pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
AR/VR for Ultrasound-guided Medical Procedures
NCT Number: NCT06550193
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Augmented Reality|Virtual Reality
Interventions: DEVICE: Ultrasound-guided procedure using AR/VR technology
Sponsor: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2025-09
Completion Date: 2025-12
Locations: Stanford University, Stanford, California, 94305, United States

Summary:
The study seeks to assess the efficacy of incorporating augmented reality (AR) or virtual reality (VR) technology into ultrasound-guided medical procedures such as regional anesthesia and line placement. By utilizing AR/VR devices, the investigators will improve the ergonomics when using ultrasound to guide procedures. The aims are to enhance visualization of anatomical structures and improve procedural accuracy for clinicians. The study aims to evaluate the feasibility, and effectiveness of integrating AR/VR technology into ultrasound-guided procedures, with the ultimate goal of improving patient outcomes.

Primary Outcome Measures: Procedure success rate (Primary Block), Document the block result in pre-op, if feasible, or PACU by testing sensory (cold spray) and motor function on all nerves covered by the block, Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU|Post-operative opioid consumption, Morphine milligram equivalents (MME) will be measured post-operatively, 12 hours after surgery|Post-operative pain scores, Trend pain scores on 11-point NRS scale (from 0 to 10) following the procedure, 12 hours after surgery
Secondary Outcome Measures: Clinician satisfaction, A short survey will be utilized to gather data on clinicians' perceptions of the ease of use, effectiveness, and overall experience with AR/VR tools compared to traditional methods., Within 24 hours of block completion|Procedure duration, Time of procedure from initial needle insertion to needle removal will be calculated, During the procedure|Needle pass/redirection, The number of times a clinician must remove the needle from the patient completely and reattempt will be calculated., During the procedure|Needle visualisation, A subjective score will be assessed on a short survey to clinicians., Within 24 hours of block completion
The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia
NCT Number: NCT06550180
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Abdominoplasty|Spinal Anaesthesia|Transversus Abdominis Plane Block (TAP Block)
Interventions: DRUG: Spinal anaesthesia group (S)|DRUG: Subcostal TAP block and spinal anesthesia group (STAP)
Sponsor: Helwan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2024-09-28
Locations: Egyptian liver hospital, Mansoura, Egypt

Summary:
The primary outcome is the time to first request of opioid analgesia. The secondary outcomes are intraoperative analgesic needs, incidence of conversion to general anaesthesia, the total opioid dose in 24 hours, Visual analogue scale (VAS) scores at 2, 4, 6, 12, and 24 hours postoperatively, and the incidence of postoperative side effects (nausea, vomiting, hypotension, bradycardia, and pruritic).

Primary Outcome Measures: The primary outcome is the time to first request of opioid analgesia., assessment of pain by visual analogue scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end., 24 hours
Secondary Outcome Measures: total dose of intraoperative analgesic needs, opioid dose by microgram, 24 hours
Neuroprotective Effect of (Nano PSO), in Patients Who Used to Consume Psychoactive Substances
NCT Number: NCT06550167
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Addiction;Drug(S);LSD|Neuroprotective
Interventions: DIETARY_SUPPLEMENT: Nano-PSO, Pomegranate seed oil (omega-5)|OTHER: PLACEBO
Sponsor: Distribuidora Biolife SA de CV
Sex: MALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2027-03-15
Locations: Irene Guadalupe Aguilar García PhD., Guadalajara, Jalisco, Mexico

Summary:
Addiction problems to psychoactive substances are becoming more frequent, which implies a serious health problem, with social, family and work repercussions. Participants with chronic consumption present important degeneration processes mediated by Neuroinflammation, oxidative stress and excitotoxicity. At the moment there is no effective treatment that can reduce the damage. The effectiveness of Omega 5 has been demonstrated in different disorders of the nervous system; However, very little has been elucidated about the mechanisms of regulation and activation in consumer patients. Omega 5 Nano-PSO has an important role in mechanisms of cell survival in different pathological events.

In this project aims to explain the possible mechanisms underlying the morphological changes and pathologies associated with oxidative stress and inflammation, since it could be a useful strategy to counteract the effects of substances of abuse on brain cells.

Omega 5 (Nano PSO) will modify the levels of neurotrophic factors through the decrease in inflammation and reactive oxygen species in patient-consumers of substances, reducing neuronal death and therefore cognitive deterioration. Methodological design Type of study: Clinical trial, randomized controlled, double blind. Research Headquarters: This work will be carried out at the University Center for Health Science with the participation of the "My family is waiting for me" rehabilitation centers. Study Period: 2 years

Primary Outcome Measures: Serum Brain-derived neurotrophic factor (BDNF) and Vascular endothelial growth factor VEGF Concentrations after treatment, ELISA kittesting will be performed on blood samples to measure BDNF and VEGF concentrations before and after Nano PSO treatment., A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
Secondary Outcome Measures: Changes in the Montreal Cognitive Assessment (MoCA) after treatment., A neuropsychological battery will be designed to evaluate different cognitive aspects and the results of (Montreal Cognitive Assessment (MoCA) obtained will be interpreted., A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers
NCT Number: NCT06550115
Acronym: SHINE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Circadian Rhythm Sleep Disorder of Shift Work Type|Metabolic Disease|Insulin Sensitivity|Blood Pressure
Interventions: BEHAVIORAL: Time-restricted eating|BEHAVIORAL: Control eating
Sponsor: Colorado State University
Collaborators: University of Colorado, Denver|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2029-06
Locations: Colorado State University, Fort Collins, Colorado, 80523, United States

Summary:
People who experience repeated bouts of circadian misalignment, such as shift workers, are at higher risk of cardiovascular disease (CVD) and Type 2 diabetes (T2D) compared to daytime workers. However, the mechanism(s) by which shift work and associated circadian misalignment increase CVD and T2D risk are unknown. This project will examine whether elevated plasma lipids are a mechanism by which circadian misalignment impairs vascular function, insulin sensitivity, glucose homeostasis and muscle lipid accumulation, which could be targeted to prevent and treat cardiometabolic disease in people who chronically experience circadian misalignment, which includes more than 20% of the US workforce.

Primary Outcome Measures: Blood pressure via 24-hour assessments, Four weeks of TRE during shift work will reduce 24-hour blood pressure versus Control., Collected during inpatient laboratory visit after 4 weeks of Control and TRE|Insulin sensitivity via clamp, Four weeks of TRE during shift work will improve insulin sensitivity versus Control., Collected during inpatient laboratory visit after 4 weeks of Control and TRE
Secondary Outcome Measures: Cerebrovascular reactivity via transcranial doppler, Four weeks of TRE during shift work will improve cerebrovascular reactvity versus Control., Collected during inpatient laboratory visit after 4 weeks of Control and TRE|Muscle lipid accumulation via lipidomics, Four weeks of TRE during shift work will reduce muscle lipid accumulation versus Control., Collected during inpatient laboratory visit after 4 weeks of Control and TRE
Other Outcome Measures: 24-hour blood sampling for lipids, glucose, insulin, and vascular markers, Four weeks of TRE during shift work will improve 24-hour markers of vascular function versus Control., Collected during inpatient laboratory visit after 4 weeks of Control and TRE
Drug Response Profiling (DRP) Registry Zurich for Hematological Malignancies
NCT Number: NCT06550102
Acronym: DRP_ZH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hematological Malignancies
Sponsor: University Children's Hospital, Zurich
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-04
Completion Date: 2031-12-31
Locations: University Children's Hospital Zurich, Zurich, ZH, 8032, Switzerland

Summary:
This study is a prospective, non-randomized feasibility study of drug response profiling (DRP) in pediatric blood cancers. Primary cancer cells are isolated from patients and screened ex vivo at single-cell resolution using automated fluorescence microscopy. Drug sensitivity fingerprints are integrated with genetic annotations to inform the treating physician about personalized treatment options. The study aims to determine the practicability of real-time drug response profiling and its actionability in identifying patient-specific cancer dependencies in refractory disease settings.

Primary Outcome Measures: Feasibility of real-time ex vivo drug screening, Rate of successful single-cell, image-based drug response profiling assays which are reported to the treating physician., 10 days
Secondary Outcome Measures: Translation to clinic, Percentage of DRP assays translated into the clinic, i.e. the referring physician decides to treat the patient with one or more of the top-ranking drugs identified by DRP, 10 day|In vitro sensitivity of cancer cells to drug perturbations, Exploring drug sensitivity and resistance patterns by ex vivo DRP and correlations to genetic characteristics and clinical response., 1 month
High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth
NCT Number: NCT06550089
Acronym: HOLDOUT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postpartum Hemorrhage|Pregnancy Complications|Cesarean Section Complications
Interventions: DRUG: Oxytocin
Sponsor: University of Chicago
Collaborators: Medical College of Wisconsin
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-12

Summary:
This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.

Primary Outcome Measures: Screen failure rate, Number of individuals who are eligible for the study but do not consent to participate, Within 8 hours prior to cesarean delivery|Fidelity rate, Frequency of fidelity to the trial, Within 8 hours prior to cesarean delivery|Trial retention rate, Frequency of participant completion of all study visits, Up to 6 weeks after cesarean delivery|Acceptability of the intervention, Frequency of acceptability of the intervention by both participants and their providers, Up to 6 weeks after cesarean delivery
Secondary Outcome Measures: Maternal flushing, During and up to 6 hours after cesarean delivery|Maternal hypotension, Mean arterial blood pressure less than 65 mmHg, During and up to 6 hours after cesarean delivery|Maternal nausea/vomiting, During and up to 6 hours after cesarean delivery|Myocardial ischemia, During and up to 24 hours after cesarean delivery|Cardiac arrhythmia, During and up to 24 hours after cesarean delivery|Quantitative blood loss greater than 1 liter, Within 24 hours after cesarean delivery|Need for blood product transfusion, inclusive of type and number of blood products transfused, Within 4 days after cesarean delivery|Frequency of increase in oxytocin rate in low-dose arm, During and up to 6 hours after cesarean delivery|Additional use of uterotonics and/or tranexamic acid, During and up to 24 hours after cesarean delivery|Placement of intrauterine balloon tamponade or suction device, During and up to 24 hours after cesarean delivery|Surgical management of hemorrhage, inclusive of hysterectomy, During and up to 24 hours after cesarean delivery|Intensive care unit admission, During and up to 24 hours after cesarean delivery|Maternal death, During and up to 6 weeks after cesarean delivery|Readmission to the hospital or reoperation, Up to 6 weeks after cesarean delivery
HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes
NCT Number: NCT06550063
Acronym: HERA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophagus Cancer|Gastric Cancer|HER2-positive Cancer|HER2-low Cancer
Sponsor: St. James's Hospital, Ireland
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2188
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2025-08-31
Locations: Trinity St James Cancer Institute, Dublin, Leinster, D08 NHY1, Ireland

Summary:
Targeted therapies offer promise to improve oncologic outcomes in esophagogastric adenocarcinoma (EGA). The landmark 'Trastuzumab for gastric cancer (ToGA)' trial established the therapeutic value of Human Epidermal Growth Factor Receptor 2 (HER2) directed therapy in advanced gastric and esophagogastric junction adenocarcinoma, setting a standard of care. Further studies, such as DESTINY-gastric01 and DESTINY-gastric02, have demonstrated the efficacy of antibody-drug conjugates (ADCs) targeting HER2-positive gastric and junctional tumours. The use of HER2-directed therapies in the curative intent setting has more recently been evaluated with favourable outcomes in phase II studies. However, data regarding the prevalence and prognostic significance of HER2 overexpression among patients undergoing treatment with curative intent are limited. Furthermore, few studies have evaluated the clinical significance of intratumoural and tumour-metastatic heterogeneity of HER2 expression, and the finding of HER2-low, in this context, which may have important implications for implementation of neoadjuvant targeted therapies in future. While limited single centre series have evaluated the clinicopathologic significance of HER2 status in EGA, no previous international multicentre study of this nature has been reported.

The goal of this international, multi-center, retrospective observational study is to elucidate the prevalence and clinical significance of HER2 expression in patients with EGA across different regions globally. The study also aims to assess the clinical significance of HER2 heterogeneity in a large, international cohort of patients with EGA, and its association with clinicopathological outcomes in patients with advanced and recurrent disease.

Primary Outcome Measures: Geographical variation in HER2 status, 2000 - 2024
Secondary Outcome Measures: Clinical TNM stage, 2000 - 2024|Overall survival, 2000 - 2024
Clinical and Molecular Features of Oral Premalignancy and Oral Cancer
NCT Number: NCT06550050
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Oral Cancer
Interventions: BEHAVIORAL: Radiation
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-31
Completion Date: 2066-12-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
Investigators will employ serial assessments of tissue biopsy and additional biomarkers that reflect burden of disease and predict treatment response. Patients enrolled on this study will be given the option to provide biological samples before, during, and after treatment, as well as functional outcomes of treatment response. These samples will be utilized to develop and validate prognostic and predictive biomarkers for patients undergoing targeted therapy, immunotherapy, surgery, chemotherapy, and/or radiotherapy.

Primary Outcome Measures: MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), The MDASI-HN is a patient-reported outcome questionnaire designed to measure the severity or burden of systemic and head- and neck-specific symptoms and their interference with or effect on patients' daily functioning (Rosenthal, Mendoza et al. 2007, Cleeland 2016). This 28-item multi-symptom inventory is rated according to the last 24 hours at their worst, with 0 being symptoms not present and 10 being as bad as the patient can imagine. Cronbach alpha reliability ranges from 0.72 to 0.92., up to 5 years
Secondary Outcome Measures: M.D. Anderson Dysphagia Inventory (MDADI), The M.D. Anderson Dysphagia Inventory (MDADI) is a written questionnaire to evaluate dysphagia-specific QOL in head and neck cancer patients (Chen, Frankowski et al. 2001). Dysphagia (swallowing difficulty) is a top priority of HNC survivors and a driver of QOL after treatment. The 20-item MDADI questionnaire quantifies an individual's global, physical, emotional, and functional perceptions of his or her swallowing ability. In an internal validation in 100 patients with HNC, concurrent validity was found to be moderate by comparison with the Performance Status Scale (Spearman correlation, 0.47-0.61). Correlation with the physical functional subscale (Spearman correlation, 0.40) and emotional subscale of SF-36 (Spearman correlation, 0.36) demonstrated convergent and divergent validity, respectively, of the MDADI. Test-retest reliability (physical, 0.86; emotional, 0.88; functional, 0.88) and international consistency reliability (overall Cronbach's alpha, 0.96) were sound., up to 5 years
Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
NCT Number: NCT06550011
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Neovascular (Wet) AMD
Interventions: DRUG: ABI-110 Low Dose|DRUG: ABI-110 Medium Dose|DRUG: ABI-110 High Dose
Sponsor: Avirmax Biopharma Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2030-02
Locations: California Retina Consultants, Bakersfield, California, 93309, United States|Bay Area Retina Associates, Walnut Creek, California, 94598, United States|Retina Research Institute of Texas, Abilene, Texas, 79606, United States|Retina Consultants of Texas - San Antonio, San Antonio, Texas, 78240, United States|Retina Consultants of Texas, The Woodlands, Texas, 77384, United States

Summary:
This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.

Primary Outcome Measures: Safety and Tolerability, Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\], 52 weeks
Secondary Outcome Measures: Preliminary Efficacy, Change from baseline to Week 52 after ABI-110 treatment in BCVA as assessed by ETDRS chart at a starting distance of 4M, 52 weeks|Pharmacokinetics, Maximum Plasma Concentration \[Cmax\], 52 weeks|Immunogenicity, Changes in Anti-AAV2 antibodies (ADA) and anti-VEGF-Trap antibodies in serum, 52 weeks|Optimal Dose, To determine the optimal dose of IVT ABI-110 injection for later phases of study, 52 weeks
Predictive Role of KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of AIS
NCT Number: NCT06549972
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Ischemic Stroke
Interventions: OTHER: Acute Ischemic Stroke
Sponsor: Ruijin Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 273
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2025-03-31
Locations: Neurology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200025, China

Summary:
This study aims to investigate the dynamic changes and differential expression characteristics of neuroinflammatory molecules such as kallikrein-related peptidase 10 (KLK10), soluble triggering receptor expressed on myeloid cells 2 (sTREM2), and glial fibrillary acidic protein (GFAP) in the plasma of patients with first-ever anterior circulation acute ischemic stroke (AIS). It will analyze the correlation between these molecules and the severity of neurological deficits, infarct volume, brain edema, hemorrhagic transformation, progressive stroke, and clinical outcomes at three months. The goal is to assess the predictive value of these molecules for AIS prognosis, guiding early treatment and new molecular targets for prevention and treatment.

Primary Outcome Measures: the Modified Rankin Scale (mRS) score, 0 No symptoms.1 No significant disability; able to carry out all usual activities, despite some symptoms. 2 Slight disability; able to look after own affairs without assistance, but unable to carry out all previous activities. 3 Moderate disability; requires some help, but able to walk unassisted.4 Moderately severe disability; unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 Severe disability; requires constant nursing care and attention, bedridden, incontinent. 6 Dead., Record the Modified Rankin Scale (mRS) score at 3 months after stroke onset
Secondary Outcome Measures: the mortality, mortality, Record mortality at 3 months after stroke onset|the occurrence of hemorrhagic transformation, based on brain CT scans to evaluate hemorrhagic transformation of cerebral infarction., Record hemorrhagic transformation within 7 days after stroke onset|the occurrence of progressive stroke, Neurological deficits are assessed using the NIHSS score. Progressive stroke is diagnosed if the NIHSS score increases by 2 points within 7 days after stroke onset., Record progressive stroke within 7 days after stroke onset
A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
NCT Number: NCT06549959
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Telitacicept Pre-filled Injection 80mg|DRUG: Telitacicept Freeze-dried powder Injection 80mg
Sponsor: RemeGen Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 248
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2024-12-31
Locations: The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, 550004, China|West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China|Tianjin People's Hospital, Tianjin, Tianjin, 300191, China

Summary:
This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.

Primary Outcome Measures: C-max, Maximum observed plasma concentration, Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57|AUC0-∞, Area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration, Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57
Secondary Outcome Measures: T-max, Time to reach maximum observed plasma concentration, Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57|Evaluation of AEs (adverse events), Through observing number of total AEs and number of subjects with AEs and other factors of AEs #to evaluate the safety and tolerance of healthy subjects., Up to Day 57
Ixovex-1 Single Agent and Combination Therapy
NCT Number: NCT06549946
Acronym: IXACT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumor|Head and Neck Cancer
Interventions: BIOLOGICAL: Ixovex-1|BIOLOGICAL: Pembrolizumab
Sponsor: Psivac Ltd
Collaborators: IQVIA Biotech
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-09
Completion Date: 2027-01-30
Locations: The Royal Marsden, London, SW3 6JJ, United Kingdom

Summary:
This is an open-label, dose de-escalating, non-randomised, multi-centre phase I/II study to determine safety and efficacy of the oncolytic virus, Ixovex-1 administered by intratumoural (IT) injection. This will be assessed in patients with palpable locally advanced, unresectable, or metastatic tumours, for whom all approved therapeutic options have been exhausted, are not available, are unlikely to have significant clinical benefit, or are declined by the patient.

Primary Outcome Measures: To determine the safety profile of Ixovex-1 when administered by intratumoural injection alone or in combination with Pembrolizumab in patients with unresectable, locally advanced, or metastatic solid tumours., Percentage of subjects with DLTs during the DLT period \[Day 1 to Day 28\].

Percentage of subjects with SAEs, overall and by maximum severity \[Day 1 to 30 days after last dose\].

Percentage of subjects with TEAEs, overall and by maximum severity \[Day 1 to 30 days after last dose\]., Through study completion, an average of 2 years|To determine the MTD and recommended Phase 2 dose of Ixovex-1., Percentage of subjects with TEAEs, overall and by maximum severity \[Day 1 to 30 days after last dose\]., Through study completion, an average of 2 years
Secondary Outcome Measures: To assess clinical efficacy using a combination of radiological imaging, medical photography, and histology., Overall response rate (CR + PR).

Best overall confirmed response - percentage of subjects at each response level (CR, PR, SD, PD)., Through study completion, an average of 2 years|Assessment of antitumour effects in injected tumours and in non-injected tumours., Change in cumulative tumour size., Through study completion, an average of 2 years
The Effect of Cryostimulation on Inflammation and Motor Functions. The Study Was Conducted to Determine the Effect of Five Days of Whole-body Cryostimulation (PBC) on Reducing Inflammation and Improving Motor Skills in Soccer Players
NCT Number: NCT06549933
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rest|Training
Interventions: OTHER: Criostymulation
Sponsor: Poznan University of Physical Education
Sex: MALE
Age: ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-11-25
Completion Date: 2024-04-15
Locations: Poznań University of Physical Education, Poznań, 61-871, Poland

Summary:
The aim of the study was to determine the effect of a 5-day PBC on reducing inflammation and improving motor skills in soccer players during the initial phase of the training period.

The five-day cryostimulation applied did not significantly affect the profile of inflammatory markers in soccer players. However, a reduction in visuo-motor reaction time (RT) was registered in PBC-treated soccer players, suggesting the potential benefits of this method in improving motor skills.

Primary Outcome Measures: IL-6 (Interleukin-6), Immunoenzymatic assay method using a diagnostic ELISA Kit, Before, after 3 days and 5 days of cryostimulation|TNF-alpha (Tumor necrosis factor-alpha), Immunoenzymatic assay method using a diagnostic ELISA Kit, Before, after 3 days and 5 days of cryostimulation|IL-10 (Interleukin-10), Immunoenzymatic assay method using a diagnostic ELISA Kit, Before, after 3, and 5 days of cryostimulation|CK (creatine kinase), Immunoenzymatic assay method using a diagnostic ELISA Kit, Before, after 3, and 5 days of cryostimulation|Cortisol, Immunoenzymatic assay method using a diagnostic ELISA Kit, Before, after 3, and 5 days of cryostimulation|Testosterone, Immunoenzymatic assay method using a diagnostic ELISA Kit, Before, after 3, and 5 days of cryostimulation
Secondary Outcome Measures: Anthropometric measurments, Analysis of body composition, Tanita BC-418, Before, after 3, and 5 days of cryostimulation
Danish Breast Cancer Group Internal Mammary Node Study
NCT Number: NCT06549920
Acronym: DBCG IMN
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: RADIATION: Internal mammary node irradiation
Sponsor: Danish Breast Cancer Cooperative Group
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 7630
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2003-01-01
Completion Date: 2034-01-01

Summary:
The DBCG IMN study is a nationwide prospective population-based cohort study allocating node-positive breast cancer patients with right-sided tumors to internal mammary node irradiation (IMNI) and patients with left-sided tumors to no IMNI.

Primary Outcome Measures: Overall survival, Censored at end of study or by emigration., 15-years.
Secondary Outcome Measures: Breast cancer mortality, Censored at end of study or by emigration., 15-years.|Distant recurrences, Censored at end of study or by emigration. Death by any cause was regarded as competing event., 15-years.
Evaluation of Biomechanical Forced During the Practice of Endoscopic Submucosal Dissection
NCT Number: NCT06549894
Acronym: ENDERGO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endoscopic Submucosal Dissection|Physiology|Musculoskeletal Disorders
Interventions: PROCEDURE: Performing endoscopic examinations
Sponsor: Centre Hospitalier Universitaire, Amiens
Collaborators: Hospices Civils de Lyon|University Hospital, Lille|Rennes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-09
Locations: Centre Hospitalier Universitaire d'Amiens, Amiens, Picardie, 80000, France

Summary:
The prevalence of musculoskeletal disorders (MSDs) among endoscopists is estimated between 29 and 89%. The most common disorders are carpal tunnel syndrome, De Quervain tenosynovitis, lateral epicondylitis and neck pain. Factors associated with MSD among gastroenterologists practicing endoscopy are: the high number of procedures (more than 20/week), the procedure time (more than 16 hours/week) and the number of years of practice.With the evolution of digestive endoscopy superficial cancer can endoscopically be removed by endoscopic submucosal dissection (ESD) avoiding surgical resections. The number of procedures is increasing, with longer examination times in case of ESD (about 2 hours). This volume of hours and procedures may in the near future further increase the risk of MSDs in the population of gastroenterologists. Some good practice recommendations have been proposed to improve practitioner comfort, similar to what is recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a seat during the procedure. There is little data on the biomechanical forced experienced by an endoscopist when performing endoscopy and colonoscopy, and none when performing ESD.

The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during an ESD the practice of submucosal dissection.

Primary Outcome Measures: variation of muscle angular during submucosal dissection, day 1
Emergent Laparoscopic Cholecystectomy With ICG Cholangiography
NCT Number: NCT06549881
Acronym: ELG-ICGC
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Cholestatic Hepatitis
Interventions: PROCEDURE: emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 97
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2024-08-01
Locations: Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, Beijing, 100730, China

Summary:
A consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. The patients were recruited in PUMCH emergency department from 2023 to 2024.

Primary Outcome Measures: incidence of intraoperative accidental bile tract injury, The primary outcome is incidence of intraoperative accidental injury involving the bile tract in emergent laparscopic cholecystectomy guided by ICG fluorescence. The injury manifests as biliary obstruction, biliary leak, or biliary stricture. Medical records will be reviewed to identify an intraoperative bile tract injury event., within 1 month after after discharge|incidence of postoperative complications, incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay, within 1 month after discharge
Secondary Outcome Measures: duration of postoperative hospital stay, Days of postoperative hospital stay, within 1 month after discharge
PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
NCT Number: NCT06549855
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometrial Cancer|Endometrioid Carcinoma|Mismatch Repair Deficiency
Interventions: DRUG: Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA)
Sponsor: Peking University People's Hospital
Collaborators: Peking Union Medical College Hospital|Peking University Third Hospital|Huazhong University of Science and Technology|Tianjin Medical University|Shandong University|Shengjing Hospital|Beijing Chao Yang Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2029-10
Locations: Peking University People's Hospital, Beijing, Beijing, China

Summary:
The objective of this study was to investigate the feasibility of a PD-1 inhibitor in combination with progesterone as a means of preserving fertility in patients with early-stage mismatch repair-deficient (MMRd) endometrial cancer who wish to preserve fertility.

Primary Outcome Measures: Complete remission (CR) rate, No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor, From start of treatment to trial completion, an average of 3 months|Time to CR, Time to CR was calculated from the commencement of fertility-preserving treatment to the date of the initial hysteroscopic examination to confirm CR, From start of treatment to trial completion, an average of 3 months
Secondary Outcome Measures: Recurrence rate, After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurrences., 6 months, 1 year, 2 year, 3 year, 4 year, 5 year after CR|Pregnancy rate, A pregnancy test shows pregnancy after CR., 1 year after CR|Live birth rate, The live birth rate is defined as the ratio of live births to pregnancies., 1 year after pregnancy|Pathological biomarker, pathological markers(such as Ki-67, estrogen receptor, progesterone receptor, p53, PTEN, MLH1, PMS2, MSH2, and MSH6) at each hysteroscopy, From the start of treatment to CR，including 3 months, 6 months, 9 months, and so forth.|CA125, Used as a tumor marker for disease monitoring, From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.|Adverse reactions, Any unfavorable response resulting from the administration of any pharmaceutical agent utilized as part of the therapeutic regimen., From the start of treatment to trial completion，including 3 months, 6 months, 9 months, and so forth.
Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial
NCT Number: NCT06549842
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Bleeding|Arterial Puncture|Catheter Complications|Occlusion of Artery
Interventions: DRUG: Heparin|DEVICE: Terumo Radial Band|DEVICE: Vaosband
Sponsor: Regional Hospital of Scranton
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-08-15
Locations: Regional Hospital of Scranton, Scranton, Pennsylvania, 18510, United States

Summary:
The Safe and Fast Radial Hemostasis using Synergistic Strategies (SAFE \&amp; FAST) trial is an interventional study aimed at reducing the incidence of radial artery occlusion (RAO) rebound bleeding, and the required compression time after transradial approach (TRA) procedures, which have become the default access for coronary procedures globally. The hypothesis is that combining lower-dose heparin and radial hemostasis with simultaneous ipsilateral ulnar artery compression could achieve these improved outcomes.

Primary Outcome Measures: Rebound bleeding, Rebound bleeding necessitating the reapplication of the hemostatic compression., 24 hours|Radial artery occlusion, Post-procedural predischarge radial artery occlusion is evaluated between 30 minutes and 24 hours after the procedure., 24 hours|Hematoma formation, Hematoma formation during or after the procedure as ranked by the EASY criteria., 24 hours
the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Hepatocellular Carcinoma
NCT Number: NCT06549829
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma
Interventions: OTHER: Nutritional optimization-led triple prehabilitation Intervention|OTHER: Conventional triple prehabilitation Intervention
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-01

Summary:
The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Interventions will continue for two weeks prior to surgery. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1,3,6 months postoperatively.

Primary Outcome Measures: Postoperative serum prealbumin, peripheral blood, One day after surgery, three days after surgery, five days after surgery|Postoperative transferrin, peripheral blood, One day after surgery, three days after surgery, five days after surgery|Postoperative retinol-binding protein, peripheral blood, One day after surgery, three days after surgery, five days after surgery
Secondary Outcome Measures: Postoperative Six-minute walk test (6MWT), walk test for six minutes, One week after surgery|grading and incidence of various types of complications, complications grade and incidence, one month after surgery|postoperative length of stay, stay hospital time, stay hospital time, an average of 10 days|30-day readmission rate, readmission rate, postoperative for 30 days|patient long-term quality of life indicators (6 months), life quality, during postoperative for 6 month
Other Outcome Measures: Drainage tube removal time, remove abdominal drainage, Postoperative, an average of 3 days
Comparison of Method for Skin Closure in Colorectal Cancer.
NCT Number: NCT06549803
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Site Infection|Colorectal Cancer
Interventions: DEVICE: skin bond|DEVICE: skin stapler
Sponsor: Yoon Suk Lee
Collaborators: Dalim BioTech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 304
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-01
Completion Date: 2025-12-31
Locations: Seoul St.Mary's hospital, the Catholic university of Korea, Seoul, Seocho, 06591, Korea, Republic of

Summary:
Compared to tissue adhesives and skin stapling devices, tissue adhesives are reported to have advantages in terms of wound infection and cost competitiveness. However, there have been no prospective randomized studies focusing on wound infection rates and cost competitiveness between skin stapling devices and tissue adhesives in colorectal cancer surgery.

In colon cancer surgery, it is still unclear which skin suturing method has advantages such as lower postoperative wound infection rate and price competitiveness. The purpose of this study is to compare clinical outcomes, including wound infection rates and cost-effectiveness, between two different wound closure methods for colorectal cancer.

Primary Outcome Measures: incidence of surgical site infection within 30 days after surgery, Comparative analysis of the frequency of surgical site infection up to 1 month after surgery in each group when tissue adhesive was applied and when skin stapling device was applied., through study completion, an average of 1 year
Secondary Outcome Measures: Postoperative pain score, Post-operative pain score by VAS score were measured and compared with each other by understanding various factors through cost-effectiveness analysis, pain level, satisfaction, etc. after surgery between existing skin stapling and tissue adhesive for colon cancer patients., through study completion, an average of 1 year|Postoperative wound dressing cost, Postoperative wound dressing cost between existing skin stapling and tissue adhesive for colon cancer patients., through study completion, an average of 1 year
The YAM-project (Youth Aware of Mental Health)
NCT Number: NCT06549764
Acronym: YAM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prevention, Suicide
Interventions: BEHAVIORAL: Youth Aware of Mental Health
Sponsor: Mental Health Services in the Capital Region, Denmark
Collaborators: Karolinska Institutet
Sex: ALL
Age: CHILD
Enrollment: 900
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-08
Completion Date: 2027-12
Locations: Child and Adolescent Mental Health Services, Hellerup, 2900, Denmark

Summary:
Two-armed, cluster, randimized feasibility trial investigating the feasibility of the Youth Aware of Mental Health (YAM) intervention provided 9th grade students.

Primary Outcome Measures: Feasibility, acceptability and fidelity outcomes, Participation rates, i.e., percentage of parents and adolescent consenting to participate, Percentage of students attending the YAM classes (≥4 out of 5 sessions), Response rates of participating students to questionnaires at three and six months of follow-up, YAM questions regarding student endorsement, Checklist of milestones on the implementation plan, Three and six month follow-up
Secondary Outcome Measures: Paykel's Suicidal Feelings in the General Population Questionnaire, Five item tool with yes/no reply options, Baseline, 3 + 6 month follow-up|WHO Well-being Scale (WHO-5), Validated measure of adolescents' quality of life. Five-item, five point likert scale (Range: all the time to at no point in time), Baseline, 3 + 6 month follow-up|Depression, anxiety, and stress scale (DASS21), 21-item sacle incl. subscales; five point likert scale (range: did not apply to me to did apply to me all or most of the time), Baseline, 3 + 6 month follow-up|General help-seeking questionnaire, Help-seeking intentions \& behaviours; two nine-item, five point likerts scales(range very likely to very unlikely), Baseline, 3 + 6 month follow-up|Kessler's Psychological Distress Scale (K-10), A 10- + 5-item likert measure (range: all the time to not a any time point), Baseline, 3 + 6 month follow-up|YAM scales, Measures of stigma and literacy; 26-item scale, reply: True/False/don't know + 16-item, five-point likert scale (range: very much agree to very much disagree), Baseline, 3 + 6 month follow-up
The Fondazione Genomic SARS-CoV-2 Study (COVID-19)
NCT Number: NCT06549712
Acronym: FOGS
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COVID-19|Genetic Predisposition
Interventions: GENETIC: identify genetic determinants of the predisposition to develop respiratory failure|GENETIC: identify genetic determinants of the predisposition to develop respiratory failure|GENETIC: identify genetic determinants of the predisposition to develop respiratory failure
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2020-03-23
Completion Date: 2023-05-31
Locations: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, Milan, Milano, 20122, Italy

Summary:
Genetic association at the genomic level (genomewide association study - GWAS), requencing by NGS (whole exome sequencing) and gene expression studies to identify the main ones hereditary genetic determinants of predisposition to the development of SARS (symptomatic pathology associated with development of insufficiency respiratory disease of any degree) in Italian subjects affected by SARSCoV-2.

Primary Outcome Measures: SNPs as identified by GWAS, We will measure the differences in genetic background between patients with severe SARS-CoV-2 infection and healthy controls from the same geographical area, and identify the genetic differences between patients with severe SARSCoV infection2 and those with mild or moderate infection., up to 36 months
Secondary Outcome Measures: rare genetic variants identified by Whole Exome sequencing (WES), Examine the possible role of rare genetic variants in determining severe COVID-19 susceptibility in individuals who have developed severe respiratory failure despite lack of comorbidity and risk factors.

Deidentified DNA samples will be sequenced to assess the genetic risk profile at the genomic level. In addition, the frequency distributions of common genetic variants will be compared between donors who have eliminated infection without developing severe symptoms and patients hospitalized for respiratory failure., up to 36 months