pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Advancing Interactive Medical Education of Anatomy Via the Metaverse Virtual 3D Printing Platform
NCT Number: NCT06456398
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Virtual Reality
Interventions: OTHER: Virtual reality
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2025-03-01

Summary:
The study aims to recruit 100 National Taiwan University 5th grade medical students who have completed a comprehensive basic anatomy course and are just entering surgical clinical rotations. Through a randomized controlled trial, educational training will be designed, and pre- and post-tests will be conducted to compare the effectiveness of learning advanced anatomy using the "Metaverse Virtual 3D Printing System" in virtual reality, versus the traditional method of "using flat diagrams to correlate with computed tomography scans." The study will assess the impact on learning outcomes, motivation, and learning experience in advanced anatomy education. We anticipate a well-structured learning model that bridges the gap between foundational and clinical medical courses.

Primary Outcome Measures: Questionnaire of Learning self-efficacy assessment, The results of questionnaires do not collect personal information. The values of the questionnaire scale do not indicate good or bad results., 1 year|Questionnaire of Motivated Strategies for Learning (MSLQ), The results of questionnaires do not collect personal information. The values of the questionnaire scale do not indicate good or bad results., 1 year|Questionnaire of Technology Acceptance Model (TAM), The results of questionnaires do not collect personal information. The values of the questionnaire scale do not indicate good or bad results., 1 year|Pre- and post-test learning tests, The results of tests will not affect academic performance., 1 year
Post-stroke Pain taVNS
NCT Number: NCT06456385
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Pain
Interventions: DEVICE: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)|DEVICE: Sham Auricular Stimulation
Sponsor: Medical University of South Carolina
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2025-06-03
Locations: Medical University of South Carolina Institute of Psychiatry, Charleston, South Carolina, 29425, United States

Summary:
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.

Primary Outcome Measures: Thermal Pain Threshold, Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants., Change from baseline pain threshold immediately post-taVNS
Secondary Outcome Measures: Subjective Pain Ratings, Participants will rate their post-stroke upper extremity pain intensity before and after the taVNS using a standard numeric pain rating scale (from minimum 0 to maximum 10, higher scores mean more pain)., Change from baseline subjective pain rating immediately post-taVNS
Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
NCT Number: NCT06456359
Acronym: PAMSARC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Desmoplastic Small Round Cell Tumor|Synovial Sarcoma
Interventions: DRUG: Signifor
Sponsor: University Hospital Heidelberg
Sex: ALL
Age: CHILD, ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-10
Locations: National Center for Tumour Diseases, University Hospital Heidelberg, Heidelberg, Baden-Württemberg, 69120, Germany

Summary:
PAMSARC is a non-commercial interventional Phase 2 clinical trial of academic research institutions, with its primary goal being to improve medical treatment of fusion driven Desmoplastic small round cell tumor (DSRCT) and Synovial sarcoma (SySa) in young adults and adolsecents with male predominance.

Current management of DSRCT and SySa includes chemotherapy, radiation and aggressive cytoreductive surgery. Despite advances in multimodal therapy, outcomes remain poor with frequent disease recurrence and very limited options for patients with advanced disease.

Selected somatostatin receptor (SSTR) family members, i.e., SSTR2, SSTR3 and SSTR5, are frequently overexpressed in DSRCT and SySa, providing the rationale for treatment with somatostatin analogues (SSA).

Pasireotide is a SSA with high affinity for SSTR1, -2, -3, and -5 and is approved for the treatment of Cushing's disease and acromegaly and has also shown activity in other cancers. In patients with advanced stage DSRCT and SySa, conventional chemotherapeutic approaches frequently lead to disease response, however, the duration of progression-free time after chemotherapy is short. The targeted approach with pasireotide after initial intensive multimodal treatment may have the potential to significantly improve outcome.

Primary Outcome Measures: progression-free survival (PFS), Assessment of clinical efficacy of pasireotide maintenance therapy, PFS, measured from study registration to radiologically confirmed disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first up to 4 years
Secondary Outcome Measures: overall survival (OS), Assessment of clinical efficacy of pasireotide maintenance therapy, OS, measured from study registration to death from any cause (censoring of patients without an event at date of last follow-up) up to 4 years
Other Outcome Measures: measurable residual disease (MRD), Assessment of MRD and identify resistance mechanisms in liquid biopsies before, during, and after pasireotide maintenance therapy, MRD before, during, and after pasireotide maintenance therapy up to 4 years
Exploring Paraspinal Electromyographic Features in Adolescent Idiopathic Scoliosis Patients
NCT Number: NCT06456333
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Scoliosis; Adolescence|Electromyography
Interventions: DEVICE: High-density surface electromyography
Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-01
Completion Date: 2024-05-31
Locations: The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310006, China

Summary:
Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional spinal deformity with onset in adolescents between the ages of 10 and 18 years, characterized by coronal curvature, sagittal imbalance and horizontal rotation of the spine. The incidence of AIS is 1-4% globally, with more females than males, and it is a common, frequent and difficult-to-treat disease that seriously jeopardizes the physical and mental health of adolescents.

Previous studies have found significant changes in the morphologic structure and physiologic characteristics of the paraspinal muscles in patients with AIS, including muscle fiber distribution, muscle contraction and relaxation capacity, the convex side of the AIS curve exhibits a higher level of electromyographic activity, and asymmetric changes in the paraspinal muscles are highly correlated with progression of scoliosis. The current single-electrode sEMG technique extracts limited muscle activity signals and is susceptible to interference from random noise. Compared with the single-electrode sEMG technique, HD-sEMG can provide rich spatiotemporal information on paraspinal muscle activity, so it is necessary to use a wide and closely spaced electrode array for signal acquisition to obtain more accurate and detailed characteristics of paraspinal muscle activity.

In summary, this study used high-density surface electromyography to collect muscle parameters of the paraspinal muscles on the concave and convex sides of AIS patients and compared them with those of healthy people to comprehensively summarize the characteristics of their paraspinal muscles, so as to provide scientific basis for the subsequent development of precise treatment plans and improvement of clinical efficacy.

Primary Outcome Measures: root mean square value （RMS）, The square root of the mean value of the amplitude of the sEMG signal over a certain time window is commonly used to assess the strength of muscle contraction and fatigue., Day 1|mean power frequncy（MPF）, The average of the power frequency distribution of the sEMG signals generated during a muscle contraction can be used to assess the force and fatigue of a muscle contraction., Day 1|fractal dimension（FD）, The complex waveforms were categorized into multiple dimensions, and each dimension was analyzed by typing., Day 1|Slope sign change(SSC), The number of times the sign of the rate of change of amplitude changes in the waveform of the sEMG signal is commonly used to indicate an impending fluctuating change in the state of the surface EMG signal., Day 1
Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery
NCT Number: NCT06456320
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Genetic Predisposition|Exposure, Environmental
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-26
Completion Date: 2027-12-31
Locations: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States|Mayo Clinic in Florida, Jacksonville, Florida, 32224, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
The purpose of this study is to use multi-omics testing on samples collected from Mayo Clinic patients to build and expand on what has been learned about genomic data.

Primary Outcome Measures: Creation of a unique integrated asset of multi-omics data, A variety of patient cohorts will be ascertained throughout this study. Data will be made available to researchers to query correlations of disease states and clinical outcomes to multi-omics findings. These insights will be invaluable to creating omics-informed care plans in the future. Standard descriptive statistics approaches will be used for analysis., Up to 5 years
Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
NCT Number: NCT06456307
Acronym: IPMH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression, Anxiety|Antenatal Depression|Postnatal Depression
Interventions: BEHAVIORAL: Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)
Sponsor: Kenyatta National Hospital
Collaborators: National Institute of Mental Health (NIMH)
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2970
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2028-03
Locations: Kenyatta National Hospital, Nairobi, Kenya|HomaBay, Siaya and Kisumu, Western Kenya, Kenya

Summary:
Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.

Primary Outcome Measures: Depression, Patient Health Questionnaire-9 (PHQ-9). Score range 0-27. Higher score indicates more severe depression symptoms; score ≥10 indicates symptoms of moderate-to-severe depression, 6-months postpartum|Anxiety, Generalised Anxiety Disorder-7 item (GAD-7). Score range 0-21. Higher score indicates more severe anxiety symptoms; score ≥10 indicates symptoms of moderate-to-severe anxiety, 6-months postpartum
Secondary Outcome Measures: Quality of life, World Health Organisation Quality-of-Life Brief Version (WHOQOL-BREF) score. Score range 0 - 100. Higher scores indicate higher quality of life., 6-months postpartum|Adverse pregnancy outcomes, Any adverse pregnancy outcomes defined as the following: Pregnancy loss, stillbirth, pre-term birth, low birth weight, intrauterine growth restriction, neonatal hospital admission and neonatal death, 6-weeks postpartum|Mechanism of action for PM+ (use of behavioral and psychosocial coping skills), Reducing Tension Checklist. Score range 0 - 40. Higher score indicates more use of behavioral and psychosocial coping skills., 6-weeks postpartum
Evaluation of a Medication Health Center to Promote Opioid Safety
NCT Number: NCT06456294
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overdose
Interventions: BEHAVIORAL: MHC Outreach Intervention
Sponsor: Kaiser Permanente
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-06-15
Completion Date: 2025-01-01
Locations: Kaiser Permanente Colorado, Aurora, Colorado, 80011, United States

Summary:
This study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. Outcomes are visits to the clinic, naloxone dispensings, Prescription Drug Monitoring reviews, and Urine Drug Screens conducted

Primary Outcome Measures: Number of participants with a Medication Health Center visit, Medication Health Center (MHC) Visits will be assessed using data from the electronic medical record., Outcomes are assessed in a two-month post-intervention period.
Secondary Outcome Measures: Number of participants with a Naloxone dispensing, Naloxone dispensings are assessed using data from the electronic medical record, Outcomes are assessed in a two-month post-intervention period.|Number of participants with a Prescription Drug Monitoring Program (PDMP) review, Prescription Drug Monitoring Program (PDMP) reviews are assessed using data from the electronic medical record, Outcomes are assessed in a two-month post-intervention period.|Number of participants with a Urine Drug Screens completed, Urine Drug Screens Completed are assessed using data from the electronic medical record, Outcomes are assessed in a two-month post-intervention period.
Multi-omics Model for Pancreatic Cancer Screening Using cfDNA
NCT Number: NCT06456281
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatic Cancer
Interventions: DIAGNOSTIC_TEST: A noninvasive cfDNA multi-omics assay
Sponsor: Fudan University
Collaborators: Nanjing Simcere Medical Laboratory Science Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 480
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2025-12-30
Locations: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China, Shanghai, Shanghai, 200032, China

Summary:
This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.

Primary Outcome Measures: Performance of cfDNA multi-omics model for discriminating pancreatic cancer versus healthy individuals., The area under the curve (AUC), sensitivity and specificity of cfDNA multi-omics model., 12 months
Secondary Outcome Measures: Performance of cfDNA multi-omics model for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals., Sensitivity of cfDNA multi-omics model at specificity of 95% for discriminating patients with pancreatic cancer and precancerous lesions versus healthy individuals., 12 months|Performance of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals., Sensitivity of cfDNA multi-omics model for discriminating precancerous lesions versus healthy individuals., 12 months|Performance of pre-defined model in clinical sub-groups of interest., Sensitivity of cfDNA multi-omics model for pancreatic cancer at different stages or in different pathological subtypes., 12 months
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
NCT Number: NCT06456268
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ACL|Opioid Use|Cryotherapy Effect|Vibration; Exposure|Pain, Postoperative
Interventions: DEVICE: VibraCool mechanical stimulation and neuromodulatory therapeutic device|DEVICE: Cryocompression (Game Ready, Bregs) device|DEVICE: Standard ice packs
Sponsor: Columbia University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2025-07-15
Locations: Columbia University Medical Center, New York, New York, 10032, United States

Summary:
The goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following anterior crucitate ligament reconstruction (ACLR), and thus residual opioids in circulation.

Primary Outcome Measures: Visual Analog Score (VAS) for pain, Scale of 0 to 10, with 10 being the worst pain and 0 being no pain. Will record daily mean VAS pain scores over the first seven post-operative days, First 7 post-operative days|Opioid use, Percent of patients discontinuing opioid use by or on post-operative day three, compared to those who continue after day three, First 3 post-operative days
Secondary Outcome Measures: Mean reduction in opioid use in mg of morphine equivalents per day, mean reduction in opioid use in milligrams of morphine equivalents per day (MMOD) of 30% from patients not using the device over the 7-day period, First 7 post-operative days|Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score, PROMIS is a computerized adaptive patient-reported test to measure interference of pain in everyday functioning. The raw score is converted to a T-score metric in which 50 is the mean and 10 is the standard deviation. Higher T-scores represent increased pain interference., First 7 post-operative days
Bupivacaine and Epinephrine Injection Study
NCT Number: NCT06456255
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Sinus Disease|Anesthesia|Bleeding
Interventions: DRUG: Sensorcaine with Epinephrine|OTHER: Sham injection
Sponsor: Amin Javer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-07

Summary:
Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.

Primary Outcome Measures: Boezzart bleeding score, Change in mean surgical field quality as determined by the Boezzart bleeding score. Boezaart score of 0 indicates no bleeding, whereas the maximum score of 5 indicates severe bleeding (constant suctioning required)., throughout study completion, one day study visit
Secondary Outcome Measures: Total blood loss, Change in total blood between injection and sham group measured in millilitres, throughout study completion, one day study visit|Surgical time, Change in surgical time between injection and sham group measure in minutes, throughout study completion, one day study visit|Mean arterial pressure (MAP), Change in Mean arterial pressure (MAP) between injection and sham group measured in millimeters of mercury (mm Hg), throughout study completion, one day study visit|Postoperative bleeding, Change in postoperative bleeding between injection and sham group measured in mililiters, throughout study completion, one day study visit|Postoperative pain, Change in postoperative pain between injection and sham group measured with a Visual Analog Scale (VAS) grading from 0 (no pain) to 5 (severe pain), throughout study completion, one day study visit
Contingency Management to Promote Smoking Cessation
NCT Number: NCT06456242
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation
Interventions: BEHAVIORAL: CounsCM+MedCM (Health Rewards)
Sponsor: University of Kansas Medical Center
Collaborators: National Institute on Drug Abuse (NIDA)|University of Oklahoma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2025-01

Summary:
Many hospitals and outpatient clinics often refer people who smoke to quitlines and provide prescriptions for smoking cessation medications, but patients rarely fully engage in counseling or use their cessation medications. This is a single-arm, open-label pilot study to provide feasibility metrics for a text-based contingency management (CM) intervention to increase engagement in smoking cessation treatment. All participants (N=20) will be referred to a state quitline and will receive a prescription for medication plus 12 weeks of a text-based CM intervention to increase engagement in quitline calls and varenicline utilization. The engagement of participants in quitline counseling will be tracked for 6 weeks and medication utilization for 12 weeks post-enrollment. The investigators will use mixed-methods to collect implementation and acceptability data to inform changes to the text-based contingency management (CM) intervention.

Primary Outcome Measures: Proportion of quitline calls completed, Completion of the five quitline calls over 6 weeks of treatment according to Kansas quitline reports, Week 6|Proportion of varenicline pills taken, Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting, Week 12
Secondary Outcome Measures: Proportion of patients adherent to varenicline, Adherence biochemically verified using saliva samples, 1.0 ng/ml as the cutoff to distinguish between participants adherent and adherent, Week 3|Proportion of self-reported varenicline pills taken, Self-reported use of varenicline from a timeline followback questionnaire assessing varenicline pills taken in each of the past 3 days, Week 3|Proportion of patients with biochemically verified smoking abstinence, Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng/ml, Week 12|Proportion of patients with self-reported smoking abstinence, Past 7 days self-reported smoking abstinence, Week 12
Time to Return of Bowel Function Following Perioperative Probiotics in Colorectal Cancer Surgery
NCT Number: NCT06456229
Acronym: PICCS-1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer|Ileus Postoperative|Flatus|Diet, Healthy
Interventions: DIETARY_SUPPLEMENT: Nestle Isocal|DIETARY_SUPPLEMENT: Nestle Boost Optimum
Sponsor: National University Hospital, Singapore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 162
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-05-01
Locations: National University Hospital, Singapore, 119074, Singapore

Summary:
There is pre-existing evidence that probiotics could be useful in the improvement of ileus rates. One metaanalysis of 30 studies demonstrated a reduction in the prevalence of post-operative ileus as determined by time to flatus, time to defecation, as well as postoperative abdominal distension (PMID:37373843). More broadly in gastrointestinal surgery, a meta-analysis of 21 randomised controlled trials similarly affirmed the speedier recovery of gastrointestinal function after surgery when probiotics were administered (PMID: 35231076). In spite of these advantages, the routine use of probiotics perioperatively for colorectal cancer surgery is not performed in Singapore. We therefore seek to perform a trial to investigate whether probiotic administration perioperatively may reduce post operative ileus rates.

Primary Outcome Measures: Time to bowel movement, This records the number of days from the day of surgery before the first bowel movement was experienced by the patient., 0 - 14 days
Secondary Outcome Measures: Time to flatus, This records the number of days from the day of surgery before the first flatus was experienced by the patient., 0 - 14 days|Adverse events, Any adverse events related to the intervention. This comprises predominantly gastrointestinal related complications, From commencement of the intervention to 30 days after surgery|Infective complications, Any infective complications which may occur in the postoperative period., From date of surgery to 30 days after surgery|Length of hospital stay, This records the number of days following surgery before the patient is discharged., 0 - 14 days
Performance Evaluation of Diagnostic Accuracy of PanTum Detect Test for Detection of Solid Tumours in Known Cancer Population and in Cancer Free Population.
NCT Number: NCT06456216
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Solid Tumor
Sponsor: Max Healthcare Insititute Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-21
Completion Date: 2023-10-20
Locations: Max Super Speciality Hospital, A Unit of Devki Devi Foundation, New Delhi, 110017, India

Summary:
Performance evaluation of diagnostic accuracy (Sensitivity and Specificity) of PanTum detect Test for detection of solid tumours in known cancer population (Sick population) and in cancer free (Healthy) population.

Primary Outcome Measures: Performance evaluation of diagnostic accuracy (Sensitivity and Specificity) of PanTum detect Test for detection of solid tumours in known cancer population (Sick population) and in cancer free (Healthy) population., PanTum Detect is a simple blood test that can detect presence of solid tumors using two important tumor biomarkers - Apo 10 and TKTL-1. Most tumors develop slowly and gradually. From the first tumor cell, to the identification of the tumor itself, there can be a timespan of many years. The turning point where a locally growing tumor develops into an invasive, metastasizing cancer is paramount for curability. It is the objective of PanTum Detect to detect a tumor in time before this critical turning point. Such locally growing tumors can often easily be removed by surgery or treated successfully., 1 YEAR
Trial of Artificial Intelligence for Chest Radiography
NCT Number: NCT06456203
Acronym: ACER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumonia|Lung Cancer
Interventions: DIAGNOSTIC_TEST: AI
Sponsor: Duke-NUS Graduate Medical School
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2025-12

Summary:
Randomized Clinical Trial of the impact of Chest radiograph AI-assisted triage and report generation upon clinical outcomes and an economic analysis of impact of AI decision support on radiology service delivery.

Primary Outcome Measures: Report generation time, Time for radiologist to produce each individual CXR report, 12 months|Turnaround Time, Time from patient arrival at radiography department to time for clinical team to receive report, 12 months|Time to discharge, Time from patient arrival at radiography department to time to discharge from hospital, 12 months
Secondary Outcome Measures: 30-day patient readmission rate, Rate of readmission of patient to hospital after discharge within 30 days, 12 months
Nociception Monitoring During Epidural Analgesia
NCT Number: NCT06456177
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pain Relief
Interventions: DEVICE: Assessment of nociception in obstetric patients during epidural analgesia
Sponsor: Carmel Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-30
Completion Date: 2024-06-30
Locations: Carmel Medical Center, Haifa, 3436212, Israel

Summary:
Introduction and aim: Nociception monitors have been used to assess pain management in anesthetized patients. The investigators set out to evaluate whether Nociception Level (NOL) monitor (PMD-200 monitor with NOL technology , (Medasense Biometrics Ltd. Ramat Gan, Israel) yields reliable readings during labor, and whether the derived NOL index will be associated with Visual analogue scale (VAS) subjective level of pain before and after the onset of epidural analgesia.

Methods:

Following approval by the intuitional review board No 0056-21-CMC, thirty parturients scheduled for epidural analgesia due to labor pains will be included in this prospective study, after informed consent for participation in the study will be obtained. NOL monitoring device will be connected to the subject finger. Epidural analgesia will be performed as per institutional standards. Data of VAS and NOL index will be collected once a minute. The association between VAS and NOL before and after the onset of adequate analgesia will be evaluated.

Primary Outcome Measures: Evaluation of pain relief using neuroaxial epidural analgesia in parturient by Visual Analog Scale (VAS), The effect of pain relief using neuroaxial epidural analgesia in awake patients with intermittent painful stimuli (uterine contractions) by reporting the Visual Analog Scale (VAS) displayed as a scale from 1-10, with 0 representing no nociception and 10 representing extreme nociception, when higher scores mean a worse outcome, 60 minutes|Evaluation of pain relief using neuroaxial epidural analgesia in parturient by Nociception Level (NOL) index, The effect of pain relief using neuroaxial epidural analgesia in awake patients with intermittent painful stimuli (uterine contractions) by monitoring the Nociception Level (NOL) index displayed as a scale from 0-100 with 0 representing no nociception and 100 representing extreme nociception, when higher scores mean a worse outcome., 60 minutes
Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC
NCT Number: NCT06456138
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: KRAS Mutation-Related Tumors|Advanced Lung Cancer|Refractory Tumor
Interventions: DRUG: Trametinib|DRUG: Anlotinib|DRUG: Tislelizumab
Sponsor: Shanghai Chest Hospital
Collaborators: BeiGene|Chia Tai Tianqing Pharmaceutical Group Co., Ltd.|Novartis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-12-31
Locations: Shanghai Chest Hospital, Shanghai, China

Summary:
Lung cancer is the most common cause of cancer-related death worldwide. Approximately 85% to 90% of lung cancer cases are non-small cell lung cancer (NSCLC), of which KRAS is one of the most common driver genes, occurring in 25-30% of lung adenocarcinomas and 3-5% of squamous cell carcinomas. KRAS-mutant NSCLC had been considered undruggable in past decades. This research sought to address a significant challenge in treating NSCLC with KRAS mutations, which are notoriously difficult to target effectively. Here, we proposal that the combined use of anlotinib and trametinib combined with tislelizumab may form an effective strategy for the treatment of KRAS-mutant NSCLC patients.

Primary Outcome Measures: RP2D, recommended phase 2 dose, up to 12 months|PFS, progression-free survival, up to 18 months
Secondary Outcome Measures: ORR, objective response rate, up to 12 months|OS, overall survival, up to 24 months|DOR, duration of response, up to 18 months|AEs, adverse events, up to 24 months
Construction and Validation of a Diagnostic Model for Predicting Molecular Residual Disease and Recurrence of Cervical Cancer Based on Circulating Tumor HPV
NCT Number: NCT06456112
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cervical Cancer
Sponsor: Anhui Provincial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 83
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-07-30
Locations: Anhui Provincal Hospital, Hefei, Anhui, 230001, China

Summary:
Systematic evaluation of the value of molecular residual lesions of cervical cancer based on circulating tumor HPV in the prognostic evaluation and recurrence monitoring of cervical cancer patients.

Primary Outcome Measures: The one-year probability of OS, OS (overall survival) is defined as the time which begins at diagnosis and up to the time of death, one year
Secondary Outcome Measures: PFS, progression free survival, 1 month post treatment
Effect of Epstein-Barr Virus on Macrophage M2/M1 Migration and EphA2 Expression in Adverse Drug Reactions
NCT Number: NCT06456086
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Adverse Drug Reactions
Interventions: BIOLOGICAL: stimulation with EB virus
Sponsor: First Affiliated Hospital of Kunming Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-12-01
Completion Date: 2024-10-31
Locations: Tang Junting, Kunming, Yunnan, 650000, China

Summary:
This study aims to investigate the effect of EBV reactivation or EBV reactivation added with dexamethasone(DXM) in patients with adverse drug reactions(CDR) , through evaluating the levels on monocyte, macrophage M2/M1 and cytokines. To investigate whether expression of EBV receptors EphA2 could specifically influence on EBV activation in CDRs. We performed a prospective longitudinal study on the frequencies of Monocyte, Macrophage, M2/M1 and cytokines included IL-4,IL-13,TNF-α,IFN-γ,IFN-β, CXCL9 and CXCL10 after onset of MPE ,SJS/TEN and control groups. PBMCs collected from peripheral blood were cocultured with EBV or EBV with DXM. We next examined whether EBV or EBV with DXM could have a strong impact on the MOs, Mac, M2/M1 and cytokines and which cytokines could be crucial for the interaction between M2/M1 and EBV, by in vitro cocultures. Finally, EphA2 were detected to evaluate reactivation of EBV.

Primary Outcome Measures: changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines, 24 hours and 48 hours
Efficacy of Pure Honey Dressing in Contrast to Alvogyl in the Resolution of Dry Socket
NCT Number: NCT06456060
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Dry Socket
Interventions: DRUG: Alvogyl|DRUG: Honey
Sponsor: Watim Medical & Dental College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-01-30
Locations: Nishtar Institute of Dentistry, Multān, Punjab, Pakistan

Summary:
Dry socket, or Alveolar Osteitis, is the most common complication that can follow a tooth extraction. Over the years, various approaches have been employed to expedite the healing process and alleviate the associated symptoms. Among these, Alvogyl has been the most commonly used dry socket dressing all over the globe. However due to Alvogyl's potential side effect of causing a foreign body reaction \& ultimately necrosis of the alveolar bone if left in the socket along with its high cost, scientists have sought to develop new techniques. Among them, Honey dressing has heralded promising properties in facilitating the resolution of dry socket, thus opening the window of a side-effect free natural viable alternative to Alvogyl. In this research, we aim to compare the efficacy of pure Honey as a dry socket dressing in comparison to Alvogyl.

Primary Outcome Measures: Pain relief, The patients will be requested to note daily pain records on a (0-10) visual analog scale, with 0 representing no pain and 10 representing the worst pain.., Patients will be reviewed at 5 min post-medication, 30 min post-medication, 60 min post-medication, 2nd day post-medication, 4th day post-medication and 7th day post-medication.
Detection of Early Airway Obstruction in Patients with COPD Using RCexp
NCT Number: NCT06456047
Acronym: COPD TiCON
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: COPD
Sponsor: East Slovak Institute for Cardiovascular Diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2028-12-31

Summary:
We hypothesize that Cexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.

Primary Outcome Measures: Association of early airway obstruction and positivity of RCexp, research correlation of RCexp1, RCexp2, and RCexp3 with FEV1 and FEV1/FVC in patients with known COPD and its correlation with healthy controls, January 2025 - December 2028
Prospective Registery of Smell/Taste Clinic Ear/Nose/Throat
NCT Number: NCT06456008
Acronym: ProspeRo'Scent
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Olfactory Disorder|Taste Disorders|Smell Dysfunction|Smell Disorder
Interventions: OTHER: Standard of care
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-06
Completion Date: 2035-12-31
Locations: UZ/KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

Summary:
Smell/taste disorders are common conditions with a significant impact on quality of life. In September 2021, a specific consultation for patients with smell and taste disorders was initiated at the ENT-HNS (ear, nose, and throat, head and neck surgery) department of UZ Leuven, partly in light of post-COVID-19 related smell disorders.

With this observational ambidirectional study, we aim to better map smell/taste disorders in the Belgian/Flemish population. Using standard-of-care diagnostic tests and structured questionnaires, we strive to gain more insight into the severity, impact, and progression/prognosis of smell/taste disorders.

Primary Outcome Measures: Chemosensory function, Observational up to 5 years follow-up
Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism
NCT Number: NCT06455982
Acronym: SAGE-2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Aging
Interventions: DIETARY_SUPPLEMENT: reduced carbohydrate menu combined with ketogenic supplement
Sponsor: Université de Sherbrooke
Collaborators: Nestlé Health Science
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-05
Completion Date: 2025-12-15
Locations: Centre de recherche sur le vieillissement, Sherbrooke, Quebec, J1H 4C4, Canada

Summary:
The present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. This study follows the KetoHome (fall 2022) and SAGE (fall 2023) projects which assessed the feasibility, acceptability and effectiveness of a reduced carbohydrate intervention alone.

Primary Outcome Measures: Plasma glucose concentration, To evaluate the possible improvement in mean glucose concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months., 2 months|Plasma ketones concentration, To evaluate the possible improvement in mean ketones concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months., 2 months|Plasma insulin concentration, To evaluate the possible improvement in mean insulin concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months., 2 months
Secondary Outcome Measures: Plasma triglycerides concentration, To evaluate the possible improvement in mean triglycerides concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months., 2 months|Plasma cholesterol concentration, To evaluate the possible improvement in mean cholesterol concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months., 2 months
Evaluation of Thriving, Substance Use, Mental Health, and Repeat Injury Among Participants in the THRIVE Program
NCT Number: NCT06455943
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Violence|Assault
Sponsor: Unity Health Toronto
Sex: ALL
Age: CHILD, ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2035-07-01

Summary:
The goal of this observational study is to determine the impact of a hospital-based violence intervention program on a person's capacity to thrive and recurrent intentional injury. The aims of this study are:

1. To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive using:

   * Established measure changes in positive psychology and clinical metrics
   * A qualitative interview using thematic content analysis
2. Plot the methodology proposed to measure the impact of THRIVE on subsequent injuries using administrative data sources

Participants will complete surveys, participate in a semi-structured interview, and have their rate of recurrent intentional injury tracked over time.

Researchers will compare the rates of intentional reinjury between participants in the THRIVE program and those who present at other hospitals with similar injuries to see if there is a difference in the rate of recurrent intentional injury a 1, 5, and 10 years.

Primary Outcome Measures: To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive., To evaluate changes in thriving, substance use, and mental health, validated measures and qualitative measures will be used. Quantitative measures collected using validated instruments will provide objective measures of change over time; while context-specific and nuanced growth will be captured through a semi-structured interview., July 2024 - December 2025|To pilot the methodology proposed to measure the impact of THRIVE on subsequent injuries within 1 year using administrative data sources, After 1.5 years of enrolment in THRIVE, study participants will be deterministically linked. Linkage will provide a wealth of baseline characteristics (demographics, income/marginalization), injury characteristics (ICD-10 coding patterns which can be contrasted to THRIVE documentation), as well as the capacity to follow these linked patients administratively over time and identify subsequent ED presentations and admission across any hospital in Ontario., March - Sept 2026
Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
NCT Number: NCT06455930
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Cerebral Palsy
Interventions: DEVICE: Stand-on ride-on power mobility device
Sponsor: University of North Florida
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-07-31
Locations: University of North Florida, Jacksonville, Florida, 32224, United States

Summary:
The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD).

The main questions we aim to answer are:

* How does the use of stand-on PMDs affect static balance in children with cerebral palsy?
* How does the use of stand-on PMDs affect dynamic balance and mobility function in children with cerebral palsy?

Children ages 4-6 years old with cerebral palsy (GMFCS levels II and III) will:

* Use individually-adapted stand-on PMDs for three months.
* Undergo tests to measure static balance, dynamic balance, and mobility function before and after the intervention.
* Receive a full biomechanical assessment (kinematics, kinetics, muscle activity, gait spatiotemporal characteristics).

Researchers will compare pre-intervention and post-intervention measurements to quantify improvements in balance, muscle activation, and mobility.

Primary Outcome Measures: Center of pressure sway area, standing, Measure of balance control during independent standing, Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
Secondary Outcome Measures: Thigh muscle co-contraction (quadriceps:biceps femoris), Agonist-antagonist muscle efficiency during functional tasks (e.g., sit-to-stand, independent static standing)., Baseline, Pre (3 months post Baseline), Post (3 months post Pre)|Center of pressure sway area, sit-to-stand, Measure of dynamic balance control during sit-to-stand, Baseline, Pre (3 months post Baseline), Post (3 months post Pre)|Trunk-pelvis coupling, Quantification of timing and magnitude of whole-body motor control coordination during functional tasks (e.g., sit-to-stand, walking turns)., Baseline, Pre (3 months post Baseline), Post (3 months post Pre)