciences Pvt. Ltd. ### Study Description A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI) ### Conditions - Clostridium Difficile Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - DBMF - Placebo ### Outcomes Primary Outcomes - To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo. Secondary Outcomes - To assess the impact of the Investigational product on Number of CDI diarrhea episodes presence of Clostridium difficile in stool samples as assessed by C. difficile toxins A & B - CARD. - To assess the impact of the Investigational product on Change in the frequency of watery stools from Bristol Stool Form Scale (BSFS) score type 7 as compared to placebo. - To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo - To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo. - To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo. ### Location - Facility: AIMS Hospital, Dombivali, Maharashtra, 421203, India @@
## National Database of Bone Metastases - NCT ID: NCT06367491 - Study ID: IRST100.12 - Status: RECRUITING - Start Date: 2013-10-08 - Completion Date: 2030-01-01 - Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ### Study Description BDMO is an Italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection. ### Conditions - Bone Metastases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Registration in a database ### Outcomes Primary Outcomes - The establishment of a National Bone Metastasis Database at the IRCCS IRST Secondary Outcomes - Evaluation of clinical factors related to the primary tumor and metastases - Evaluation of clinical factors related to the primary tumor and metastases - Evaluation of clinical factors related to the primary tumor and metastases - Impact of treatment on skeletal events (SRE) - Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE) - Evaluation of biological factors related to the primary tumour and metastases ### Location - Facility: A.U.S.L. Imola, Imola, Bologna, N/A, Italy @@
## Evaluation of Nerve Conduction Study - NCT ID: NCT06367478 - Study ID: SPEMG - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-08-01 - Completion Date: 2024-10-22 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description the investigators study different modality to obtain nerve evoked reponses. They use different parameters of acquisition and stimulation and they compare amplitude and latency of nerve conduction response ### Conditions - Nerve Condition - Health, Subjective ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - best amplitude of nerve conduction study Secondary Outcomes ### Location - Facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan, Milan, N/A, 20122, Italy @@
## Feasibility and Acceptability of HCV Treatment in Pregnancy - NCT ID: NCT06367465 - Study ID: 202308056 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-02-28 - Lead Sponsor: Washington University School of Medicine ### Study Description Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug useParticipant Duration: Approximately 1 year.Aims:Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy. ### Conditions - Hepatitis C - Pregnancy Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Glecaprevir-pibrentasvir ### Outcomes Primary Outcomes - Medication adherence and treatment completion rates. Secondary Outcomes - Patient satisfaction Questionnaire - Virologic outcome and clinical success at Day 28 post treatment - Sample size estimation for future study ### Location - Facility: Barnes Jewish Hospital, Saint Louis, Missouri, 63110, United States @@
## Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate - NCT ID: NCT06367452 - Study ID: CAEP 107.001.23 - Status: COMPLETED - Start Date: 2023-10-31 - Completion Date: 2024-03-30 - Lead Sponsor: Tecnoquimicas ### Study Description The goal of this clinical pilot study is to evaluate the pharmacokinetic profile of magaldrate in a group of 10 healthy women, after the administration of a 10 mL drug suspension containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate and 120 mg of simeticone. The main question it aims to answer is the amount of magnesium and/or aluminum, if any, absorbed into the plasma from this oral administration.Participants will take the medication 30 minutes after a standard breakfast. Both groups of participants will take the standard meal but one group will take the medication and the other one won't.Researchers will compare the levels of both ions in plasma in a group to see if there is any absorption, quantifying the basal plasma levels and comparing with the levels obtained after the meal and the medication, when it applies. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Sodium alginate + sodium bicarbonate + magaldrate + simeticone ### Outcomes Primary Outcomes - Cmax for Aluminum - AUC for Aluminum - Cmax for Magnesium - AUC for Magnesium Secondary Outcomes - Amount of aluminum ions absorbed after drug administration vs amount provided by food ### Location - Facility: CAEP, Campinas, Sao Paulo, 13087-567, Brazil @@
## Examining the Effects of Virtual Reality Exercise on Mental Health - NCT ID: NCT06367439 - Study ID: FN-10984 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2025-06 - Lead Sponsor: University of Victoria ### Study Description The primary purpose of this investigation is to examine the effectiveness of virtual reality (VR) exercise (Supernatural exergaming via Meta Platforms Technologies, LLC) for improving mental health as indicated by (1) both short-term mood (one exercise bout) and long-term (10-weeks) mood (depression and anxiety symptoms), (2) well-being (i.e., vitality) over a 10-week period, and (3) perceived cognitive function over a 10-week period. The secondary purpose of this study is to examine the effectiveness of VR exercise for improving both physical activity behaviour and physical activity motivation (attitudes, capability, opportunity, behavioural regulation, habit, identity) over a 10-week period. The tertiary purpose is to examine whether key motivational variables (e.g., attitudes, capability, opportunity, behavioural regulation, habit, identity) regarding Supernatural use explain variability in Supernatural use over time. ### Conditions - Mental Health - Mood - Well-Being, Psychological - Physical Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Supernatural Condition - Supernatural Condition ### Outcomes Primary Outcomes - Depression and anxiety mood symptoms - Well-being: subjective vitality - Perceived cognitive function Secondary Outcomes - Short-term Mood - Core Affect Measure - Feeling Scale - Core Affect Measure - Felt Arousal Scale ### Location - Facility: Behavioural Medicine Lab, Victoria, British Columbia, V8W3N4, Canada @@
## A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People - NCT ID: NCT06367426 - Study ID: Pharmacobio - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Pharmacobio ### Study Description The study is a Phase I, randomized double-blind, placebo-controlled, single and multiple dosing, dose-escalation study of the oral administration of DDN-A-0101 in healthy adults and elderly subjects ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DDN-A-0101 (SAD) - DDN-A-0101 (MAD) - Placebo (SAD) - Placebo (MAD) ### Outcomes Primary Outcomes - Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs - Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs - Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs - Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG - Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement - Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests - Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests - Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests - Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma - Assessment of pharmacokinetics of Quercitrin in plasma - Assessment of pharmacokinetics of Quercitrin in plasma - Assessment of pharmacokinetics of Quercitrin in plasma - Assessment of pharmacokinetics of Quercitrin in plasma - Assessment of pharmacokinetics of Quercitrin in plasma - Assessment of pharmacokinetics of Quercitrin in plasma - Assessment of pharmacokinetics of Quercitrin in plasma - Assessment of pharmacokinetics of Quercitrin in urine - Assessment of pharmacokinetics of Quercitrin in urine - Assessment of pharmacokinetics of Quercitrin in urine Secondary Outcomes - Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test - Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test ### Location - Facility: Seoul National University College of Medicine and Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## Effects of Protein and NAC Co-ingestion on Skeletal Muscle Recovery - NCT ID: NCT06367413 - Study ID: UTH-PRoNAC Study - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-09-30 - Lead Sponsor: University of Thessaly ### Study Description Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of recovery. The enhanced performance capacity during the first phase of recovery in response to NAC supplementation might be attributed to the altered redox status in skeletal muscle as a consequence of the NAC-mediated elevation of reduced glutathione (GSH) levels. The rise in GSH results in a redox-dependent attenuation of immune cell mobilisation and reduction of oxidative stress response, leading to a blunted rise of muscle damage and inflammatory markers during the first 2-3 days of recovery. However, following exercise-induced muscle damage, protein synthesis increases in skeletal muscle over the next 24-48 hours to support its repair process, and thus protein supplementation might accelerate the recovery process by enhancing the protein synthetic response. Therefore, the present study aims at investigating for first time the combined effect of NAC and whey protein supplementation on the short-term (during the first 72 hours) recovery process of skeletal muscle following damaging exercise (eccentric exercise) and compared it with the well-documented efficacy of NAC supplementation. The results of this study might be particularly useful for athletes, such as those in soccer and basketball, that participate in 3 games or intense training sessions during the same macrocycle with only 48-72 hours of recovery in-between. ### Conditions - Aseptic Muscle Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - NAC - NAC + Whey Protein ### Outcomes Primary Outcomes - Change in maximal voluntary isometric muscle contraction. - Change in countermovement jump height. - Change in delayed onset of muscle soreness (DOMS) - Change in reduced glutathione content. - Change in oxidized glutathione content. - Change in catalase activity. - Change in protein carbonyl concentration - Change in myoglobin concentration in blood. Secondary Outcomes - Participants' lean body mass - Participants' daily physical activity-related energy expenditure. - Participants daily dietary intake. - Participants' resting metabolic rate. - Participants' cardiorespiratory fitness status. - Participants' fat free mass. - Participants' fat mass. - Participants' body fat percent. ### Location - Facility: Department of Physical Education and Sport Science, University of Thessaly, Tríkala, Karies, 42100, Greece @@
## Validation of Pediatric Sleep Questionnaire on a Swedish Cohort - NCT ID: NCT06367400 - Study ID: SwePSQ - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2034-12-31 - Lead Sponsor: Uppsala University ### Study Description This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing. ### Conditions - Obstructive Sleep Apnea - Sleep Disorder - Sleep Disorders in Children - Obstructive Sleep Apnea of Child ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pediatric Sleep Questionnaire ### Outcomes Primary Outcomes - Level of baseline PSQ - Changes of baseline PSQ after treatment Secondary Outcomes - PSQ vs OSA-18 - PSQ vs. PSG - PSQ levels of healthy controls vs children with OSDB ### Location - Facility: Akademiska hospital, Uppsala, N/A, N/A, Sweden @@
## Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment - NCT ID: NCT06367387 - Study ID: STUDY23080191 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: Jessica Merlin ### Study Description This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv).The research study is testing two different interventions along with usual clinical care:1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain.2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation.There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention. ### Conditions - Opioid Use Disorder - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Patient-Oriented Dosing (POD) - Pain Self-Management (PSM) - Usual Care - Standard Buprenorphine Dosing Condition ### Outcomes Primary Outcomes - Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline - Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline Secondary Outcomes - Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline - Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline - Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline - Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline - Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline - Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline ### Location - Facility: Outpatient Addiction Treatment Services (OATS), Baltimore, Maryland, 21201, United States @@
## MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL - NCT ID: NCT06367374 - Study ID: BGB-11417-2002-IIT；BDH-CLL-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2030-07-30 - Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China ### Study Description This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment. ### Conditions - Chronic Lymphocytic Leukemia - Small Lymphocytic Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sonrotoclax - Zanubrutinib ### Outcomes Primary Outcomes - 4-Year Progressive Free Survival (PFS) Rate Secondary Outcomes - Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD) - Complete Response Rate (CRR; Complete Response/Complete Response with Incomplete Blood Count Recovery [CR/CRi]) Rate - Overall Response Rate (ORR) - Duration of Response (DOR) - Progression Free Survival (PFS) - Overall Survival (OS) - Time to Next Therapy (TTNT) - Overall survival rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis - NCT ID: NCT06367361 - Study ID: SIDISI 201221 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2028-03 - Lead Sponsor: Universidad Peruana Cayetano Heredia ### Study Description Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Children and adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population PK modeling studies will be performed in the first 24 hours after the first dose of oxfendazole. ### Conditions - Fascioliasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oxfendazole - Triclabendazole ### Outcomes Primary Outcomes - Parasitological cure rate of chronic fascioliasis - Egg reduction rate day 7 - Egg reduction rate day 30 Secondary Outcomes - Safety information on day 0 - Safety information on day 3 - Safety information on day 7 - Safety information on day 30 - Laboratory safety information day 7 - Laboratory safety information day 30 - Population pharmacokinetics model constructs for oxfendazole - Population pharmacokinetics model constructs for oxfendazole sulfone - Population pharmacokinetics model constructs fenbendazole ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi - NCT ID: NCT06367348 - Study ID: R01AA031445 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2028-05 - Lead Sponsor: University of California, San Francisco ### Study Description With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi. ### Conditions - HIV/AIDS - Alcohol Abuse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mlambe ### Outcomes Primary Outcomes - Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test - Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test - Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test Secondary Outcomes - Viral Suppression measured using whole blood viral load tests - Antiretroviral medication adherence measured using a Visual Analog Scale - Antiretroviral medication adherence measured using a Visual Analog Scale - Antiretroviral medication adherence measured using a Visual Analog Scale - Medical appointment adherence assessment - Medical appointment adherence assessment - Medical appointment adherence assessment - Number of drinking days measured using the "Timeline follow-back" method - Number of drinking days measured using the "Timeline follow-back" method - Number of drinking days measured using the "Timeline follow-back" method - AUDIT-C score measured using the Alcohol Use Disorders Identification Test. - AUDIT-C score measured using the Alcohol Use Disorders Identification Test. - AUDIT-C score measured using the Alcohol Use Disorders Identification Test. - PEth level measured using a Phosphatidylethanol biomarker test - PEth level measured using a Phosphatidylethanol biomarker test - PEth level measured using a Phosphatidylethanol biomarker test ### Location - Facility: Invest in Knowledge Initiative (IKI), Zomba, N/A, N/A, Malawi @@
## Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer - NCT ID: NCT06367335 - Study ID: ETIC - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2022-12-31 - Lead Sponsor: University of Milano Bicocca ### Study Description The main objective of the study is to evaluate the presence of predictors (single characteristics at the baseline and / or a combination of two or more parameters) useful for predicting the development of Drug-Induced liver Injury (DILI) during treatment with cyclin-dependent kinase inhibitors (CKI) with the possibility of obtaining a pre-treatment prognostic score that can assist the clinician in pre-therapy decision making. ### Conditions - DILI ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ribociclib, palbociclib, abemaciclib ### Outcomes Primary Outcomes - Incidence of DILI Secondary Outcomes - withdrawal of therapy - delayed reprise of antineoplastic therapy ### Location - Facility: University of Milano-Bicocca,, Monza, N/A, 20900, Italy @@
## Statins and Post-ERCP Acute Pancreatitis (Stark Project) - NCT ID: NCT06367322 - Study ID: EMP-PARA-20170-01 - Status: COMPLETED - Start Date: 2017-01-10 - Completion Date: 2018-09-30 - Lead Sponsor: Hospital General Universitario de Alicante ### Study Description Post-endoscopic retrograde cholangiopancrepatography (ERCP) acute pancreatitis (PEAP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic acid (ASA) treatment is unclear. The aim of the study is to investigate whether statins and chronic ASA intake are associated with lower risk of PEAP. ### Conditions - Post-ERCP Acute Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Statin ### Outcomes Primary Outcomes - To assess the incidence and relative risk of PEAP according to statin use. Secondary Outcomes - To assess the effect of chronic use of other drugs on the incidence and relative risk of PEAP. - To assess the effect of other factors (demographic and endoscopic) on the incidence and relative risk of PEAP and severity of PEAP (severity according to the Revised Atlanta Classification). ### Location - Facility: Alicante, Alicante, N/A, 03010, Spain @@
## ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - NCT ID: NCT06367309 - Study ID: 2023 - 02357 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2030-12-31 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.The main questions it aims to answer are:* pain after the operation* rate of complications* rate of recurrence and reoperations* quality of life.Participants will:Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes. ### Conditions - Ventral Hernia - Abdominal Wall Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extended totally extraperitoneal repair - Intraperitoneal onlay mesh ### Outcomes Primary Outcomes - primary outcome: pain numeric rating scale (NRS) - pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a Secondary Outcomes - pain mid-term - recurrence and reoperation - LOS - Functional recovery - Adverse events - Quality of life (SF 12) ### Location - Facility: St. Clara Hospital, Basel, Basel-Stadt, 4058, Switzerland @@
## Resistance Exercise Training in the Older Population With Obesity - NCT ID: NCT06367296 - Study ID: RETOPO2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Universidad de La Frontera ### Study Description Background:Aging leads to an alteration in the immune response, characterized by a chronic inflammatory state, and a progressive decrease in muscle quantity and quality, a situation that increases in women and in the presence of obesity. With respect to muscle quality, intramuscular infiltration of adipose tissue has been considered a relevant parameter, involved in the relationship between aging-obesity-inflammation. As a therapeutic strategy, physical training with resistance exercises (or also known as strength training) has been shown to be effective in increasing skeletal muscle mass in this age group. However, its role on muscle quality in normal-weight versus obese older women has not been fully addressed.Hypothesis:A 12-week resistance exercise training program is effective in improving muscle quality, immune response and physical performance in normal weight and obese older women. In addition to the above, the investigators hypothesize that women with obesity will present greater baseline alterations, so the percentage of change will be higher compared to older women with normal weight after the training program.Goals:The primary aim of this study is to evaluate the effects of a 12-week resistance exercise training on muscle quality (infiltration of intramuscular adipose tissue), immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range.Methodology:The present clinical trial will consider 2 groups of older women between 60 and 79 years old: normal weight (BMI=18.5 to 24.9 kg/m 2 and % fat \<25.9) and obese (BMI =30 to 39.9 Kg/m 2 and fat % \>32). Participants will perform 12 weeks of training with resistance exercises 3 times a week. Before and after training, intramuscular infiltration of adipose tissue (echogenicity) will be measured by ultrasound, followed by aspects of muscle architecture (muscle thickness, penile angle and fascicle length) and functional parameters of muscle quality (maximum strength determined by 1 repetition maximum-1RM, maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer). Finally, fasting blood samples will be obtained (immune response) and physical performance, body composition, physical activity level, and quality of life will be evaluated. ### Conditions - Aging - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Prolonged resistance exercise training ### Outcomes Primary Outcomes - Change in intermuscular adipose tissue (measured via ultrasonography) after prolonged resistance-type exercise training Secondary Outcomes - Change in muscle thickness (measured via ultrasonography) after prolonged resistance-type exercise training - Change in pennation angle (measured via ultrasonography) after prolonged resistance-type exercise training - Change in fascicle length (measured via ultrasonography) after prolonged resistance-type exercise training - Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training - Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training - Change in hand grip strength (measured via JAMAR(R) handheld dynamometer) after prolonged resistance-type exercise training - Change in maximum voluntary isometric strength (measured via Force transducer) after prolonged resistance-type exercise training. - Change in muscle power of the lower limbs (measured via Five Times Sit to Stand test) after prolonged resistance-type exercise training. - Change in Immune response in blood (measured via flow cytometry) after prolonged resistance-type exercise training. - Change in NETosis in blood (measured via IncuCyte) after prolonged resistance-type exercise training. - Change in Whole body lean mass (measured via Bioimpedance) after prolonged resistance-type exercise training. - Change in Whole body fat mass (measured via Bioimpedance) after prolonged resistance-type exercise training. - Change in Physical activity level (measured via IPAQ short version) after prolonged resistance-type exercise training. - Change in Quality of Life level (measured via SF-36) after prolonged resistance-type exercise training. ### Location - Facility: Universidad de La Frontera, Temuco, IX Región De La Araucanía, 4780000, Chile @@
## Metformin Treatment of Patients With Hand Osteoarthritis - NCT ID: NCT06367283 - Study ID: 2023-509181-38-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-04 - Lead Sponsor: Marius Henriksen ### Study Description To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms. ### Conditions - Hand Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metformin - Placebo ### Outcomes Primary Outcomes - Finger pain Secondary Outcomes - Function - Thumb base pain - Hand pain - Physician tender joint count - Patient global assessment - Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale - Hand strength - Number of treatment responders ### Location - Facility: The Parker Institute, Bispebjerg and Frederiksberg hospital, Copenhagen, Frederiksberg, 2000, Denmark @@
## The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies - NCT ID: NCT06367270 - Study ID: UW 23-361 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2027-08-31 - Lead Sponsor: The University of Hong Kong ### Study Description Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity. ### Conditions - Peritoneal Metastases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pressured Intraperitoneal Aerosol Chemotherapy ### Outcomes Primary Outcomes - Clinical benefit rate (CBR) Secondary Outcomes ### Location - Facility: Queen Mary Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy - NCT ID: NCT06367257 - Study ID: Emento App - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: University of Erlangen-Nürnberg Medical School ### Study Description Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition. ### Conditions - Squamous Cell Carcinoma of Head and Neck ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - App Usage - Standard of Care ### Outcomes Primary Outcomes - Change in rates of weight loss with additional app-based Patient Care Secondary Outcomes - Frequency of deteriorations in health status subjectively reported by patients and recorded via the app. - Frequency of additional app-triggered contacts of the clinic with the patients - Frequency of critical health conditions (physician-verified) detected earlier by the app. - Change in quality of life measured per questionnaires - Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy. - Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy. - Rate of therapy interruptions/discontinuations - Overall survival - Disease-free/progression-free survival - Change of Loco-regional tumor control ### Location - Facility: Universitätsklinikum Erlangen, Strahlenklinik, Erlangen, Bavaria, 91054, Germany @@
## Transplant Wellness Program - NCT ID: NCT06367244 - Study ID: TWP2023 - Status: RECRUITING - Start Date: 2023-11-16 - Completion Date: 2033-11 - Lead Sponsor: University of Calgary ### Study Description Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of overall health. Prehabilitation, or using rehabilitation in the period before surgery, can improve the pre, during, and post operative experience for the patient. Although exercise as prehabilitation has been well established in organ transplant, the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term. Supporting wellness behaviour change, such as exercise, stress reduction, and sleep, is associated with improved quality of life (QoL), mood, and improvements in well-being. Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes. The Transplant Wellness Program (TWP) is an exercise behaviour change program that includes additional wellness components such as nutrition, stress reduction, and sleep programs to support overall health and QoL of transplant patients. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QoL. The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant, depending on length of time from study enrollment to transplant surgery. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services use. Collected outcomes will include program reach, effectiveness measures such as changes in physical fitness, adoption by healthcare practitioners, implementation of the program, and maintenance. In addition, will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes, such as the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization. ### Conditions - Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Transplant Wellness Program - Kidney and Liver ### Outcomes Primary Outcomes - Self-reported exercise - Generic self-reported quality of life - Kidney disease quality of life. - Liver disease quality of life Secondary Outcomes - Frailty - Hand grip strength - Lower extremity flexibility - Aerobic Endurance - Lower extremity muscular strength - Balance - Nutrition - Sleep - Mental Health - Self-efficacy - Program implementation and evaluation - Health economic evaluation ### Location - Facility: University of Calgary, Calgary, Alberta, T2N 1N4, Canada @@
## SCGs as a Proxy for Determining the Cognitive Status of Older Adults - NCT ID: NCT06367231 - Study ID: Pro00134554 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-01 - Lead Sponsor: University of Alberta ### Study Description Detecting memory problems early is crucial for treating conditions like Mild Cognitive Impairment (MCI), which often leads to dementia. Currently, doctors use tests in clinics to check for these issues. However, there's a growing need for better methods to monitor our cognitive skills over time. Computer games emerge as a cost-effective solution for assessing the brain functions of older adults.In our study, we are investigating the potential of computer games to reflect the cognitive skills of older adults. We developed the VibrantMinds platform, featuring five games: Whack-a-Mole, Bejeweled, Mahjong Solitaire, Word Search, and Memory Game. We have evaluated these games for ease of use, enjoyment, and their impact on brain functions. Now, our goal is to determine whether these games can offer valuable insights into the cognitive skills of older adults.We are collecting demographic data, game-playing data, and cognitive test results. Our analysis will determine the correlation between game data, cognitive test outcomes, and demographic information. Additionally, we will assess both the perceived and observed engagement of older adults as they play the games. ### Conditions - Mild Cognitive Impairment - Dementia - Alzheimer Disease - Healthy Aging - Cognitive Decline ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - VibrantMinds ### Outcomes Primary Outcomes - Cognition - Global Secondary Outcomes - Cognition - Global - Cognition - Executive Function - Game Performance - Game Engagement ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS - NCT ID: NCT06367218 - Study ID: S058 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-08-01 - Lead Sponsor: Tongji Hospital ### Study Description Non-tracheal intubated combined anesthesia with preserved spontaneous breathing significantly enhances the quality and speed of recovery post-VATS for patients undergoing lung nodule surgery. The "opioid-sparing strategy," which substitutes ketamine for opioids during surgery, not only provides effective analgesia but also protects perioperative lung function and reasonably prevents the occurrence of opioid-related adverse reactions; it also reduces medical costs and shortens the average hospital stay. However, the degree of benefit to patients lacks high-level clinical evidence. This study aims to comprehensively assess the effect of opioid-free combined anesthesia with preserved spontaneous breathing for VATS lung nodule surgery on postoperative rapid recovery from multiple aspects including postoperative lung function and pulmonary complications, pain, gastrointestinal function, nausea/vomiting, cognitive function, and depression/anxiety, intending to expand the dataset and application prospects in this field, and increase feasibility experience. ### Conditions - Video-assisted Thoracoscopic Lung Surgery；Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - opioid based strategy - opioid-free strategy - Laryngeal mask airway; Preserved spontaneous breathing - Double lumen tracheal tube; Mechanical ventilation ### Outcomes Primary Outcomes - Lung function 30 days after surgery Secondary Outcomes - Intraoperative respiratory parameters - Intraoperative respiratory parameters - Intraoperative respiratory parameters - Intraoperative respiratory parameters - Intraoperative respiratory parameters - Perioperative stage indicators - Perioperative stage indicators - Postoperative pain - Postoperative Lung function - Postoperative Lung function - Postoperative pulmonary complications - Postoperative gastrointestinal function - Postoperative depression/anxiety - Postoperative cognitive function - Time of first exercise after surgery - The 6-minute walking experiment - Length of stay - Quality of life measurement - Intraoperative circulation parameters - Intraoperative circulation parameters - Intraoperative circulation parameters - Intraoperative circulation parameters - Intraoperative circulation parameters - Intraoperative circulation parameters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations - NCT ID: NCT06367205 - Study ID: LY2023-135-A - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-06-30 - Lead Sponsor: RenJi Hospital ### Study Description Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies. ### Conditions - Delayed Graft Function - End Stage Renal Disease - Kidney Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Goal-Directed Fluid Therapy (GDFT) - Regular Fluid Therapy ### Outcomes Primary Outcomes - The incidence of delayed graft function (DGF) Secondary Outcomes - The area under the curve of serum creatinine levels from postoperative day 1 to 7 - Duration of DGF - Number of dialysis sessions during postoperative hospitalization - Total urine output on the second postoperative day - Duration of intensive care unit (ICU) stay - Length of hospitalization - Incidence of readmission within 30 days post-discharge ### Location - Facility: the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China @@
## School Readiness Intervention for Preschool Children With Sickle Cell Disease - NCT ID: NCT06367192 - Study ID: SKITS2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-10 - Lead Sponsor: St. Jude Children's Research Hospital ### Study Description The study participant is being asked to take part in this clinical trial, a type of research study, because the participant is a young child with sickle cell disease or the caregiver of a child with sickle cell disease. This study is being done to test a school readiness program for children with sickle cell disease (ages 4-6 years old).Primary ObjectiveAssess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 4-6) diagnosed with sickle cell disease.Secondary ObjectivesObjective 1:Measure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (4-6) diagnosed with sickle cell disease.Objective 2:Examine implementation factors (i.e., barriers and facilitators) during post-intervention. ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - The adapted Kids in Transition to School Intervention - Standard school resources ### Outcomes Primary Outcomes - Feasibility of Intervention Measure - Acceptability of Intervention Measure Secondary Outcomes - Bracken School Readiness Assessment - 3rd Edition - Woodcock Johnson Tests of Achievement - Fourth Edition - NIH Toolbox Flanker Test - Head-Toes-Knees-Shoulders Revised - Behavior Rating Inventory of Executive Functioning Preschool or Child - The Parenting Scale ### Location - Facility: St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States @@
## Virtual Reality and AI Wound-detecting System - NCT ID: NCT06367179 - Study ID: 202401039RINC - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-02-04 - Lead Sponsor: National Taiwan University Hospital ### Study Description This study is an experimental study. The main caregivers of pressure injury patients in the plastics surgery ward and general medicine ward of the hospital in Taipei City who are over 20 years old, have good communication skills in Chinese and Taiwanese or who can read Chinese are the research objects. During the study process, pre-tests will be given to the accepted subjects, which are the correctness evaluation scale of caregiver's pressure injury wound dressing change and caregiver self-efficacy scale, and then the accepted subjects will be divided into experimental group and control group. The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system, while the control group maintained the traditional pressure injury health education with oral introduction and health education leaflet. After the intervention measures are given, a post-test (same as the pre-test content) will be conducted within two days. Finally, analyze the effectiveness of the intervention of virtual reality pressure injury education video and artificial intelligence wound detecting system on caregivers of pressure injury improve wound care correctness and increase self-efficacy. ### Conditions - Pressure Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Virtual reality and AI use - Health education leaflet ### Outcomes Primary Outcomes - Accurate dressing change rate of pressure injury Secondary Outcomes - Pressure injury dressing change of self-efficacy ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, 100225, Taiwan @@
## Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins - NCT ID: NCT06367166 - Study ID: RyazanSMU - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-01 - Completion Date: 2026-05-01 - Lead Sponsor: Ryazan State Medical University ### Study Description The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin). ### Conditions - Varicose Veins of Lower Limb - Varix - Vascular Diseases - Leg Edema ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - "Venarus®" (diosmin and hesperidin) - Endovenous laser ablation (EVLA) with miniphlebectomy - Elastic compression - Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores ### Outcomes Primary Outcomes - changes in biomarkers of venous wall remodeling - Changes in biomarkers expression in venous wall Secondary Outcomes ### Location - Facility: RyazanSMU, Ryazan, N/A, N/A, Russian Federation @@
## A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood - NCT ID: NCT06367153 - Study ID: 1447-0007 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-07 - Completion Date: 2024-08-24 - Lead Sponsor: Boehringer Ingelheim ### Study Description The main objective of this trial is to investigate the effect of multiple oral doses of BI 1569912 on the pharmacokinetics of a single oral dose of repaglinide, midazolam and bupropion (i.e. sensitive CYP2C8, CYP3A4 and CYP2B6 substrates). ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BI 1569912 - repaglinide - midazolam - bupropion ### Outcomes Primary Outcomes - Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Secondary 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) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke - NCT ID: NCT06367140 - Study ID: SYU 2021-06-001-002 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Sahmyook University ### Study Description The study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. The research has been approved by the Ethics Committee of Kyungdong University and adheres to the ethical standards laid out in the Declaration of Helsinki. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - EMG-triggered CIMCT device - general cycling training ### Outcomes Primary Outcomes - Muscle Strength - Static Balance - Timed Up and Go (TUG) - Berg Balance Scale - Functional Reach Test (FRT) - Modified Barthel Index (MBI) Secondary Outcomes ### Location - Facility: Department of Physicla Therapy, Sahmyook University, Seoul, N/A, 01795, Korea, Republic of @@
## Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening - NCT ID: NCT06367127 - Study ID: Pingfanghu - Status: ENROLLING_BY_INVITATION - Start Date: 2023-10-09 - Completion Date: 2024-12-31 - Lead Sponsor: Shanghai Changzheng Hospital ### Study Description Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.Presently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE. ### Conditions - Hepatic Encephalopathy - Covert Hepatic Encephalopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of Beans Clamping in 1 minute Secondary Outcomes - Participants' feedback on CBT1 test ### Location - Facility: Shanghai Changzheng hospital, Shanghai, N/A, N/A, China @@
## Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration) - NCT ID: NCT06367114 - Study ID: ssCART-19-II-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd ### Study Description This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. ### Conditions - Relapsed or Refractory Acute Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ssCART-19 - Fludarabine - Cyclophosphamide ### Outcomes Primary Outcomes - Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL). Secondary Outcomes - Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia. - Best overall response (BOR)assessment during the 3 months after ssCART-19 infusion. - Duration of response (DOR) - Recurrence free survival (RFS) - Event Free Survival (EFS) - Overall survival (OS) - Incidence of adverse events following ssCART-19 infusion - Pharmacodynamic of ssCART-19 cells - Pharmacodynamic of ssCART-19 cells - Pharmacodynamic of ssCART-19 cells ### Location - Facility: Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd., Shanghai, Shanghai, 201210, China @@
## AR Stimulation Effects on Gait, Anxiety, and Brain Connectivity in Parkinson's Disease - NCT ID: NCT06367101 - Study ID: 202002525B0 - Status: RECRUITING - Start Date: 2022-01-18 - Completion Date: 2025-07-31 - Lead Sponsor: Chang Gung University ### Study Description A project aims at addressing gait impairments and non-motor symptoms such as anxiety and stress in Parkinson's disease (PD) patients through a novel approach involving heart rate variability (HRV) feedback and Augmented Reality (AR) training. The project is based on the premise that improving HRV, which reflects the adaptability of the autonomic nervous system, can enhance both motor functions like gait and non-motor symptoms. ### Conditions - Parkinson Disease(PD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AR training with gait and HRV feedback ### Outcomes Primary Outcomes - Walking Speed - Step Length - Step Time - Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR) - Time-Domain Index of HRV：pNN50 - Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD) - Frequency-Domain Index of HRV: Low Frequency (LF) - Frequency-Domain Index of HRV: High Frequency (HF) - Frequency-Domain Index of HRV: Ratio of LF to HF Power - Total Time to Complete the Time Up and Go test (TUG test) Secondary Outcomes - Double Support Time - Single Support Time - Swing Time - Stance Time - Cadence - Total UPDRS-III Score - Total NFOG-Q Score - Overall PDQ-39 Score - Total HADS Score - Overall PSQI Score - Non-linear Index of HRV: SD1 - Non-linear Index of HRV: SD2 - Non-linear Index of HRV: Ratio of SD1-to-SD2 ### Location - Facility: Chang Gung University, Taoyuan, N/A, 333, Taiwan @@
## Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer - NCT ID: NCT06367088 - Study ID: Sophia - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-30 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients. ### Conditions - Triple-negative Breast Cancer - Cadonilimab ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cadonilimab ### Outcomes Primary Outcomes - Objective Response Rate Secondary Outcomes - AE ### Location - Facility: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China @@
## A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma - NCT ID: NCT06367075 - Study ID: AK104-sarcoma-202401 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-03-31 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin. ### Conditions - Advanced Soft-tissue Sarcoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cadonilimab - Adriamycin ### Outcomes Primary Outcomes - objective response rate (ORR) Secondary Outcomes - Disease control rate (DCR) - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Adverse event (AE) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## General Anesthesia/Surgical Exposure on White Matter Development in Children - NCT ID: NCT06367062 - Study ID: SH9H-2023-T296 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University ### Study Description International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development. ### Conditions - Neurodevelopmental Delay ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI ### Outcomes Primary Outcomes - MRI-based assessment of brain development Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma - NCT ID: NCT06367049 - Study ID: 2023-FXY-230-NPC - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-03-01 - Lead Sponsor: Sun Yat-sen University ### Study Description Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer.DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening.There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma.Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer. ### Conditions - Nasopharyngeal Carcinoma - Early Diagnosis of Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Methylation-specific PCR ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity ### Location - Facility: Sun yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Effect of Hypericum Perforatum Oil on Ecchymosis and Pain - NCT ID: NCT06367036 - Study ID: 2021-52 - Status: COMPLETED - Start Date: 2022-01-02 - Completion Date: 2023-06-15 - Lead Sponsor: Uskudar University ### Study Description Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test. ### Conditions - Pain - Ecchymosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Topical hypericum perforatum oil intervention ### Outcomes Primary Outcomes - Pain point - Ecchymosis Secondary Outcomes ### Location - Facility: Hatice Demirdağ, Üsküdar, İstanbul, 34672, Turkey @@
## Effectiveness of Brahma Kumaris Raja Yoga Meditation on Quality of Life of Youth in the Deaddiction Center of Biratnagar - NCT ID: NCT06367023 - Study ID: 32-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03-30 - Lead Sponsor: Manipur International University ### Study Description Drug addiction is a public health problem, mainly youths are involved in the addiction and the major reason were due to peer pressure. Spiritual meditation is thought to foster a deeper sense of meaning, which creates new sources of positive reinforcement, increasing motivation for alternative behavior patterns, such as entering treatment or maintaining abstinence. Cluster Randomized Control Trial will be performed for 1-year period where mixed method study design will be performed. The major variables will be Anxiety and depression score, Happiness index, Quality of life, Rate of Relapse, Age, Gender, Occupation, Education, Income, Family Size, Family Income, Family support, Social status- High/Middle/Low, History of drug use self, Types of drugs, Duration of usage: Reason of drug use, how they have started, Amount of drugs, Frequency of use, Family history of drug use, Money spent on drugs per month. A modified validated Questionnaire will be used. CRCT will be done by CONSORT Guidelines. A total of 160 samples will be taken, (40 from each center, two were given Meditation intervention and 80 were given standard treatment as a control group) and 16 qualitative interviews will be taken (4 from each center). The intervention will be given for 3 months, for 6 days one hour per day Rajyoga meditation basic course will be provided, followed by a 1-hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group, and in the control group standard treatment will be given. Follow-up will be done after 1 month of discharge from the rehabilitation centers. Ethical clearance will be taken from the Ethical Review Board (ERB) of the Nepal Health Research Council (NHRC). This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention. ### Conditions - Prevalence - Depression - Happiness - Quality of Life - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Rajyoga Meditation Practice ### Outcomes Primary Outcomes - Anxiety score - Depression score - quality of life score Secondary Outcomes - Rate of Relapse ### Location - Facility: Rehabilitation center, Biratnagar, Koshi, 56613, Nepal @@
## Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients - NCT ID: NCT06367010 - Study ID: MR-36-24-010942 - Status: COMPLETED - Start Date: 2019-01-01 - Completion Date: 2024-04-01 - Lead Sponsor: Jiangxi Provincial Cancer Hospital ### Study Description A retrospective analysis was conducted on patients with radioiodine-refractory thyroid carcinoma (RRTC) who underwent radioactive 125I seed implantation combined with anlotinib from January 2019 to October 2024 at Jiangxi Cancer Hospital. Data on tumor size changes before and after treatment, serological tests (including serum TG, TgAb, CTn, CEA, etc.), changes in patients' pain scores, and side effects were collected to evaluate the clinical efficacy and safety of this therapy. ### Conditions - Thyroid Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Iodine-125 brachytherapy combine with Anlotinib ### Outcomes Primary Outcomes - The CT images were used to measure the change in the maximum diameter of the lesion in millimeters. - Serological assessment - Use the Numerical Rating Scale (NRS) to record patients' pain scores. - Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Secondary Outcomes ### Location - Facility: Jiangxi Cancer Hospital, Nanchang, Jiangxi, 330029, China @@
## Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test - NCT ID: NCT06366997 - Study ID: CQGOG0207 - Status: COMPLETED - Start Date: 2019-10-09 - Completion Date: 2023-05-05 - Lead Sponsor: Chongqing University Cancer Hospital ### Study Description The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study. ### Conditions - Epithelial Ovarian Cancer - Adnexal Mass ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value. Secondary Outcomes ### Location - Facility: No.181, Hanyulu Road, Shapingba District, Chongqing, Chongqing, 400030, China @@
## Outcome of Plastibell Circumcision Versus Open Method Circumcision - NCT ID: NCT06366984 - Study ID: Adeel4 - Status: COMPLETED - Start Date: 2022-01-11 - Completion Date: 2022-08-11 - Lead Sponsor: Children Hospital and Institute of Child Health, Lahore ### Study Description To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital.Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition). ### Conditions - Bleeding - Site Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - plastibell - open method ### Outcomes Primary Outcomes - infection Secondary Outcomes ### Location - Facility: The Children Hospital, Lahore, Punjab, 42000, Pakistan @@
## The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction - NCT ID: NCT06366971 - Study ID: auhucgun01 - Status: COMPLETED - Start Date: 2023-12-01 - Completion Date: 2024-03-31 - Lead Sponsor: Biruni University ### Study Description The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD. ### Conditions - Sacroiliac Joint Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The Patient Education - The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training ### Outcomes Primary Outcomes - The Level of Low Back Pain - Mobility - Flexibility - Lumbar Range of Motion - Posture - Trunk Muscle Endurance Secondary Outcomes ### Location - Facility: Istanbul Atlas University, Istanbul, Kagıthane, 34408, Turkey @@
## Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion - NCT ID: NCT06366958 - Study ID: Dorsal wrist ganglion - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2025-04-02 - Lead Sponsor: Assiut University ### Study Description compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion ### Conditions - Hand Ganglion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - excision of dorsal wrist ganglion ### Outcomes Primary Outcomes - comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion Secondary Outcomes - compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC - NCT ID: NCT06366945 - Study ID: SYSKY-2024-157-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2029-05-30 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis ### Conditions - Head and Neck Squamous Cell Carcinoma - Head and Neck Cancer - HNSCC - Head Cancer Neck ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Carboplatin - Tislelizumab - Polymeric Micellar Paclitaxel - Surgical Resection of Primary +/- Neck Dissection - Post-operative radiation therapy ### Outcomes Primary Outcomes - Major pathological response (MPR) rate of metastatic lymph nodes Secondary Outcomes - Major pathological response (MPR) rate of primary tumor - Event-free survival (EFS) - Overall survival（OS） - Incidence of treatment-related adverse events - EORTC QLQ-C30 - pathological downstaging rate - Distant metastasis-free survival(DMFS) rate - logical regional-free survival(LRFS) rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models - NCT ID: NCT06366932 - Study ID: DermAtOmics-II - Status: RECRUITING - Start Date: 2023-09-25 - Completion Date: 2025-09 - Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz ### Study Description This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Second-line systemic treatment - Folllow-up of second-line systemic treatment already started ### Outcomes Primary Outcomes - Percentage of patients with primary non-response to second-line treatment. Secondary Outcomes - Percentage of patients achieving EASI-75 - Time to treatment failure after week 16 - Mean percentage of change in Eczema Area and Severity Index (EASI) score - Percentage of change in SCORAD (SCORing Atopic Dermatitis) - Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis) - Change of IGA (Investigator Global Assessment) - Time to IGA score of 0/1 (Investigator Global Assessment) - Change of BSA (Body surface area) - Change in NRS - Change in RECAP - Percentage of patients having a variation of 4 points in their improvement in DLQI - Change in POEM (Patient-Oriented Eczema Measure) - Rate of adverse events associated to second-line systemic treatment - Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage) ### Location - Facility: Hospital La Paz, Madrid, N/A, 28046, Spain @@
## Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients - NCT ID: NCT06366919 - Study ID: DPT/Batch-Fall19/559 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-15 - Lead Sponsor: Superior University ### Study Description Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients ### Conditions - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Alexander Technique (AT) - Feldenkrais Technique (FT) ### Outcomes Primary Outcomes - Northwick Park Neck Pain Questionnaire - REEDCO Posture Assessment and Sleep Quality Scale Secondary Outcomes ### Location - Facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, Lahore, Punjab, N/A, Pakistan @@
## 10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma - NCT ID: NCT06366906 - Study ID: SYSKY-2023-426-01 - Status: COMPLETED - Start Date: 2023-05-10 - Completion Date: 2024-02-10 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis. ### Conditions - HNSCC - AI - Radiomic - MRI ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The Resnet50 deep learning (DL) model ### Outcomes Primary Outcomes - AUC(the area under the curve) values of the model Secondary Outcomes ### Location - Facility: Sun yat-sen memorial hospital, Guangzhou, Guangdong, 510000, China @@
## Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants - NCT ID: NCT06366893 - Study ID: PR(AG)297/2019 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-03-04 - Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute ### Study Description Docosahexaenoic acid (DHA) and arachidonic acid (AA) have a critical effect on the health and neuronal development of the fetus and newborn. Their deficiency has been associated with increased neonatal morbidity, especially in preterm newborns at birth. Direct DHA supplementation during the first few weeks of life could prevent this deficiency.The aim is to increase DHA levels in the red blood cell membrane while maintaining the fetal proportion to AA in preterm infants through enteral administration of DHA/AA in a safe, tolerated, and effective manner. This approach aims to avoid the decline in DHA/AA levels and the consequences of their deficiency.The study is a single-center, prospective, randomized, controlled, open-label study involving preterm infants admitted to the Neonatology Department of Vall d'Hebron University Hospital in Barcelona. ### Conditions - Infant, Premature, Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - DHA/AA emulsion supplement for preterm infant ### Outcomes Primary Outcomes - Percentage comparison of erythrocyte membrane levels of DHA and AA Secondary Outcomes - Tolerance of DHA emulsion administration - Compare the presence of pathologies in preterm infants between the supplemented group and the control group ### Location - Facility: Hospital Materno Infantil Vall d'Hebron, Barcelona, N/A, 08035, Spain @@
## Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn - NCT ID: NCT06366880 - Study ID: 2022.HPS.DI.434 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-12-15 - Lead Sponsor: Hospital Pediátrico de Sinaloa ### Study Description Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants.The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice.The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants. ### Conditions - Cholestasis in Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Parenteral nutrition cycling ### Outcomes Primary Outcomes - Incidence of cholestasis on Day 28 of admission. Secondary Outcomes - are total plasma bilirrubine profiles - the incidence of hypoglycaemia ### Location - Facility: Hospital Pediatrico de Sinaloa, Culiacán, Sinaloa, 80200, Mexico @@
## An Open Platform of Serious Games for Cognitive Intervention - NCT ID: NCT06366867 - Study ID: Pro00097579 - Status: RECRUITING - Start Date: 2022-08-03 - Completion Date: 2025-12-01 - Lead Sponsor: University of Alberta ### Study Description Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning. ### Conditions - Mild Cognitive Impairment - Dementia - Alzheimer Disease - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - VibrantMinds ### Outcomes Primary Outcomes - Cognition - Global Secondary Outcomes - Depression - Agitation - Occupational Performance - Engagement - Affect ### Location - Facility: CapitalCare Group Inc Facilities, Edmonton, N/A, T5J 3M9, Canada @@
## UK ANDROMEDA-Shock-2 RCT - NCT ID: NCT06366854 - Study ID: IRAS: 332418 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-04-30 - Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust ### Study Description The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care. ### Conditions - Septic Shock ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personalised fluid and haemodynamic resuscitation ### Outcomes Primary Outcomes - hospital mortality - organ support - length of stay Secondary Outcomes - mortality - vital organ support - length of stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stigma and Psychological profilE in REctal-anal caNcer pAtients - NCT ID: NCT06366841 - Study ID: 6439 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-04-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description In 2022, Italy is estimated to have 48,100 cases of colon-rectum cancer. Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. The diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. Symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. While distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. Colorectal cancer is associated with specific socially stigmatized challenges. Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. Anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. In other forms of cancer, stigma has been linked to personality traits. Given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. Currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. Aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time. ### Conditions - Rectal Cancer - Anal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Psychological tests administration ### Outcomes Primary Outcomes - Evaluation of rectal and anal cancer stigma Secondary Outcomes - Evaluation of psychological characteristics in rectal and anal cancer - Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version - Toronto Alexithymia Scale - EORTC QLQ - CR29 and EORTC QLQ-ANL27 ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Prediction Models for Complications After CRT in Esophageal Cancer - NCT ID: NCT06366828 - Study ID: 11446 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2030-06 - Lead Sponsor: University Medical Center Groningen ### Study Description The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer ### Conditions - The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - retrospective ### Outcomes Primary Outcomes - Multivariable NTCP models will be developed for the prediction of the following - Cardiac events grade II or higher (CTCAE v 5.0), including: - Mortality - Complication Sum Score, that will be determined in Delphi consensus Secondary Outcomes - Patient-rated dysphagia - Patient-rated nausea - Patient-rated fatigue / daily functioning - Hospitalization after esophagectomy (days) - Intensive care unit stay after esophagectomy (days) ### Location - Facility: Radboud UMC, Nijmegen, Gelderland, 6525GA, Netherlands @@
## phenotypeS in Non Ambulant Duchenne Muscular Dystrophy - NCT ID: NCT06366815 - Study ID: 4619 - Status: RECRUITING - Start Date: 2022-08-30 - Completion Date: 2025-12-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function ### Conditions - Duchenne Muscular Dystrophy - Natural History - Motor Function; Retardation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Different Phenotypes of non ambulant patients with Duchenne Muscular Dystrophy ### Outcomes Primary Outcomes - motor function - respiratory function - cardiac function Secondary Outcomes - identify patterns of severity and of progression related to differnt genotypes ### Location - Facility: IRCCS catholic univeristy, Roma, N/A, N/A, Italy @@
## Cohort Construction and Prognostic Model Construction for Multiple Myeloma - NCT ID: NCT06366802 - Study ID: Prognosis model-MM09 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-05-03 - Completion Date: 2027-05-02 - Lead Sponsor: The First Affiliated Hospital of Soochow University ### Study Description Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes. ### Conditions - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Progression free survival(PFS) ### Location - Facility: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China @@
## Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia - NCT ID: NCT06366789 - Study ID: ZE46-0134-0002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-12 - Lead Sponsor: Eilean Therapeutics ### Study Description This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 mutated Relapsed or Refractory Acute Myeloid Leukemia ### Conditions - AML With Gene Mutations ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ZE46-0134 ### Outcomes Primary Outcomes - The incidence of DLTs Secondary Outcomes - Incidence of AE/SAE - Incidence of clinically significant abnormal laboratory results - Incidence of abnormal clinically significant ECG results - Number of patients with AEs of Grade ≥ 3 - Number of treatment-related deaths - Plasma Cmax - Plasma Css - Plasma Cmin - Plasma AUC - Number of patients attaining any type of Complete Remission (CR, CRh, CRi) by Cycle 6 - Number of patients attaining CR by Cycle 6 - Number of patients attaining response (CR, CRh, CRi, MLFS) by Cycle 6 ### Location - Facility: Linear Clinical Research Ltd, Perth, Nedlands, WA, 6009, Australia @@
## Emulated Study of Vitamin D Correction vs Non-Correction - NCT ID: NCT06366776 - Study ID: 23-278 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: The Cooper Health System ### Study Description * This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database.* The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels. ### Conditions - Vitamin D Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A. - Ten healthcare utilization parameters among the corrected Treatment Group and the uncorrected Control Group A. Secondary Outcomes - Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B). - Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Gradient Pressure Elastic Stocking Treatment After Endovenous Radiofrequency Ablation - NCT ID: NCT06366763 - Study ID: ChengduUTCMvs5 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-08-01 - Lead Sponsor: Chengdu University of Traditional Chinese Medicine ### Study Description Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. ### Conditions - Vascular Diseases, Peripheral - Venous Insufficiency of Leg - Varicose Veins of Lower Limb ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Questionnaires ### Outcomes Primary Outcomes - Pain after radiofrequency ablation - Bleeding after radiofrequency ablation - Tension blisters after radiofrequency ablation Secondary Outcomes - The rate of occlusion of treated vein post-procedure - Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14) - Clinical Change using Venous Clinical Severity Score (VCSS) ### Location - Facility: Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, 610000, China @@
## A Study of Barzolvolimab in Patients With Prurigo Nodularis - NCT ID: NCT06366750 - Study ID: CDX0159-10 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-06 - Lead Sponsor: Celldex Therapeutics ### Study Description The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis. ### Conditions - Prurigo Nodularis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - barzolvolimab - Matching Placebo ### Outcomes Primary Outcomes - Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12. Secondary Outcomes - Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4. - Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24. - Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24). - Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24. - Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24. - Proportion of participants with Investigator Global Assessment for activity of chronic prurigo (IGA-CPG-A) score of 0 or 1 at Weeks 4, 12 and 24. - Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24. - Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24. - Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24. - Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24. - Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24. - Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24. - Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24. - Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24. - Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. - Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. - Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24. - Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24. - Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24. - Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24. - Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24. - Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD. - Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24. - Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study. ### Location - Facility: Revival Research Institute, LLC, Troy, Michigan, 48084, United States @@
## En-mass Retraction by Lingual Retractor Versus Clear Aligner Appliances - NCT ID: NCT06366737 - Study ID: CEBD-CU-2024-03-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Cairo University ### Study Description en-mass retraction by lingual retractor versus clear alighner therapy ### Conditions - Maxillary Prognathism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lingual Retractor Appliance - clear aligner ### Outcomes Primary Outcomes - patient satisfaction ( time , cost , quality) Secondary Outcomes - inclination of upper anterior teeth ### Location - Facility: Faculty of Dentistry, Cairo, N/A, N/A, Egypt @@
## LIFT: Life Improvement Trial - NCT ID: NCT06366724 - Study ID: 2024P000087 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-06 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance.This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial.The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete.The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition. ### Conditions - ME/CFS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Pyridostigmine - Low-Dose Naltrexone - Placebo ### Outcomes Primary Outcomes - Functional Capacity - Physiologic Response - Oxygen Uptake Efficiency Slope (OUES) - Physiologic Response - Oxygen Utilization (VO2) - Physiologic Response - Heart Rate Recovery (HRR) Secondary Outcomes - Post-Exertional Malaise - PROMIS-29-Pain - Daily Activity - Heart Rate Variability - Blood Oxygen - Resting Heart Rate - DANA Brain Vital-Simple Reaction Time (SRT) - DANA Brain Vital-Procedural Reaction Time (PRT) - DANA Brain Vital-Memory Search (MS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remote Telemedicine Fetal Monitoring Feasibility Study - NCT ID: NCT06366711 - Study ID: 23/BW/MAT/NO/754 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Birmingham Women's NHS Foundation Trust ### Study Description During pregnancy, certain conditions may arise that mean regular monitoring of both mother and baby are needed to ensure timely interventions and avoid the need for further treatments. These situations include problems with high blood pressure, obstetric cholestasis (characterised by liver-related itchiness), preterm premature rupture of membranes (PPROM), and a history of stillbirth. Monitoring typically involves assessing the mother's blood pressure and urine, recording the baby's heart rate over a specific duration, and conducting regular ultrasound scans. Such monitoring can require frequent hospital visits, often multiple times a week, which can be very time consuming. More recently, new technology has emerged, enabling remote monitoring of mother and baby outside of the hospital setting, such as their own home. However, research on these technologies is still very limited.Our study aims to address this research gap by inviting women with the above conditions to volunteer for home-based monitoring, alongside their routine hospital care. Participants will be divided into three groups: one group will use transducers, attached to the mothers tummy, to capture the baby's heartbeat; another group will use a handheld ultrasound device connected to their mobile phones, allowing them to observe the baby; and a third group will use both devices. All device information will be transmitted securely to the healthcare professional for analysis. The investigators aim to assess the feasibility of conducting remote monitoring of mother and baby, whilst understanding how acceptable the technology is received.Importantly, the data collected will only be evaluated by the research team and will not be intended to influence patient's current planned antenatal care. Women will receive comprehensive training on the devices. The study will additionally gather feedback from participating women through questionnaires, both at the study's outset and its conclusion, regarding their experiences and emotions related to the research. ### Conditions - Pregnancy, High Risk - Telemonitoring - Telemedicine - Ultrasound - Cardiotocography ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Pregnabit Pro device and PregnaOne platform - Pulsenmore device ### Outcomes Primary Outcomes - The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring. - The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring. Secondary Outcomes - The number of participants completing the full schedule of home maternal-fetal monitoring episodes. - To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home? - The number of women approached who agreed to participate within the study. - What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring. - What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring. - What are the emotions of participants prior to and following usage of home maternal-fetal monitoring. - What are the emotions of participants prior to and following usage of home maternal-fetal monitoring. - The number of participants with unexpected clinical outcomes detected whilst using home monitoring devices, which warrants patients to attend maternity triage for assessment and/or modification of ones antenatal care. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia - NCT ID: NCT06366698 - Study ID: 23-55 - Status: RECRUITING - Start Date: 2023-11-21 - Completion Date: 2025-12-30 - Lead Sponsor: Arrowhead Regional Medical Center ### Study Description This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded. ### Conditions - Iron Deficiency Anemia of Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Venofer 200 MG Per 10 ML Injection - Ferrous sulfate ### Outcomes Primary Outcomes - Hemoglobin difference - Ferritin difference - Delivery Hemoglobin - Rates of blood transfusion - Symptoms Secondary Outcomes - Preterm delivery - Depression - Birthweight ### Location - Facility: Arrowhead Regional Medical Center, Colton, California, 92324, United States @@
## Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy - NCT ID: NCT06366685 - Study ID: YJS20230170 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-02-01 - Lead Sponsor: Mengmeng Yuan ### Study Description Esophageal cancer imposes a significant burden in China, accounting for over 60% of the global disease burden. While surgery remains a common and highly effective treatment for esophageal cancer, patients often experience multiple physical and psychological symptoms postoperatively, severely affecting their recovery outcomes and quality of life. Although existing exercise or psychological intervention programs have shown some effectiveness, issues such as relatively singular intervention content, imprecise intervention timing, and vague intervention details persist.This project, based on previous research foundations (including the development of symptom measurement tools and the identification of key recovery periods), is guided by symptom management theory and knowledge translation models. Taking a perspective of the synergistic impact of physical and psychological symptoms, the study focuses on patients undergoing esophageal cancer surgery. Initially, evidence-based literature review, focus group interviews, and expert consultations were conducted to develop a combined exercise and psychological intervention program, integrating subjective (CSCA_EC) and objective (6MWT) measurement indicators, named "Recovery For EC." Subsequently, the program was preliminarily applied in clinical settings using a mixed-methods approach, combining quantitative quasi-experimental design (108 cases) and qualitative interviews to assess its acceptability. The final clinical trial version of the Recovery For EC program was developed to provide patients with a tool for self-monitoring recovery outcomes and offer clinical healthcare professionals guidance for implementing precise and personalized rehabilitation management. ### Conditions - Esophageal Cancer - Exercise Training - Psychotherapy - Rehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise and Psychological Intervention ### Outcomes Primary Outcomes - the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC) Secondary Outcomes - 6-Minute Walk Test - Hospital Anxiety and Depression Scale (HADS) - Postoperative Complications ### Location - Facility: Anhui Medical University, Hefei, Anhui, 234000, China @@
## Evaluating the Human Immune Response to the JYNNEOS Vaccine - NCT ID: NCT06366672 - Study ID: 202312043 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Washington University School of Medicine ### Study Description This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow. ### Conditions - Vaccinia - Virus Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection - Phlebotomy - Research bronchoscopy - Skin punch biopsy - Bone marrow aspiration ### Outcomes Primary Outcomes - Change in magnitude of the MVA-BN antigen-specific T cell response in the blood - Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma Secondary Outcomes - Change in magnitude of the MVA-BN antigen-specific T cell response in the lower airways - Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid ### Location - Facility: Washington University in Saint Louis School of Medicine Emergency Care and Research Core, Saint Louis, Missouri, 63110, United States @@