pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Secular Change of Height in Turkish Young Adults
NCT Number: NCT06514924
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Growth Alteration|Obesity
Interventions: OTHER: height and weight measurement
Sponsor: Istanbul University
Sex: ALL
Age: ADULT
Enrollment: 465
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-06-01
Locations: Istanbul University, Istanbul, Turkey

Summary:
Current Turkish growth reference charts based on anthropometric measurements of individuals with high socioeconomic status in Istanbul in 1989-2002 (TK2002) had shown an increase of mean adult height (1.4 and 2.7 cm in males and females) compared with 1978. Given recent improvements in nutrition, hygiene and access to preventive health services, it is hypothesized that this positive secular trend may continue. A prior power analysis (95% power) showed that at least 122 subjects of each sex were needed to detect a 1.8 cm height increase (p=0.05) vs TK2002. In 2023-2024 a sample of Turkish young adults (18-26 years) was randomly selected from 65,000 students at Istanbul University, originating from every region of Turkey (TK2024). Height, weight, and socioeconomic status (SES, categorized into four groups) were recorded and body mass index (BMI) was calculated. Adult height and BMI were compared with TK2002 and with young adults of Turkish origin living in the Netherlands measured in 2009 (NL2009).

Primary Outcome Measures: Change in Mean Adult Height (cm), Mean height difference in centimeters between the cohorts (Objective: To compare the mean adult height of young Turkish adults in 2023-2024 (TK2024) with those in 2002 (TK2002) and young adults of Turkish origin living in the Netherlands in 2009 (NL2009)), 01.09.2023- 01.05.2024|Change in Body Mass Index (BMI, kg/m²), Mean BMI difference and percentage of participants classified as overweight or obese between the cohorts (Objective: To compare the BMI of young Turkish adults in 2023-2024 (TK2024) with those in 2002 (TK2002) and young adults of Turkish origin living in the Netherlands in 2009 (NL2009)) (BMI was calculated as weight (kg) divided by height (m²), with weight measured using a digital scale (SECA 813, Hamburg, Germany).), 01.09.2023- 01.05.2024
Secondary Outcome Measures: Association between Height and Socioeconomic Status (SES), Comparison of mean height across different SES groups, 01.05.2024-01.07.2024|Association between BMI and Socioeconomic Status (SES), Comparison of mean BMI across different SES groups, 01.05.2024-01.07.2024|Regional Differences in Height, Mean height differences across regions, 01.05.2024- 01.07.2024|Regional Differences in BMI, Mean BMI differences across regions (), 01.05.2024 - 01.07.2024
Laparoscopic Cholodochotomy in Management of CBD Stones
NCT Number: NCT06514911
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Management of CBD Stones
Interventions: PROCEDURE: primary closure following Laparoscopic cholodochotomy in management of CBD stones|PROCEDURE: T-tube drainage following Laparoscopic cholodochotomy in management of CBD stones
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-12-30
Locations: Sohag University Hospital, Sohag, Egypt

Summary:
The aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus T-tube drainage in laparoscopic common bile duct exploration for management of CBD stones and provide evidence-based guidance to the selection of the most appropriate operative technique.

Primary Outcome Measures: biliary leakage in the management of CBD stones, peritoneal collection of bile after common bile duct exploration, 3 days after the operation
Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma
NCT Number: NCT06514898
Acronym: MATCHPOINT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Recurrent Group 3 Medulloblastoma|Recurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma
Interventions: BIOLOGICAL: TTRNA-DC vaccines with GM-CSF|BIOLOGICAL: TTRNA-xALT|DRUG: Td vaccine|BIOLOGICAL: autologous HSCs|DRUG: Pembrolizumab
Sponsor: University of Florida
Collaborators: Children's National Research Institute
Sex: ALL
Age: CHILD, ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-12

Summary:
This is a pilot study in a small number of children and young adults with relapsed/progressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.

Primary Outcome Measures: Number of participants with immunotherapy-related dose-limiting toxicities after treatment with TTRNA-DCs, TTRNA-xALT and HSCs plus PD1 blockade, Number of subjects with immunotherapy-related dose-limiting toxicities including 1) Grade III or greater non-neurologic toxicity; 2) Grade III neurologic toxicity that does not improve to Grade II or better within 5 days; or 3) Grade IV neurologic toxicity.

For the purposes of evaluating the safety of ACT combined with PD-1 blockade, dose limiting toxicities will be assessed during the period beginning with administration of ex vivo expanded tumor-reactive (TTRNA- xALT) through 2 weeks post TTRNA -DC vaccine #9.

Safety will be defined as \< 1 DLT out of six enrolled and treated subjects., enrollment to completion of DLT window; up to 12 months|Number of enrolled participants who receive qualified immunotherapy products out of the total number of participants enrolled., Feasibility will be defined as capacity to enroll, manufacture, and administer qualified immunotherapy products (TTRNA-DCs, TTRNA-xALT and HSCs) to at least 66.7% of enrolled subjects., enrollment up to 12 months
Silver Diamine Fluoride Application on Root Caries Fillings
NCT Number: NCT06514885
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Root Caries
Interventions: OTHER: SDF solution application|OTHER: Tonic water
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 184
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2026-10-01
Locations: The University of Hong Kong, Hong Kong, Hong Kong

Summary:
The goal of this clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings.

The main questions to answer

1. Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application;
2. Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries.

Participants will be allocated into two group

1. prior SDF application before receiving root caries fillings
2. directly receiving root caries fillings without any SDF application

Primary Outcome Measures: Clinical outcome, Compare the success rate of restorations placed in root caries lesions that have prior SDF application or that of restorations placed without prior SDF application, 24 months follow-up
Secondary Outcome Measures: Patient-based subjective evaluation, Compare patient-based subjective evaluations on the two different approaches in treating root caries lesions.

The Chinese version of General Oral Health Assessment Index (GOHAI) will be adopted as a tool to assess the oral health-related quality of life (OHRQoL) of the participants. It contains 12 questions covering three domains: physical function, pain and discomfort, and psychosocial function. The total GOHAI score is generated by adding up the score of each response to the 12 questions, and the total score ranges from 12 to 60. A higher score indicates a better perceived OHRQoL., 24 months follow-up
Home Accidents Among Turkish Older Men and Women
NCT Number: NCT06514872
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Age Problem
Interventions: OTHER: prevalance and determinants of home accidents
Sponsor: Ataturk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8225
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2023-12-30
Locations: Mevlana Gul, Yakutiye, Erzurum, 25240, Turkey

Summary:
Background: Home accidents are a significant public health issue in developed and developing countries. The present study aims to identify the factors associated with home accidents among older individuals in Türkiye.

Methods: Microdata obtained from the Türkiye Health Survey conducted by the Turkish Statistical Institute (TUIK) in 2019 and 2022 were utilized in the present study. Binary logistic regression analysis was used to determine factors influencing home accidents.

Primary Outcome Measures: Factors contributing to home accidents among older individuals to ensure home safety, The research utilised microdata from the Türkiye Health Survey, published by the Turkish Statistical Institute (TUIK) in 2019 and 2022. The study's dependent variable is the occurrence of home accidents, measured by the question, "Have you experienced a home accident resulting in injury in the last 12 months? (Yes, No)." The independent variables of this study are gender, education level, marital status, employment status, general health status, presence of arthrosis, urinary incontinence, wearing glasses, experiencing difficulty in carrying or holding items, experiencing difficulty in affording health care services, and survey year., 2019-2022
Repair of Inguinal Hernia
NCT Number: NCT06514859
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inguinal Hernia
Interventions: PROCEDURE: Laparoscopic repair of inguinal hernia|PROCEDURE: Open repair of inguinal hernia
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-12-30
Locations: Sohag University Hospital, Sohag, Egypt

Summary:
The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.

Primary Outcome Measures: Recurrence in management of inguinal hernia, Rate of recurrence in both open and laparoscopic repair of inguinal hernia, 6 months after operation
Utilizing the Michigan Neuropathy Screening Instrument for Early Detection of Diabetic Neuropathy
NCT Number: NCT06514846
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Polyneuropathy
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2025-06-01
Locations: Faculty of medecine Sohag university, Sohag, Egypt

Summary:
The study aims to Compare the diagnostic accuracy of the Michigan Neuropathy Screening Instrument (MNSI) (using MNS questionnaire, ,Inspection, vibratory sensation, Ankle reflexes Exam, 10 g monofilament needle examination), routine NCS, and the U/S of the median, posterior tibial, and sural nerves in identifying diabetic peripheral neuropathy in patients recently diagnosed with type 2 diabetes.

Primary Outcome Measures: Early detection of Diabetic Neuropathy, Utilizing the Michigan Neuropathy Screening Instrument, routine nerve conduction study, and nerve ultrasound for early detection of Diabetic Neuropathy, Searching in patients diagnosed within 1 year or less
Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
NCT Number: NCT06514833
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep
Interventions: BEHAVIORAL: lifestyle recommendations to nap regularly|OTHER: No recommendations to nap regularly
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-19
Completion Date: 2028-08-18
Locations: Xinhua Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai, 200092, China

Summary:
To examine the effects of napping in pregnant women with sleep disturbances on offspring neurodevelopment, the researchers will recruit 80 pregnant women with sleep disturbances. These women will receive lifestyle recommendations to nap regularly and will choose whether or not to nap. The participants will wear wrist-worn accelerometers to record their 24-hour sleep patterns for seven consecutive days during the early, middle, and late stages of pregnancy. The neurodevelopment of their offspring will be assessed at 6 months, 12 months, 18 months, and 2 years of age.

Primary Outcome Measures: Bayley Scales of Infant and Toddler Development score, The Bayley Scales of Infant and Toddler Development (Bayley-III) evaluates five key developmental domains:

1. Cognitive Development.
2. Language Development.
3. Motor Development.
4. Social-Emotional Development.
5. Adaptive Behavior., Children at 24 months
Secondary Outcome Measures: Ages and Stages Questionnaires (ASQ) score, ASQ typically evaluates the following areas:

1. Communication.
2. Gross Motor.
3. Fine Motor.
4. Problem Solving.
5. Personal-Social., Children at 12 months|Ages and Stages Questionnaires (ASQ) score, ASQ typically evaluates the following areas:

1. Communication.
2. Gross Motor.
3. Fine Motor.
4. Problem Solving.
5. Personal-Social., Children at 6 months
Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure
NCT Number: NCT06514820
Acronym: EXPOSURE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction
Sponsor: University Medical Center Groningen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-16
Completion Date: 2025-12-31
Locations: University Medical Center Groningen, Groningen, 9713GZ, Netherlands

Summary:
To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF.

Primary Outcome Measures: Ventricular interdependence, the effect of epicardial fat on ventricular interdependence at peak exercise, Baseline
Secondary Outcome Measures: VO2-max, the effect of epicardial fat on VO2-max at peak exercise, Baseline|LV/RV diastolic strain rate, the effect of epicardial fat on ventricular diastolic strain rate measured on echocardiography at peak exercise, Baseline|slope of early LV/RV filling, the effect of epicardial fat on slope of early ventricular filling measured on echocardiography at peak exercise, Baseline|left and right atrial reservoir strain, the effect of epicardial fat on atrial emptying fraction measured on echocardiography at peak exercise, Baseline|left and right atrial emptying fraction, the effect of epicardial fat on atrial reservoir strain measured on echocardiography at peak exercise, Baseline|pulmonary artery distensibility, the effect of epicardial fat on pulmonary artery distensibility measured on echocardiography at peak exercise, Baseline|pulmonary artery pulsatility, the effect of epicardial fat on pulmonary artery pulsatility measured on echocardiography at peak exercise, Baseline|cardiac output, the effect of epicardial fat on cardiac output at peak exercise, Baseline
A Phase 2 Study WU-CART-007 in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
NCT Number: NCT06514794
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: T-cell Acute Lymphoblastic Leukemia|Lymphoblastic Lymphoma
Interventions: BIOLOGICAL: WU-CART-007
Sponsor: Wugen, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-13
Completion Date: 2028-12-30

Summary:
The main purpose of this study is to evaluate the Composite Complete Remission Rate (CRc) of WU-CART-007 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) patients and to evaluate the efficacy of WU-CART-007 to induce complete Minimum Residual Disease (MRD) negative response

Primary Outcome Measures: R/R Cohort - Composite Complete Response Rate, CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi), 24 months|MRD Pos Cohort - Response Rate, Defined as the efficacy of WU-CART-007 to induce complete MRD negative response, 24 months
Secondary Outcome Measures: Objective Response Rate, ORR is defined as proportion of patients that achieve CR + CRi, and partial response (PR) in patients with EMD only (R/R Cohort), 24 months|MRD Response Rate (R/R Cohort), Defined as the efficacy of WU-CART-007 to induce complete MRD response as determined by central flow-based MRD assay (R/R Cohort), 24 months|Duration of Response, Time of response to the time of disease relapse and/or change in MRD status, 24 months|Overall Survival, Time from study drug administration (Day 1) to death on study, 24 months|Hematopoietic Stem Cell Transplant (HSCT) rate, Rate of successful HSCT through study treatment, 24 months
The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia
NCT Number: NCT06514781
Acronym: ICU
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Severe Pneumonia
Sponsor: Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-12-31
Locations: Xiangya Hospital Central South University, Changsha, Hunan, 410008, China

Summary:
This study collected data from 600 patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. It also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia.

Primary Outcome Measures: Mechanical ventilation duration, It is defined as the time from intubation (for patients intubated after ICU admission) or ICU admission (for patients already intubated upon ICU admission) to extubation, 2024.01-2024.12
Secondary Outcome Measures: The patient's sedation success rate, The level of sedation was assessed using the Richmond Agitation-Sedation Scale (RASS). Successful sedation was defined by meeting both of the following criteria: a) the proportion of time during the study medication period that the RASS score was between +1 and -2 was ≥ 70.0%; b) no rescue therapy was used., 2024.01-2024.12
JY231(JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL)
NCT Number: NCT06514768
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia( B-ALL )
Interventions: BIOLOGICAL: JY231
Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2026-06-30
Locations: 920th HJointLogistics, Kunming, Yunnan, China

Summary:
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia( B-ALL )

Primary Outcome Measures: Overall Response Rate (ORR), Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR)., At 2,4,8 and 12 weeks after infusion
Secondary Outcome Measures: Progression-free survival (PFS), Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause., Up to 24 weeks after infusion|Overall survival (OS), Overall survival (OS) is the time from randomization to death from any cause., Up to 24 weeks after infusion|Duration of remission (DOR), Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD., Up to 24 weeks after infusion|Incidence of Treatment Related adverse events (AEs), The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included., Up to 12 months after infusion
Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain
NCT Number: NCT06514755
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Knee Pain|Osteoarthritis
Interventions: PROCEDURE: GNA followed by GAE|PROCEDURE: GAE alone
Sponsor: Zagazig University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2025-04-30

Summary:
The goal of this clinical trial is to evaluate whether performing genicular nerve ablation (GNA) before geniculate artery embolization (GAE) improves pain relief and knee function in patients with chronic knee pain. The main questions it aims to answer are:

* Does performing GNA prior to GAE enhance pain relief, as measured by the Visual Analog Scale (VAS), at 3 months post-procedure?
* Does the sequential approach improve knee function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)?

Study investigators will compare two groups to see if the sequential approach (GNA followed by GAE) provides better outcomes compared to GAE alone.

Participants will:

* Undergo either sequential GNA followed by GAE or GAE alone
* Have their knee pain and function assessed at baseline, 1 month, 3 months, and 6 months post-procedure
* Complete a structured patient satisfaction questionnaire (PSQ) at 3 months post-procedure
* Be monitored for procedure-related adverse events up to 6 months post-procedure,

Primary Outcome Measures: Reduction in Knee Pain, This outcome measures the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement., 3 months post-procedure
Secondary Outcome Measures: Improvement in Knee Function, Assessed by changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, which measure pain, stiffness, and physical function of the knee and hip joints. A lower WOMAC score indicates better joint function., Assessed at 1 month, 3 months, and 6 months post-procedure|Incidence of Procedure-Related Adverse Events, Monitoring and recording any adverse events related to the genicular nerve ablation procedures, From the time of procedure up to 6 months|Patient Satisfaction with the Procedure, Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure., 3 months post-procedure
The Effects of Different Ventilation Modes on Patients With Pulmonary Lobe Resection
NCT Number: NCT06514729
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Injury|Lung Inflammation
Interventions: PROCEDURE: Adopting different ventilation modes during the operation
Sponsor: Mao Enting
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-01-01
Completion Date: 2025-05
Locations: Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, 563000, China

Summary:
The objective of this study was to discuss the effects of different ventilation modes on patients with plasma inflammatory factor and respiratory function in patients with pulmonary removal.

Primary Outcome Measures: Clinical Pulmonary Infection Score, The clinical pulmonary infection score index is mainly used to evaluate the severity of pulmonary infection, which involves many factors, including: body temperature, white blood cell count, tracheal secretions, oxygenation, X-ray chest X-ray, and the progress of pulmonary infiltrates. The maximum score is 12 points, and the severity of infection is directly proportional to its score., Within 15 days after surgery
Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis
NCT Number: NCT06514716
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis|Pain, Musculoskeletal
Interventions: PROCEDURE: Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI)|PROCEDURE: Geniculate Artery Embolization alone (GAE alone)
Sponsor: Zagazig University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-03-30

Summary:
The goal of this clinical trial is to investigate the effectiveness and safety of intra-articular corticosteroid injection (IACI) in alleviating post-procedural pain and improving early outcomes in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The main questions it aims to answer are:

* Does intra-articular corticosteroid injection reduce pain levels post-procedure compared to GAE alone?
* Does the combination of GAE and IACI improve functional outcomes and patient-reported outcomes compared to GAE alone?

Investigators will compare patients receiving GAE with IACI to those receiving GAE alone to see if the addition of IACI provides superior pain relief and functional improvement.

Participants will:

* Undergo geniculate artery embolization, with or without intra-articular corticosteroid injection.
* Have their pain levels assessed using the Visual Analog Scale (VAS) at 1 week, 2 weeks, and 4 weeks post-procedure.
* Complete functional outcome assessments using the KOOS and WOMAC scores.
* Report any adverse events throughout the study period.

Primary Outcome Measures: Change in Pain Intensity, Pain intensity will be measured using the Visual Analog Scale (VAS) at baseline, 1 week, 2 weeks, and 4 weeks post-procedure., 1 week, 2 weeks, and 4 weeks post-procedure
Secondary Outcome Measures: Functional Improvement (KOOS), Functional improvement will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 week, 2 weeks, and 4 weeks post-procedure., 1 week, 2 weeks, and 4 weeks post-procedure|Functional Improvement (WOMAC), Functional improvement will be assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 1 week, 2 weeks, and 4 weeks post-procedure., 1 week, 2 weeks, and 4 weeks post-procedure|Incidence of Procedure-Related Adverse Events, Monitoring and recording any adverse events related to the genicular nerve ablation procedures, Throughout the study period|Patient Satisfaction with the Procedure, Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure., 4 weeks post-procedure
Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
NCT Number: NCT06514703
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: PROCEDURE: CT-Guided Genicular Nerve Ablation|PROCEDURE: Fluoroscopic-Guided Genicular Nerve Ablation
Sponsor: Zagazig University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-03-30

Summary:
The goal of this study is to evaluate the comparative effectiveness of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain and improving function in adults diagnosed with knee osteoarthritis refractory to conservative treatment.

The main questions it aims to answer are:

* Does CT-guided genicular nerve ablation provide superior pain relief compared to fluoroscopic-guided genicular nerve ablation?
* Is there a significant difference in functional improvement between the two techniques?

Researchers will compare the outcomes between the CT-guided and fluoroscopic-guided groups to determine which method achieves better pain relief, functional enhancement, safety profile, and patient satisfaction.

Participants will:

* Undergo either CT-guided or fluoroscopic-guided genicular nerve ablation.
* Attend scheduled follow-up visits to assess pain levels, knee function, and any adverse events.
* Complete standardized questionnaires to provide feedback on pain relief, functional improvement, and overall satisfaction with the procedure.

Primary Outcome Measures: Reduction in Knee Pain, This measure assesses the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement., 3 months post-procedure
Secondary Outcome Measures: Improvement in Knee Function, Assessed by changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, which measure pain, stiffness, and physical function of the knee and hip joints. A lower WOMAC score indicates better joint function., Assessed at baseline, 1 month, 3 months, and 6 months post-procedure|Incidence of Procedure-Related Adverse Events, Monitoring and recording any adverse events related to the genicular nerve ablation procedures, From the time of procedure up to 6 months|Patient Satisfaction with the Procedure, Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure., 3 months post-procedure
Postoperative Memories and Level of Sedation for Tracheal Intubation Using Fiberoptic Bronchoscopy/Videolaryngoscopy
NCT Number: NCT06514690
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Difficult Airway|Postoperative Memories|Tracheal Intubation
Interventions: OTHER: Sedation
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-29
Completion Date: 2025-05-29
Locations: Susana González Suárez, Barcelona, Cataluña, 08035, Spain|Susana González Suárez, Barcelona, Cataluña, 08035, Spain

Summary:
Antecedentes In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation.

Objective: To determine and compare the existence of postoperative memories of the patients and the different levels of sedation (Ramsay scale) obtained during the intubation procedure.

Methods Prospective observational study that includes 100 patients older than 18 years who are going to undergo surgery, who need fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation. Patients with an unexpected difficult airway, under 18 years of age and/or with cognitive impairment will be excluded. After checking the tracheal intubation, the general anesthesia indicated for each patient will be used.

Twenty-four hours after tracheal extubation, the patient will be questioned about the pain presented during the fiberoptic bronchoscopic/videolaryngoscopic procedure and postoperative memories based on a modified Brice questionnaire. At 30 days after surgery, the postoperative memories of the patients will be evaluated again by telephone interview.

Primary Outcome Measures: Incidence of postperative memories, * Determine and compare, between study groups, the existence of postoperative memories according to Brice's questionnaire, in patients who need conscious tracheal intubation, under the effects of intravenous sedation.
* Determine and compare, between study groups, postoperative memories for each sedation level of the Ramsay scale., 24 hours after tracheal extubation and 30 days after
Secondary Outcome Measures: Determine other adverse effects:, Record patients who present respiratory depression (SpO2 \<90%), discomfort (cough and movements), during fiberoptic bronchoscopy/videolaryngoscopy procedure
Non-Surgical Treatment of Peri-Implantitis With Ultrasonic Carbon Tip
NCT Number: NCT06514677
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peri-Implantitis|Alveolar Bone Loss
Interventions: PROCEDURE: Ultrasonic Carbon Tip|PROCEDURE: Titanium Curette
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2025-12-01
Locations: Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology, Kütahya, 43100, Turkey

Summary:
As the frequency of dental implants increases, the incidence of complications and peri-implant diseases also increases. Early diagnosis and treatment of the disease is important to prevent consequences up to implant loss. Non-surgical treatment is the recommended treatment in the first stage due to its shorter duration and low morbidity rate. Non-surgical treatment of peri-implantitis provides clinical improvements such as reduced bleeding on probing (20-50%) and, in some cases, reduced pocket depth (≤ 1 mm). This study aims to clinically and radiographically compare two different mechanical treatments in patients with mild and moderate peri-implantitis.

Primary Outcome Measures: Periodontal depth decrease, Periodontal pocket depth (PD) decreasing baseline to 12th month, Baseline to 12th month
Secondary Outcome Measures: marginal bone level changes, Marginal bone level changes will be calculated at standardized periapical radiography, Baseline to 12th month
Evaluation of the Effects of Probiotic Toothpastes on Periodontal Health
NCT Number: NCT06514664
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Diseases|Periodontitis|Gingivitis
Interventions: OTHER: Using Probiotic Toothpaste
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-10
Completion Date: 2024-12-10
Locations: Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology, Kütahya, 43100, Turkey

Summary:
This controlled, randomized clinical study aims to evaluate the possible effects of probiotic toothpaste on the success of periodontal treatment in smokers and non-smokers with clinical data.

The main question(s) it aims to answer are:

Does applying probiotic toothpaste in addition to periodontal treatment have a positive effect on the gingival of periodontitis patients who are smokers and non-smokers?

The study includes four groups; Group 1: Use of probiotic toothpaste + smoking patient Group 2: Use of regular toothpaste + smoking patient Group 3: Use of probiotic toothpaste + non-smoking patient Group 4: Use of regular toothpaste + non-smoking patient

Primary Outcome Measures: Periodontal pocket depth changes, Periodontal pocket depth changes will be measured with periodontal probe at baseline and third month postoperatively, 3 month follow up
Computational Mathematical Analysis in Vastus Medialis Between a MTrP and Non Painful Point
NCT Number: NCT06514638
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Trigger Point Pain, Myofascial
Interventions: OTHER: Ultrasound imaging
Sponsor: Samuel Fernández Carnero
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-13
Completion Date: 2024-06-23
Locations: Nursing and Physiotherapy Faculty Study Officials, Alcalá De Henares, Madrid, 28871, Spain

Summary:
With the help of ultrasound, the goal of the study is to asses the differences between MTR points and non painful points, in order to characterize the identification of MTR througought ultrasound. Being a complex process that needs to be standarized for each muscle, the study takes place in the vastus medialis.

Primary Outcome Measures: Echogenicity, Information measures of correlation at 0º, 45º, 90º, 135º expressed as mean+-standard deviation, Through study completion, an average of 3 months
Sleep Quality in Carpal Tunnel Syndrome, Splinting and Kinesiotaping
NCT Number: NCT06514625
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carpal Tunnel Syndrome
Interventions: DEVICE: splint
Sponsor: Konya Beyhekim Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2023-11-01
Locations: Konya Beyhekim Research and Training Hospital, Konya, Selçuklu, 42060, Turkey

Summary:
The effect of conservative treatments on sleep quality in carpal tunnel syndrome is unclear.

Comparing the effect of splinting and kinesiotaping in carpal tunnel syndrome on functional status, pain, grip strength, nerve cross-sectional area and sleep quality.

Participants were divided into 3 groups. One group received night splint and nerve tendon gliding exercises, one group received kinesiotaping and nerve tendon gliding exercises, and one group received only nerve tendon gliding exercises. Participants were evaluated by a blinded investigator at baseline and at 3 months by Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire, Pittsburgh Sleep Quality Index (PSQI), Jamar hand dynamometer and ultrasonography.

Primary Outcome Measures: sleep quality, Evaluated with "The Pittsburgh Sleep Quality Index "., at baseline and third month|median nerve cross-sectional area, Measured at the wrist by ultrasonography., at baseline and third month
LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis.
NCT Number: NCT06514612
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acquired Blepharophimosis
Interventions: DRUG: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers|OTHER: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers
Sponsor: Santen SAS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 234
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-02-01

Summary:
A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis

Primary Outcome Measures: Change from baseline in Marginal Reflex Distance (MRD1) on Day 14 at 4 hours after PM dose., Change from baseline in MRD1 (Marginal Reflex Distance, Distance from the centre of the pupil to central upper lid margin) on Day 14 at 4 hours after PM dose. This is to evaluate the efficacy of STN1013800 dosed twice daily in the treatment of acquired blepharoptosis on Day 14, Day 14 at 4 hours
Secondary Outcome Measures: PRO (Patient Reported Outcome): PGIC (Subject Global Impression of Change) on Day 14, 4 hours after PM dose, To assess the degree of improvement experienced by subjects since start of the trial (PRO), Day 14 at 4 hours
CRP, Procalcitonin and Pro-BNP as Diagnostic and Prognostic Markers in AECOPD
NCT Number: NCT06514599
Acronym: AECOPD
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COPD Exacerbation Acute
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-15
Completion Date: 2024-04-15
Locations: Ministry of Health, University of Health Sciences, İstanbul Kanuni SUltan Suleyman TRaining and Research Hospital, İstanbul, Küçükçekmece, 34303, Turkey

Summary:
Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) are one of the chief causes for admission to Emergency Department. AECOPD is a significant cause for mortality and morbidity worldwide. Emergency Medicine Physicians frequently manage these patients. Predicting the severity and possible prognosis of AECOPD is an important task for Emergency Medicine Physicians as treatment options and aggressiveness may depend on these predictions. In our study we aimed to compare different biomarkers such as Procalcitonin, Pro-Brain Natriuretic Peptide (Pro-BNP) and C-Reactive Protein (CRP) on their efficacy at predicting the severity and prognosis of AECOPD.

We analyzed the data of the selected 196 patients with the diagnosis AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guide who were admitted to our Emergency Department between 15/02/2023 and 15/02/2024.

Primary Outcome Measures: Attack Severity, Mild, Moderate and Severe, At admission
Secondary Outcome Measures: Mortality, AECOPD-related death, 28 days
Vaccine Immunity and Inflammation in the Aging Person Living With HIV
NCT Number: NCT06514547
Acronym: VIVID
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: HIV Infections|Age
Interventions: BIOLOGICAL: Conjugate Pneumococcal Vaccine 20 (PCV20)
Sponsor: Hennepin Healthcare Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-07-01
Completion Date: 2030-12-14
Locations: Hennepin Healthcare System, Minneapolis, Minnesota, 55415, United States

Summary:
This study will track immune responsiveness to conjugate pneumococcal vaccines over time to help determine how long protection from this vaccine lasts in individuals with chronic medical conditions (in this study - HIV) and with age.

Primary Outcome Measures: Primary objective, Evaluate the impact of HIV status on pneumococcal vaccine immunogenicity and durability as measured pneumococcal-specific Ab concentration, memory B cell responses (frequency and phenotype) and CD4 T cell responses (frequency and phenotype) at an acute (primary comparison) and memory (secondary comparison) post-vaccination timepoints., 30 days and 2 years
Secondary Outcome Measures: Secondary objective, Explore the impact of advanced age on pneumococcal vaccine immunogenicity and durability in PLWH. This will be evaluated by evaluating the relationship of age and pneumococcal-specific Ab concentration, memory B cell responses (frequency and phenotype) and CD4 T cell responses (frequency and phenotype) at acute and memory timepoints., 30 days and 2 years
Post Marketing Study on Pluvicto in Korea
NCT Number: NCT06514521
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: OTHER: Lutetium vipivotide tetraxetan
Sponsor: Novartis Pharmaceuticals
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 278
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-31
Completion Date: 2027-07-31

Summary:
Post marketing study on Pluvicto in Korea

Primary Outcome Measures: Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions, The safety assessment will consist of occurrence status of all adverse events (AEs)/adverse drug reactions (ADRs), serious AEs (SAEs)/serious ADRs and unexpected AEs/unexpected ADRs.

Safety data will be collected from all subjects over the study period. Subjects will be followed up for AEs until 30 days after the last dose of Pluvicto., Until 30 days after the last dose of Pluvicto, up to 33 months
Secondary Outcome Measures: Objective response rate (ORR) as assessed by investigator, Clinical assessment on disease status by investigator will be collected to assess objective response rate (ORR). If results are not available at study schedule, the nearest and available data will be collected. In case of subject follow up loss or discontinuation for any reason, ORR will be assessed based on the data collected at the date of the last contact of the subject., 4th±1 week from the last dose|Radiographic progression-free survival (rPFS), rPFS, defined as the time from study assignment to the date when the first sign of disease progression or death due to any cause, whichever occurs first., Up to 33 months
Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients
NCT Number: NCT06514508
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Multiple Myeloma
Interventions: DRUG: Motixafortide+G-CSF|DRUG: Placebo+G-CSF
Sponsor: Guangzhou Gloria Biosciences Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-12-31
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China|Harbin The First Hospital, Harbin, Hei Longjiang, 150010, China

Summary:
This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.

Primary Outcome Measures: Proportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions, Up to day 6
Secondary Outcome Measures: Proportion of patients who collect ≥2.0 × 10^6 CD34+ cells/kg in 1 apheresis session, Up to Day 5|Proportion of patients who collect ≥6.0 × 10^6 CD34+ cells/kg in 1 apheresis session, Up to Day 5|Number of CD34+ cells/kg collected, Up to Day 8|Maximum plasma concentration (Cmax), Up to Day 8|Time from transplantation to neutrophil engraftment, Up to post transplantation Day 29|Time from transplantation to platelets engraftment, Up to post transplantation Day 29|Graft durability at 100 days post-transplantation, Graft durability is defined as maintenance of at least 2 of the following 3 criteria:

* Platelet count ≥50 × 10\^9/L without transfusion for at least 2 weeks.
* Hemoglobin level ≥10 g/dL with no erythropoietin support or transfusions for at least 1 month.
* Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L for 1 week., Up to post transplantation Day 100|Change from Baseline in peripheral blood CD34+ cell concentration, Up to Day 8|Incidence of adverse events (AEs) and serious adverse events (SAEs), Up to Day 38