pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Investigation of Q Angle in Osteoporosis Patients
NCT Number: NCT06475794
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoporosis
Interventions: OTHER: Patients with osteoporosis group|OTHER: Patients with osteoarthritis group
Sponsor: Firat University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2024-07-30
Locations: Songul Baglan Yentur, Elazığ, 23100, Turkey

Summary:
Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).

Primary Outcome Measures: Q angle assessment, Q angle will be evaluated with goniometer., 1 minute
Secondary Outcome Measures: Pain assessment, Pain assessment will be done with the Visual Analog Scale (VAS). This measurement is performed with a chart in which no pain is written on one end and very severe pain is written on the other end., 1 minute|Muscle strength assessment, Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Muscle strength is graded on a scale of 0 to 5 according to muscle tone and ability to resist the force of gravity., 2 minutes|Foot posture assessment, Foot posture will be evaluated with the Foot Posture Index (FPI). API is an easy-to-apply, valid and reliable method that provides information about the degree of pronation and supination of the foot with a single numerical result and evaluates the foot in a multidimensional and comprehensive manner., 1 minute
The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.
NCT Number: NCT06475768
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myocardial Stiffness
Interventions: DIAGNOSTIC_TEST: Stress Echocardiogram|DIAGNOSTIC_TEST: Cardiovascular Magnetic Imaging (cMRI)|DIAGNOSTIC_TEST: Cardiac Magnetic Resonance Elastography (cMRE)
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-07

Summary:
The purpose of this research is to study postmenopausal female masters athletes to see if they will show greater myocardial stiffness and reduced exercise capacity than premenopausal females and similarly aged male masters athletes.

Primary Outcome Measures: Myocardial stiffness, Myocardial stiffness will be measured by magnetic resonance elastography (kPa), Day 14
Secondary Outcome Measures: Left ventricular filling pressures with exercise, Left ventricular filling pressures with exercise will be measured by stress echocardiography, Baseline|Exercise capacity, Exercise capacity will be measured by stress echocardiography, Baseline
Neoadjuvant/Adjuvant Tislelizumab Combined With Anlotinib and Platinum Doublet Chemotherapy With Resectable NSCLC
NCT Number: NCT06475755
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer|Anti Angiogenesis
Interventions: DRUG: Immunochemotherapy combined with antiangiogenic|DRUG: Immunochemotherapy
Sponsor: Tang-Du Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 178
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2027-12-31
Locations: Tangdu Hospital of the Fourth Millitary Medical University, Xi'an, Shaanxi, 710000, China

Summary:
This is a Phase II, prospective, randomized, open label, controlled, multi-center study, aim to evaluate the activity of Tislelizumab and Anlotinib and chemotherapy compared with Tislelizumab and chemotherapy before surgery, followed by Tislelizumab alone as adjuvant therapy. The primary objective of this study is to evaluate and compare pathological complete response rate(pCR).

Primary Outcome Measures: pathological complete response (pCR) in Intent-to-Treat (ITT) analysis set, pathological complete response (pCR): defined as no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment., through study completion, an average of 1 year
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
NCT Number: NCT06475742
Acronym: OPUS OLE
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Lupus Erythematosus, Systemic
Interventions: DRUG: Cenerimod
Sponsor: Idorsia Pharmaceuticals Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 680
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2028-05
Locations: Accurate Clinical Research Inc. - Lake Charles, Lake Charles, Louisiana, 70605, United States|Accurate Clinical Research Inc., Baytown, Texas, 77521, United States

Summary:
The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.

The main questions it aims to answer are:

* Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus.
* How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years.

Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year.

In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for at least 1 year and up to 3 years.

Primary Outcome Measures: Treatment-emergent adverse events, Occurrence of treatment-emergent adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period)., Day 1 (post dose) to a maximum of 3.5 years|Serious adverse events, Occurrence of serious adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period)., Day 1 (post dose) to a maximum of 3.5 years|Adverse events of special interest, Occurrence of adverse events of special interest up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).

Adverse events of special interest include the anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities, i.e., adverse events related to:

* Effects on heart rate and rhythm
* Hypotension
* Hypertension
* Cardiovascular
* Hepatobiliary disorders / liver enzyme abnormalities
* Pulmonary
* Eye disorders
* Infections
* Skin malignancies
* Non-skin malignancies, Day 1 (post dose) to a maximum of 3.5 years
A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants
NCT Number: NCT06475729
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Citrate-Free Mirikizumab
Sponsor: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 440
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2024-11
Locations: CenExel ACT, Anaheim, California, 92801, United States|Fortrea Clinical Research Unit, Daytona Beach, Florida, 32117, United States|Clinical Pharmacology of Miami, Miami, Florida, 33014-3616, United States|QPS Missouri, Springfield, Missouri, 65802, United States|Fortrea Clinical Research Unit, Dallas, Texas, 75247, United States|Fortrea Clinical Research Unit, Madison, Wisconsin, 53704, United States

Summary:
The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector.

Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.

Primary Outcome Measures: Maximum Concentration (Cmax) of Mirikizumab, Cmax of Mirikizumab, Predose up to 71 Days Postdose|Area under the Curve from Zero to Infinity (AUC [ 0 to ∞]) of Mirikizumab, AUC \[ 0 to ∞\] of Mirikizumab, Predose up to 71 Days Postdose|Area under the Curve from Zero to Time to Last Concentration (AUC [0 to tlast]) of Mirikizumab, AUC \[0 to tlast\] of Mirikizumab, Predose up to 71 Days Postdose
OrthoCor Advanced Trial for Knee Osteoarthritis
NCT Number: NCT06475677
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee|Osteo Arthritis Knee
Interventions: DEVICE: OrthoCor Advanced System
Sponsor: Caerus Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-18
Completion Date: 2024-11
Locations: Andrews Research & Education Foundation, Gulf Breeze, Florida, 32561, United States

Summary:
The objective of this clinical trial is to show that PEMF therapy, heat, recovery metrics, and compliance data provided by the OrthoCor Advanced System improves pain and quality of life for patients with osteoarthritis. The main question it aims to answer is:

Does therapy from the OrthoCor Advanced System improve symptoms of osteoarthritis?

Researchers will compare range of motion measurements, sit to stand test results, and functional survey answers to see if there are any changes after 4 weeks of therapy with the OrthoCor Advanced System.

Participants will use the OrthoCor Active System for 30 minutes twice daily and complete recovery measurements daily using an application.

Primary Outcome Measures: Adverse Events, Primary Safety Endpoint: Number of Adverse Events, during 4 weeks of treatment|VAS pain score, Primary Efficacy Endpoint: Pain score from 0-10 on the Visual Analog pain Scale (VAS), with 0 indicating no pain and 10 indicating the worst pain imaginable, before, during, and after 4 weeks of treatment
Secondary Outcome Measures: Knee AROM, Active Range of Motion (AROM) for the Knee, before and after 4 weeks of treatment|Sit-to-stand, Number of times in 30 seconds patient can perform sit-to-stand motion, before and after 4 weeks of treatment|KOOS survey, Knee injury and Osteoarthritis Outcome Score (KOOS) survey, from 0-100% with 0% indicating the worst function possible and 100% indicating full function, before and after 4 weeks of treatment|Pain medication use, Daily recording of pain medication taken, during 4 weeks of treatment|Joint motion tracking, Joint motion tracking data recorded by the application during daily recovery exercises, during 4 weeks of treatment
Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial
NCT Number: NCT06475664
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Colorectal Cancer
Interventions: OTHER: Personalized legal care services
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2026-02-01

Summary:
This is a single center single-arm, pilot study of proactive and early connection with free legal care services for persons with advanced colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period. All participants continue to receive standard of care as prescribed by their treating physician.

Primary Outcome Measures: The Perceived Stress Scale 4 (PSS-4), A 4-item measure of perceived stress., baseline, 3 months, 6 months|The Cancer Behavior Inventory-Brief Version (CBI-B), A 12-item measure of self-efficacy coping with cancer., baseline, 3 months, 6 months|The COmprehensive Score for financial Toxicity (COST), A 12-item measure of financial toxicity., baseline, 3 months, 6 months|The National Comprehensive Cancer Network's (NCCN) Distress Thermometer, A single-item measure of psychological distress., baseline, 3 months, 6 months|The Spitzer Uniscale (UNISCALE), A single-item measure of overall quality of life., baseline, 3 months, 6 months|Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I), A 9-item measure of perceptions of interpersonal relationships with a patient navigator (i.e. CLC)., baseline, 3 months, 6 months|Pearlin Mastery Scale, A 7-item measure of psychological coping

(mastery)., baseline, 3 months, 6 months|The Life Engagement Test (LET), A 6-item measure of purpose in life, defined as the extent to which a person engages in activities that are personally meaningful., baseline, 3 months, 6 months|Rosenberg Self-Esteem (RSE) Scale, A 10-item measure of self-esteem., baseline, 3 months, 6 months|Cancer Related Behavior Questionnaire, A 31-item measure of comfort facing cancer related issues., baseline, 3 months, 6 months|Cancer Legal Care Services Questionnaire, A 13-item measure of CLC, baseline, 3 months, 6 months
Characterization and Contribution of Genome-wide DNA Methylation (DNA Methylation Episignatures) in Rare Diseases With Prenatal Onset
NCT Number: NCT06475651
Acronym: FOETEPISIGN
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rare Fetal Genetic Diseases|Congenital Malformation
Interventions: GENETIC: Methylation analysis
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: CHILD, ADULT
Enrollment: 63
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2024-12
Locations: Department of Genomic Medicine for Rare Diseases and the Multidisciplinary Center for Prenatal Diagnosis of the Necker-Enfants malades Hospital, Paris, 75015, France

Summary:
It is necessary to define reference DNA Methylation Episignatures from fetal DNA. The hypotheses are:

* It is possible to define reference DNA Methylation Episignatures from fetal DNA extracted from amniotic fluid or frozen tissues collected during the postmortem examination
* Fetal DNA Methylation Episignatures may be different to postanal DNA Methylation Episignatures defined on DNA extracted from blood

Primary Outcome Measures: Epigenetic signature associated with pathogenic variations in the CHD7 gene (CHARGE Syndrome), Evidence of epigenetic signature from fetal tissue DNA in fetuses with pathogenic or probably pathogenic variation, 12 months|Epigenetic signature associated with pathogenic variations in the KMT2D gene (KABUKI syndrome), Evidence of epigenetic signature from fetal tissue DNA in fetuses with pathogenic or probably pathogenic variation, 12 months
Secondary Outcome Measures: Differential methylation between fetal and postnatal epigenetic signature, Evidence of differential methylation between fetal an postnatal epigenetic signature, 12 months|Differential methylation between tissue and amniotic fluid epigenetic signatures, Evidence of differential methylation between tissue and amniotic fluid epigenetic signatures, 12 months|Statistical prediction parameter for each epigenetic signature, Measurement of the statistical prediction parameter for each epigenetic signature, 12 months|Identification of a new epigenetic signature in foetal pathologies, Identification of news epigenetic signatures of exclusively pathologies associated with the HYLS1, TCTN3 and FLVCR2 genes, 12 months
Brachial Artery Pulsatility Index in Supraclavicular Block
NCT Number: NCT06475638
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brachial Plexus Anesthesia
Interventions: DEVICE: brachial artery doppler
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 89
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-12-01
Locations: Cairo University, Cairo, Egypt

Summary:
we aimed to evaluated accuracy of brachial artery doppler derived indices such as change in pulsatility index, resistive index, and waveform morphology in predicting successful supraclavicular block

Primary Outcome Measures: the change in pulsatility index as a predictor to successful supraclavicular block, the difference between the index before and after the block divided by the index value before the block, baseline and at 5 minutes interval after block for 30 minutes
Secondary Outcome Measures: change in resistive index as a predictor for successful block, baseline then at 5 minutes interval for 30 minutes|change in waveform morphology as a predictor to successful block, baseline and within 10 minutes of block
Using the GTOS to Stratify the Mortality Risk of Adult Trauma Patients
NCT Number: NCT06475612
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Trauma Injury
Interventions: OTHER: Death|OTHER: Survival
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40068
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-17
Completion Date: 2024-06-07
Locations: Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, 83301, Taiwan

Summary:
Trauma significantly impacts both short- and long-term health outcomes, resulting in substantial mortality. Early identification and risk stratification in trauma patients are crucial for timely medical interventions. The Geriatric Trauma Outcome Score (GTOS), designed by incorporating age, the Injury Severity Score (ISS), and the need for packed red blood cell transfusion, has emerged as a valuable prognostic tool for elderly trauma patients, but its applicability to general trauma patients remains underexplored.

Primary Outcome Measures: Mortality outcome, Mortality outcome of trauma patients., Through hospital stay of patients, an average of 14 days.
Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
NCT Number: NCT06475586
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Psoriasis Vulgaris|Diabetes Type 2
Interventions: DRUG: Semaglutide
Sponsor: University of Banja Luka
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-03
Completion Date: 2024-06-10
Locations: University of Banja Luka, Faculty of Medicine, Banja Luka, 78000, Bosnia and Herzegovina

Summary:
The use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response

Primary Outcome Measures: clinical characteristics of patients with psoriasis, clinical examination by a dermatovenerologist (PASI SCORE- Psoriasis Area and Severity Index). To assess disease activity, i.e. skin surface affected by changes (erythema, infiltration and extent of squamous matter), investigators used the PASI score. According to the European consensus, mild psoriasis is defined as PASI≤10 and DLQI≤10, while moderate psoriasis is defined as PASi\>10 and DLQI\>10., up to 12 weeks|Determine BMI Body Mass Index, e.g., weight and height will be combined to report BMI in kg/m\^2, up to 12 weeks|Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23, ELISA-Enyzme linked immunosorbent assay technique -Bio Legend ELISA MAX Deluxe Sets, Bio Legend, San Diego, CA.

same units, up to12 weeks|Correlation between the course and prognosis of the disease after the treatment, the Wilcoxon Mann-Whitney test for two independent groups will be used. Spearman's correlation analysis will be used to determine the correlation between parameters, binary logistic regression, up to 12 weeks|Change in HgbA1C,, by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) will be expressed in %, up to 12 weeks|lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides, Biochemical analyses Clinical colorimetric tests, and results will be expressed in same units, up to 12 weeks|fasting insulin, Biochemical analyses, up to 12 weeks|Change in inflammation marker level: CRP,, Biochemical analyses-Turbid metric test, up to 12 weeks|fasting glycemia, by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic), up to 12 weeks|urate, Biochemical analyses, up to 12 weeks
Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients
NCT Number: NCT06475573
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Impaired Glucose Regulation|Overweight and Obesity
Interventions: DIETARY_SUPPLEMENT: dietary fiber probiotic beverages|OTHER: whole grain porridge
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-03-01
Completion Date: 2024-10-31
Locations: The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China

Summary:
This study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.

Primary Outcome Measures: fasting blood glucose, fasting blood glucose after an overnight fast, Baseline and after 8-week intervention|2-hour postprandial blood glucose, 2-hour postprandial blood glucose after 75g Glucose Tolerance Test, Baseline and after 8-week intervention
Secondary Outcome Measures: Body weight, Body weight, Baseline; after 4-week intervention; after 8-week intervention|body composition, body composition measured by Bioelectrical impedance analysis, including body fat percentage, visceral fat area, skeletal muscle mass, Baseline; after 4-week intervention; after 8-week intervention|Lipid profile, Total cholesterol, triglycerides, HDL, LDL, Baseline and after 8-week intervention
Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
NCT Number: NCT06475560
Acronym: DanCap
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer
Interventions: DIAGNOSTIC_TEST: CCE arm|DIAGNOSTIC_TEST: OC arm
Sponsor: Odense University Hospital
Collaborators: Centre of Excellence Centre for clinical implementation of capsule endoscopy (CICA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2025-12
Locations: Odense University Hospital, Odense C, 5000, Denmark

Summary:
The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional optical colonoscopy (OC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of OC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed.

One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an OC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an OC. A low reinvestigation rate (\<25%-30%) is desirable for patient preference and the economy.

Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.

Primary Outcome Measures: Cost analysis, Cost of CCE-pathway compared to OC-path-way, 1 year
Secondary Outcome Measures: Reinvestigation rate of CCE, Technically insufficient examinations or plus number of ex-aminations followed by second-stage OC due to positive CCE findings, 1 year|Diagnostic tool evaluation / Performance evaluation, NPV, PPV, Sensitivity, Specificity, 1 year|Comparative analysis of detection rates for CCE and OC, Polyp detection rate in both pathways, categorized as "\<6 mm", "6-9 mm" and "\>9 mm", 1 year|Predictive value of FIT, Concentration of faecal haemoglobin and the risk of findings, 1 year|Gut microbiome, The composition of the microbiome and the risk of findings, 1 year
Inflammation and Postoperative Atrial Fibrillation in Cardiac Surgery
NCT Number: NCT06475547
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation|Inflammation
Interventions: OTHER: Descriptive
Sponsor: Odense University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2025-01-01
Locations: Odense University Hospital, Cardiac Surgery Department, Odense, 5000, Denmark

Summary:
Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, marked by an irregular and rapid heart rate, and associated with increased morbidity, longer hospital stays, and higher costs. Its complex pathophysiology involves atrial remodeling, inflammation, and autonomic dysregulation. Surgical trauma and cardiopulmonary bypass trigger an inflammatory response, releasing cytokines. Epicardial fat around the heart secretes pro-inflammatory cytokines, and its increased thickness is linked to higher inflammation and atrial fibrillation. This study uses RNA sequencing (RNA-seq) to profile gene expression in epicardial fat, identifying key genes involved in inflammation and metabolism. By comparing patients with and without POAF, RNA-seq reveals differentially expressed genes associated with postoperative atrial fibrillation.

Primary Outcome Measures: Differential expression of genes, The primary endpoint of this study is to identify differentially expressed (DE) genes using RNA sequencing (RNA-seq) data. Post-sequencing, we will utilize the default settings and statistical methods provided by DESeq2 to determining statistically significant differences in gene expression between the experimental conditions.

The gene signal is measured in normalized counts per kilobase or in Fragments Per Kilobase of transcript per Million mapped reads., The sample is taken at the time of surgery.
A Randomised, Controlled, Double-blinded, Multi-country, Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
NCT Number: NCT06475521
Acronym: GAIA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Interventions: OTHER: Infant Formula
Sponsor: Nutricia Research
Sex: ALL
Age: CHILD
Enrollment: 579
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-30
Completion Date: 2027-12-31

Summary:
To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks. And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test Product, compared to subjects receiving the Control Product. Also, other anthropometric parameters will be investigated up to 52 weeks.

A Breastfed reference group, exclusively breastfed for at least 16 weeks, will also be included.

Primary Outcome Measures: Weight gain, To demonstrate equivalence in mean weight gain per day from baseline to 16 weeks post-baseline in subjects receiving the Test product, compared to subjects receiving the Control product, Baseline to 16 weeks post-baseline
Secondary Outcome Measures: Neurocognitive Development, Demonstrate better neurocognitive development as measured by the Bayley Scales of Infant and Toddler Development (Bayley-3) cognitive composite score at 52 weeks post-baseline in subjects receiving the Test product, compared to subjects receiving the Control product., 52 weeks post baseline
Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips
NCT Number: NCT06475482
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cheilitis
Interventions: OTHER: Lip hydrant|OTHER: Petroleum gel
Sponsor: Chulalongkorn University
Sex: ALL
Age: ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-03
Completion Date: 2024-03-27
Locations: Faculty of dentistry, Chulalongkorn university, Bangkok, 10330, Thailand

Summary:
* The goal of this clinical trial is to evaluate the efficacy of the novel polyherbal lip hydrant on dryness, fine lines and color of the lips in 66Thai people aged between 18-40 years old. The inclusion criteria will include subjects with subjective complaint of dry lips.The main question it aims to answer is Does the novel polyherbal lip hydrant improve biophysical barrier of the lips?
* Participant will be asked to apply the lip hydrant or the petroleum gel once a day before bedtime, and refrain from using other lip products throughout the clinical trial period (28 days).
* Researchers will compare control group (Petroleum gel) with lip hydrant group to see whether biophysical barrier (wrinkles, colors, fine lines, roughness) improve or not.

Primary Outcome Measures: Objective evaluation, Objective evaluation; using

* Fotofinder to take a photograph of the lips.
* Modified visual assessment scale to assess lip roughness score divided to 4 levels (1=not dry 2= dry without desquamated 3 = dry with slightly desquamated 4 = dry with heavy desquamated) and lip wrinkle score divided into 3 levels (1 = Almost no vertical wrinkle 2 = No deep vertical wrinkle 3= Many deep vertical wrinkle)
* Antera 3D. (Texture, wrinkle, melanin pigment and hemoglobin) the value from Antera appear as the number with no unit,
* Digital camera to evaluate overall clinical improvement of the lips, 30 minutes per 1 participant
Secondary Outcome Measures: Subjective evaluation, will be assessed at day 0 (baseline), day 1 and day 28 by using a self-reported questionnaire in scale from 1-10 points for patient's dry lip score which higher score means more dry lip feeling, 5 minutes per 1 participant
Description of the Immune Deficiency in Patients With Untreated Chronic Lymphocytic Leukemia and Search for Predictive Factors of Infectious Risk
NCT Number: NCT06475469
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Lymphocytic Leukemia
Interventions: BIOLOGICAL: Blood sampling & Chest CT without injection
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2022-05-10
Completion Date: 2028-06
Locations: Chu Reims, Reims, 51092, France

Summary:
Chronic Lymphocytic Leukemia (CLL) is the most common adult leukemia in western countries. CLL is most often discovered incidentally when a blood test carried out for another reason highlights an increase of subpopulation of white cells called lymphocytes. It is also sometimes diagnosed when complications such as an increase in the size of the lymph nodes or a decrease in other blood lines (red blood cells and platelets) occur. Its evolution is heterogeneous and only patients with symptoms require treated. CLL is aso characterized by its hability to induce immunodeficiency, which tends to worsen over time, even in patients who do not receive any treatment. Thus, patients with CLL have more infections than the general population, and these infectious complications are the leading cause of death. Similarly, vaccination, whether directed against classical pathogens such as influenzae or more recently against SARS-CoV2, is less effective in patients with CLL. The causes of this immune deficiency are not completely elucidated and the objective of our study is to analyze different subpopulations of lymphocytes thanks to a blood sample. The investigators thus hope to be able to determine more precisely the reasons underlying these infections in order to better prevent them.

Primary Outcome Measures: Immunophenotyping, Description of some circulating B and T cell subsets, At inclusion
Secondary Outcome Measures: Bronchectasies, presence of bronchiectasis (Non-contrast thin section thoracic CT-scan allowing to detect the ) and if present the severity index (Bhalla score), At inclusion
Efficacy of Pyrotinib Plus Capecitabine in HER2-positive MBC With Active Brain Metastases That Have Failed ADCs
NCT Number: NCT06475443
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Breast Cancer in the Brain
Interventions: DRUG: pyrotinib plus capecitabine
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2027-01-31

Summary:
To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs

Primary Outcome Measures: Objective Response Rate of Intracranial Lesion (CNS-ORR) by investigator, CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria, 2 months
Secondary Outcome Measures: Clinica Benifit Rate of Intracranial Lesion(CNS-CBR) by investigator, CNS-CBR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria, 6 months|Disease Control Rate（DCR）by investigator, DCR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria, 6 months|Progression-Free Survival (PFS), PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, 1.5 year
Fecal Microbiota Transplantation in the Treatment of Major LARS
NCT Number: NCT06475430
Acronym: FMT-LARS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Anterior Resection Syndrome|Fecal Microbiota Transplantation
Interventions: BIOLOGICAL: fecal microbiota transplantation|DIETARY_SUPPLEMENT: Formulated probiotic supplements
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2026-12-31

Summary:
Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.

Primary Outcome Measures: bowel function, LARS score, 4 weeks and 8 weeks|Shannon index, biodiversity monitoring, 8 weeks
Neoadjuvant Adebrelimab + DOS in Locally Advanced Resectable Gastric Cancer
NCT Number: NCT06475417
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Cancer
Interventions: DRUG: Adebrelimab combined with DOS
Sponsor: Tang-Du Hospital
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-24
Completion Date: 2026-04-26
Locations: Tangdu Hospital Affiliated to the Fourth Military Medical University, Xi'an, Shannxi, 710038, China

Summary:
To evaluate the efficacy and safety of adebrelimab combined DOS in neoadjuvant treatment of locally advanced resectable gastric cancer.

Primary Outcome Measures: Pathological complete response rate（pCR）, Pathological complete response rate according to Becker standard, 7 days after surgery
Secondary Outcome Measures: Major pathologic response (MPR), MPR is defined as less than 10% residual viable tumor after neoadjuvant therapy., 7 days after surgery|Disease-free survival（DFS）, The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer, Long term follow-up will continue until the death of the subject or the end of the study, at least three years|R0 resection rate, Proportion of R0 level surgery performed., postoperative 6 hours|Overall Survival（OS）, Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause)., Long term follow-up will continue until the death of the subject or the end of the study, at least three years|Objective response rate（ORR）, Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response., 7 days before surgery|Event-free survival（EFS）, The length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay., Preoperative progression, postoperative recurrence, and death from any cause|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Adverse reactions to chemotherapy and immunotherapy were graded according to the NCI-CTCAE4.0 grading criteria, Long term follow-up will continue until the death of the subject or the end of the study, at least three years
A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers
NCT Number: NCT06475404
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Mucopolysaccharidosis Type II|Metabolic Diseases
Interventions: BIOLOGICAL: verenafusp alfa 6 mg/kg|BIOLOGICAL: verenafusp alfa 9 mg/kg|BIOLOGICAL: verenafusp alfa 12 mg/kg
Sponsor: AO GENERIUM
Sex: MALE
Age: ADULT
Enrollment: 18
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-04-06
Completion Date: 2023-09-20
Locations: State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department", Moscow, 117556, Russian Federation

Summary:
It is a phase I open-label single-dose, dose-escalation cohort study to evaluate of the tolerance, safety, and pharmacokinetics of GNR-055 in healthy volunteers

Primary Outcome Measures: Proportion of participants with Adverse Events, Adverse events, Laboratory tests, Vital signs, Physical examination, 12-lead electrocardiogram, Allergic reactions, Infusion reactions, Antidrug antibody, Day 28
Secondary Outcome Measures: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity, Day 4|Pharmacokinetics: Peak Plasma Concentration (Cmax), Analysis of equivalence of Cmax, Day 4
The Effects of L-arginine Supplementation on Anaerobic Exercise Performance
NCT Number: NCT06475391
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skeletal Muscle|Human Performance
Interventions: DIETARY_SUPPLEMENT: L-arginine|DIETARY_SUPPLEMENT: Placebo
Sponsor: University of Manitoba
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-14
Completion Date: 2024-12-31
Locations: Applied Research Centre; Active Living Centre, Winnipeg, Manitoba, R3T 2N2, Canada

Summary:
The purpose of this study is to evaluate if acute ingestion of L-arginine will enhance anaerobic exercise performance in young, healthy, and recreationally active adults.

Primary Outcome Measures: Grip Strength, Grip strength measurement in kilograms of force produced on a hand held dynamometer., 5 minutes|Counter movement vertical jump, Counter movement vertical jump performance height in centimeters., 3 minutes|Wingate anaerobic cycle ergometer test, Maximum pedaling power output for 30 seconds of all-out sprinting on a cycle ergometer., 30 seconds
Salt Water Gargling on Swallowing Following ACDF
NCT Number: NCT06475365
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Degeneration Spine|Cervical Radiculopathy|Cervical Stenosis|Cervical Spondylosis|Cervical Myelopathy|Dysphagia
Interventions: OTHER: Sodium chloride gargle
Sponsor: University of Southern California
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2025-12-31
Locations: Keck Medical Center of the University of Southern California, Los Angeles, California, 90089, United States

Summary:
The goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride, hereafter referred to as "saltwater" or "saline" in reducing the difficulty of swallowing following multi-level anterior cervical discectomy and fusion (ACDF) procedures. The study population will consist of generally healthy adults ages 18 - 80. The main question it aims to answer is:

If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water.

Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves difficulty swallowing following surgery.

Patients in the control arm will be asked to:

- Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively).

Patients in the experimental/interventional arm will be asked to:

* Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively).
* Gargle with a warm saltwater solution once on POD 0, and thrice daily from POD 1 to POD 7.

Primary Outcome Measures: Number of Participants with a SWAL-QOL Score of Greater Than 14, The Swallowing-Related Quality of Life (SWAL-QOL) questionnaire is a 44-question assessment that measures the severity of oropharyngeal dysphagia (difficulty swallowing) and the impact it has on quality of life. Patients with score of greater than or equal to 14 are indicative of have some sort of difficulty with swallowing. This will be used to assess if patients in the Salt Water Gargle arm (intervention) have any relief after completing the described intervention., 0 - 1 month
Secondary Outcome Measures: Neck Disability Index (NDI) Score of 30 to 100, On the NDI, a scores of ranging from 30 - 100 are indicative of mild to severe disability with respect to function of the neck. This will be used to assess if there is a correlation between a high SWAL-QOL score and a high NDI score., 0 - 1 month
Predicting Responses to Exhausting, Prolonged, And Repeated Exercise Demands (PREPARED) for Heat
NCT Number: NCT06475339
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperthermia|Fatigue; Heat
Interventions: OTHER: 30/30 work/rest cycle|OTHER: 30/20 work/rest cycle|OTHER: 40/30 work/rest cycle|OTHER: 20/12 work/rest cycle
Sponsor: State University of New York at Buffalo
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2027-03
Locations: Center for Research and Education in Special Environments, Buffalo, New York, 14214, United States

Summary:
The overall goal of this project is to identify a work/rest cycle that allows for faster mission completion needed in emergency situations, compared to current Army heat guidance, while mitigating heat strain and neuromuscular fatigue. This project will determine the trade-off between faster mission completion and risk of heat strain and physical performance decrements. Completion of this project will allow military leaders to make informed decisions by understanding the impact of their choices on the magnitude of physical performance decrements and expected heat casualties, setting up hot weather missions for success.

Primary Outcome Measures: Core temperature, Maximum gastrointestinal temperature reached during the work protocol, 180 minutes of work|Isometric mid-thigh pull strength, Maximum voluntary contraction strength assessed using a force plate, 180 minutes of work
Secondary Outcome Measures: Metabolic cost, Collected expired air using a one-way mask will be analyzed using a metabolic cart to calculate metabolic heat production, 180 minutes of work|Heart rate, Maximum heart rate measured using a telemetry strap throughout the work protocol, 180 minutes of work|Mean skin temperature, Maximum skin temperature measured using buttons at four skin sites, 180 minutes of work|Vastus lateralis electromyography, Wireless electromyography electrodes placed lengthwise over the vastus lateralis muscle belly, 180 minutes of work