pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Skin Wetting in Burn Survivors
NCT Number: NCT06529757
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Burn Injury
Interventions: OTHER: Whole body cooling|OTHER: Non-cooling
Sponsor: University of Texas Southwestern Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-31
Completion Date: 2026-07-31
Locations: Institute for Exercise and Environmental Medicine, Dallas, Texas, 75231, United States

Summary:
This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering \~20% to 40% of their body surface area, and subject having burns \>40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling or whole body skin wetting.

Primary Outcome Measures: Core Temperature, During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise., Prior to and throughout the bout of exercise; an average of 90 minutes.
Secondary Outcome Measures: Mean Skin Temperature, Average skin temperature from six sites., Prior to and throughout the bout of exercise; an average of 90 minutes.|Rate Pressure Product, Obtained from heart rate and systolic blood pressure., Prior to and throughout the bout of exercise; an average of 90 minutes.|Whole body sweat rate, Whole body sweat rate will be measured from pre and post nude body mass measures., Before and after exercise. 2 min per measure.
Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling
NCT Number: NCT06529744
Acronym: CRND TorCA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dementia|Alzheimer Disease|Dementia With Lewy Bodies|Vascular Dementia|Frontotemporal Dementia|Mild Cognitive Impairment|Corticobasal Syndrome|Progressive Supranuclear Palsy|Parkinson Disease|Primary Progressive Aphasia
Sponsor: University Health Network, Toronto
Collaborators: Sunnybrook Health Sciences Centre|Baycrest|Centre for Addiction and Mental Health|Toronto Dementia Research Alliance (TDRA)|University of Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-11
Completion Date: 2027-11
Locations: Baycrest, North York, Ontario, M6A 2E1, Canada|Sunnybrook Health Sciences Centre, Toronto, Ontario, M4N 3M5, Canada|Toronto Western Hospital, University Health Network, Toronto, Ontario, M5T 2S8, Canada|Centre for Addiction and Mental Health, Toronto, Ontario, M6J 1H1, Canada

Summary:
To develop a model to predict disease progression in a large cohort of patients across a variety of neurodegenerative diseases, including Mild Cognitive Impairment (MCI) and dementia due to any neurodegenerative disease, including Alzheimer's Disease (AD), Lewy Body Disease (LBD), Vascular Disease (VaD) and Frontotemporal lobar degeneration (FTLD).

Primary Outcome Measures: Cognitive phenotype, Change in TorCA scores and individual domains, Baseline, 6-month follow-up, 1-year follow-up
Secondary Outcome Measures: Assessment of DNA methylation (DNAm), Examining epigenetic clock related to neurodegenerative onset and compared to chronological age to investigate the link between DNAm and disease progression., Baseline|Neurodegenerative protein levels in biofluids and skin biopsy, Differences in protein levels between neurodegenerative diagnoses and predictive ability for change in TorCA, Baseline, 6-month follow-up, 1-year follow-up|Structural and Functional Differences between neurodegenerative diseases via MRI of the brain, Brain volumes and white matter hyperintensity (WMH) load corresponding to TorCA scores., Baseline
Michigan Split-belt Treadmill Training Program to Improve Acute Knee Biomechanics After ACL Reconstruction
NCT Number: NCT06529679
Acronym: Mi-SPA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ACL|ACL Injury
Interventions: BEHAVIORAL: Split-belt Training|BEHAVIORAL: Tied-Belt Training
Sponsor: University of Michigan
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

Summary:
The goal of this study is to determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in patients with ACL reconstruction.

Our main question for this aim are:

1. Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking?
2. Are training-mediated aftereffects in the knee joint moment different between subjects who train early stance knee loading versus subjects who train mid-stance knee loading?

Primary Outcome Measures: ACL Limb Sagittal Plane Knee Joint Moment, Peak sagittal plane knee moment recorded from the ACL limb during walking gait, Before (10min), during (20min), & after training (10min)
Other Outcome Measures: Non-ACL Limb Sagittal Plane Knee Joint Moment, Peak sagittal plane knee moment recorded from the Non-ACL limb during walking gait, Before (10min), during (20min), & after training (10min)|ACL Limb Vertical Ground Reaction Force, Peak vertical ground recorded from the ACL limb during walking gait, Before (10min), during (20min), & after training (10min)|Non-ACL Limb Vertical Ground Reaction Force, Peak vertical ground recorded from the Non-ACL limb during walking gait, Before (10min), during (20min), & after training (10min)|ACL Limb Internal Knee Joint Reaction Force, Internal knee joint reaction force for the ACL limb estimated using musculoskeletal modeling, Before (10min), during (20min), & after training (10min)|Non-ACL Limb Internal Knee Joint Reaction Force, Internal knee joint reaction force for the Non-ACL limb estimated using musculoskeletal modeling, Before (10min), during (20min), & after training (10min)
Medical Residents Learning Weight Management Counseling Skills
NCT Number: NCT06529666
Acronym: MRWeight
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Weight Management|Patient Counseling|Video Communication Asssessments
Interventions: BEHAVIORAL: Didatic Session 1: Core Foundation Course|BEHAVIORAL: The 3Ps Program|BEHAVIORAL: Didactic session 2|BEHAVIORAL: Email reinforcement|BEHAVIORAL: PowerPoint of the foundational course
Sponsor: University of Massachusetts, Worcester
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Albert Einstein College of Medicine|Penn State University|The Methodist Hospital Research Institute|Boston University|Stanford University|Temple University|University of California, Davis|Stony Brook University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 630
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-06-10
Completion Date: 2027-12-30
Locations: Stanford University, Palo Alto, California, 94304, United States|UC Davis, Sacramento, California, 95820, United States|Boston University, Boston, Massachusetts, 02118, United States|Albert Einstein College of Medicine, Bronx, New York, 10467, United States|Stony Brook, East Setauket, New York, 11733, United States|Penn State University, Hershey, Pennsylvania, 17033, United States|Temple University, Philadelphia, Pennsylvania, 19140, United States|Houston Methodist, Houston, Texas, 77030, United States

Summary:
The goal of this study is to addresses the lack of weight management training physicians receive during their residency training. The main questions it aims to answer are:

* How affective is the MRWeight curriculum at increasing medical residents weight management counseling (WMC) skills.
* Evaluate residents' adoption of WMC skills in encounters with their patients
* what would be the best way to get residents to adopt the WMC skills Residents in the comparison group will receive a course on obesity and weight management. The residents in the intervention group will have to attend 2 informational sessions and will receive 6 email modules on WMC. Both groups will also take part in 3 assessments over the course of 18 months to see which group has better WMC skills.

Primary Outcome Measures: WMC skills VCA (video Communications assessment) assessment, Residents in both arms will be asked to complete the assessment VCA vignettes that will include a series of vignettes representing challenging cases. 4-6 trained raters blinded to the residents' study arm (intervention vs. comparison) will rate the residents' responses., Completed during month 1 and again at month 12 post recruitment.|Change in WMC skills assessment, This measure will be assessed using an online survey at baseline (study start), at 12 months, and 18 months., Completed during months 1, 12 and 18 post recruitment.
Secondary Outcome Measures: Change in adoption scale Scores at eighteen months, This measure will be assessed using an online survey at baseline (study start), at 12 months, and 18 months., Completed during months 1, 12 and 18 post recruitment.
Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla
NCT Number: NCT06529653
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Horizontal Ridge Deficiency
Interventions: PROCEDURE: autogenous bone wedge
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2022-10-30
Completion Date: 2024-12-30
Locations: oral and maxillo facial Surgery Department; Faculty of dentistry, Cairo University., Cairo, Egypt

Summary:
The current study aimed to evaluate both the quality and quantity of gained and maintained bone width after ridge splitting utilizing autogenic bone wedges versus mixed bone particles for horizontal ridge augmentation in the anterior esthetic zone.

Primary Outcome Measures: bone width in (mm) by cone beam pre, immediate post operative and 6 months postoperative, after ridge augmentation in both groups, the bone width will be measured immediately postoperatively and 6 months postoperatively with cone beam and the measurements of the three intervals (pre-, immediate and 6 months postoperatively) will be compared in both groups to evaluate the amount of gained and maintained bone width, 6 months
Secondary Outcome Measures: percentage of areas of new bone (%), The harvested core biopsies would be stained with H\&E and Massons trichrome stain and be microscopically examined to determine percentage areas of newly formed bone, 6 months
Periosteal Pedicle Flap Versus Subepithelial Connective Tissue Graft in Management of Gingival Recession
NCT Number: NCT06529640
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingival Recession
Interventions: PROCEDURE: SCTG followed by coronally postionting flap|PROCEDURE: periosteal flap followed by coronally postionting flap
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2024-11-01

Summary:
Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.

Primary Outcome Measures: the percentage of root coverage (%RC), to measure the coverage percentage of root recession by UNC periodontal probe Preoperative recession depth - Postoperative recession depth /Preoperative recession depth x 100, at base line, 1 month and 3 months after treatment
Secondary Outcome Measures: recession depth, to measure vertical recession by UNC periodontal probe from cemento-enamel junction (CEJ) to the gingival margin., at base line, 1 month and 3 months after treatment|recession width, to measure horizontal recession by UNC periodontal probe the distance between the CEJ and the gingival margin, at base line, 1 month and 3 months after treatment|clinical attachment gain, to measure the periodontal attachment gain after treatment by UNC periodontal probe subtracting the sulcus depth from the distance between the free gingival margin and the mucogingival junction., at base line, 1 month and 3 months after treatment|keratinized tissue gain, measure the gain in keratinized gingivaby UNC periodontal probe from the most apical point of the gingival margin to the mucogingival junction (MGJ) at the middle buccal point., at base line, 1 month and 3 months after treatment
GDF-8 Levels in ICSI Cycles
NCT Number: NCT06529627
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility
Interventions: PROCEDURE: Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection
Sponsor: University of Alexandria
Sex: FEMALE
Age: ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-01-31
Locations: Shatby maternity university hospital, Alexandria, 03312, Egypt

Summary:
The aim of this study is to investigate the role of GDF-8 in regulating progesterone levels during controlled ovarian stimulation in patients undergoing ICSI-ET and to evaluate its effects on pregnancy rates.

The main questions are

* Does serum GDF-8 correlate with serum Progesterone levels during ovarian stimulation?
* Does serum GDF-8 serum level at different time-points during ovarian stimulation correlate with pregnancy rate?

participants will undergo ICSI-ET cycle using the long GnRH-agonist protocol and serum levels of GDF-8 and progesterone will be measured at three time-points during the trial: on day of hCG trigger administration, on day of oocyte pickup, and 14 days after embryo transfer

Primary Outcome Measures: Clinical pregnancy, visualization of intra-uterine gestational sac with a pulsating fetal pole within 5 weeks of embryo transfer, 5 weeks after embryo transfer|Serum Growth Differentiation Factor - 8 (GDF-8), serum levels of GDF-8, three time-points: on day of trigger, on day of OPU, and 14 days after ET
An In-situ Detection for MicroRNA
NCT Number: NCT06529614
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: OTHER: In-situ detection for Micro-RNA
Sponsor: Tongji Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2025-04
Locations: Tongji Hospital, Wuhan, Hubei, 430030, China

Summary:
We designed a new in-site detection method for MicroRNA in the serum of patients with breast cancer.

Primary Outcome Measures: Sensitivity and specificity of test, 8 months
Estimation of (suPAR) in Chronic Periodontitis With Post-radiotherapy on HNCs Patients
NCT Number: NCT06529588
Acronym: HNCs
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Head and Neck Cancer|Chronic Periodontitis|Radiotherapy Side Effect
Interventions: RADIATION: Radiation
Sponsor: Al-Maarif University College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2023-10-23
Locations: Ahmed A. Al-Kubaisi, Ramadi, Anbar, 31001, Iraq

Summary:
This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).

Primary Outcome Measures: Measure of serum suPAR level, Measure of serum suPAR level in patients head and neck cancer who received radiotherapy, 6 months|Clinical Periodontal parameters measured, Periodontal parameters included (CAL, PI, GBI, PPD) measured by using a millimeter periodontal probe in patients with head and neck cancer who received radiotherapy., 6 months
Secondary Outcome Measures: Oral pH-saliva was measured, Oral pH-saliva collected from outcomes and measured pH-saliva by using pH-meter in patients who underwent radiotherapy., 6 month
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
NCT Number: NCT06529575
Acronym: PACH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pediatric ALL|Cardiac Defect
Sponsor: University of Pennsylvania
Collaborators: Children's Hospital of Philadelphia|Baylor College of Medicine|Columbia University|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 650
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-14
Completion Date: 2028-12
Locations: Columbia University Medical Center, New York, New York, 10032, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Texas Children's Hospital, Houston, Texas, 77030, United States

Summary:
This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings. Many factors can affect how well pulse oximeters work; for example, movement and even fingernail polish. Some studies in adults show that skin color may also affect the pulse oximeter reading. In this study, we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations. The study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the "gold standard" blood sample measurement.

Primary Outcome Measures: Pulse Oximeter Bias, Pulse oximeter bias is the difference between the pulse oximeter value (estimated % oxygen saturation measured via pulse oximeter) and the gold standard measure of arterial oxygen saturation (% oxygen saturation in blood sample measured via co-oximeter)., The variables used to calculate Pulse Oximeter Bias are collected once during the cardiac catheterization procedure. This is a cross-sectional observational study; participants are not followed longitudinally.
Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment
NCT Number: NCT06529549
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: OTHER: Organoid-Based Drug Sensitivity Screening
Sponsor: Sun Yat-sen University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-24
Completion Date: 2027-12-31
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This observational study aims to learn about the effects and safety of organoid-based drug sensitivity screening in mCRPC patients with bone metastases that progressed after first-line treatment. The main question it seeks to answer is:

Do doctors choose treatment agents based on organoid-based drug sensitivity screening results for mCRPC patients, resulting in a better response?

Participants already took bone metastasis biopsies for genetic testing based on current clinical guidelines. This study only takes residual tissue from biopsies for organoid culture.

Primary Outcome Measures: Prostate Specific Antigen (PSA) Response Rate, Proportion of patients with a 50% decrease in PSA from baseline, From enrollment to primary completion of study (up to approximately 3 years)
Secondary Outcome Measures: Radiologic Progression-free Survival (rPFS), Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first., 3 years|Objective Response Rate (ORR), Proportion of patients in complete remission (CR) plus partial remission (PR), From enrollment to primary completion of study (up to approximately 3 years)|Duration of Response (DOR), Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause., From enrollment to primary completion of study (up to approximately 3 years)|Overall Survival (OS), Time between the start of treatment and death from any cause, From enrollment to primary completion of study (up to approximately 3 years)
Tislelizumab in People With Colorectal Cancer
NCT Number: NCT06529523
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Colorectal Cancer
Interventions: DRUG: Tislelizumab
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: BeiGene USA, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2028-07
Locations: Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria|Obafemi Awolowo University Teaching Hospital, Ile-Ife, Nigeria

Summary:
The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug.

All participants in this study will be treatment naïve (they have not yet received treatment for their cancer), and their cancer will be mismatch repair deficient (dMMR). dMMR cancer can happen when your cells are unable to repair mistakes made during the cell division process.

Primary Outcome Measures: objective response rate of PD-1 blockade with tislelizumab, (ORR, defined as CR or PR) as measured by RECIST 1.1 in patients with mismatch repair deficient metastatic colorectal adenocarcinoma (cohort 1) and in patients with mismatch repair deficient localized (stage II/III) rectal adenocarcinoma (cohort 2)., 2 years
REThinkWELL- the Use of Therapeutic Game to Reduce Mental Health Symptoms in Children and Adolescents
NCT Number: NCT06529510
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotional Problem|Mental Health Issue
Interventions: BEHAVIORAL: REThink therpeutic game
Sponsor: Babes-Bolyai University
Collaborators: The Executive Agency for Higher Education, Research, Development and Innovation Funding
Sex: ALL
Age: CHILD
Enrollment: 279
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-20
Completion Date: 2022-08-30
Locations: Babes-Bolyai University, Cluj-Napoca, Romania

Summary:
To test the effect of a game-based intervention in reducing clinical and subclinical symptoms of children and adolescents.

Primary Outcome Measures: Mental health, Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties., baseline assessment, one week prior to the intervention|Changes in mental health, Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties., post-test assessment, one week after the intervention|Irrationality, The Child and Adolescent Scale of Irrationality (CASI, Bernard \& Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement"). The minimum score is 28 and the maximum score is 140. Higher scores represent higher levels of irrationality., baseline assessment, one week prior to the intervention|Changes in irrationality, The Child and Adolescent Scale of Irrationality (CASI, Bernard \& Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement"). Higher scores represent higher levels of irrationality., post-test assessment, one week after the intervention
Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children
NCT Number: NCT06529497
Acronym: ERADICATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Diarrhoea
Interventions: DRUG: Racecadotril
Sponsor: Liaquat National Hospital & Medical College
Sex: ALL
Age: CHILD
Enrollment: 260
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2024-12-02

Summary:
Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.

Primary Outcome Measures: Stool frequency, Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups, 48 hours
Secondary Outcome Measures: Hospital Duration, Total duration of hospital stay taken in hours, 48 Hours
Foot Bath Effects on Chemotherapy-Induced Fatigue in Pediatric Oncology
NCT Number: NCT06529484
Acronym: FBECIFPO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries
Interventions: OTHER: Warm Water Foot Bath Intervention
Sponsor: Koç University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2025-08-30

Summary:
This study aims to evaluate the effects of foot baths on chemotherapy-induced fatigue in pediatric oncology patients. Current literature lacks studies assessing this intervention in the pediatric population. Chemotherapy, a common cancer treatment, often results in side effects such as nausea, vomiting, constipation, diarrhea, taste changes, mouth ulcers, and notably, fatigue. Fatigue affects 51-86% of pediatric cancer patients and significantly impacts their quality of life. Addressing fatigue comprehensively is crucial for improving patients' quality of life. Non-pharmacological methods like foot baths have shown promise in reducing chemotherapy-related fatigue. Previous studies with gynecological cancer patients and others have found that warm water foot baths can alleviate fatigue and improve relaxation by reducing sympathetic activity and facilitating oxygen and nutrient delivery to the brain. This randomized controlled trial is designed to scientifically evaluate the efficacy of foot baths in alleviating fatigue in pediatric patients post-chemotherapy.

Primary Outcome Measures: Parental Fatigue Scale Points, Fatigue levels will be assessed using the Visual Fatigue Scale provided by the Oncology Nursing Society, measured daily over a period of 7 days. The final assessment will be conducted on the 7th day using the 12-Item Pediatric Oncology Fatigue Scale and the Parental Fatigue Scale for 7-12 Year Old Pediatric Oncology Patients., measured daily over a period of 7 days.
Effect of Massage After CABG on Pain, Sleep Quality and Serum Cortisol Level
NCT Number: NCT06529471
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Care|Massage|Pain|Cortisol
Interventions: OTHER: Massage group
Sponsor: Kocaeli University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2024-07-24
Locations: Kocaeli University, Kocaeli, Türkiye, 41380, Turkey

Summary:
The patient in the surgical treatment and care process has difficulty in meeting the need for sleep in the hospital, and accordingly, their habits, attitudes and behaviors regarding sleep and rest change (Yılmaz et al. 2008). Studies have shown that hospitalized patients experience sleep deprivation (Aksu and Erdoğan 2017). The decrease in sleep duration and quality is an important component affecting recovery after surgery. Studies have reported that massage reduces physical and emotional stress and increases sleep quality, while back massage reduces pain, anxiety and sleep disorders (Dreyer et al. 2015; Boitor et al. 2017; Ünal and Akpınar 2016).

It has been reported that back massage reduces cortisol levels and blood pressure, slows heart rate and improves sleep quality (Pınar and Afşar 2015). This study was planned as a case-control study to evaluate the effect of massage therapy applied after open cardiovascular surgery on patients' pain, sleep quality and serum cortisol levels. It is thought that the study will create literature information on the sleep quality, pain and serum cortisol levels of patients after open heart surgery.

Primary Outcome Measures: Primary Outcome Measure, Richard-Campbell Sleep Scale: RCSQ is a 6-item scale that evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart from 0 to 100 using the visual analog scale technique. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases., Before the recruit pre-test (RCSQ- survey scale) will be applied. A post-test (RCSQ survey scale) will be administered again two days after the intervention.]
Secondary Outcome Measures: Secondary Outcome Measure, Serum Cortisol Level Analysis: Blood samples will be placed in tubes containing separator gel (SST-yellow tube) and serum cortisol levels will be analyzed in the relevant laboratory., Before the recruit pre-test (serum cortisol-blood test) will be applied. A post-test (serum cortisol-blood test) will be administered two days after the intervention.]
Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects
NCT Number: NCT06529445
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Interventions: DRUG: High Dose VC004 Capsules|DRUG: Median Dose VC004 Capsules|DRUG: Low Dose VC004 Capsules
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-08-26
Locations: Zhongda Hospital,Affiliated to Southeast University, Nanjing, Jiangsu, 210009, China

Summary:
This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate Food effect and Relative bioavailability of VC004 Capsules in healthy subjects

Primary Outcome Measures: Maximum Observed Plasma Concentration (Cmax), Day1-Day7|Peak time(Tmax), Day1-Day7|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）, Day1-Day7
A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery
NCT Number: NCT06529432
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Local Analgesia Via Nerve Block
Interventions: DRUG: Bupivacaine Liposome Injection|DRUG: Bupivacaine Hydrochloride Injection
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2026-10-12
Locations: Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, 200032, China

Summary:
The objective of this study is to evaluate the efficacy, safety, and tolerability of bupivacaine liposomes for paravertebral nerve block in the treatment of thoracoscopic postoperative pain, and to evaluate the relevant human pharmacokinetics.

Primary Outcome Measures: Area under the time curve of pain intensity during exercise (or cough) for 72 hours after administration, 0 minute to 72 hours after administration
Secondary Outcome Measures: Area under the curve of pain intensity and time in exercise (or cough) state in 0-12h, 12-24h, 12-48h and 12-72h after administration, 0 minute to 72 hours after administration|Area under the curve of pain intensity and time in resting state in 0-12h, 12-24h, 12-48h, 12-72h and 0-72h after administration, 0 minute to 72 hours after administration|Pain intensity scores in resting state and exercise (or cough) state, including within 30 minutes after anesthesia recovery and various time points after administration (6h, 8h, 12h, 18h, 24h, 30h, 36h, 48h, 72h), recovery from anesthesia to 72 hours after administration|The duration of the first pain intensity score ≥4 points during exercise (or cough) after anesthesia recovery, 0 minute to 72 hours after administration|The duration of the first pain intensity score ≥4 points at rest after anesthesia recovery, 0 minute to 72 hours after administration|Maximum pain intensity score during exercise (or cough) within 72 hours after administration, 0 minute to 72 hours after administration|Percentage of painless (pain intensity score ≤1 at rest) subjects at planned time points, 0 minute to 72 hours after administration|Proportion of subjects who did not use remedial analgesia in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h, 0 minute to 72 hours after administration|Cumulative use of remedial analgesics in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h, 0 minute to 72 hours after administration|Time of first use of remedial analgesics, The first time additional analgesic medication is required due to insufficient analgesic efficacy., The time of the first pain intensity rating to 72 hours after administration|Subjects' analgesic satisfaction scores, 72 hours after administration|Investigators' analgesic satisfaction scores, 72 hours after administration
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
NCT Number: NCT06529406
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Relapsing Multiple Sclerosis
Interventions: DRUG: Ozanimod
Sponsor: University of Colorado, Denver
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2029-08-01
Locations: Cleveland Clinic, Las Vegas, Nevada, 89106, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States

Summary:
A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.

Primary Outcome Measures: New T2 lesions count, Number of new T2 lesions on MRI scans., 36 months|Serious infections, Infections requiring hospitalization, intravenous antibiotic use, or prolonged antibiotic use for treatment of an infection for at least 30 days., 36 months
Secondary Outcome Measures: Relapses, Protocol and/or suspected relapses, 36 months|IgG and IgM levels, IgG and IgM levels, 36 months|Infections, All infections including opportunistic infections., 36 months|No Evidence of Disease Activity (NEDA-3), Not meeting any of the following criteria:

1. Evidence of Relapse activity - collected every 3 months via phone calls/clinic visits.
2. MRI disease activity - presence of new T2 lesions from MRI scans conducted at any timepoint.
3. 6 months Confirmed Disability progression (CDP6): measured by the EDSS assessed at baseline and every 6 months. CDP6 is defined as an increase in Expanded Disability Status Scale (EDSS) score of ≥1.5 if baseline EDSS was 0; or ≥1.0 points if baseline EDSS was ≥0.5-≤5.5; or by ≥0.5 points if baseline EDSS ≥6, sustained over two consecutive visits., 36 months|Neurofilament light (NfL) and Glial Fibrillary Acid Protien (GFAP), Neurofilament light (NfL) and Glial Fibrillary Acid Protien (GFAP), 36 months|Brain parenchymal and thalamic volume loss, Brain parenchymal and thalamic volume loss, 36 months|Adverse Events, Adverse Events, 36 months
Other Outcome Measures: Symbol Digital Modalities Test, A 4 points or 10% change in cognition, 36 months|9-hole peg test, A 20% change in hand function, 36 months|25-foot walk speed, A 20% change in walking speed, 36 months|Multiple Sclerosis Functional Composite (MSFC), A change in any of the above three criteria, 36 months|PRO outcomes, Include treatment satisfaction (TSQM), MS fatigue scale (Modified Fatigue Impact Scale \[MFIS\]), or quality of life (MSIS-29). A minimum of 5% change., 36 months|Changes in employment, Changes in employment and full employment status., 36 months.
The Analgesic Effect of (SHAC) Block Versus Suprascapular Nerve Block in Arthroscopic Shoulder Surgeries
NCT Number: NCT06529393
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Pain|Postoperative Pain
Interventions: PROCEDURE: SHAC block|PROCEDURE: suprascapular nerve block
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-12
Locations: New Trauma Hospital, Assiut, Egypt

Summary:
The aim of the study is to compare the post-operative analgesic effect of Shoulder anterior capsule (SHAC) block with Suprascapular nerve block for arthroscopic shoulder surgery with a hypothesis that both Shoulder anterior capsule (SHAC) block and Suprascapular nerve block are effective in providing postoperative analgesia for arthroscopic shoulder surgery.

Primary Outcome Measures: effect on postopeartive pain after shoulder arthrscopy, the pain intensity assessment at rest and on coughing using Numerical Rating Scale (NRS) This will measure pain intensity from 0 to 10 , 0: no pain 3:mild pain 7:moderate pain 10:severe pain, baseline
Secondary Outcome Measures: -inceidence of (POVN) 24 hours postoperatively -Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure), patients complaint from occurrence of nausea and vomiting, first 24 hours|-Time of the first opioid request, time of the first opioid request , concentration and occurrence of complications (hypotension,bradycardia,itching,urinary retention.) all over 24 hours postoperatively, first 24 hour|-Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure), occurrence of any complications from technical errors, first 24 hours
Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children
NCT Number: NCT06529367
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Home Vision|Office-Based Snellen Visual Acuity|Myopic Children
Interventions: OTHER: Snellen chart
Sponsor: South Valley University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-31
Completion Date: 2025-02-01
Locations: South Valley University, Qinā, 83523, Egypt

Summary:
This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.

Primary Outcome Measures: Agreement of visual acuity between office and home, Agreement of visual acuity between office and home will be assessed., immediately after test performing
Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders
NCT Number: NCT06529341
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety Disorders|High-definition Transcranial Direct Current Stimulation
Interventions: OTHER: High-definition transcranial direct current stimulation|OTHER: High-definition transcranial direct current stimulation pseudo-stimulation control group
Sponsor: Nanjing Medical University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-12-30
Locations: Nanjing Brain Hospital, Nanjing, Jiangsu, 210024, China

Summary:
1. Current research has found that tDCS has a positive effect on improving the negative attention bias of AD patients, and this study uses HD-tDCS intervention to improve the cognitive function and neural mechanisms of AD patients in the OFC to provide a theoretical basis for AD neural mechanism research. Verify Hypothesis 1: HD-tDCS cathodal stimulation of the left OFC reduces the excitability of this region, modulates its connectivity with the attentional function network, and thus changes the emotional experience of social threat.
2. Currently, there is no consensus on the stimulation parameters for tDCS in the treatment of AD, and more evidence is needed to prove and explore. It is hoped that the HD-tDCS intervention protocol will become an effective treatment method for improving cognitive function and clinical symptoms in AD patients. Hypothesis 2: The HD-tDCS with intensified stimulation parameters (2mA, twice a day, with a 20-minute interval, for 5 consecutive days) has an impact on the main and secondary clinical variables of AD patients.

Primary Outcome Measures: Hamilton Anxiety Scale, HAMA was assessed at baseline and late 5 days after treatment by a professionally trained physician (non-trial intervention) to understand the effectiveness of treatment. Clinical efficacy evaluation criteria: 75% was recovered, 50% was significant, 25% was effective, and \<25% was invalid., 1 week
Trunk Stabilization vs. Core Stability Exercises: Impact on Balance and Walking Ability in Cerebral Palsy.
NCT Number: NCT06529328
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: core stability
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-12-20
Locations: Riphah International university, Lahore, Punjab, 54000, Pakistan

Summary:
Brain lesions cause cerebral palsy, a chronic condition that affects movement, posture, and balance. Its causes range in age from pregnancy to postpartum, and they can impact the neurological, musculoskeletal, and sensory systems. This causes problems with balance, movement, and posture. It is essential to intervene early for improved life quality. Maintaining a constant center of gravity within your support base is referred to as balance. Walking is putting one foot on the ground at all times and lifting and lowering each foot in turn. The stability of the trunk and core is necessary for muscle coordination and deliberate motions. A study compares the efficiency of trunk stabilization and core exercises to enhance balance and evaluates mobility changes, such as altered muscle strength, endurance, and gait, as a result of two treatment approaches.

Primary Outcome Measures: Pediatric Reach Test (Pediatric Functional Reach Test), Functional Reach will be measured, 8weeks|Manual Ability Classification System, ability of children with cerebral palsy to handle objects with the help of their hands., 8weeks
Effects of Point-of-Care Ultrasound in Multidisciplinary Medical Wards
NCT Number: NCT06529315
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Point-of-care Ultrasound
Interventions: OTHER: Point-of-Care Ultrasound
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2025-07

Summary:
Point-of-care ultrasound (POCUS) is a bedside portable ultrasound technique utilized by healthcare providers to offer rapid and non-invasive diagnostic imaging. POCUS has proven particularly effective in critical care and emergency settings. However, its application in general medical wards, where patients often present with multiple comorbidities, remains under-researched. Additionally, the feasibility of nurse practitioners (NPs) performing POCUS is promising. Despite limited research on POCUS by less experienced operators, NP-conducted POCUS could provide timely, high-quality care, especially in situations with limited physician availability. The routine use of POCUS in patient admissions to medical wards may improve diagnostic accuracy, reduce diagnostic resource utilization, and shorten hospital stays.

Primary Outcome Measures: Proportion of accurate diagnosis, The proportion of accurate physician diagnosis achieved at 48 hours after admission to medical wards, At 48 hours after admission to medical wards
Secondary Outcome Measures: Hospital mortality, Rate of hospital mortality of the participants, Until death, hospital discharge or up to 28 days|Rate of ICU transfer, Rate of participants requiring ICU care, Within 7 days after admission to medical wards|Length of hospital stay, The length of hospital stay of the participants, Until death, hospital discharge or up to 28 days|Categories and numbers of invasive procedures, Categories and numbers of invasive procedures required by the participants, Within 7 days after admission to medical wards|Categories and numbers of imaging studies, The requests for additional categories and numbers of imaging studies for the participants, Within 7 days after admission to medical wards