pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Endothelial Dysfunction in Post-infection Fatigue Syndromes
NCT Number: NCT06463106
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Chronic Fatigue Syndrome|Long COVID
Sponsor: FH Joanneum Gesellschaft mbH
Sex: ALL
Age: ADULT
Enrollment: 107
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-01
Completion Date: 2022-12-01
Locations: FH JOANNEUM University of Applied Sciences, Graz, 8020, Austria

Summary:
Post-infection chronic fatigue syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID-19 condition (Long Covid), are conditions primarily characterized by debilitating fatigue. This fatigue can range from mild, where patients are still able to participate in some social activities (e.g., school, work), to moderate and severe, where sufferers are predominantly homebound and bedridden. As a result, ME/CFS and Long Covid not only negatively impact the quality of life of affected individuals and their caregivers but also represent a substantial and often silent burden on healthcare systems worldwide, including Austria. This is primarily because most cases remain undiagnosed due to the lack of standardized clinical assessments and diagnostic markers. Endothelial dysfunction, which is well known to affect blood flow, oxygen and nutrient delivery, and waste removal in the body, has been described as one of the key factors behind the symptoms experienced by ME/CFS and Long Covid patients. However, the mechanisms that might explain the development of endothelial dysfunction remain largely unexplored. Therefore, this project aims to evaluate key biological aspects related to the function of endothelial cells - a layer of cells lining blood vessels - using plasma samples from an Austrian cohort of ME/CFS and Long Covid patients. We expect that the findings from our study will provide new insights to better understand endothelial dysfunction in post-infection chronic fatigue syndromes, leading to improved patient stratification and tailored treatment alternatives.

Primary Outcome Measures: Circulating levels of L-arginine metabolites, Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS), 6 months|Markers of endothelial inflammation, ELISA, 6 months|Production of reactive oxygen species (ROS) in endothelial cells, Fluorometric assay, 6 months|Endothelial permeability, 3D culture model, 6 months|Angiogenesis, 3D culture model, 6 months|Epigenetic and transcriptomic patterns in endothelial cells, Genome wide DNA methylation and RNA sequencing (RNA-seq), 6 months
Differential Diagnosis of Cognitive Disorders of Psychiatric or Neurodegenerative Origin
NCT Number: NCT06463093
Acronym: ATEPDIPSY
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurocognitive Disorders
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2025-07-02
Locations: Nancy's hospital, Vandœuvre-lès-Nancy, 54511, France

Summary:
The aim of the research is to analyze whether 18F-FDG PET helps in the diagnosis and therefore in the management of the patient.

Primary Outcome Measures: Neuro cognitive disorders and disorders of neurodegenerative origin in psychiatric population, Change of the diagnosis before the PET and after the PET, one day
How Does Implementing a GetUp Assist Device in Addition to a Daily Low-intensity Functional or Traditional Training Program Affect Norwegian Female Office Workers' Physical Health After 12 Weeks?
NCT Number: NCT06463041
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck, Shoulder and Arm Syndrome
Interventions: OTHER: Experimental, comparator and control
Sponsor: Aalborg University
Collaborators: The Research Council of Norway
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-02
Completion Date: 2025-03-01
Locations: SSA Steinkjer, Steinkjer, Nord-Trøndelag, 7711, Norway

Summary:
This study aims to quantify the effect of daily transition routines between sitting and standing behaviour with an additional daily low-intensity traditional or functional training program on the physical health of sedentary Norwegian female workers after 12 weeks of implementation into their working environment.

Primary Outcome Measures: Norwegian Short-Form Health Survey (SF-36), Measure (i) physical function, (ii) Energy/fatigue, (iii) pain, and (iv) general health, 3 months|Neck and shoulder trouble questionnaire from the Nordic musculoskeletal questionnaire, Measure neck-shoulder discomfort, 3 months|Numeric rating scale, Measure neck-shoulder discomfort from 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable, 3 months|Y-balance test, Quantify dynamic postural control, 3 months|The Danish step test, Estimating cardiorespiratory fitness, 3 months|Chair-sit-and-reach test, Measuring hamstrings flexibility, 3 months|Back scratch test, Measuring upper-body/ shoulder flexibility, 3 months|CS-30 test, Measuring lower-body strength, 3 months|Hand Grip Strength test, Measuring hand Grip Strength, 3 months
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer
NCT Number: NCT06463028
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometrial Cancer
Interventions: DRUG: Sapanisertib|DRUG: Serabelisib|DRUG: Paclitaxel
Sponsor: Faeth Therapeutics
Collaborators: GOG Foundation
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2029-09

Summary:
This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel and the efficacy and safety of serabelisib with paclitaxel versus paclitaxel alone in participants with advanced or recurrent endometrial cancer.

Primary Outcome Measures: Objective Response Rate (ORR), Defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR)., Up to 2 years
Secondary Outcome Measures: Progression free survival (PFS), Defined as the time from randomization until the date of disease progression (per RECIST 1.1) or death., Up to 5 years.|Overall survival (OS), Defined as the time from randomization to death., Up to 5 years.|Clinical benefit rate (CBR), Defined as the percentage of participants who achieve confirmed complete response (CR), confirmed partial response (PR), or have stable disease (SD) of at least 16 or 24 weeks., Up to 5 years.|Duration of response (DoR), Defined as time from the date of first documented response until date of documented progression or death., Up to 5 years.|Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs), Graded according to the National Cancer Institute (NCI CTCAE V5.0)., Up to 2 years.
Posterior Tibial Nerve PRF for Diabetic Neuropathic Pain
NCT Number: NCT06463015
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Neuropathies, Painful|Diabetic Neuropathy Peripheral
Interventions: PROCEDURE: ultrasound-guided posterior tibial nerve pulsed radiofrequency
Sponsor: Diskapi Teaching and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-12
Completion Date: 2024-12-30
Locations: Diskapi Training and Research Hospital, Ankara, Turkey

Summary:
This study aimed to evaluate the efficacy of ultrasound (US)-guided posterior tibial nerve pulsed radiofrequency (PTN PRF) in the treatment of painful diabetic peripheral neuropathy (DPNP) refractory to conservative treatments. For this evaluation, the visual analog scale (VAS), PainDETECT neuropathic pain scores, and Jenkins Sleep Scale (JSS) will be used before and after the PTN PRF.

Primary Outcome Measures: Visual analog scale, Visual analog scale (VAS) is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain), Change from baseline to 1st and 3rd month after treatment
Secondary Outcome Measures: painDETECT neuropathic pain questionnaire, The painDETECT questionnaire, is a screening tool designed to identify neuropathic pain components in patients with chronic pain. The unabbreviated name is "painDETECT questionnaire". The score ranges from 0 to 38, with higher scores indicating a greater likelihood of neuropathic pain. Higher scores mean a higher likelihood of neuropathic pain and a worse poor outcome. A total score of 19 or more is indicative of likely neuropathic pain., Change from baseline to 1st and 3rd month after treatment|The Jenkins Sleep Scale, The Jenkins Sleep Scale (JSS) is a scale used to measure sleep quality. The JSS consists of four items related to common sleep problems: difficulty falling asleep, waking up several times during the night, difficulty staying asleep, and waking up tired. It uses a Likert-type scale ranging from 0 to 5, where 0 represents "not at all" and 5 corresponds to "22-31 days." The total JSS score is the sum of four items, with a range from 0 (no sleep problems) to 20 (most sleep problems). Higher scores indicate more acute sleep difficulties. Therefore, in this context, higher scores on the JSS reflect worse sleep outcomes., Change from baseline to 1st and 3rd month after treatment
Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea (AMPLE)
NCT Number: NCT06463002
Acronym: AMPLE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea
Interventions: DIAGNOSTIC_TEST: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment
Sponsor: National University Hospital, Singapore
Collaborators: Alexandra Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-09
Locations: National University Hospital, Singapore, SG, 119228, Singapore

Summary:
To compare the blood pressure control and cognitive responses of three groups of patients: those diagnosed with Obstructive Sleep Apnea (OSA) and treated with Continuous Positive Airway Pressure (CPAP) for at least six months, those diagnosed with OSA but not treated, and those without OSA.

Primary Outcome Measures: 24-hour mean systolic blood pressure, A 24-hour ambulatory blood pressure monitoring will be performed, Within 4 weeks after consent (one time)|Montreal Cognitive Assessment (MoCA), Montreal Cognitive Assessment scale (0-30). Lower the scale means more severe cognitive impairment, Within 4 weeks after consent (one time)
Secondary Outcome Measures: Office systolic blood pressure, Office blood pressure will be record, Within 4 weeks after consent (one time)|Epworth Sleepiness Scale, Epworth Sleepiness Scale (4-24). Higher scale means more severe daytime sleepiness, Within 4 weeks after consent (one time)|Nocturnal blood pressure dipping, Percentage of Participants with \>10% drop in nocturnal systolic blood pressure based on the ambulatory BP monitoring, Within 4 weeks after consent (one time)|24-hour systolic blood pressure <130 mmHg, 24-hour systolic blood pressure \<130 mmHg based on the ambulatory BP monitoring, Within 4 weeks after consent (one time)|24-hour systolic blood pressure <120 mmHg, 24-hour systolic blood pressure \<120 mmHg based on the ambulatory BP monitoring, Within 4 weeks after consent (one time)|Montreal Cognitive Assessment (MoCA) <27, Prevalence of participants with Montreal Cognitive Assessment (MoCA) \<27, Within 4 weeks after consent (one time)|Montreal Cognitive Assessment (MoCA) <20, Prevalence of participants with Montreal Cognitive Assessment (MoCA) \<20, Within 4 weeks after consent (one time)|MoCA score <27 (for those with >10 years of education) and <26 (for those with ≤10 years of education), Prevalence of participants with MoCA score \<27 (for those with \>10 years of education) and \<26 (for those with ≤10 years of education), Within 4 weeks after consent (one time)
Postoperative Pulmonary Complications in Adult PNL Patients
NCT Number: NCT06462976
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Postoperative Pulmonary Complication|Mechanical Power
Interventions: OTHER: mechanical power calculation
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-10
Completion Date: 2025-12-10
Locations: Gamze Talih, Kayseri, Turkey

Summary:
The aim of this study is to investigate the effect of different surgical positions (supine/prone) on lung mechanical power (MP) and its relationship with postoperative pulmonary complications in patients planned to percutaneous nephrolithotomy (PNL) under general anesthesia.

Primary Outcome Measures: mechanical power, mechanical power=0.098\*minute ventilation \*(Ppeak-0.5\*(Pplato-PEEP), 2 year
Experiment Among Smokers in Which Two Variables Are Manipulated: Ostracism and Concealability
NCT Number: NCT06462950
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ostracism
Interventions: BEHAVIORAL: Do men and women differ in their reactions to the experimental conditions.
Sponsor: Dickinson College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 340
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2028-05
Completion Date: 2028-12

Summary:
The goal of this experimental study is to learn about the effects of ostracism and concealment among adult smokers. The main aims are:

1. Determine the causal consequences of gendered stigmatization. Specifically, do women react more strongly than men to exclusion (as opposed to inclusion) especially when their gender is revealed (as opposed to concealed) for outcomes such as smoking stigma, stress, cognitive depletion, smoking attitudes, and smoking cessation intentions (Study 3)?
2. Examine the moderating roles of cultural context. Specifically, contrasting the cultural context in the US and Denmark (where gender norms are more egalitarian) do Danish smokers show fewer gender differences than US smokers in how they describe and react to their smoking stigmatization experiences (Study 1, 2, and 3)?

Primary Outcome Measures: Cognitive depletion, The Stroop Color-Word Interference Test measures the executive control needed to suppress reading a word and instead naming the color of the word. The test will be adminstered once immediately after the experimental task., 10 min
Feasibility of Gadolinium Contrast Reduced Brain MRI: the Potential of Deep Learning
NCT Number: NCT06462924
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Artificial Intelligence|Deep Learning
Interventions: DEVICE: DeepGad
Sponsor: DeepMeds
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 101
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-30
Completion Date: 2024-09-15

Summary:
MRI scans were performed using 3 different 1.5T scanners with an eight-channel head coils. Following a 3D pre-contrast T1w scan, a low-dose contrast-enhanced 3D T1w scan was obtained using 20% (0.02 mmol/kg) of the standard dosage of gadoterate meglumine.

The subjects were immediately administered the remaining 80% (0.08 mmol/kg) of the contrast agent to reach the standard dose of 0.1 mmol/kg, which served as a training ground truth for further quantitative assessment. All three acquisitions were performed during a single imaging session, with no additional gadolinium dose administered above the standard protocol.

Primary Outcome Measures: Image quality, Image quality using a 5-point Likert scale covering 1 (none), 2 (poor), 3 (moderate), 4 (good), and 5(excellent) ratings, 1 Day After MRI session|Vessel conspicuity, (0) no normal vessels observed, (1) significant decrease in conspicuity with potential impact on diagnosis, (2) mild decrease in conspicuity with unlikely impact on diagnosis, (3) normal conspicuity, (4) mild increase in conspicuity with unlikely impact on diagnosis, and (5) significant increase in conspicuity with potential impact on diagnosis., 1 Day After MRI session
Secondary Outcome Measures: Enhancement pattern, (a) no enhancement, (b) homogeneous enhancement, (c) heterogeneous enhancement, (d) ring enhancement, (e) linear enhancement, and (f) other enhancement., 1 Day After MRI session
The Effect of Omega-3 Fortified Smoothies on Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
NCT Number: NCT06462898
Acronym: H2FO3
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutrition, Healthy
Interventions: DIETARY_SUPPLEMENT: Omega-3 Fortified Protein Smoothie|DIETARY_SUPPLEMENT: Non-Fortified Protein Smoothie
Sponsor: Uniformed Services University of the Health Sciences
Collaborators: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-02-01
Completion Date: 2024-09-30
Locations: Fort Campbell, Fort Campbell North, Kentucky, 42223, United States|Fort Drum, Fort Drum, New York, 13602, United States

Summary:
The goal of this clinical trial is to test the effect of omega-3 on physical performance and recovery of Soldiers.

Objectives 1: Assess the impact of 8-weeks of daily consumption of 1600mg of omega-3 fortified smoothie on O3I response.

Objective 2: Determine the relationship between O3I and measures of performance and recovery.

Participants will:

* Be randomly assigned to placebo group or to the omega-3 fortified smoothie group.
* The intervention group will take omega-3 fortified smoothies and controls will consume a non-fortified smoothie, five days a week for 8 weeks.
* Participate in Army Combat Fitness Tests (ACFT)
* Complete surveys that assess dietary intake, physical activity (PAQ) and sleep quality (PSQI).
* Complete a finger prick to determine omega-3 index.

Assessments will be collected pre/post intervention. Researchers will compare intervention and placebo groups to see if omega-3 levels increase, and improve physical performance and recovery.

Primary Outcome Measures: Omega-3 Index, Omega-3 Index will be measured through finger prick, obtaining 1-2 drops of blood on a collection card to be sent to OmegaQuant for analysis. A score of 8-12% is desirable, 4-7.9% is moderate and \< 4% is low., Week 1 and Week 8|Army Combat Fitness Test (ACFT), ACFT test will be performed at Week 1 baseline and Week 8 post-intervention to show changes in physical performance., Week 1 and Week 8
Living Alone is Predictive of Non-home Discharge Following Elective Total Hip Arthroplasty: a Matched-pairs Cohort Analysis
NCT Number: NCT06462885
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Arthropathy of Hip|Perioperative/Postoperative Complications
Interventions: BEHAVIORAL: home support, hiving alone|BEHAVIORAL: home support, living with others
Sponsor: University of Virginia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5677
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-01
Completion Date: 2022-01-30
Locations: University of Virginia, Charlottesville, Virginia, 22908, United States

Summary:
The goal of this observational study is to assess the effect of living alone on total hip arthroplasty thirty-day outcomes. The main questions it aims to answer are:

Is living alone associated with discharge disposition (home versus non-home)? Is living alone associated with greater incidences of secondary adverse events?

Participants will be sampled from the 2021 American College of Surgeons National Surgical Quality Improvement Program

Primary Outcome Measures: Discharge disposition, Home versus non-home, Thirty days
Secondary Outcome Measures: Requiring home services, Thirty days|Functional status at discharge, Dependent versus independent, Thirty days|Postoperative delirium, Thirty days|Hospital length of stay, Thirty days|Unplanned resource utilization, Unplanned readmission and return to the operating room, Thirty days|Wound complications, Superficial surgical site infection (SSI), deep incisional SSI, organ space SSI, and wound dehiscence, Thirty days|Systemic complications, Cardiac arrest, myocardial infarction, stroke, reintubation, pneumonia, deep venous thrombosis, pulmonary embolism, bleeding, sepsis, septic shock, and acute kidney injury, Thirty days|Bleeding events, Requiring transfusion, Thirty days|Mortality, Thirty days
To Study the Efficacy of Intravenous Neostigmine in Resolution of Acute GI Paralysis in Critically Ill Cirrhotics
NCT Number: NCT06462872
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Critically Ill Cirrhotics
Interventions: OTHER: observational study
Sponsor: Institute of Liver and Biliary Sciences, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-15
Completion Date: 2025-02-27
Locations: Institute of Liver & Biliary Sciences, New Delhi, Delhi, 110070, India

Summary:
Aim: To determine the efficacy of intravenous neostigmine in the resolution of acute GI paralysis in patients with Critically Ill Cirrhosis (CIC).

Study population: Critically ill cirrhosis patient admitted in liver ICU with new onset acute GI tract paralysis and develop feed intolerance.

Study period - 1 years Sample Size

• All the consecutive patients admitted in liver ICU during the study time period (Dec 2023 -September 2024) will be screened and those patients meeting with inclusion and exclusion criteria will be enrolled, we intend to enroll 70 patients for the study.

Primary Outcome Measures: To study the proportion of patients reinitiated on enteral nutrition within 24 hours after radiological resolution., 24 hours
Secondary Outcome Measures: Proportion of patients having passage of stool after intravenous neostigmine within 24-hours., 24 hours|Time to passage of stool in between two groups., 7 days|Change in intra-abdominal pressure after resolution (IAP before and after), 7 days|Serial change in gastric residual volumes (GRV), 7 days|Calorie intake in 7 days, 7 days|Change in SOFA score., 7 days|Change in APACHE score, 7 days|Number of patients with new onset organ failure, 7 days|Number of patients with new onset SBP, 7 days|Number of patients with new onset infections, 7 days|Number of patients with need for rescue treatment., 7 days|Proportion of patients showing radiological resolution within 48-Hours and 72- hours., within 48-Hours and 72- hours|Adverse effects related to the treatment and need for atropine usage., 7 days|Survival at 7-days, 7 days|Stool microbiome study based on 16S RNA sequencing (Sample willbe stored in bio-bank)., 7 days
Effect of Sensory Integration in Diplegic Cerebral Palsy
NCT Number: NCT06462859
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diplegic Cerebral Palsy
Interventions: OTHER: Sensory Integration Therapy Group|OTHER: Neurodevelopmental Treatment Group
Sponsor: Halic University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-01-01
Completion Date: 2020-04-30
Locations: Ziya Special Education and Rehabilitation Center, Istanbul, Kagıthane, 34408, Turkey

Summary:
The purpose of this study is to compare the effects of sensory integration therapy (SIT) applied in addition to neurodevelopmental treatment (NDT) on Motor Function, Balance, and Trunk Control in diplegia cerebral palsy

Primary Outcome Measures: Gross Motor Function Measure-88 (GMFM-88), The evaluation is organized into sections based on different motor skills: Section A covers lying and rolling, Section B includes sitting, Section C focuses on crawling and kneeling, Section D assesses standing, and Section E includes walking, running, and jumping. Altogether, there are 88 items: Section A (17 items), Section B (20 items), Section C (14 items), Section D (13 items), and Section E (24 items). The minimum clinically important difference (MCID) ranges from 0.8 to 1.6 for a medium effect size and 1.3 to 2.6 for a larger effect size., 8 weeks
Secondary Outcome Measures: Pediatric Balance Scale (PBS), The PBS includes 14 items designed to assess daily life activities and functional skills. Each section is scored from 0 to 4, with a maximum total score of 56. A higher score indicates better functional balance performance., 8 weeks|Trunk Control Measurement Scale (TCMS), This assessment includes 15 items where children follow commands to perform movements within specific subsections, with their performance scored accordingly. The total score ranges from 0 to 58, with higher scores denoting better trunk control. The items gauge gross motor functions by assessing the child's performance. Each section is rated on a 4-point Likert scale, and percentages are calculated for each section. The final score is obtained by summing these percentages and dividing by 5., 8 weeks
Evaluation of Clinical Characteristics and Pathological Findings in Patients With Suspected Appendicitis
NCT Number: NCT06462846
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Appendicitis
Sponsor: Golestan University of Medical sciences
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 291
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-19
Completion Date: 2024-05-30
Locations: Golestan University of Medical Sciences, faculty of medicine, Gorgan, Golestan, 4918936316, Iran, Islamic Republic of

Summary:
As we know, one of the most common reasons for people to visit health centers and hospitals (15%) is abdominal pain, and appendicitis is at the top of their diagnosis in the 2-4th decade of age, which in most cases For treatment, considering the patient's condition and the need for surgery, appendectomy is the first method. One of the things that helps us a lot in this area is the epidemiology and incidence of this disease in the target society, which sometimes varies in different regions. One of the things that can be checked in this disease is the age and gender of the person and its incidence in different age ranges.

Primary Outcome Measures: The accuracy of imaging in determining the size of the appendix in patients with suspected appendicitis, comparison of the appendix size reported in radiologic studies with pathologic findings, One year
Secondary Outcome Measures: correlation between CRP levels and pathologic findings in patients with suspected appendicitis, Comparison of CRP levels in the different stages of appendicitis according to pathologic reports, One year|correlation between WBC measures and pathologic findings in patients with suspected appendicitis, Comparison of WBC measures in the different stages of appendicitis according to pathologic reports, One year|sex distribution in patients with suspected appendicitis, the prevalence and percentage of each sex group in patients with suspected appendicitis, one year|Age distribution in patients with suspected appendicitis, the prevalence and percentage of each age group in patients with suspected appendicitis, one year|prevalence of clinical findings in patients with suspected appendicitis, prevalence and percentage of each clinical finding (fever, anorexia, shifting pain, tenderness, rebound tenderness, rovsing sign, psoas sign) in patients with suspected appendicitis, one year
SAINT for MDD in an Inpatient Setting Follow-on
NCT Number: NCT06462820
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Major Depressive Disorder|Major Depressive Episode|Suicidal Ideation
Interventions: DEVICE: Active SAINT Stimulation|DEVICE: Sham SAINT Stimulation
Sponsor: Magnus Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2026-02-28
Locations: University of Iowa, Iowa City, Iowa, 52242, United States|Weill Cornell Medicine, Manhattan, New York, 10021, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|University of Texas, Ausin - Department of Psychiatry and Behavioral Sciences, Austin, Texas, 78712, United States

Summary:
Randomized, multi-site, sham-controlled, double-blinded study

Primary Outcome Measures: Montgomery-Asberg Depression Rating Scale (MADRS) Remission Rates, Ten item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in patients with mood disorders.

We will assess the difference in MADRS scores/remission rates between the per-protocol active SAINT group compared to those who received per-protocol sham treatment at the immediate post treatment visit., Screening/Baseline, Immediate Post Visit
Secondary Outcome Measures: Modified Scale for Suicidal Ideation (M-SSI), A revised version of the Scale for Suicidal Ideation (SSI; Beck et al., 1979). The MSSI is an 18 item scale that contains 13 items from the SSI and 5 additional items.

We will assess the mean change in the M-SSI from baseline to immediate post treatment visits between the per-protocol active SAINT group compared to those who received per-protocol sham treatment., Screening/Baseline, Immediate Post Visit|Columbia Suicide Severity Rating Scale (C-SSRS), We will use both the Lifetime and the Since Last Visit versions of the C-SSRS to assess suicidality from baseline to immediate post treatment between the per-protocol active SAINT group compared to those who received per-protocol sham treatment., Screening/Baseline, Immediate Post Visit|Montgomery-Asberg Depression Rating Scale (MADRS) Response Rates, We will assess the difference in MADRS response rates (reduction \>50% of MADRS baseline score) between the per-protocol active SAINT group compared to those who received per-protocol sham treatment at the immediate post treatment visit., Screening/Baseline, Immediate Post Visit
First In Human Study of CX-801 in Advanced Solid Tumors
NCT Number: NCT06462794
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor, Adult
Interventions: DRUG: CX-801|DRUG: pembrolizumab
Sponsor: CytomX Therapeutics
Collaborators: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 121
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2029-06-30
Locations: University of California San Francisco, San Francisco, California, 94158, United States|University of Pittsburgh Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States

Summary:
The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.

Primary Outcome Measures: Safety and tolerability of CX-801 as monotherapy and combination therapy, The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level, 44 months|Determine the recommended Phase 2 dose (RP2D), The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level, 44 months
Secondary Outcome Measures: Objective response rate (ORR), ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment., 60 months|Duration of response (DOR), DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first., 60 months|Progression-free survival (PFS), PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first., 60 months|Disease control rate (DCR), DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment., 60 months|Duration of disease control (DODC), DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first., 60 months|Overall survival (OS), OS defined as the time from the first dose of study intervention to death due to any cause., 60 months
Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment
NCT Number: NCT06462781
Acronym: LIGHT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Refractory Migraine
Interventions: DRUG: Lidocaine hydrochloride|DRUG: Methylprednisolone sodium succinate|OTHER: Standard of Care
Sponsor: The Cooper Health System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 230
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03
Completion Date: 2027-03
Locations: Cooper University Health Care, Camden, New Jersey, 08103, United States

Summary:
The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).

The main questions this study aims to answer are:

* Is this treatment safe for chronic migraine patients?
* Is this treatment effective for chronic migraine patients?

Participants will:

* Be treated once with lidocaine and steroid infused into the middle meningeal arteries (two blood vessels in the brain).
* Attend appointments scheduled 1 week, 6 weeks, and 12 weeks after the treatment for a checkup.
* Keep a log of their symptoms.

Primary Outcome Measures: Rate and Duration of Symptomatic Relief, Change in headache assessment scores (MIDAS, verbal pain scale, numeric pain scale) and patient-reported quantitative and qualitative headache symptoms, From screening enrollment to the end of study follow-up at 12 weeks
Secondary Outcome Measures: Number of Participants with Adverse Events, Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event, From screening enrollment to the end of study follow-up at 12 weeks
Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis
NCT Number: NCT06462768
Acronym: NETOSE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Systemic Sclerosis|Other Connective Tissue Disease|Systemic Lupus Erythematosus|Dermatomyositis|ANCA Associated Vasculitis
Interventions: OTHER: Blood sample
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-27
Completion Date: 2029-04-27
Locations: Chu Reims, Reims, 51092, France

Summary:
Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS).

Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE.

The investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and/or at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.

Primary Outcome Measures: Quantification of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls., Comparative analysis of the quantity of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, other connective tissue diseases and healthy controls. Neutrophils from SSC, other connective tissue diseases and healthy subjects will be used., Day 0
Secondary Outcome Measures: Analysis of the composition of Neutrophil Extracellular Traps (NETs), Comparative analysis of the composition of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, other connective tissue diseases and healthy controls. Neutrophils from SSC, other connective tissue diseases and healthy subjects will be used., Day 0|Analysis of the cytokines influencing Neutrophil Extracellular Traps NETs production in vitro, Comparative analysis of the quantity of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils from SSC patients in vitro by differents cytokines, Day 0
Perioperative Database of Chinese Elderly Patients for Postoperative Acute Kidney Injury
NCT Number: NCT06462755
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Postoperative Acute Kidney Injury
Interventions: OTHER: No intervention
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 57089
Study Design: Observational Model: |Time Perspective: p
Start Date: 2009-01-01
Completion Date: 2018-12-31

Summary:
To develop and externally validate a risk prediction model for postoperative acute kidney injury (PO-AKI) in elderly patients undergoing major noncardiac surgery, addressing the current gap in predictive tools for this vulnerable population.

The endpoint was the occurrence of PO-AKI within seven days following surgery. Diagnoses were based on the Kidney Disease: Improving Global Outcomes (KDIGO) criterion. Potential PO-AKI-related perioperative data were retrieved and extracted from electronic medical record for model derivation and validation.

Clinicians may consider implementing this externally validated risk prediction model to stratify elderly patients' PO-AKI risks in the early postoperative phases of noncardiac surgery in elderly patients.

Primary Outcome Measures: Number of participants with postoperative acute kidney injury, Postoperative acute kidney injury, within seven days following surgery
Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma
NCT Number: NCT06462742
Acronym: MALRIC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Overall Survival|Disease-free Survival
Interventions: PROCEDURE: Microwave ablation (MWA) versus Liver Resection (LR)
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2009-01-01
Completion Date: 2029-06-01
Locations: Chinese PLA General Hospital, Beijing, Beijing, 100853, China

Summary:
Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. The goal of this observational study is to study the efficacy of ablation in treating iCCA by comparing its prognosis with surgery. The main questions it aims to answer are:

* Whether microwave ablation could achieve similar efficacy with liver resection in treating iCCA
* What is the risk factor for ablation or surgery in treating iCCA
* What kind of iCCA patients could receive ablation as their first-line treatment In this real-world multicenter cohort study, we will collect data of iCCA patients from hospitals who underwent microwave ablation (MWA) or liver resection (LR) for tumors within Milan criteria. Survival will be compared between patients treated by MWA or LR.

Primary Outcome Measures: Overall survival, OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death, More than 3 years]|Disease-free survival, DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier., More than 3 years
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
NCT Number: NCT06462729
Acronym: RESTORE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Degenerative Disc Disease|Lumbar Disc Disease|Spine Disease|Lumbar Spine Degeneration
Interventions: DEVICE: LDGraft|DEVICE: LDGraft|OTHER: Allograft Bone
Sponsor: Locate Bio Pty Ltd
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
Completion Date: 2027-07
Locations: Newcastle Private Hospital, Newcastle, New South Wales, 2305, Australia

Summary:
The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).

Primary Outcome Measures: Radiographic Fusion, Radiographic fusion defined as evidence of bridging bone by CT scan, 12 months and 24 months|Secondary Surgical Intervention, No index level secondary surgical intervention, 12 months and 24 months|Oswestry Disability Index (ODI) Score, At least 15-point improvement in Oswestry Disability Index (ODI) compared to baseline, 12 months and 24 months|Neurological Condition, No new or worsening persistent lumbar spine neurological condition compared to baseline, 12 months and 24 months|Serious Device-Related Adverse Events, No serious device-related adverse events, 12 months and 24 months
Secondary Outcome Measures: Radiographic Outcomes, Radiographic outcomes including bridging bone, radiolucency, device condition, migration, subsidence, angular motion, and translational motion, 6 weeks, 3 months, 6 months, 12 months and 24 months|Visual Analog Score (VAS) Back, Improvement in the Visual Analog Score (VAS) back pain of 20mm compared to baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months|Visual Analog Score (VAS) Change Back, Mean change in back VAS over time intervals, 6 weeks, 3 months, 6 months, 12 months and 24 months|Visual Analog Score (VAS) Leg, Improvement in the Visual Analog Score (VAS) worst leg of 20mm compared to baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months|Visual Analog Score (VAS) Change Leg, Mean change in leg VAS over time intervals, 6 weeks, 3 months, 6 months, 12 months and 24 months|Oswestry Disability Index (ODI) Score, Improvement in ODI of 15 points compared to baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months|Oswestry Disability Index (ODI) Change, Mean change in ODI over time intervals, 6 weeks, 3 months, 6 months, 12 months and 24 months
A Phase l Study of By101298, an Oral DNA-PK Inhibitor, in Patients With Advanced Solid Tumors
NCT Number: NCT06462716
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor, Adult
Interventions: DRUG: BY101298 Capsules
Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-25
Completion Date: 2025-06-30
Locations: Cancer Hospital Affiliated to Shandong First Medical University / Shandong Cancer Research Institute / Shandong Cancer Hospital, Jinan, Shandong, 250117, China

Summary:
BY101298 is an innovative DNA-dependent protein kinases (DNA-PK) highly selective small molecule inhibitor. DNA-dependent protein kinases (DNA-PK plays a key role in the NHEJ repair pathway to repair DNA double-strand breaks (DSBs).

Primary objective is to assess the safety and tolerability of BY101298 in patients with advanced malignant solid tumors. The secondary Objectives are to characterize the pharmacokinetic (PK) profile of BY101298 in patients with advanced malignant solid tumors and to assess the preliminary efficacy of BY101298 in patients with advanced malignant solid tumors.

Primary Outcome Measures: To assess the safety and tolerability of BY101298 in patients with advanced solid tumors, Grade and frequency of adverse events and serious adverse events, through study completion (an average of 1.5 years)|To assess the maximum tolerated dose (MTD), Incidence of Dose limiting Toxicities (DLTs), through study completion (an average of 1.5 years)
Secondary Outcome Measures: To assess preliminary antitumor activity of BY101298 in patients with advanced solid tumors, ORR, through study completion (an average of 1.5 years)|To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors, AUC, through study completion (an average of 1.5 years)|To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors, Cmax, through study completion (an average of 1.5 years)|To assess pharmacokinetics (PK) parameters of BY101298 in patients with advanced solid tumors, T1/2, through study completion (an average of 1.5 years)
Surveillance of Emerging Pathogens to Ensure Blood Supply Safety
NCT Number: NCT06462677
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Babesioses, Human
Interventions: DIAGNOSTIC_TEST: Babesia NAT
Sponsor: Canadian Blood Services
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 17600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-02
Completion Date: 2030-12-30

Summary:
Babesia is a parasite that can be transmitted from the bite of a tick to an individual. While many some people may not have any symptoms from infection, others may experience anything from flu-like symptoms to joint pain, hemolytic anemia, or jaundice. Should an infected individual donate blood, they could pass the infection to a recipient through their blood donation. In 2018, Canadian Blood Services (CBS) screened blood donations between June and October, and Babesia was found in 0.002% - 0.0007% of donors. This prevalence is slightly less than other areas where Babesia testing is not mandated for blood donors (such as Arizona and Oklahoma), and several logs less than areas where Babesia testing is mandated for blood donations. Based on these data, a later Canadian Babesia case, and risk modelling by CBS, a risk-based decision-making (RBDM) process was initiated. The RBDM strongly emphasizes consistent monitoring and frequent testing for Babesia among Canadian blood donors. This proactive strategy is aimed at minimizing the risk of Babesia transmission through donated blood. This study will span five years and examine the prevalence of Babesia, other tick-borne diseases (such as Anaplasma and Powassan virus), and other emerging pathogens which may impact the blood supply.

Primary Outcome Measures: Prevalence of Babesia in Canadian Blood Donors, All whole blood donors in Manitoba will be tested for Babesia, Anticipated July 2 2024 to Oct 25 2024