pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Pain, Anxiety and Depression in Patients With Resectable Head and Neck Squamous Cell Carcinoma
NCT Number: NCT06575322
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: Carboplatin（ neoadjuvant）|DRUG: Paclitaxel （neoadjuvant）|DRUG: Anti-PD-1 Drugs|PROCEDURE: Surgical resection
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 302
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-03-01
Locations: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guanzhou, Guangdong, 510000, China

Summary:
The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on pain, anxiety and depression in patients with operable head and neck squamous cell carcinoma: a prospective cohort study

Primary Outcome Measures: Brief Pain Inventory (Short Form), The BPI-SF contains 15 items that measure pain severity and pain interference, with each item assessed on an 11-point numeric rating scale ranging from "no pain" (0) to "worst pain imaginable" (10)., Baseline, 9 weeks, 6 months, 12 months|HADS, HADS is a 14-item self-report scale, including two subscales: anxiety (HADS-A) and depression (HADS-D). The total HADS score ranges from 0 to 42, and the subscales range from 0 to 21., Baseline, 9 weeks, 6 months, 12 months
Secondary Outcome Measures: Major pathological response rate, Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects, Within 30 days after surgery|Complete pathological response rate, Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects, Within 30 days after surgery
Predicting Cerebral Palsy in Infants With White Matter Injury Using MRI
NCT Number: NCT06575283
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy|Periventricular White Matter Abnormalities
Interventions: OTHER: No intervention will be performed in this cohort study
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Collaborators: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine|Shenzhen Children's Hospital|Zunyi Medical College|Wuxi Women's & Children's Hospital
Sex: ALL
Age: CHILD
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31
Locations: The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China

Summary:
The goal of this study is to determin the MRI features associated with cerebral palsy and to develop prediction models of pediatric disorders by combining MRI with artificial intelligence.

The main questions it aims to answer are:

* How to achieve features on conventional MRI associated with cerebral palsy?
* How to predict the risk of cerebral palsy in infants aged 6 to 2 years based on conventional MRI and deep learning? Researchers will compare characteristics of periventricular white matter injury with cerebral palsy to those without cerebral palsy.

Participants will be asked to provide MRI data, clinical diagnoses information, and follow-up outcomes.

Primary Outcome Measures: Accuracy of the model predicting cerebral palsy, Determine the accuracy of PVWMI classification and cerebral palsy prediction. The higher the value, the better the model performance., From September 2024 to December 2025
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
NCT Number: NCT06575270
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypoxemia|Skin Pigment|Congenital Heart Disease
Sponsor: Icahn School of Medicine at Mount Sinai
Sex: ALL
Age: CHILD, ADULT
Enrollment: 92
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-12
Locations: Mount Sinai Hospital, New York, New York, 10029, United States

Summary:
Recent retrospective studies have demonstrated differences between pulse oximeter values (SpO2) and measured arterial oxygen saturation (SaO2) in patients identifying as Black or Hispanic. These retrospective studies have limitations because self-reported race is likely not an accurate metric for level of skin pigmentation and the retrospective nature of these studies may impact the accuracy of simultaneous measures of arterial oxygen saturation and pulse oximeter values. The few prospective studies that have evaluated this issue have utilized color-matching techniques to quantify skin pigmentation, and fewer studies have directly measured skin pigmentation in relation it to pulse oximeter accuracy. The aim of this study is to prospectively measure pulse oximeter accuracy in relation to measured levels of skin pigmentation in the congenital heart disease population.

Primary Outcome Measures: Level of Skin Pigmentation, Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by color spectrophotometry. Pulse oximeter accuracy will be measured using the Accuracy Root Mean Squared (ARMS), mean bias, and proportional bias (Bland-Altman)., Day 1 of study participation
Secondary Outcome Measures: Fitzpatrick Skin Tone Scale, Pulse Oximeter Accuracy in measuring skin pigmentation as measured by Fitzpatrick Skin Tone Scale Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Fitzpatrick Scale. Scale from I-VI, with higher number indicating darker skin tone, Day 1 of study participation|Monk Skin Tone Scale, Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Monk Skin Tone Scale. Scale from 1-10, higher numbers indicates darker skin tone., Day 1 of study participation|Number of participants who experience at least one episode of occult hypoxemia, Incidence of occult hypoxemia, defined as SpO2 ≥92% despite SaO2≤88%, as it relates to measured skin pigment and incidence of occult hypoxemia will be described. Incidence will be measured by assessing the total number of participants who experience at least one episode of occult hypoxemia., Day 1 of study participation
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
NCT Number: NCT06575257
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: Darolutamide|DRUG: Goserelin 3.6 mg
Sponsor: Xijing Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2029-05
Locations: The First Affillated Hospital, the Air Force Medical University, Xi'an, Shanxi, 710032, China

Summary:
The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.

Primary Outcome Measures: Pathologic Complete Response Rate, The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy, After 12 weeks of neoadjuvant therapy + RP + PLND|Proportion of Subjects With Minimal Residual Disease, The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy, After 12 weeks of neoadjuvant therapy + RP + PLND
Secondary Outcome Measures: Rate of Stage Degradation, Clinical or pathological stage degradation after neoadjuvant therapy, After 12 weeks of neoadjuvant therapy + RP + PLND|Rate of Positive Surgical Margins, The proportion of subjects with positive surgical margins after radical prostatectomy, After 12 weeks of neoadjuvant therapy + RP + PLND|Rate of Complete Serum Remission, The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 3 months of treatment, After 12 weeks of neoadjuvant therapy|Proportion of subjects without PSA progression, The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy, 2 years after RP|Imaging Response Rate, The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm, After 12 weeks of neoadjuvant therapy|Recovery time of urinary continence (day), The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day., 1 years after RP|biochemical recurrence-free survival (bRFS), biochemical recurrence-free survival (bRFS) defined as time to PSA ≥ 0.2 ng/ml after radical prostatectomy., 3 years after RP|metastasis-free survival (MFS), time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging., 5 years after RP
Accuracy and User Performance Evaluation of PixoTest HbA1c Measurement System
NCT Number: NCT06575231
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes|HbA1c
Interventions: DIAGNOSTIC_TEST: in-vitro
Sponsor: China Medical University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2016-07-01
Completion Date: 2017-06-30

Summary:
To evaluate the accuracy user performance of PixoTest HbAc1 measurement system and to collect feedback from subjects.

Primary Outcome Measures: HbA1c, HbA1c testing can be performed at any time of day and without special patient preparation., 3 minutes
The Effectiveness of Virtual Reality Training Program
NCT Number: NCT06575218
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alzheimer Disease
Interventions: DEVICE: Virtual reality training|OTHER: Conventional exercise and cognitive exercise|OTHER: control
Sponsor: Yeditepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-21
Completion Date: 2024-09-06
Locations: Ebru Akbuğa Koç, İstanbul, Turkey

Summary:
Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. VR technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community.

Primary Outcome Measures: Montreal cognitive assessment scale, MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment., 12 weeks|Berg Balance Scale, BBS measures static and dynamic balance in elderly individuals, 12 weeks|Time up and Go Test, TUG test evaluates fall risk, mobility and physical performance in the elderly, 12 weeks
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
NCT Number: NCT06575192
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Breast Reconstruction
Interventions: DEVICE: ARTIA Reconstructive Tissue Matrix|OTHER: No Intervention
Sponsor: AbbVie
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 783
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-18
Completion Date: 2029-12-02

Summary:
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.

Primary Outcome Measures: Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1, Number of participants with at least one major complication related to breast reconstruction., Month 18|Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2, Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale., Up to Month 18|Number of Participants with Adverse Events (AEs), An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment., Up to Approximately 36 Months
Secondary Outcome Measures: Occurrence of Capsular Contracture per Breast, Number of participants with an occurrence of capsular contracture per breast., Month 36
The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure
NCT Number: NCT06575166
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ventral Hernia|Incisional Hernia|Parastomal Hernia
Interventions: DEVICE: Abdominal wall tension|DEVICE: Intra-abdominal pressure
Sponsor: The Cleveland Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-16
Completion Date: 2025-08-16
Locations: Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States

Summary:
This is a prospective cohort study. Patients have an incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.

Primary Outcome Measures: Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications, Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Post-operative complications measured in proportion of events, 1 year
Secondary Outcome Measures: Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs), Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs), 1 year|Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm), Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs) Hernia defect size (length and width in cm), 1 year|Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O), Intra-abdominal pressure using TraumaGuard catheter in mmHg Abdominal wall tension measured using tensiometer in pounds Airway pressure measured on mechanical ventilator in cmH2O, 1 year|Temporal changes in renal function (serum Creatinine), Creatinine reported on routine laboratory blood work (comprehensive metabolic panel) measured over time, 1 year
Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery
NCT Number: NCT06575140
Acronym: APS-PILOT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Stroke, Acute|Stroke, Ischemic|Stroke, Hemorrhagic|Hemiparesis|Hemiparesis;Poststroke/CVA|Weakness of Extremities as Sequela of Stroke|Stroke Sequelae|Upper Extremity Paresis
Interventions: DEVICE: Associative Peripheral Stimulation (APS) 1.0|DEVICE: Peripheral Neuromuscular Stimulation
Sponsor: Ahmed A. Rahim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-12-18
Completion Date: 2024-12
Locations: General Hospital of Mexico, Mexico City, Mexico|La Raza National Medical Center, Mexico City, Mexico|National Institute of Neurology & Neurosurgery, Mexico City, Mexico

Summary:
Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.

Primary Outcome Measures: Maximum Average of Range of Motion (ROM), Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes., 5 weeks|Fugl-Meyer Assessment Upper-Extremity (FMA-UE), Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes., 5 weeks
Secondary Outcome Measures: Maximum Average of Range of Motion (ROM), Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes., 3 months|Fugl-Meyer Assessment Upper-Extremity (FMA-UE), Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes., 3 months|Action Research Arm Test (ARAT), Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes., 5 weeks|Action Research Arm Test (ARAT), Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes., 3 months
Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study
NCT Number: NCT06575127
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neoplasm Malignant|Colon Cancer Stage 4
Interventions: DRUG: FOLFOXIRI Protocol
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-17
Completion Date: 2026-09-01
Locations: Al Hussien University Hospital, Cairo, Cairo Governorate, 11311, Egypt

Summary:
This prospective Phase II study aims to evaluate the efficacy and safety of a modified FOLFOXIRI regimen in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI, though effective, is known for its high toxicity, necessitating close monitoring and dose adjustments. .

The primary endpoint is to assess the impact on the objective response rate and evaluate both acute and delayed toxicity. The secondary endpoints include studying the treatment's effectiveness as conversion therapy, along with disease-free survival (DFS) and overall survival (OS). The tertiary endpoint focuses on evaluating predictive and prognostic factors of significance.

This study seeks to balance the efficacy of FOLFOXIRI with a modified dose to minimize toxicity while maintaining therapeutic benefits, providing a potentially safer and effective option for patients with MCRC.

Primary Outcome Measures: Treatment-related adverse events, evaluate treatment-related acute and delayed toxicity, 12 months|Objective Response Rate, To assess the impact of the treatment on the objective response rate, 6 months
Secondary Outcome Measures: Conversion therapy, To assess the treatment's efficacy as a conversion therapy, transforming initially unresectable tumors to resectable ones, response rates will be evaluated every 4 treatment cycles according to RECIST v1.1 (Eisenhauer EA, 2009):

Complete Response (CR): Disappearance of all lesions and pathological lymph nodes.

Partial Response (PR): ≥30% decrease in the sum of the longest diameters (SLD) of target lesions, no new lesions, and no progression in non-target lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Progressive Disease (PD): ≥20% increase in SLD or the appearance of new lesions.

Patients eligible for surgery may receive up to 8 cycles before surgical evaluation. Those showing favorable response will be referred for potential surgical intervention., 4 months|Progression free survival, to study the impact of treatment on progression free survival, 12 months|Overall survival, to study the impact of treatment on overall survival, 24 months
Other Outcome Measures: Prognostic and predictive values, To evaluate predictive and prognostic factors of significance and its impact ORR, PFS and OS, 24 month
COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory
NCT Number: NCT06575114
Acronym: CVWIOABOSDT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Old Age; Debility|Vaccine Hesitancy|Vaccine Refusal
Interventions: OTHER: Self-determination theory-based health education measures
Sponsor: Jing-Shan Deng
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 264
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-09-01
Completion Date: 2023-11-17
Locations: Taizhou Hospital, Taizhou, Linhai, 317000, China

Summary:
Introduction: The COVID-19 vaccine is an effective measure for preventing and controlling COVID-19 epidemics, and the World Health Organization lists older adults as a high-priority group for COVID-19 vaccination. However, the willingness of older people to be vaccinated against COVID-19 remains an important issue in achieving herd immunity. We investigated the effectiveness of a COVID-19 vaccine intervention for older adults, based on self-determination theory.

Methods and analysis: Questionnaires were administered to assess vaccine willingness at baseline and at 6 weeks following educational intervention programs concerning vaccination against COVID-19. Four nursing homes with a population size of over 100 will be selected and randomized into intervention and control groups. The control group will undergo conventional intervention methods, and the intervention group will undergo a comprehensive intervention program based on self-determination theory.

Ethics and dissemination: The study has been approved by the Ethics Committee of Taizhou Hospital, Zhejiang Province, China (approval number: K20230832).

Primary Outcome Measures: Willingness to vaccinate, Changes in Vaccination Wiilingness Scores for the Elderly, 6 weeks
Secondary Outcome Measures: Basic psychological needs, Changes in Basic psychological needs Scores for the Elderly, 6 weeks|Vaccine literacy, Changes in Vaccine literacy Scores for the Elderly, 6 weeks
Pneumatic Tourniquet Application in Upper Extremity Surgeries
NCT Number: NCT06575088
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Wound|Complication of Surgical Procedure
Interventions: OTHER: Standard tourniquet pressure (250 mmHg)|OTHER: Limb occlusion pressure|OTHER: Cotton Pad|OTHER: Elastic stockinette
Sponsor: Bursa City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-10-14
Completion Date: 2023-09-29
Locations: Republic of Turkey Ministry of Health Bursa City Hospital, Bursa, Turkey

Summary:
Purpose: This study investigated the effect of cuff pressure and the selection of protective padding material(PPM) on the prevention of skin complications associated with pneumatic tourniquet(PT) application in upper extremity surgery.

Methods: This randomized controlled trial was conducted between October 2022 and September 2023 at the Hand Surgery Clinic of XXX. Standard tourniquet pressure (STP) or limb occlusion pressure (LOP) was applied as PT cuff pressure. Cotton pads or elastic stockinette was used for PPM under the cuff. Patients were categorized into four groups; (i) STP with a cotton pad; (ii) STP with an elastic stockinette; (iii) LOP with a cotton pad; and (iv) LOP with an elastic stockinette. Total of 200 patients were included in the study, with 50 patients in each group. Skin complications were evaluated postoperatively at 0, 30, and 180 min.

Primary Outcome Measures: Redness, Redness was defined as a reddish appearance on the skin, in contrast to a normal skin appearance., through study completion, an average of 1 year|Tourniquet scar, A tourniquet scar is a scar on the skin in the form of wrinkles and folds aligned with the structure of the sleeve., through study completion, an average of 1 year|Petechiae, Petechiae was defined as the occurrence of pinpoint-sized hemorrhages under the skin of the sleeve., through study completion, an average of 1 year|Bulla, A bulla is considered a fluid-filled blister on the skin., through study completion, an average of 1 year
Pilot Study of RR-HNK in OCD
NCT Number: NCT06575075
Acronym: (HNKO)
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Obsessive-Compulsive Disorder
Interventions: DRUG: RR-HNK/Hydroxynorketamine|DRUG: Placebo
Sponsor: Carolyn Rodriguez
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-11-30

Summary:
The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.

Primary Outcome Measures: Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), Change in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS., Baseline (Visit 3) to Week 1 (Visit 8), up to 1 week
The Effect of Different Treatment Methods on the Apical Closure and Treatment Success in Permanent First Molars
NCT Number: NCT06575062
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Symptomatic Reversible Pulpitis (Disorder)
Interventions: PROCEDURE: Direct Pulp Capping with ProRoot MTA|PROCEDURE: Pulpotomy with ProRoot MTA
Sponsor: Ataturk University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-05
Completion Date: 2024-12-16
Locations: Ataturk University Faculty of Dentistry, Erzurum, Turkey

Summary:
The purpose of this thesis study is to evaluate the clinical and radiographic success of direct capping and pulpotomy applications using ProRoot MTA (mineral trioxide aggregate) in lower permanent first molars with reversible pulpitis symptoms that have not yet completed their root development. Additionally, the study aims to assess the effects of these treatments on maturogenesis, specifically root development and apical closure.

Primary Outcome Measures: Clinical success after pulpotomy or direct pulp capping treatment, This outcome measure evaluates the absence of pathological signs or symptoms in the treated tooth, including no abscess formation, no swelling, no fistula development, no abnormal mobility, and no post-operative pain. Additionally, the absence of pain on palpation or percussion of the tooth is assessed., 6 Month - 1 Year|Radiographic assessment after pulpotomy or direct pulp capping treatment, This outcome measure involves the radiographic evaluation of the treated tooth post-pulpotomy or direct pulp capping. The assessment focuses on the absence of root resorption (both internal and external), no furcation involvement, no periapical radiolucency, and no loss of lamina dura. Additionally, a normal appearance of the periodontal ligament space is expected. The natural progression of root formation and root apex closure, known as maturogenesis, will be monitored according to Moorrees classification (stages R½, R¾, Rc, A½, and Ac), ensuring the process follows this sequence., 6 Month - 1 Year
Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery
NCT Number: NCT06575049
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Post-Operative Hematoma|Seroma as Procedural Complication|Post-Op Complication
Sponsor: Seoul National University Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-05-01
Completion Date: 2026-02-20

Summary:
We aim to compare the incidence rates of seroma (fluid collection) and hematoma (blood clot) following breast cancer surgery between the conventional non-steroidal anti-inflammatory drug (NSAID) Ketorolac and MAXIGESIC. We seek to determine the complication rates in patients receiving MAXIGESIC post-surgery, hypothesizing that the higher dosage of ibuprofen in MAXIGESIC compared to Ketorolac will result in lower complication rates.

Primary Outcome Measures: Postoperative hemovac or JP total drainage amount, Postoperative hemovac or JP total drainage amount, within 3 months|hematoma incidence, hematoma incidence, within 3 months|Seroma incidence, Seroma incidence, within 3 months
Secondary Outcome Measures: Length of hospital stay, Length of hospital stay and re operation rate, within 3 months|Complication, * When hematoma occurs: Whether transfusion is required and whether EB band is applied, check the amount when aspirating (diagnosis criteria color: sanguinous, old bloody \[brownish\], operation (hematoma evacuation)
* When seroma occurs: check the amount when aspirating (diagnosis criteria color: serous, serosanguinous)
* Complication: Whether abscess occurs, within 3 months
Sugammadex Dose Finding Under Two Years Old
NCT Number: NCT06575036
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neuromuscular Blockade
Interventions: DRUG: Sugammadex
Sponsor: Sang-Hwan Ji
Sex: ALL
Age: CHILD
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-05-31
Locations: Seoul National University Hospital, Seoul, 03080, Korea, Republic of

Summary:
This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.

Primary Outcome Measures: 50% effective dose, Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients., From start of sugammadex administration to 2 minute after end of administration|95% effective dose, Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients., From start of sugammadex administration to 2 minute after end of administration
Secondary Outcome Measures: TOF result, Response to train-of-four stimulation after administration of sugammadex, From start of sugammadex administration to 2 minute after end of administration|Residual blockade, Incidence of recurarization in the postanesthesia care unit, From start of sugammadex administration to 24 hours after end of administration|Blood pressure, Noninvasive blood pressure after sugammadex administration measured in the operating room and postanesthesia care unit, From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)|Pulse oximetry, Pulse oximetry after sugammadex administration measured in the operating room and postanesthesia care unit, From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases
NCT Number: NCT06575023
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Placenta Accreta
Interventions: PROCEDURE: Tamponade of lower uterine segment in management of placenta accreta spectrum cases|PROCEDURE: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases
Sponsor: Assiut University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 222
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-08-30

Summary:
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .

Primary Outcome Measures: amount of intraopertive blood loss., compare of amount of blood loss between two methods by adding collected blood in suction apparatus in milliliters to amount of biood in the soaked towels, 2 years
Secondary Outcome Measures: ICU admission, yes or no admission number of days if there is ICU admission cause of admission, 2 years|Re exploration, if there is exploration or no cause of re-exploration outcome of re-exploration, 2 years|drop of HB level postoperative, result of substitution of HB level postoperative from preoperative in gmldl, 2 years|blood transfusion, amount of transfused blood units, 2 years
Exparel v Dexamethasone in RCR
NCT Number: NCT06575010
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Rotator Cuff Tears|Postoperative Pain
Interventions: DRUG: Liposomal bupivacaine|DRUG: Bupivacaine Hcl 0.5% Inj|DRUG: Dexamethasone
Sponsor: Rothman Institute Orthopaedics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2025-08-30
Locations: Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, 19107, United States

Summary:
Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.

Primary Outcome Measures: Postoperative narcotic medication use, Participants will be asked to record the amount of medication they take to control pain after surgery, 14 days|Postoperative pain levels, This will be measured by providing participants the visual analog scale (VAS) questionnaire as well as a postoperative pain recording diary to complete after surgery, 14 days
Expanded Access Program for RP in Adults
NCT Number: NCT06574997
Status: AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Retinitis Pigmentosa
Interventions: DRUG: OCU400
Sponsor: Ocugen
Sex: ALL
Age: ADULT, OLDER_ADULT
Locations: Associated Retina Consultants, Phoenix, Arizona, 85020, United States

Summary:
This intermediate-size patient population expanded access program is to provide access to investigational product OCU400 for up to 75 patients with Retinitis Pigmentosa (RP) outside of the ongoing clinical trial Phase 3 program for patients who do not have access to alternative Food and Drug Administration (FDA)-approved products for treatment of the disease.
Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients
NCT Number: NCT06574984
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Congenital Bleeding Disorder|Haemophilia A
Interventions: DRUG: Turoctocog alfa
Sponsor: Novo Nordisk A/S
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-26
Completion Date: 2024-11-30

Summary:
The study has descriptive purposes, with aim of assessing how turoctocog alfa is used in the everyday practice and to provide a baseline for the management of haemophilia A and does not involve any change in the clinical management of participants. Data will be extrapolated from the existing paper based medical records and uploaded to an electronic database specifically created for the study. Baseline information/history will be recorded at time of switching from previous FVIII replacement therapy to turoctocog alfa from the enrolled participants and outcomes will be collected according to participants visit format.

Primary Outcome Measures: Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy, Measured as count of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12., From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa
Secondary Outcome Measures: ABRs among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy, Measured as number of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12 across 4 age segments ( less than \[\<\] 8 years, 8-14 years, 15-18 years, greater than \[\>\] 18 years)., From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa|Change of primary prophylaxis regimen, Measured as Yes/No., From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa|Dose of turoctocog alfa, Measured as international uniit per kilogram (IU/kg)., At month 12 after switching to turoctocog alfa|Haemostatic response to turoctocog alfa, Measured as excellent, good, moderate, none., At baseline and at month 12|Spontaneous ABR, Measured as number of reported spontaneous bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12., At month 12 after switching to turoctocog alfa|Annualized joint bleed rate (AJBR), Measured as number of reported joint bleeding episodes divided by the observation period in months multiplied by 12., At month 12 after switching to turoctocog alfa|New target joint, Measured as number resolution (Yes/No) affected joints., At month 12 after switching to turoctocog alfa|Severity of bleeding, Measured as mild / moderate / severe., At month 12 after switching to turoctocog alfa
Clinical Study of CD38\CS1 Chimeric Antigen Receptor T Cells in the Treatment of Refractory/Recurrent Multiple Myeloma
NCT Number: NCT06574958
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: ORR,OS,PFS
Interventions: BIOLOGICAL: CD38/CS1 injection
Sponsor: The Second Hospital of Shandong University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-30
Completion Date: 2025-01-15
Locations: Second Hospital of Shandong University, Shandong, Shandong, 250000, China

Summary:
The investigators developed a dual-target CAR-T targeting CD38 and CS1. Previous experimental results showed that the investigators double-target CAR-T not only had a good killing effect on CD38/CS1 double-positive tumor cells, but also had a high killing rate on CD38 or CS1 single-positive tumor cells. The investigators further study also found that the killing rate of the investigators dual-target CAR-T after mixing CD38 and CS1 monoyang tumor cells was over 80%. The advantage of the investigators dual-target CAR-T product is that the killing effect on single-yang, double-yang and single-yang mixed tumors is stable, and the killing rate is above 80% (see Figure 1). It has a wide killing range and can effectively reduce the phenomenon of tumor immune escape. Therefore, the investigators dual CAR products have good advantages and development potential.

Primary Outcome Measures: ORR, sCR、CR、VGPR、PR, one year
Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).
NCT Number: NCT06574945
Acronym: ESK，LEEP
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Esketamine|Loop Electrosurgical Excision|Propofol
Interventions: DRUG: intravenous injection of propofol only|DRUG: intravenous injection of propofol +esketamine
Sponsor: Qian Wu
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-01-07
Completion Date: 2022-10-28
Locations: The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China

Summary:
The goal of this prospective, randomized controlled study study is to investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP).Ninety female patients undergoing LEEP were randomly allocated to three groups.It aims to answer :1.The effect of esketamine combined with propofol in respiration, circulation, etc,during LEEP. 2.The appropriate dosage of esketamine when combined with propofol in LEEP anesthesia.

Primary Outcome Measures: Respiratory Rate, The respiratory rate (RR) was monitored from 3-lead ECG, Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics|Heart Rate, The heart rate (HR) was monitored using 3-lead ECG, Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics|Mean Arterial Pressure, The mean arterial pressure (MAP) was monitored using Noninvasive blood pressure monitor, Immediately upon entering the operating room, 1 and 5 minutes after injection of anesthetics|Venous Carbon Dioxide, The venous carbon dioxide (PvCO2) was monitored using blood-gas analyzer, Immediately upon entering the operating room and 5 minutes after injection of anesthetics
Secondary Outcome Measures: number of additional propofol usage, The number of additional propofol was recorded, On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes|postoperative awakening time, The postoperative awakening time (MOAA/S score \>4) was recorded, On the day of surgery, from the instant completion of surgery to the moment the patient wakes up (when MOAA score >4),up to 10 minutes|number of jaw thrust maneuver or face mask ventilation, The number of jaw thrust maneuver or face mask ventilation was recorded, On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes|incidences of postoperative vertigo, nausea, agitation and delirium, incidences of postoperative vertigo, nausea, agitation and delirium were recorded, On the day of surgery,from the moment the patient wakes up (when MOAA score >4) to the moment the patient leaving the recovery room,up to 30minutes
The Effect of Multi-Strategy Approaches on Limiting Digital Exposure
NCT Number: NCT06574932
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Wellness 1
Interventions: BEHAVIORAL: Multi-Strategic Approach
Sponsor: Universiti Putra Malaysia
Collaborators: Green International University
Sex: ALL
Age: ADULT
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-27
Completion Date: 2025-05-10

Summary:
In the digital age, university students are increasingly immersed in a technology-driven environment where smartphones, social media, and various digital platforms play a central role in their daily lives. While these technologies offer significant benefits, such as enhanced connectivity, access to information, and educational resources, they also pose potential risks to mental health. Excessive screen time, constant connectivity, and the pressure to maintain an online presence can lead to negative outcomes, including anxiety, depression, sleep disturbances, and reduced academic performance.

Primary Outcome Measures: Generalized anxiety, Generalized anxiety change will be measured by (GAD-7). seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21.Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety., 6-months from baseline
Secondary Outcome Measures: Depression, Depression change will be measured by PHQ-9. PHQ-9 scores can be used to plan and monitor treatment. To score the instrument, tally the numbers of all the checked responses under each heading (not at all=0, several days=1, more than half the days=2, and nearly every day=3). Add the numbers together to total the score on the bottom of the questionnaire. PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms, 6-months from baseline
Physical Exercise on Simple Inflammatory Markers, Systemic Immune Inflammation Index, and Systemic Immune Response Index
NCT Number: NCT06574893
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia|Physical Exercise
Interventions: OTHER: physical exercise
Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-04
Completion Date: 2024-08-31
Locations: Kartal Dr Lütfi Kırdar Şehir Hastanesi, İstanbul, Turkey

Summary:
Mental health is defined as a state of well-being in which a person can realize their talents, cope with the normal stresses of life, and support society by working efficiently and productively. In other words, mental health is a dynamic internal balance that enables individuals to use their diversity of skills in harmony with the universal values of society.

Primary Outcome Measures: sociodemographic characteristics., It will be asked to fill out a structured questionnaire covering their sociodemographic characteristics., 12 weeks|simple inflammatory markers, Index Calculation Based on Complete Blood Count, 12 weeks