pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Impact of Preoperative VFA on Intraoperative Adverse Events in Patients Undergoing Laparoscopic Radical Gastrectomy
NCT Number: NCT06506331
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Sponsor: Fujian Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 490
Study Design: Observational Model: |Time Perspective: p
Start Date: 2012-12-01
Completion Date: 2024-02-01

Summary:
Preoperative visceral fat area (VFA) is associated with an increased incidence of postoperative complications in gastric cancer (GC). However, the relationship between VFA and intraoperative adverse events (iAEs) remains unclear. Therefore, this study aimed to evaluate the impact of preoperative VFA on iAEs in patients undergoing laparoscopic radical gastrectomy for GC, using data from two prospective trials. Simultaneously, a predictive model for iAEs was constructed to provide a basis for the early identification of high-risk populations and the implementation of personalized perioperative management measures.

Primary Outcome Measures: intraoperative adverse events(iAEs), Intraoperative adverse events (iAEs) are important indicators for evaluating surgical quality and encompass a range of circumstances such as intraoperative bleeding, injury, and anesthesia-related events that may impact postoperative outcomes, During surgery
Secondary Outcome Measures: Postoperative complications, Postoperative complications were evaluated according to the Clavien-Dindo classification and categorized as surgical or medical, 30 days after surgery
A Joint Model Based on Deep Learning to Predict Multidrug-resistant Klebsiella Pneumoniae Liver Abscess
NCT Number: NCT06506318
Acronym: CLASS2401
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Abscess
Sponsor: Shengjing Hospital
Collaborators: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)|Guilin Medical University, China|Hebei General Hospital|Xijing Hospital|Hebei Medical University Third Hospital|The First Affiliated Hospital of Dalian Medical University|The People's Hospital of Liaoning Province|Fourth People's Hospital of Shenyang|Sir Run Run Shaw Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 550
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-03-01
Locations: Shengjing hospital of China medical university, Shenyang, Liaoning, 110004, China

Summary:
The goal of this observational study is to train a deep learning-based model to predict multidrug-resistant Klebsiella pneumoniae liver abscess and evaluate it on a multi-center database.

Primary Outcome Measures: Result of bacteria culture, The result of bacteria culture of abscess decides which group the patients belong. This result was obtained from bacteria culture tests which were done by department of laboratory medicine., The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.|Result of drug resistant test, Our destination is to find out the potential differences between Esbl(+) \& Esbl(-) liver abscess., The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.
A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC)
NCT Number: NCT06506292
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Adebrelimab (SHR-1316)|XELOX|GC/GEJC
Interventions: DRUG: Adebrelimab|DRUG: XELOX
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-08-01
Locations: Tianjin Cancer Institute and Hospital, Tianjin, Tianjin, 300052, China

Summary:
To observe and evaluate the efficacy and safety of adebrelimab combination chemotherapy regimen in the perioperative treatment of surgically resectable gastric cancer/adenocarcinoma of the gastroesophageal junction.

Primary Outcome Measures: Pathological completeresponse, pCR, Disappearance of tumor cells from resected specimen, After surgical excision with follow up of an average of 1 year
Secondary Outcome Measures: Major Pathological response, MPR, the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of tumor cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% tumor cells., After surgical excision with follow up of an average of 1 year|Objective response rate,ORR, Defined as proportion of patients who have a best response of CR or PR, From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year|R0 resection rate, Patients who underwent radical resection as a percentage of the total number of patients who underwent surgical resection, After surgical excision with follow up of an average of 1 year|Event Free Survival, EFS, From date of surgery until the date of recurrence detection., From treatment initiation to progressive disease, discontinuation of the treatment for any reason, or death due to any cause, assessed up to 1 year|Disease control rate, DCR, Defined as proportion of patients who have CR or PR or SD, From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year|Disease-free survival, DFS, Duration of survival before cancer recurrence or death, From treatment initiation to cancer recurrence or death due to any cause, assessed up to 1 year|Overall Survival, OS, Defined as the time from enrollment to death from any cause, From treatment initiation until death due to any cause, assessed up to 3 year|AE/SAE, Incidence of Adverse Events (AE)/Serious Adverse Events (SAE) (as measured by NCI-CTCAE 5.0), Up to 1 year
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
NCT Number: NCT06506279
Acronym: MRPICS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic
Interventions: DEVICE: CorTec Brain Interchange (BIC) System
Sponsor: University of Washington
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-15
Completion Date: 2030-06-15

Summary:
Using the CorTec Brain Interchange (BIC) System, we will examine the effect of a plasticity-inducing therapy regime on the rehabilitation of upper limb impairment post-stroke. This study's main objective is to implement and evaluate neuroplasticity-inducing stimulation. The stimulation methods for inducing neuroplasticity have been selected based on prior preclinical and intraoperative work that has shown promise in providing rehabilitative benefits for stroke patients. We will be structuring this study as an open prospective feasibility study.

Primary Outcome Measures: Measuring upper limb impairment in stroke rehabilitation, The primary outcome measure in the study focus on measuring upper limb impairment to ensure that the use of the CorTec Brain Interchange system is not detrimental for use in studying stimulation paradigms to improve stroke rehabilitation. Limb impairment will be assessed for all patients weekly during the rehabilitation period and at all monthly post-rehab monitoring visits using the primary behavioral measures of the study, UEFM (Upper Extremity Fuegl-Myer) arm motor score and the WMFT (Wolf Motor Function Test), which will track individual trends of motor improvement and motor function, respectively. In four subjects the degree of potentially confounding variables (such as injury and/or patient variability) will likely inhibit extrapolation of therapeutic outcomes to the stroke population at large., Two years
Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants
NCT Number: NCT06506266
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Asthma
Interventions: OTHER: HFA-152a|OTHER: HFA-134a|OTHER: Radiolabeled saline solution
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2024-09-30
Locations: GSK Investigational Site, Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Summary:
The main goal of the study is to assess the effect of the administration of reference propellant \[HFA-134a (1,1,1,2 - Tetrafluoroethane)\] and test propellant \[HFA-152a (1 - Difluoroethane)\] in healthy adults on mucociliary clearance (MCC).

Primary Outcome Measures: Area under the percent radiolabeled particle retention-time curve up to 4 hours [AUC(0-4h)] following administration of nebulized inhalation of saline solution, Up to 4 hours on Day 7
Secondary Outcome Measures: Percent radiolabeled particle retention at 1 hour after nebulized inhalation of saline solution, 1 hour after inhalation of saline solution on Day 7|Percent radiolabeled particle retention at 1.5 hours after nebulized inhalation of saline solution, 1.5 hours after inhalation of saline solution on Day 7|Percent radiolabeled particle retention at 3 hours after nebulized inhalation of saline solution, 3 hours after inhalation of saline solution on Day 7|Number of participants with adverse events (AEs) and serious adverse events (SAEs), Up to 56 days
Massage for GAD: Neuroimaging and Clinical Correlates of Response
NCT Number: NCT06506253
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Generalized Anxiety Disorder
Interventions: OTHER: Swedish Massage Therapy|OTHER: Light Touch Therapy
Sponsor: University of Utah
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Sex: ALL
Age: ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-08
Locations: Huntsman Mental Health Institute, Salt Lake City, Utah, 84108, United States

Summary:
This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety.

This is a randomized research study and subjects will be randomized into one of two study touch intervention groups, and will have an equal chance of being placed in one of the groups:

1. Swedish massage therapy twice per week for 6 weeks.
2. Light touch therapy twice per week for 6 weeks.

The Primary Objective is to identify brain networks activated by touch interventions using fMRI brain imaging in subjects with generalized anxiety disorder.

Subjects will undergo two fMRI scanning sessions (one before and one after) twice per week for 6 weeks of touch intervention. Subjects will also be asked to complete questionnaires on anxiety, stress and depression.

Primary Outcome Measures: Pre-to-post-treatment change in resting state functional connectivity, Identification of brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the fearful faces task in subjects with GAD., 6 weeks
Secondary Outcome Measures: Pre-to-post-treatment change in response to fearful/angry faces task and clinical response on the HAM-A., Correlation of pre-to-post-treatment change in rsFC with changes in anxiety scores (HAM-A) within both treatment groups., 6 weeks|Autonomic activity (heart rate variability, heart rate, pulse)., Correlation of changes in autonomic measures with clinical response and rsFC., 6 weeks
Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus
NCT Number: NCT06506214
Acronym: ADlupus
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cutaneous Lupus
Interventions: OTHER: Questionnaires
Sponsor: University Hospital, Toulouse
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 233
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-08
Completion Date: 2024-10-08
Locations: University Hospital Montpellier, Montpellier, 34090, France|APHP Hôpital Saint-Louis, Paris, 75010, France|Hôpital Tenon, Paris, 75020, France|University Hospital Toulouse, Toulouse, 31400, France

Summary:
This multicenter study aims to evaluate treatment adherence and satisfaction of patients with cutaneous lupus, influenced by perception of the disease, fear of side effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or higher on the Medical Adherence Self-Report Inventory scale.

Primary Outcome Measures: Evaluation of adherence to treatment of patients with cutaneous lupus., Adherence is defined by a VAS greater than or equal to 80% on the Visual Analog Scale of the MASRI (Medical Adherence Self-Report Inventory) questionnaire., Inclusion day
Legs Dysmetria in Total Hip Replacement: Does Hip Approacches and Navigation Decrease the Risk?
NCT Number: NCT06506201
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Osteoarthritis
Interventions: DEVICE: Velys hip navigation|PROCEDURE: Standard of care
Sponsor: Istituto Ortopedico Rizzoli
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 136
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-13
Completion Date: 2027-05-12
Locations: Istituto Ortopedico Rizzoli, Bologna, 40136, Italy

Summary:
The purpose of this study is to collect clinical and radiological data from the case series of patients surgically treated with total hip arthroplasty at the Rizzoli Orthopaedic Institute.

The primary objective is to evaluate in terms of safety and efficacy the reduction of legs dysmetria and proper acetabular cup inclination intraoperatively when comparing anterior, direct lateral, and postero-lateral hip approaches conducted via traditional or navigation-assisted surgery.

The secondary objectives of the study are to evaluate, by comparing navigation-assisted and non-navigation-assisted hip approaches, intraoperatively the correct positioning of the prosthesis by analyzing the acetabular cup version; surgical timing; and number of intraoperative radiographs taken. In addition, the accuracy of preoperative planning will be assessed and a clinical evaluation performed during a follow-up of one year.

Primary Outcome Measures: Legs dysmetria in millimeters calculated in anteroposterior x-rays, Legs lenght dysmetria in total hip replacement surgery, Intraoperatory
Secondary Outcome Measures: Cup orientation in grade° calculated in anteroposterior x-rays, Cup orientation in total hip replacement surgery, Intraoperatory
Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects
NCT Number: NCT06506175
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight or Obese, Type 2 Diabetes
Interventions: DRUG: HRS9531 tablets
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2024-11-30
Locations: The affiliated hospital of Qingdao University, Qingdao, Shandong, 266000, China

Summary:
The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.

Primary Outcome Measures: AUCtau, Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing, 0-24hrs after the 10th dosing
Secondary Outcome Measures: Tmax, Time to maximum plasma concentration, First dose at day 1 and post-dose at day 10|Cmax, The maximum plasma concentration, First dose at day 1 and post-dose at day 10|t1/2, Terminal half-life, First dose at day 1 and post-dose at day 10|Incidence and severity of adverse events, Screening period up to Day 45|Anti-HRS9531 antibody, Before First dose at day 1 to Day 45
Evaluation of Fluoxetine in Refractory Constipation Treatment
NCT Number: NCT06506136
Acronym: EFoRT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Refractory Constipation
Interventions: DRUG: Fluoxetine|DRUG: Placebo
Sponsor: Yang Bin
Sex: ALL
Age: ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-30

Summary:
The goal of this clinical trial is to determine if fluoxetine is effective in treating refractory constipation in adults. It will also assess the safety profile of fluoxetine when used for this condition. The main questions it aims to answer are:

Does fluoxetine improve bowel movement frequency and Complete Spontaneous Bowel Movements (CSBM) in participants with refractory constipation? What adverse effects do participants experience while taking fluoxetine? Researchers will compare fluoxetine to a placebo (a look-alike substance that contains no active drug) to evaluate its efficacy and safety in treating chronic constipation.

Participants will:

Take fluoxetine or a placebo daily for 12 weeks Visit the clinic every 4 weeks for checkups and tests Maintain a diary of their CSBM, Spontaneous Bowel Movements (SBM), bowel movements, stool consistency, and any side effects experienced

Primary Outcome Measures: Complete Spontaneous Bowel Movements (CSBM), CSBM is defined as a bowel movement that occurs within the last 24 hours without the aid of medications or manual assistance, where the patient feels a sense of satisfactory evacuation with a feeling of complete emptying., Weeks 0, 2, 4, 6, 8, 10, 12
Secondary Outcome Measures: Proportion of patients with ≥3 CSBM per week, Weeks 0, 2, 4, 6, 8, 10, 12|Change in the average weekly CSBM compared to baseline over the 12-week treatment period, Weeks 0, 2, 4, 6, 8, 10, 12|Proportion of participants using rescue medications (bisacodyl, PEG, or glycerin enema) and the weekly dosage of rescue medications used, Weeks 0, 2, 4, 6, 8, 10, 12|Change in PAC-QOL self-assessment scores from baseline, Weeks 0, 2, 4, 6, 8, 10, 12|Change in the average straining score for SBM over 12 weeks compared to baseline, 0 = Not difficult; 1 = Slightly difficult, requires some effort to defecate; 2 = Difficult, requires significant effort to defecate; 3 = Very difficult, requires a lot of effort to defecate., Weeks 0, 2, 4, 6, 8, 10, 12|Change in the average stool consistency score for SBM over 12 weeks compared to baseline, Weeks 0, 2, 4, 6, 8, 10, 12
Patient-Ventilator Dyssynchrony Detection With a Machine Learning Algorithm
NCT Number: NCT06506123
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Respiratory Failure
Interventions: DEVICE: Artificial Intelligence Detection and Classification of Patient-Ventilator Dyssynchronies
Sponsor: University of Sao Paulo General Hospital
Collaborators: Magnamed Tecnologia Medica S/A
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-25
Completion Date: 2025-12-24
Locations: Heart Institute, University of São Paulo, Sao Paulo, SP, 05403900, Brazil

Summary:
This is a diagnostic study aiming to compare accuracy to detect and classify patient-ventilator dyssynchronies by a machine learning algorithm, compared to the gold-standard defined as dyssynchronies diagnosed and classified by mechanical ventilator and esophageal pressure waveforms analyzed by experts.

The main question of this study is:

• Are patient-ventilator dyssynchronies accurately detected and classified by an artificial intelligence algorithm when compared to experts analyzing esophageal pressure and mechanical ventilator waveforms?

Primary Outcome Measures: Diagnostic Accuracy of the Artificial Intelligence algorithm, Sensitivity, specificity, positive predictive value, negative predictive value of the artificial intelligence algorithm to detect and classify patient-ventilator dyssynchronies. These accuracy indexes will be estimated for each kind of dyssinchrony: ineffective effort, autotriggering, double triggering, reverse triggering, reverse triggering with a double cycle, 3 days
Secondary Outcome Measures: Pendelluft detection, Percentage of cycles with pendelluft detected with the artificial intelligence algorithm compared to the percentage of cycles with pendelluft detected with the esophageal pressure, 3 days
Functional and Non-Functional CSF Shunt Flow Measured With a Second-Generation Wireless Thermal Device
NCT Number: NCT06506045
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hydrocephalus
Interventions: DEVICE: FlowSense
Sponsor: Rhaeos, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2024-12
Locations: CHOC Commerce Tower, Orange, California, 92868, United States|Cedars-Sinai Accelerator, West Hollywood, California, 90048, United States|Tampa Marriott Water Street, Tampa, Florida, 33602, United States|MATTER, Chicago, Illinois, 60611, United States|Industrious, Evanston, Illinois, 60201, United States|Northwest Special Recreation Association, Rolling Meadows, Illinois, 60008, United States|Texas Medical Center Innovation, Houston, Texas, 77021, United States|Industrious, Seattle, Washington, 98015, United States

Summary:
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Primary Outcome Measures: Study Device Sensitivity, Study device sensitivity will be calculated as TP / (TP + FN)., Up to 1 hour|Study Device Specificity, Study device specificity will be calculated as TN / (TN + FP), Up to 1 hour
Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection
NCT Number: NCT06506032
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Post-Sternotomy Deep Sternal Wound Infection
Interventions: DRUG: Intravenous Vancomycin administration|OTHER: Standard postoperative therapy
Sponsor: University Hospital Ostrava
Collaborators: University of Ostrava|Masaryk University|Masaryk Memorial Cancer Institute|Technical University of Ostrava
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-07-30
Completion Date: 2023-12-31
Locations: University of Ostrava, Ostrava, Moravian-Silesian Region, 703 00, Czechia|Technical University of Ostrava, Ostrava, Moravian-Silesian Region, 708 00, Czechia|University Hospital Ostrava, Ostrava, Moravian-Silesian Region, 708 52, Czechia|Masaryk University, Brno, South-Moravian Region, 625 00, Czechia|Masaryk Memorial Cancer Institute, Brno, South-Moravian Region, 656 63, Czechia

Summary:
Only a limited number of studies have been published that monitored the penetration of antibiotics from blood into exudate in patients treated with negative pressure wound therapy (NPWT), and that evaluated the adequacy of current dosage regimens according to antibiotic tissue concentrations. A higher migration rate of several antibiotics (including vancomycin) to exudate has been reported in patients with skin ulcers, skin defects, burns, and traumatic wounds treated with NPWT compared to patients without NPWT.

In the present study, the investigators will evaluate the pharmacokinetic profile and wound penetration of vancomycin in open-heart surgery patients with post-sternotomy deep sternal wound infection receiving NPWT.

Primary Outcome Measures: Vancomycin penetration into exudate, To determine the vancomycin penetration into the wound during NPWT, the investigators compared the vancomycin total (bound + unbound) average exudate concentration to the vancomycin total (bound + unbound) average serum concentration on the first study day. The same calculation was used to determine the penetration ratio for free (unbound) vancomycin concentrations on the first study day.

For samples from three consecutive days, the investigators compared the vancomycin total (bound + unbound) through exudate concentrations with the vancomycin total (bound + unbound) through serum concentrations. The same calculation was used to determine the penetration ratio for free (unbound) vancomycin concentrations on three consecutive days., repeated measurements for the total of 72 hours
Secondary Outcome Measures: Identification of pre-, intra-, and postoperative risk factors for deep sternal wound infection (DSWI) development, The investigators will identify independent risk factors for DSWI by comparing patients with and without DSWI after cardiac surgery., 3 days|Recurrence of DSWI, The investigators will assess the recurrence of DSWI in the study subjects., 1- year follow-up|Determination of mortality, The investigators will assess the in-hospital, 90-day, and all-cause mortality in the study subjects., 1- year follow-up
A Comparison of Early Outcome of Surgical Management of Proximal Humerus Fracture in Adults During COVID-19 Pandemic- A Prospective Cohort Study
NCT Number: NCT06506006
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Proximal Humerus Surgery in Covid Recovered Patients
Interventions: BIOLOGICAL: Covid infection
Sponsor: B.P. Koirala Institute of Health Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-04-01
Completion Date: 2022-01-30
Locations: B.P.Koirala Insitute of Helath Sciences, Dharān Bāzār, Koshi, 56700, Nepal

Summary:
The goal of this observational study is to learn the outcome of proximal humerus fracture surgery in patients who had it delayed due to COVID infection and compare it with normal patients with same fracture and treatment. The main question it aims to answer is:

• Do the patients with proximal humerus fracture undergoing delayed fixation secondary to COVID infection have the same outcome as that of the normal patients?

The outcome of patients of both group will be assessed objectively via the standard Neer"s shoulder score and compared using independent variable T test.

Primary Outcome Measures: neer's shoulder score, functional scoring that includes combined score of range of motion, pain, function and anatomy, maximum score of 100 and minimum of 0 and higher score means better result, 6 months
Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels
NCT Number: NCT06505967
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NAD+ Levels in the Blood
Interventions: DIETARY_SUPPLEMENT: Qualia NAD+|OTHER: Placebo
Sponsor: Qualia Life Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-10
Completion Date: 2024-09-09
Locations: Qualia Life Sciences, Carlsbad, California, 92011, United States

Summary:
The goal of this clinical trial is to determine if Qualia NAD+ effectively increases NAD+ levels in the blood and to evaluate its safety.

Researchers will compare Qualia NAD+ to a placebo (a look-alike substance that contains no active drug) to assess its efficacy in increasing NAD+ levels in the blood.

Participants will:

Take Qualia NAD+ or a placebo every day for 4 weeks. Undergo blood tests before and after the trial.

Primary Outcome Measures: NAD+ Levels in the Blood, 4 weeks
LOWER URINARY TRACT SYMPTOMS
NCT Number: NCT06505954
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lower Urinary Tract Symptoms
Interventions: OTHER: Survey study
Sponsor: University of Gaziantep
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 278
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-12
Completion Date: 2024-08-30
Locations: Gaziantep University, Gaziantep, Şehitkamil, 27310, Turkey

Summary:
Lower urinary tract symptoms (LUTS) are observed in individuals with pathologies affecting the lower urinary system, such as detrusor overactivity, sphincter weakness, or sensory bladder disorder. LUTS can be categorized into storage, voiding, and post-micturition symptoms. Storage problems include increased frequency of urination, nocturia, urinary urgency, and incontinence. Voiding symptoms include decreased urine flow rate, hesitancy, and terminal dribbling, while post-micturition symptoms include post-micturition dribble and a sensation of incomplete bladder emptying. The prevalence of LUTS increases with age and is influenced by factors such as metabolic syndrome, gender, caffeine consumption habits, chronic psychological stress, bladder dysfunction, smoking, alcohol use, and constipation.

This study aims to investigate the prevalence of LUTS and contributing factors among medical students, a young population undergoing a stressful educational process.

A 43-question survey was prepared for all medical students from years 1 to 6. The survey included the Constipation Scoring System (CSS) to evaluate constipation, the Generalized Anxiety Disorder-7 (GAD-7) score to assess anxiety levels, and the Core Lower Urinary Tract Symptom Score (CLSS) to query LUTS. The survey also collected data on participants' dietary habits, smoking, alcohol and caffeine consumption, living conditions, age, gender, body mass index (BMI), and educational level. The study was approved by the local ethics committee of Gaziantep University (approval number 2024/234).

Primary Outcome Measures: Prevalence of lower urinary tract symptoms, Last six months
Secondary Outcome Measures: Contributing factors, data on participants' dietary habits, smoking, alcohol and caffeine consumption, living conditions, age, gender, body mass index (BMI), and educational level,anxiety level and constipation degree will be assessed., Last six months
Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS
NCT Number: NCT06505941
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Acute Respiratory Distress Syndrome
Interventions: DRUG: umbilical cord mesenchymal stem cell|DRUG: Placebo
Sponsor: Southeast University, China
Collaborators: Zhongda Hospital|Yinguan Biologics, Shenzheng
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2027-02-20

Summary:
The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.

Primary Outcome Measures: The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome., The 28-day mortality of patients receiving umbilical cord mesenchymal stem cell therapy, The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
Secondary Outcome Measures: The efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome., Oxygenation index situation change (PaO2/FiO2) of patients receiving umbilical cord mesenchymal stem cell therapy, The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send'
NCT Number: NCT06505915
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Study Different Fasting Protocols in Patients for Elective Cesarean Deliveries
Interventions: DIETARY_SUPPLEMENT: Pre op Carbohydrate drink|OTHER: Clear fluid as per sip til send policy
Sponsor: The Rotunda Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-12
Completion Date: 2024-12
Locations: Rotunda Maternity Hospital, Dublin, Ireland

Summary:
Women undergoing elective caesarean deliveries are fasted for long periods prior to surgery. Recently, Rotunda Maternity Hospital have started using two fasting protocols at the Rotunda prior to elective caesarean section, one uses carbohydrate drinks, and the other encourages women to sip water until they are called to the operating theatre. The evidence to support the use of either one is very limited. This study would help streamline one of the protocols.

Primary Outcome Measures: General well-being of the patient, Compare fasting protocols using a 0-10 Visual analogue Score (VAS) for patient focused comfort outcomes including anxiety, thirst, hunger, nausea and comfort, 24 hours post op
Secondary Outcome Measures: General well-being of the patient, Intraoperative nausea and vomiting Pre-op urinary keytone level Pre-op blood sugar level Quality of Recovery(QOR11) score at 24 hours, 24 hours post op
The Effect of Local Anesthesia for Pain Reduction During Radial Arterial Puncture in the Emergency Department
NCT Number: NCT06505889
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain Control
Interventions: OTHER: Local anesthesia methods
Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-09-30
Locations: Queen Savang Vadhana Memorial Hospital, Chon Buri, Chon Buri,, 20110, Thailand

Summary:
The objective of this clinical trial is to investigate if local anesthesia using topical analgesic drug (10% lidocaine spray) or cryo-analgesic (Ice pack) can reduce pain levels during and after arterial blood sampling procedure. The research questions of this study includes:

* Can local anesthesia using topical analgesic drug (10% lidocaine spray) or cryo-analgesic (Ice pack) reduce pain levels during arterial blood sampling?
* Is the first-attempt success rate of arterial blood sampling higher when using local anesthesia (lidocaine spray or ice pack) compared to standard practice without anesthesia?
* Do individuals with prior experience of arterial blood sampling report lower pain scores during and after the procedure compared to those without prior experience?

Primary Outcome Measures: Pain score both during and after the arterial blood sampling procedure., Pain score will be assessed using a horizontal numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing "no pain" and 10 representing "the worst pain.", Participants will rate their pain score both during and at 30 seconds after the arterial blood sampling procedure.
Secondary Outcome Measures: The first-attempt success rate for arterial blood sampling procedure when using local anesthesia., First-attempt success refer to blood sample being successfully drawn from the radial artery at the first trial of skin penetration without needle being withdrawn, During the arterial blood sampling procedure.|Pain scores of individuals with prior experience undergoing arterial blood sampling procedure, Pain scores of individuals with prior experience undergoing arterial blood sampling compared to individuals without prior experience.

Pain score will be assessed using a horizontal numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing "no pain" and 10 representing "the worst pain.", Participants will rate their pain score both during and at 30 seconds after the arterial blood sampling procedure.
Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease
NCT Number: NCT06505876
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: BEHAVIORAL: Basic treatment|DEVICE: Oral Tube Feeding|DEVICE: Nasogastric Tube Feeding
Sponsor: Chao Phya Abhaibhubejhr Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2025-06

Summary:
This is a prospective, randomized controlled clinical trail that involved patients with Chronic Obstructive Pulmonary Disease.The goal of this clinical trial is to compare the clinical effect of Oral Tubes vs Nasogastric Tubes in patients with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Oral esophageal Tube Feeding better improve the nutritional status and pulmonary infection

Primary Outcome Measures: Chronic Obstructive Pulmonary Disease Assessment Test, It is a simple questionnaire used to assess symptoms and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD). The scale consists of 8 items covering the most common symptoms and impacts on quality of life in COPD patients, such as cough, sputum production, and breathlessness. Each item is graded on a scale of 0 to 5, where patients select the score that best reflects their experience. The total score ranges from 0 to 40, with higher scores indicating more severe symptoms., day 1 and day 15
Quality of Life After Transanal Total Mesorectal Excision Compared to Traditional Total Mesorectal Excision
NCT Number: NCT06505863
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rectal Cancer|Quality of Life|Functional Outcome|Surgery
Interventions: PROCEDURE: Transanal total mesorectal excision
Sponsor: Cantonal Hospital of St. Gallen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-12-31
Locations: Cantonal Hospital of St.Gallen, Saint-Gall, 9000, Switzerland

Summary:
The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. This study will compare short-term and long-term QoL and functional outcomes after taTME compared to traditional abdominal TME (laparoscopic, robotic, and open approach)

Primary Outcome Measures: Quality of life (QoL), Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30):

* Overall QoL
* QLQ-total, 5 years after initial operation
Secondary Outcome Measures: Functional outcomes, Assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30):

* physical functioning
* role functioning
* cognitive functioning
* emotional functioning
* social functioning
* fatigue
* pain
* nausea and vomiting
* appetite loss
* dyspnea
* insomnia
* constipation
* diarrhea
* financial difficulties, 5 years after initial operation
Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients
NCT Number: NCT06505850
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Postoperative Sore Throat|Subglottic Airway Injury|Endotracheal Tube Cuff
Interventions: DEVICE: Tapered-shaped cuff tracheal tube|DEVICE: Cylindrical-shaped cuff tracheal tube
Sponsor: Tri-Service General Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 176
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-18
Completion Date: 2025-06-30

Summary:
This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat

Primary Outcome Measures: The incidence of postoperative sore throat, Postoperative 48 hours|The severity of postoperative sore throat, 1, none; 2, mild (complains of sore throat only on asking); 3, moderate (complains of sore throat on her own); 4, severe (change of voice or hoarseness, associated with throat pain), Postoperative 48 hours
Secondary Outcome Measures: Intraoperative fentanyl consumption, The end of surgery|Intraoperative propofol consumption, The end of surgery|Intraoperative rocuronium consumption, The end of surgery|The degree of subglottic injury, None: no subglottic injury; mild: mucosal hyperemia and edema and/or slight submucosal hematoma; moderate: moderate submucosal hematoma; severe: mucosal laceration and/or mucosal bleeding), Intraoperative (The time point at extubation)
JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）
NCT Number: NCT06505837
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer
Interventions: DRUG: Arm1: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy|DRUG: Arm 2: JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Collaborators: Sponsor GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 356
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2026-12-30
Locations: Hunan Cancer Hospital, Changshang, Hunan, 410013, China

Summary:
This is a multicenter, open-Lable, randomized, phase III clinical study to compare the pharmacokinetic profile, efficacy, and safety of Toripalimab injection (subcutaneous) (JS001sc) and Toripalimab injection (JS001) in combination with standard chemotherapy as first-line treatment for recurrent or metastatic Non-Squamous Non small cell lung cancer

Primary Outcome Measures: Observed serum Ctrough at Cycle 1, Measured valley concentration at the end of cycle 1 (Ctrough), the end of Cycle 1 (Each cycle is 21 days)|Model-predicted area under the concentration-time curve(AUC) from 0 to 21 days at Cycle 1, The area under the drug time curve of cycle 1 simulated by a population pharmacokinetic model, the end of Cycle 1 (Each cycle is 21 days)
Secondary Outcome Measures: Objective response rate (ORR), Comparison of Objective response rate (ORR) between JS001sc and JS001 in first-line patients with relapsed or metastatic non-squamous NSCLC, up to 2years|Progression-free survival (PFS), Comparison of first-line Progression-free survival (PFS) between JS001sc and JS001 in patients treated with relapsed or metastatic non-squamous NSCLC, up to 2years|6-month progression-free survival(PFS) rate, The 6-month progression-free survival(PFS) rate in first-line patients treated with relapsed or metastatic non-squamous NSCLC was compared between JS001sc and JS001, up to 6-month|Disease control rate (DCR), Comparison of first-line Disease control rate (DCR) between JS001sc and JS001 in patients with relapsed or metastatic non-squamous NSCLC, up to 2years|Duration of response (DoR), Comparison of first-line Duration of response (DoR) between JS001sc and JS001 in patients treated with relapsed or metastatic non-squamous NSCLC, up to 2years|Safety: adverse events (AEs), The safety of JS001sc and JS001 as first-line treatment in subjects with relapsed or metastatic non-squamous-scale NSCLC was compared by adverse event rate (percentage of participants with treaty-related adverse events assessed by CTCAEv5.0) and abnormal laboratory parameters., up to 2years
The Effect of Creative Drama Education's Effects Tendencies and Emotion Management Skills
NCT Number: NCT06505785
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Creative Drama|Emotion Management Skills|Tendencies|Midwifery Student
Interventions: OTHER: The creative drama group
Sponsor: Ataturk University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-03-30
Completion Date: 2024-07-11
Locations: Ataturk Universty, Erzurum, Yakutiye, 25240, Turkey

Summary:
An experiential and active approach to learning can be implemented in education in higher education through all the arts. In this context, one of the artistic methods that supports active and experiential learning is creative drama. Creative drama is an educational method that is designed to achieve specified cognitive, affective and psychomotor goals and has no age or subject restrictions.This study is planned to examine the effect of the creative drama method on student midwives' empathic tendencies and their ability to manage their emotions.

Primary Outcome Measures: Empathic Tendencies, Empathic Tendency Scale (ETS) was developed by Dökmen (1988) to increase empathy potential in daily life. It is a Likert-type scale and consists of 20 questions and each section is given a score from 1 to 5. 3,6,7,8,11,12,13,15 while adding up the points. Questions

are collected mutually. The minimum score to be obtained from the scale is 20 and the maximum score is 100. The total score represents the subjects' empathic scores. The higher the score, the higher the empathic feature; The trait of being low indicates that the empathic trait is low. The reliability of the scale is .82., 5-10 minutes
Secondary Outcome Measures: Emotion Management Skills, It was developed by Çeçen in 2006. EMS consists of a total of 28 items, 8 of which are positive and 20 are negative. EMS is a 5-point Likert-type self-evaluation performance ranging from Not at All Suitable for Me (1) to Completely Suitable for Me (5). The highest

score that can be obtained from the scale is 140 and the lowest score is 28. While scoring the scale, reverse scores are converted in cases 1, 3, 4, 5, 6, 7, 9, 11, 13, 14, 15, 16, 18, 20, 22, 23, 24, 25, 27 and 28, which are expressed negatively. . . High scores indicate that individuals are competent in organizing their information. The scale consists of five sub- dimensions; Being able to express emotions verbally 3, 4, 7, 9, 23, 25, 27; Being able to show emotions as they are; 15, 16, 18, 20, 24,28; Ability to control the reactions of negative formations 1, 5, 11, 13; Coping 2, 17, 21, 26; Anger management includes articles 6, 22, and 14., 5-10 minutes