pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial
NCT Number: NCT06489366
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urolithiasis|Proximal Ureteral Stone
Interventions: DEVICE: Thulium Fiber laser (TFL) lithotripsy|DEVICE: Ho: YAG lithotripsy
Sponsor: Zhongnan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-26
Completion Date: 2025-02-26
Locations: Zhongnan Hospital, Wuhan University,, Wuhan, Hubei, 430071, China

Summary:
The efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.

Primary Outcome Measures: Stone-free rate (SFR), Stone-free rate (SFR) after single-session laser lithotripsy using a semirigid ureteroscope without an auxiliary procedure assessed by CT/X-ray at 2-4 weeks follow-up after laser lithotripsy., 2-4 weeks after surgery
Secondary Outcome Measures: Operative time, the time of laser lithotripsy, Immediately during surgery|Intraoperative complications, bleeding, ureteral perforation, ureteral wall injury, or intraoperative adverse events leading to termination of surgery, Immediately during surgery|Postoperative complications, Occurrence of postoperative complications, 2-4 weeks after surgery|Additional procedures, If semi-rigid ureteroscopy combined with laser lithotripsy fails, it is converted to flexible ureteroscopy, PCNL, laparoscopic lithotomy. In addition, ESWL treatment is performed before the double-J stent is removed after surgery.lithotripsy, and postoperative ESWL treatment before removal of the ureteral stents, among others., Intraoperatively and before removal of the Ureteral stents
P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease
NCT Number: NCT06489340
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetic Kidney Disease
Interventions: DRUG: 2HPβCD
Sponsor: ZyVersa Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-07-11

Summary:
This is an open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) given intravenously in adult patients with type 2 diabetes with diabetic kidney disease (DKD) and proteinuria.

Primary Outcome Measures: Percent change in 24-hour urinary albumin to creatinine ratio (UACR), Percentage change in log-transformed urinary albumin to creatinine ratio (UACR) from day 1 (baseline) to week 12 (end of treatment), From Day 1 (baseline) to Week 12 (end of treatment)|Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability), Number of adverse events (AEs), serious adverse events (SAEs), discontinuations over the 12-week treatment period, 12 Weeks
Secondary Outcome Measures: Absolute change in 24-hour urinary albumin to creatinine ratio (UACR), Absolute change in log transformed 24-hour urinary albumin to creatinine ratio (UACR) from Day 1 (baseline) to Week 12 (end of treatment), From Day 1 (baseline) to Week 12 (end of treatment)|Absolute change in 24-hour urinary protein to creatinine ratio (UPCR), Absolute change in log transformed 24 hour urinary protein to creatinine ratio (UPCR) from Day 1 (baseline) to Week 12 (end of treatment), From Day 1 (baseline) to Week 12 (end of treatment)|Population trough pharmacokinetics of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD), Trough plasma concentration of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) on Day 1, Day 29, Day 57, and Day 85, compared with pre-dosing concentrations on Day 1 and Day 4, Day 1, Day 29, Day 57, Day 85|Effects of 2-HPβCD on hearing based on changes in pure tone air conduction threshold from Day 1 to Week 16, and percent changes in tinnitus, and sense of fullness or stuffiness in the ears based on a Hearing Monitoring Questionnaire, Changes in pure tone air conduction threshold based on audiometry testing from Day 1 to Week 16. Percent changes in the presence of tinnitus (ringing in the ears), and a sense of fullness or stuffiness in the ears based on responses to a Hearing Monitoring Questionnaire from Day 1 to Week 16, From Day 1 to Week 16
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
NCT Number: NCT06489327
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preoperative Anxiety
Interventions: DRUG: melatonin (Circadin ®) 0.2 mg/kg|DRUG: melatonin (Circadin ®) 0.4 mg/kg|DRUG: placebo group
Sponsor: Al-Azhar University
Collaborators: Al-Ayen Iraqi University
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-12
Completion Date: 2024-12-15
Locations: Facualty of Pharmacy, Al Azhar University, Cairo, 11765, Egypt|Al-Ayen Univerisity, Madīnat Bābil, Babel, 51015, Iraq

Summary:
Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.

In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.

Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.

Primary Outcome Measures: preoperative anxiety, The child's anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as "calm," while the other end shows "maximum anxiety." The patients were asked to assess their own anxiety and mark it on the anxiety line., 24 hours
Secondary Outcome Measures: preoperative sedation, The sedation level will be assessed using Ramsay Sedation Scale. It divides a patient's level of sedation into six categories ranging from severe agitation at 1 to deep coma at 6., 24 hours
Mechanisms for Laser-Induced Rejuvenation
NCT Number: NCT06489301
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Cancer
Interventions: DEVICE: Fractionated Laser Resurfacing
Sponsor: Wright State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2028-12
Locations: Wright State Physicians, Fairborn, Ohio, 45324, United States

Summary:
It has shown that laser wounding of geriatric skin protects it against skin cancer. The purpose of this study is to determine the origin of cells called fibroblasts which are present after treatment with Fractionated Laser Resurfacing (FLR). These cells restore a youth-like ultraviolet B (UVB) response, but where they come from is currently unknown. The study recruits subjects who are scheduled to undergo abdominoplasties to investigate the origin of those cells stimulated by laser treatment.

Primary Outcome Measures: To test if the new fibroblasts that develop in response to fractionated laser resurfacing (FLR) wounding are derived from blood-derived monocytes., Identify cells in the skin that have been wounded by FLR at 2 weeks and 1 week previously, for cells that co-express markers for both fibroblasts and monocytes by using single cell RNA-sequencing, 2 weeks prior to skin removal and 1 week prior to skin removal|To test if possible cells transitioning from monocytes to fibroblasts are found in the top part of the dermis (papillary dermis)., Using tissue RNA-seq, PI will define if co-expressing cells are in the papillary dermis., 2 weeks prior to skin removal and 1 week prior to skin removal
Secondary Outcome Measures: To define the number and types of cells populating the skin following fractionated laser resurfacing (FLR) wounding, Define the number and types of cells following FLR wounding at 2 weeks and 1 week prior to skin removal by using single-cell RNA-seq., 2 weeks prior to skin removal and 1 week prior to skin removal|To define the locations of the number of cells populating in the skin following fractionated laser resurfacing (FLR) wounding, Define the locations of the number cell following FLR wounding at 2 weeks and 1 week prior to skin removal by using tissue RNA-seq., 2 weeks prior to skin removal and 1 week prior to skin removal|To define the locations of the types of cells populating in the skin following fractionated laser resurfacing (FLR) wounding, Define the locations of the different cell types following FLR wounding at 2 weeks and 1 week prior to skin removal by using tissue RNA-seq., 2 weeks prior to skin removal and 1 week prior to skin removal
ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer
NCT Number: NCT06489288
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastric Cancer|ERAS|Laparoscopic Gastrectomy
Interventions: OTHER: ERAS protocol
Sponsor: Xijing Hospital
Collaborators: First Hospital of China Medical University|First Affiliated Hospital of Wenzhou Medical University|Peking University Cancer Hospital & Institute|Tongji Hospital|General Hospital of Ningxia Medical University|Second Affiliated Hospital of Suzhou University|The First Affiliated Hospital with Nanjing Medical University|Nanfang Hospital, Southern Medical University|Gansu Provincial Hospital|Fudan University|Changzhi People's Hospital|Zhejiang University|First Affiliated Hospital Xi'an Jiaotong University|First Affiliated Hospital, Sun Yat-Sen University|The Second Affiliated Hospital of Shandong First Medical University|Guangdong Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2656
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-01
Completion Date: 2025-12-01
Locations: Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, 710000, China

Summary:
The number of totally laparoscopic total gastrectomy is gradually increasing, but the safety of ERAS in these term is still unknown and further multicenter randomized controlled studies are needed.

Primary Outcome Measures: QLQ-STO22, Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery, Changes in quality of life in QLQ-STO22 before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery|QLQ-C30 (V3.0), Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery, Changes in quality of life in QLQ-C30 (V3.0) before surgery, on the 7th day after surgery, and 1 ,6,12month after surgery|Complication rate, Complications rate and Clavien-Dindo classification within 1 month after surgery, 1month|DFS, Disease-free survival rate at 1 and 3 years after surgery, 1 and 3 years
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
NCT Number: NCT06489249
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Electronic Cigarette Use|Endothelial Dysfunction|Inflammation
Interventions: DRUG: Placebo|DRUG: Salsalate 750 MG Oral Tablet [DISALCID]
Sponsor: University of Iowa
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2026-10
Locations: University of Iowa, Iowa City, Iowa, 52242, United States

Summary:
The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.

Primary Outcome Measures: Microvascular endothelial function (Cutaneous conductance, %maximum) following salsalate treatment compared to placebo treatment, Endothelium-dependent vasodilation assessed as cutaneous conductance response (cutaneous conductance = local red blood cell flux/mean arterial pressure; %maximum) to local heating of the skin (42 degrees Celcius)., a total of 2 times throughout the study (approximately 4 weeks): 1) at the completion of 4 days of oral salsalate treatment, and 2) at the completion of 4 days of placebo treatment
Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants
NCT Number: NCT06489223
Acronym: YooTET
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea Syndrome
Interventions: DEVICE: Orofacial Myofunctional Rehabilitation Pacifier
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: CHILD
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-03-01
Locations: : Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon, Lyon, 69500, France

Summary:
The development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with Down syndrome.

This protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test.

If acceptability and tolerance are satisfactory, an effectiveness study will be carried out to determine whether this medical device could prove useful in preventing the occurrence of Obstructive Sleep Apnea Syndrome (OSAS) in very young children, via orofacial myofunctional rehabilitation

Primary Outcome Measures: assess the acceptability of the pacifier in the mouth while awake, cumulative time during which the pacifier is kept in the mouth over three 15-minute sessions of awake testing. The pacifier will be judged as accepted if at least 15 minutes of pacifier in the mouth are accumulated over the 3 tests carried out., Day 1 inclusion
Secondary Outcome Measures: Evaluate the attitude of infants when taking the pacifier in the mouth, presence of grimaces when offering the pacifier in the mouth or non-nutritive sucking behavior during each test, Day 1 inclusion|Evaluate whether the pacifier is held in the mouth while awake, Number of times the child rejects the pacifier and the maximum duration of uninterrupted hold in the mouth during the 15 minutes of each test, Day 1 inclusion|Evaluate how well the pacifier stays in the mouth during sleep, Time during which the pacifier is kept in the mouth during sleep until spontaneous rejection, measured from a video recording, correlated to the parameters recorded by polysomnography (sleep efficiency, apnea-hypopnea index, number of microphones -arousals, total sleep time and sleep latency)., Day 1 inclusion, during the night|Assessment of the safety of the pacifier in infants, Recording of any adverse events, Day 1 inclusion
A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block
NCT Number: NCT06489210
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nerve Pain
Interventions: PROCEDURE: popliteal block
Sponsor: Helwan University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2018-04-01
Completion Date: 2021-04-30
Locations: Zagazig University Hospitals, Zagazig, Egypt

Summary:
Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.

Primary Outcome Measures: assessment of intraoperative and postoperative pain in different groups after intervention, pain severity levels via visual analogue scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient was asked to mark on this line where the intensity of the patient lies, 24 hours after operation
AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients
NCT Number: NCT06489197
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: ESCC|Advanced Esophageal Squamous Cell Carcinoma
Interventions: DRUG: Ivonescimab combined with albumin paclitaxel and cisplatin
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-30
Locations: Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China

Summary:
This is a single arm，phase 2 study evaluating the safety and efficacy of Ivonescimab(AK112) combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma (ESCC). In this study, patients with advanced esophageal squamous cell carcinoma who had not received any systematic treatment in the past will be enrolled.

The research will be conducted in two stages. In the first part, 6 patients were enrolled in the group. After the last subject in the group completed at least 21 days of observation after the first medication, the researchers will conduct a preliminary safety and effectiveness assessment. If the safety and tolerability are good, it will enter the second expansion part till the study enrolled 30 patients. Patients who met the inclusion criteria were treated with AK112 (20mg/kg, intravenous infusion, d1, Q3W) in combination with albumin paclitaxel (220mg/m2, intravenous infusion, d1, Q3W) and cisplatin (75mg/m2, intravenous infusion, d1, Q3W), of which the maximum treatment time of chemotherapy was up to six cycles, and the maximum treatment time of AK112 was 24 months. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.

Primary Outcome Measures: Objective Response Rate,ORR, Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1., 6 months
Secondary Outcome Measures: Overall survival,OS, Defined as the time between signing the informed consent form to death due to various causes., 24 months|Progression free Survival,PFS, Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause., 12 months|Disease Control Rate,DCR, Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1., 6 months|Duration of Response,DoR, Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause., 6 months
Other Outcome Measures: Incidence of adverse events, Use NCI-CTCAE version 5.0 for classification and grading., 24 months
The Real World Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China
NCT Number: NCT06489184
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: CLL
Interventions: DRUG: Zanubrutinib
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 490
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-12-30
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China

Summary:
This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

Primary Outcome Measures: Progression Free Survival (PFS), PFS is defined as the duration from date of Zanubrutinib initiation to date of disease progression (PD \[according to the physician's evaluation\]) or death from any cause, up to two years
Secondary Outcome Measures: Overall Survival, OS is defined as the time from the starting date of Zanubrutinib to the date of death due to any cause., up to two years|Time to Next Therapy (TTNT), The TTNT will be calculated as the difference between Zanubrutinib initiation date and initiation date of the first next therapy for CLL, up to two years|Adverse Events, Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations, up to two years
Research on Laparoscopic Fertility-Sparing Surgery in Early-Stage Cervical Cancer
NCT Number: NCT06489171
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cervical Cancer
Interventions: PROCEDURE: Received laparoscopic-assisted vaginal radical trachelectomy
Sponsor: Peking Union Medical College Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 132
Study Design: Observational Model: |Time Perspective: p
Start Date: 2003-01-01
Completion Date: 2023-10-31

Summary:
Purpose: To evaluate the oncological and obstetrical outcomes of women with early-stage cervical cancer who underwent laparoscopic-assisted vaginal radical trachelectomy (LAVRT). All women with early-stage cervical cancer who planned to undergo fertility-preserved radical trachelectomy. The obstetric outcome evaluation was restricted to women with ≥12 months of follow-up and an active desire to conceive. The oncological outcome was evaluated in all patients.

Statistical methods: Statistical analyses were performed using IBM SPSS Statistics, version 26. The t-test is used for analyzing the continuous variables and the chi-squared test for categorical variables.

Primary Outcome Measures: Progression-Free Survival, the date of the treatment to the date of disease progression or death from any cause in the absence of progression, 5-10 years|Pregnancy rate after surgery, Postoperative patients who have successfully conceived, 5 years|Recurrence rate, The ratio of recurrent patients to the total enrolled patients, 20years
Secondary Outcome Measures: Average operation time, The length of the surgery, Intraoperative|bleeding volume, the amount of blood loss in the patient, Intraoperative
Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade
NCT Number: NCT06489158
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Sponsor: Peking Union Medical College Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
1. Explore VOCs indicators that can effectively distinguish between benign and malignant breast diseases.
2. The accuracy of VOCs indicators and ultrasound 4a/4b/4c diagnosis will be compared in determining benign and malignant diseases based on pathological gold standards.

Primary Outcome Measures: Exhaled VOC Biomarkers, The relationship between exhaled VOC and breast cancer grading will be studied. 168 patients with With Breast Ultrasound BI-RADS 4 Grade were enrolled. Exhale gas was collected and tested using mass spectrometer. Exhaled VOC biomarkers characteristics in admitted women with breast ultrasound BI-RADS 4 grade will be investigated., 1 year
Single-cell Multi-omics Analyses of OCT-diagnosed Plaque Subtypes in Coronary Artery Disease (MOOP-CAD)
NCT Number: NCT06489119
Acronym: MOOP-CAD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease
Sponsor: Harbin Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-07
Completion Date: 2026-07-15
Locations: The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150081, China

Summary:
The MOOP-CAD study program characterizes, for the first time, the pathophysiological processes and molecular mechanisms of coronary atherosclerotic plaque progression by combining in vivo intravascular imaging techniques with circulating immune single-cell multi-omics analysis. In this study, the investigators evaluate the imaging characteristics of coronary plaques by optical coherence tomography (OCT) and invasive angiography, and study the correlation between plaque characteristics and the multi-omics immune characteristic profiles.

Primary Outcome Measures: Incidence of MACE, The incidence of major adverse cardiovascular events in patients (Major adverse cardiovascular events is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina), 1 year following hospital discharge
Secondary Outcome Measures: Incidence of SCD, The incidence of sudden cardiac death in patients, 1 year following hospital discharge|Incidence of nonfatal myocardial infarction, The incidence of nonfatal myocardial infarction in patients, 1 year following hospital discharge|Incidence of target vessel revascularization, The incidence of target vessel revascularization in patients, 1 year following hospital discharge
Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury
NCT Number: NCT06489106
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injury Cervical
Interventions: DEVICE: Activity based upper extremity training with and without stimulation
Sponsor: University of Louisville
Collaborators: The Craig H. Neilsen Foundation
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31

Summary:
The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators will start by exploring the best places and strengths for applying scTS on the neck, the added benefits of applying scTS on the lower back (T11-T12), and comparing the effects of using activity based upper extremity training (a control treatment) alone versus combining it with scTS to help children with chronic SCI regain hand function.

Primary Outcome Measures: Hand grip, Voluntary maximal hand grip force, 12 weeks|Hand control, Peak to peak distance on hand grip force, 12 weeks
Secondary Outcome Measures: Functional neurophysiological assessment-Upper extremity, Multi-muscle activation patterns, 12 weeks|Pediatric Neurorecovery scale, Pediatric Neurorecovery scale (NRS) is a validated clinical scale that assesses a child's (age 1-12 years) neuromuscular capacity to perform everyday tasks without behavioral compensation, physical assistance, or assistive device. The total score is the sum of all tasks on a scale from 1-12. For a total of 12 items, the highest score being 144 and lowest a sore of 12. Higher scores indicate improved function., 12 weeks|Capabilities of upper extremity test, The Capabilities of the Upper Extremity Test (CUE-T) is a performance measure intended to assess upper extremity function following spinal cord injury. The CUE-T is an objective measure of the ability to complete actions and tasks involving the arm and hand in individuals with tetraplegia and can be used clinically, for research and in clinical trials. Respondents answer questions on a 7-point scale that represents their self-perceived difficulty in performing the action, with 1 indicating "totally limited, can't do at all" and 7 indicating "not at all limited". The total score is the sum of all responses, and ranges from 32 to 224, with higher scores indicating greater function., 12 weeks|Box and block test, The Box and Block Test (BBT) measures unilateral gross manual dexterity and is validated in pediatric population. The score is the number of blocks carried from one compartment to the other in one minute. Each hand is scored separately. Higher scores within 1-minute indicate better manual dexterity., 12 weeks
Survival and cArdiovascular eVents in Patients With Acute Myocardial Infarction
NCT Number: NCT06489080
Acronym: SAVING
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myocardial Infarction|Coronary Artery Disease
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2028-12-31
Locations: Division of Cardiology, Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
This prospective and prospective cohort study aims to establish a long-term follow-up cohort of patients with acute myocardial infarction, and combine multi-omics studies, wearable devices, artificial intelligence technology, etc., to describe the clinical characteristics of patients with acute myocardial infarction and the changing trend of treatment strategies, and analyze the related influencing factors. Explore new biomarkers and indicators affecting recurrent cardiovascular events for accurate risk stratification and risk prediction; To evaluate the factors affecting lifestyle intervention, drug efficacy and safety, and their impact on outcome, and improve chronic disease management mode, in order to improve the quality of life and prognosis of patients.

Primary Outcome Measures: Major Adverse Cardiovascular Events, Composite end points of Cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, 5 years
Secondary Outcome Measures: Secondary Adverse Cardiovascular Events, All-cause death, non-cardiac death, myocardial infarction, hospitalization for coronary revascularization, hospitalization for heart failure, hospitalization for acute coronary syndrome, ischemic stroke, hemorrhagic stroke, 5 years
Study of the Thyroid Function and Echostructural Morphology in Patients Affected With Rasopathies (ECORAS2023)
NCT Number: NCT06489067
Acronym: ECORAS2023
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: RASopathy
Sponsor: University of Bari Aldo Moro
Sex: ALL
Age: CHILD, ADULT
Enrollment: 115
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-15
Completion Date: 2024-06-30
Locations: University of Bari, Bari, 70124, Italy

Summary:
The study aims to evaluate the prevalence of thyroid disease, particularly with autoimmune pathogenesis (isolated hyperthyrotropinemia, hyperthyroidism, hypothyroidism, thyroid nodules) and/or morphostructural abnormalities of the thyroid gland in patients with RASopathy genetically confirmed by NGS technique (analysis of the genes: BRAF, CBL, HRAS, KRAS, LZTR1, MAP2K1, MAP2K2, MRAS, NRAS, PPP1CB, PTPN11, RAF1, RIT1, RRAS2, SHOC2, SOS1, SOS2) and to compare the data obtained in our sample with those of the general population.

The secondary aim of the study is to evaluate the association between vitamin D deficiency and/or other abnormalities of bone metabolism and thyroid disease and/or morphostructural anomalies of the thyroid gland in patients with RASopathy.

Primary Outcome Measures: Number of patients with RASopathies presenting with thyroid function and ultrasound abnormalities compared to the general population (observational study), Patients will undergo blood sampling for TSH, fT3, fT4, thyroid autoimmunity and a systematic color Doppler ultrasound examination of the thyroid gland. Setting a confidence level of 95% and a margin of error of 10%, the sample size is of 96 patients. The level of statistical significance will be α=0.05. Demographic, anthropometric and clinical data will be collected according to standard criteria for each center. Continuous variables will be reported as mean and standard deviation, or median and IQR, depending on their distribution. Categorical variables will be expressed as absolute and relative frequency (%). Parametric and non-parametric statistical tests will be performed depending on the variables and their distribution. Correlation analyses will be performed between the different variables., 6 months
Secondary Outcome Measures: Number of patients with RASopathies presenting with bone disease, Evaluate the association between vitamin D deficiency and/or bone disease and thyroid function and/or morphostructural abnormalities of the thyroid gland in patients with RASopathy. For each patient biomarkers of bone metabolism (calcium, phosphorus, vitamin D, ALP bone isoenzyme, PTH, osteocalcin) will be evaluated in order to find a possible association with thyroid abnormalities. In order to evaluate the association between the different variables (primarily, biomarkers of bone metabolism) and the outcomes measured (thyroid dysfunction or ultrasound abnormalities), binary logistic regression models will be built, adjusting for possible confounding factors., 6 months
Effects of Peer-based Education on Adolescent Oral Health Literacy
NCT Number: NCT06489054
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Literacy
Interventions: OTHER: Peer education|OTHER: Conventional education
Sponsor: University of Sao Paulo
Sex: ALL
Age: CHILD, ADULT
Enrollment: 360
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-03-04
Completion Date: 2024-09
Locations: Universidade de São Paulo, São Paulo, 01246904, Brazil

Summary:
This project aims to identify whether an oral health peer education strategy can influence the level of functional literacy and oral health attitudes of adolescents aged 15 to 19 years. An experimental study will be carried out, a non-randomized controlled community trial, with two groups of educational strategy in oral health: peer education (experimental group) and conventional education (control group). For data collection, three questionnaires will be applied: for socioeconomic, demographic and dental data; assessment of oral health literacy (BOHL-AQ); and assessment of oral health attitudes; the last two being applied before and after the intervention.

Primary Outcome Measures: Oral health literacy, A specific questionnaire, Brazilian Oral Health Literacy-Adults Questionnaire - BOHL-AQ, will be used to measure oral health literacy before and after the oral health education intervention., The first data collection (baseline) occurred 2 months after participant recruitment and the second collection will be after the intervention, 3 months after baseline.
Secondary Outcome Measures: Attitudes related to oral health, A questionnaire will be used to measure attitudes related to oral health before and after the oral health education intervention., The first data collection (baseline) occurred 2 months after participant recruitment and the second collection will be after the intervention, 3 months after baseline.
Evaluating Microarray Pharmacogenetic Testing in Cancer Patients
NCT Number: NCT06489041
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Gastrointestinal Cancer
Interventions: GENETIC: Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"
Sponsor: Wake Forest University Health Sciences
Collaborators: Atrium Health Levine Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-05
Locations: Atrium Health Levine Cancer, Charlotte, North Carolina, 28204, United States

Summary:
The purpose of this research is to evaluate the impact of a microarray PGx test on prescribing/dosing of drugs and cancer treatments in patients with cancer who are currently eligible for single-gene DPYD testing.

Primary Outcome Measures: Number of potentially actionable results based on pharmacogenomic (PGx) test, A potentially actionable result refers to any genotype or phenotype that is associated with specific drug-gene interactions from the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines or the FDA's Table of Pharmacogenetic Associations. The number of potentially actionable results is a count variable that represents the total occurrences of such genotypes or phenotypes identified in a participant., Baseline
Secondary Outcome Measures: The presence of at least one drug-gene interaction, Drug-gene interactions is defined as an interaction between the medication(s) taken by the subject and the genetic variant(s) the subject possesses based on the PGx test. The presence or absence of such interactions is assessed using the guidelines provided by the Clinical Pharmacogenetics Implementation Consortium (CPIC) or the FDA's Table of Pharmacogenetic Associations. The presence of at least one drug-gene interaction is a binary variable (yes/no)., Baseline, at 3 months and at 6 months after receiving the microarray profiling results|The presence of at least one PGx best practice advisory (BPA) alert, BPA alert is fired within the Epic electronic health record (EHR) system for the participant when there is presence of a drug-gene interaction at the time of medication order entry. The presence of at least one PGx best practice advisory (BPA) alert for each participant is a binary variable (yes, no)., within 6 months of receiving the microarray profiling results|Percentage of prescriptions that trigger PGx best practice advisory (BPA) alerts, Percentage of prescriptions that trigger PGx best practice advisory (BPA) alert among all prescriptions for each participant, within 6 months of receiving the microarray profiling results|Taking actions from PGx best practice advisory alerts, Taking actions after receiving PGx best practice advisory alerts includes remove or keep drug, order or do not order an e-consult, patient previously tolerated/responded treatment, not appropriate, or other. Taking actions is a binary variable (yes, no)., within 6 months of receiving the microarray profiling results
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
NCT Number: NCT06489028
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Venous Leg Ulcer
Interventions: DRUG: allo-APZ2-CVU|DRUG: Placebo
Sponsor: RHEACELL GmbH & Co. KG
Collaborators: FGK Clinical Research GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-09
Locations: RHEACELL Clinical Trial Site, Miami, Florida, 33136, United States|RHEACELL Clinical Trial Site, Boston, Massachusetts, 02114, United States|RHEACELL Clinical Trial Site, Multiple Locations, Austria|RHEACELL Clinical Trial Site, Multiple Locations, Czechia|RHEACELL Clinical Trial Site, Multiple Locations, France|RHEACELL Clinical Trial Site, Multiple Locations, Germany|RHEACELL Clinical Trial Site, Multiple Locations, Hungary|RHEACELL Clinical Trial Site, Multiple Locations, Italy|RHEACELL Clinical Trial Site, Multiple Locations, Netherlands|RHEACELL Clinical Trial Site, Multiple Locations, Poland|RHEACELL Clinical Trial Site, Multiple Locations, Slovakia|RHEACELL Clinical Trial Site, Multiple Locations, Sweden|RHEACELL Clinical Trial Site, Multiple Locations, United Kingdom

Summary:
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.

Primary Outcome Measures: Complete wound closure, Complete wound closure already persisting for at least two weeks, 18 weeks
Secondary Outcome Measures: Complete wound closures at each post-baseline follow-up visit, Complete wound closures at each post-baseline follow-up visit, at each post-baseline follow-up visit (starting the day after intervention until month 16)
DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters
NCT Number: NCT06489002
Acronym: DEDICATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Determinants of Health|Primary Care|Diabetes Mellitus, Type 2|Hypertension
Interventions: OTHER: Implementation Support
Sponsor: OCHIN, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-04
Completion Date: 2028-06

Summary:
DEDICATE will refine and test the effectiveness of evidence-based implementation support strategies designed to support care management teams' sustained use of electronic health record (EHR)-based functionalities to address unmet social needs through improved clinical-community linkages. This study will test the hypothesis that providing implementation support to health center care management teams will lead to increased adoption of EHR functionalities and increased social needs screenings and referrals to community organization to address unmet social needs through a cluster-randomized trial. This study's results will have implications for patients with social needs receiving care management in primary care settings.

Primary Outcome Measures: Social needs screening, Binary variable of whether the patient has been screened for social needs, From six months prior to the intervention, assessed up to 12 months.|Social needs referral, Binary variable of whether patients with unmet social needs received referrals to a community organization, From six months prior to the intervention, assessed up to 12 months.
Secondary Outcome Measures: Community-based services receipt for referred social needs, Binary outcome of receipt of community services (closed-loop referral) among patients with social needs who were referred to community organizations, From six months prior to the intervention, assessed up to 12 months.|Controlled hypertension, Binary outcome of blood pressure control (defined as \<140/90) at the most recent visit among patients with hypertension, From six months prior to the intervention, assessed up to 12 months.|Controlled type 2 diabetes mellitus, Binary outcome in HbA1c control (defined as \<9%) at the most recent visit among patients with diabetes mellitus, From six months prior to the intervention, assessed up to 12 months.
A Study on TIL for the Treatment of Advanced Solid Tumors
NCT Number: NCT06488950
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Advanced Solid Tumor|Tumor Infiltrating Lymphocytes|Treatment Side Effects|Effects of Immunotherapy
Interventions: BIOLOGICAL: GC203 TIL(gene-edited TIL) or autologous TILs
Sponsor: Shanghai Juncell Therapeutics
Collaborators: Third Affiliated Hospital of Naval Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-01
Completion Date: 2027-06-30
Locations: Third Affiliated Hospital of Naval Medical University, Shanghai, China

Summary:
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Primary Outcome Measures: Adverse Events, To characterize the safety profile of GC304 (TIL) and natural autologous TIL in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events., 6 months
Secondary Outcome Measures: Objective Response Rate (ORR), Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), Up to 36 months|Disease Control Rate (DCR）, Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1, Up to 36 months|Duration of Response (DOR), The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1, Up to 36 months|Progression-Free Survival (PFS), The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1, Up to 36 months