pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Development and Validation of an Automated Self-administered Visual Acuity System
NCT Number: NCT06540001
Acronym: AutoVA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Visual Impairment
Interventions: DEVICE: Automated visual acuity
Sponsor: Tan Tock Seng Hospital
Collaborators: Singapore Institute of Technology|Nanyang Technological University|Lee Kong Chian School of Medicine, Nanyang Technological University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08-01
Completion Date: 2025-08-01

Summary:
Visual acuity tests, commonly conducted in clinics and used for health screenings, are becoming more in demand due to an aging population. Current online self-eye check apps are limited as they don\&#39;t accurately reflect true distance vision assessed in clinical settings. These tests, performed by trained personnel, are time-consuming and can cause delays in clinics. This project aims to develop an automated Visual Acuity (VA) station using AI technologies like speech-to-text and computer vision, hypothesizing that it can match the accuracy of manual assessments by clinic staff, thus potentially reducing waiting times and improving efficiency.

Primary Outcome Measures: Best corrected visual acuity with and without pinhole using Snellen letters and numbers, Best corrected visual acuity will be expressed in metres (e.g. 6/6-1), and will be converted to LogMAR for analysis., 1 year
Effectiveness of Evening Primrose Oil for Induction of Labor
NCT Number: NCT06539975
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Induction of Labor
Interventions: DRUG: Evening Primrose Oil 1000 MG
Sponsor: Assiut University
Sex: FEMALE
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12-10
Completion Date: 2025-10-12

Summary:
Effectivness of primrose oil in induction of labour .

Primary Outcome Measures: The interval between induction of labor and delivery, comparing between the interval between induction of labor and delivery in two groups one is using evening primrose oil + misoprostol and the other using misoprostol only., induction of labor may take more than 24 hours
Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease
NCT Number: NCT06539962
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Interstitial Lung Disease|Cardiovascular Morbidity
Interventions: DIAGNOSTIC_TEST: Krebs von den Lungen-6 (KL-6)
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-10-01
Locations: Faculty of Medicine, Assiut University, Assiut, 711111, Egypt

Summary:
A group of Interstitial pulmonary fibrosis will be recruited from Assiut university hospital outpatient clinic.

Evaluation will be done regarding cardiovascular comorbidities (Cardiovascular comorbidities will be evaluated with thorough assessment including; history, ECG, Lipid profile and echocardiography).

Lipid profile, CRP and KL-6 level will be assessed for recruited personnel. Regression analysis will be used to identify risk factors for cardiovascular comorbidities among IPF patients.

Primary Outcome Measures: percentage of patients with IPF who develop cardiovascular comorbidities, Prevalence, clinical pattern of cardiovascular comorbidities among Interstitial pulmonary fibrosis cases, 6 months
Secondary Outcome Measures: accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases, accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases, 6 months
Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes
NCT Number: NCT06539923
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes|Sarcopenia
Interventions: OTHER: retrieving data
Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 839
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-08-01
Locations: SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital, Istanbul, Turkey

Summary:
Sarcopenia, characterized by a progressive loss of skeletal muscle mass and function, is particularly common in individuals with T2DM and is often associated with insulin resistance, chronic inflammation and oxidative stress. The Sarcopenia Index (SI), calculated as serum creatinine divided by serum cystatin C, is a practical tool for assessing sarcopenia and is used in many clinical settings. In this study, we aimed to investigate the relationship between sarcopenic index and variables such as age, diabetes duration, diabetes control and complication-related parameters such as NT-proBNP and Fib4 score in patients with type 2 diabetes.

Primary Outcome Measures: Age, relationship between sarcopenic index and age, baseline|diabetes duration, relationship between sarcopenic index and diabetes duration, baseline|Glycemic control, relationship between sarcopenic index and glycemic control using HbA1c levels, baseline|NT-proBNP, relationship between sarcopenic index and NT-proBNP (NT terminal pro-brain natriuretic peptide-use for assessing heart failure) levels, baseline|FIB4 score, relationship between sarcopenic index and Fib4 score ( reflecting hepatic fibrosis risk), baseline
Modified TIPS Block for Total Knee Arthroplasty
NCT Number: NCT06539910
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Knee Arthropathy|Anesthesia, Local
Interventions: PROCEDURE: General Anesthesia|PROCEDURE: TIPS block|PROCEDURE: Modified TIPS block|PROCEDURE: Mutimodal analgesia
Sponsor: Alexandria University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03
Locations: Alexandria Faculty of Medicine, Alexandria, 21651, Egypt

Summary:
The is carried out to compare triple injection peri-sartorial block to a modified block including an extra local anesthetic injection deep to the adductor longs muscle via a medial to lateral approach regarding the peri-operative analgesia following total knee arthroplasty (TKA)

Primary Outcome Measures: Postoperative opioid rescue analgesic requirements, Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes. Total postoperative morphine consumption will be measured, 24 hours
Secondary Outcome Measures: The time to the 1st demand dose of rescue analgesia, The time to the 1st demand dose of rescue analgesia will be recorded, 24 hours|Resting and dynamic VAS assessment, Resting and dynamic VAS assessment will be carried out every 4 hours, 24 hours|Timed Up and Go (TUG) test, Timed Up and Go (TUG) test, 24 hours|30-second Chair Stand Test (30s-CST), 30-second Chair Stand Test (30s-CST), 24 hours
Does the Phoenix Pediatric Sepsis Prognosis Prediction Scale Work
NCT Number: NCT06539884
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Phoenix Score, International 2005 SIRS Criterias and PRISM III, PELOD Scoring
Interventions: OTHER: Observational
Sponsor: Oguz Dursun
Sex: ALL
Age: CHILD, ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-12-15
Locations: Akdeniz University, Konyaaltı, Antalya, 07100, Turkey|Akdeniz University, Konyaaltı, Antalya, 07100, Turkey|Akdeniz University, Antalya, Turkey

Summary:
The aim of this study to understand the compatibility of Phoenix Score, International 2005 SIRS criterias and PRISM III, PELOD scoring systems. Defining pediatric sepsis in our research, epidemiology, scoring systems and prognosis. In addition, we will evaluate the advantages and disadvantages of the Phoenix criteria and assess the compatibility in pediatric sepsis scoring systems. The subject of our research is the use of the Phoenix criteria for pediatric sepsis. The aim of this study was to evaluate whether the 2005 SIRS - Sepsis diagnostic and grading criteria, pSOFA, PRISM III and PELOD scores are compatible and to compare their prognostic predictive power. The study is a 1-year prospective observational study. Patients will not undergo any interventional procedure or blood tests due to this study. No intervention will be made in the treatment protocol.

In this study, Akdeniz University medical patients admitted to the Faculty of Pediatric Emergency Department with clinical sepsis suspicion will be included in the study. In 2024 it was aimed to evaluate whether the Phoenix criteria, which are recommended to be used to evaluate the prognosis of sepsis in pediatric patients, are compatible with the 2005 SIRS sepsis diagnosis and grading criteria, pSOFA, PRISM III and PELOD scores, which were widely used for this purpose in previous years and described in detail in the introduction section, and to compare their predictive power in terms of morbidity and mortality.

Primary Outcome Measures: Newly proposed Phoenix score comparing with previous scores, : The results of the study will improve the epidemiology of sepsis, prognosis the newly proposed Phoenix score compared with previous scores in the assessment of the Phoenix score will provide It will provide a basis for further prospective studies., 1.5 year
The Role of Ultrasonography in the Diagnosis of Double Crush Syndrome
NCT Number: NCT06539871
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Double Crush Syndrome|Earthquake|Peripheral Nerve Injuries
Sponsor: Marmara University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2024-09
Locations: Marmara University Pendik Training and Research Hospital, Istanbul, Pendik, 34899, Turkey

Summary:
The Role of Ultrasonography in Detecting Additional Peripheral Nerve Injuries Overshadowed by Clinical and Electrodiagnostic Data in Patients with Peripheral Nerve Injury After the February 6, 2023 Earthquake

Primary Outcome Measures: Ultrasonographic measurements, For patients with nerve damage in the upper extremities, ultrasonographic examination of the median, ulnar and radial nerves from both upper extremities was performed. Median, ulnar and radial nerves were examined from the wrist level to the axilla. Diameter measurements were made from various points and recorded.

For patients with nerve damage in the lower extremity, ultrasonographic examination of the sciatic, peroneal and tibial nerves was performed. Sciatic, peroneal and tibial nerves were examined from the ankle level to the gluteal fold level. Diameter measurements were made from various points and recorded., Ultrasonography examination was performed in 4 patients at the end of the 1st month after the earthquake, in 6 patients at the 3rd month, and in 5 patients at the 6th month.|Electroneuromyographic data, All patients were examined electrophysiologically. Relevant data and electrophysiological diagnoses were recorded., ENMG examination was performed in 4 patients at the end of the 1st month after the earthquake, in 6 patients at the 3rd month, and in 5 patients at the 6th month.
Other Outcome Measures: Information obtained from the patient, Demographic data of all patients, the cities where they were affected by the earthquake, the duration of their stay under the rubble, comorbidities, and the treatments (medical or surgical) they received after the earthquake were recorded., This information was obtained at the time of initial presentation in all patients.
Investigation of the Effect of Massage Application on Functional Status and Depression in Postpartum Mothers
NCT Number: NCT06539858
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Depression, Post-Partum|Massage|Functional Status
Interventions: OTHER: massage
Sponsor: University of Yalova
Sex: FEMALE
Age: ADULT
Enrollment: 28
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-10
Completion Date: 2024-12-30
Locations: University of Yalova, Yalova, Turkey

Summary:
Postpartum depression is a condition with high morbidity in mothers and negatively affects all family relationships. It has been observed that depression in the mother at only 2 months of age negatively affects the relationship between the baby and the mother, and that mothers who are depressed and therefore their babies feel more negatively. Symptoms usually start to appear from the 2nd or 3rd week after birth. At the same time, most people focus on the physical characteristics of the mother after birth, such as her reproductive system, while ignoring her full functionality. Full functionality is a multidimensional concept that includes personal care, baby care, family care, social and professional activities. In the first weeks after discharge, the functional status of the mother may differ as a result of the roles she assumes at home. Since the breastfeeding period will begin in new mothers, different treatment methods are preferred instead of drug treatment, one of which is massage therapy. It is thought that massage therapy relaxes the muscles and changes psychological factors. Previous studies conducted on postpartum women show that massage has a positive and healing effect on mothers. While previous studies frequently mention its effects on depression, it has also been observed that there are few studies mentioning its functional status. In light of this information, the aim of this study is to investigate the effects of massage on functional status and depression in postpartum women. For this purpose, there will be 2 groups randomized as intervention and control groups. The intervention will be performed as a 45-minute massage once a week for 4 weeks. Data will be collected before the first intervention and after the last intervention.

Primary Outcome Measures: depression, will be evaluated with the internationally accepted Edinburgh Postpartum Depression Scale., 4 weeks|functionality, The change in functionality will be evaluated using the postpartum functional status inventory., 4 weeks
Intestinal Flora and Immunity in Monoclonal Gammopathy Patients
NCT Number: NCT06539832
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma|MGUS|Gut Microbiota|Infections|M-Protein
Sponsor: Zhujiang Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2026-12-30
Locations: Zhujiang Hospital of Southern Medical University, Guanzhou, Guangdong, 510280, China

Summary:
This study aims to investigate the characteristics of the gut microbiota and immune function status in patients with monoclonal gammopathy complicated by infection, and to analyze the correlation between the two.200 patients diagnosed with monoclonal gammopathy by MALDI-TOF MS were included, of which 100 had concurrent infections and 100 did not. An additional 100 healthy controls, matched for age and gender, were also enrolled.By comparing the composition of the gut microbiota and immune function markers (such as peripheral blood immune cell profiles and cytokine levels) between the patient groups and the control group, the study will evaluate the dysbiosis of the gut microbiota and abnormal immune status in patients with monoclonal gammopathy complicated by infection. The aim is to explore the correlation between the gut microbiome alterations and immune dysfunction, in order to provide a basis for further investigation of the underlying mechanisms.

Primary Outcome Measures: M-protein detection, Plasma samples from all patients will be screened and qualitatively analysed for M proteins using MALDI-TOF MS to determine the presence of patients with monoclonal gammaglobulinemia., 24 months|microbiome, To assess the value of the microbiome in predicting the prognosis of patients with monoclonal gammopathy and in diagnosing co-morbidities. To analyse the microbial composition of patient stool samples using 16S rRNA gene sequencing and metagenomics., 24 months|immunological function, To assess the number and function of peripheral blood immune cells (T-cells, B-cells, NK-cells, etc.) in patients with monoclonal gammaglobulinaemia. To further investigate the potential therapeutic value of intestinal microecological modulation in improving the immune status of MGUS patients., 24 months|metabonomics, To assess changes in plasma metabolomics in patients with monoclonal gammaglobulinaemia. Metabolomics is a large-scale study of small molecules such as fatty acids, bile acids, and lipid mediators., 24 months
Clinical Study Evaluating the Effect of Losartan
NCT Number: NCT06539806
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Cancer
Interventions: DRUG: Losartan 50mg Tab
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2026-08-20
Locations: Tanta University Hospital, Tanta, Egypt

Summary:
The pancreas is two organs packaged into one. The islets of Langerhans serve critical endocrine functions, and the exocrine portion is a major source of enzymes that are essential for digestion.

Pancreatic cancer (PC) is more commonly referred to as pancreatic infiltrating ductal adenocarcinoma in addition to being the second leading cause of cancer death in the United States, after lung cancer in 2020.

Whereas pancreatic cancer is the seventh cause of death from cancer in Asia in 2020. Although it is substantially less common than the other malignancies, pancreatic carcinoma is near the top of the list of killers because it is a highly aggressive carry.

Primary Outcome Measures: the patient response rate, the patient response rate which will be measured using response evaluation criteria in solid tumors (RECIT 1.1)., one year
Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
NCT Number: NCT06539793
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia Syndrome
Interventions: OTHER: Aerobic Exercises|OTHER: Transcutaneous electrical nerve stimulation
Sponsor: Ahmed Alshimy
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-07-03
Locations: Al Ryada University for Science and Technology, Sadat, Menoufia, Egypt

Summary:
Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.

Primary Outcome Measures: Pain Numeric Pain Rating Scale, Assessment of pain intensity (0-no pain, 10-most intense pain), 4 weeks|Biochemical analysis, Assessment of pain intensity through the change of blood cortisol level, plasma cytokine level, antinuclear antibody (ANA) level. Blood samples will be taken between the hours of 08:00-09:00 in the morning. Two blood samples will be taken from the patients before and after treatment., 4 weeks|Fibromyalgia Impact Questionnaire, Assess functional outcome, 4 weeks|Pressure Pain Thresholds, Assess pain sensitivity through pressure algometer, 4 weeks
Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
NCT Number: NCT06539767
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Arterial Aneurysm Wall Enhancement on HRMRI
Sponsor: Zhujiang Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-12-31
Locations: Zhujiang Hospital, Guangzhou, Guangdong, China

Summary:
This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.

Primary Outcome Measures: High resolution MRI aneurysm features, Enhancement grade was defined as follows: grade 0 for none enhancement, grade 1 for focal enhancement, involved the neck, the intermediate portion, the dome, or a bleb;grade 2 for thin annular enhancement (maximum thickness≤1 mm) , grade 3 for thick annular enhancement(maximum thickness\>1 mm) ., 1 year
Secondary Outcome Measures: postoperative mRS score, MRS score definition: The MRS score, also known as the Modified Rankin Scale, is a scale used to evaluate the neurological recovery status of stroke patients. It is divided into seven levels, Level 0: completely asymptomatic. Level 1: Despite symptoms, without obvious disabilities, able to complete all frequently engaged work and activities.

Level 2: Mild disability, unable to complete all work and activities, but able to handle personal affairs without the need for assistance from others.

Level 3: Moderate disability, requiring assistance from others to walking without assistance.

Level 4: Severe disability, unable to walk without the help of others, unable to take care of one's own needs.

Level 5: Severe disability, bedridden, urinary and fecal incontinence, requiring continuous care, and requiring multiple 24-hour care from others.

Level 6: Death. The higher the mRS score, the worse the patient's prognosis., 1 year|postoperative aneurysm occlusion rate, Raymond classification, grade I: complete embolism; Grade II: residual aneurysm neck;, 1 year
Patient Satisfaction During Cesarean Delivery
NCT Number: NCT06539754
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Satisfaction
Interventions: BEHAVIORAL: Music
Sponsor: Geisinger Clinic
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2025-08-01

Summary:
The goal of this interventional study is to determine whether listening to music during cesarean delivery increases the participants satisfaction. Participants and their support person will be asked to mark their satisfaction on a visual analog scale. Vital signs will be recorded during their procedure.

Primary Outcome Measures: Participant satisfaction, Visual analog scales from 0-10 (0=extremely unsatisfied, 10=extremely satisfied) will be collected by the patient marking on the line prior to the procedure and during skin closure., This is collected during the study duration, on average 6 hours.
Secondary Outcome Measures: Support person satisfaction, Visual analog scales from 0-10 (0=extremely unsatisfied, 10=extremely satisfied) will be collected by the support person marking on a line during the participant's skin closure., This is collected through the duration of the study, on average 6 hours,|Heart rate, Participants heart rate will be recorded at the time of consent and during skin closure., This will be collected during the study duration, an average 6 hours.|Blood pressure, Participants blood pressure will be recorded at the time of consent and during skin closure., This will be collected during the study duration, an average 6 hours.
Variability in Analgesic Response to Ibuprofen
NCT Number: NCT06539741
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Impacted Third Molar Tooth|Pain, Acute
Interventions: DRUG: Ibuprofen 400 mg|DRUG: Acetaminophen 500mg|DRUG: OxyCODONE 5 mg Oral Tablet
Sponsor: University of Pennsylvania
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-09
Locations: University of Pennsylvania School of Dental Medicine, Philadelphia, Pennsylvania, 19104, United States

Summary:
Nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, are recommended as first-line treatment for post-surgical dental pain. However, there is variability in analgesic response, and some patients require supplemental opioids for adequate pain relief. The goal of this study is to identify the factors that contribute to the need for opioid after third molar extraction to help limit unnecessary opioid prescriptions in patients who will have good pain relief with ibuprofen alone.

Primary Outcome Measures: Supplemental Opioid Use, Use of oxycodone in addition to ibuprofen + acetaminophen, Up to 7 days after third molar extraction
Secondary Outcome Measures: Gene Expression Profiling, mRNA levels will be measured in peripheral blood mononuclear cells, Up to 7 days after third molar extraction|COX-1 activity, COX-1 activity will be measured ex vivo using a whole blood assay and in vivo by quantifying concentrations of prostaglandin metabolites in urine., Up to 7 days after third molar extraction|COX-2 activity, COX-2 activity will be measured ex vivo using a whole blood assay and in vivo by quantifying concentrations of prostaglandin metabolites in urine., Up to 7 days after third molar extraction|DNA sequencing, Assessment of genetic variation, 1 day|Pain intensity score, Rating of pain from 0 (no pain) to 10 (worst imaginable pain), Up to 7 days after third molar extraction|Inflammatory mediator profiling, Assessment of cytokines in plasma, Up to 7 days after third molar extraction|Complete blood count with differential, Assessment of proportions of red blood cells, white blood cells, and platelets in whole blood, Up to 7 days after third molar extraction
Comparison of Visual Field Assessments Between Three Perimeters
NCT Number: NCT06539715
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Glaucoma
Interventions: DIAGNOSTIC_TEST: Visual field assessment
Sponsor: Gainesville Eye Associates
Collaborators: Sengi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-25
Completion Date: 2025-08-25
Locations: North Georgia Eye Associates, Gainesville, Georgia, 30501, United States

Summary:
A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.

Primary Outcome Measures: Total acquisition time (both eyes), Visit 1 (Day 0)
Secondary Outcome Measures: Mean deviation (MD), Visit 1 (Day 0)|Pattern standard deviation (PSD), PSD is a measure of visual field irregularity., Visit 1 (Day 0)|Foveal threshold (FT), FT provides an estimate for best-corrected visual acuity., Visit 1 (Day 0)|Patient questionnaire, A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) to assess comfort, ease of use, and anxiety with each device., Visit 1 (Day 0)
Other Outcome Measures: Visual field index (VFI), Visit 1 (Day 0)|Setup time, Visit 1 (Day 0)|False positives and false negatives (frequency), Visit 1 (Day 0)
Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.
NCT Number: NCT06539702
Acronym: Bethesda3
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Platelet Disorder|BRAF V600E|Thyroid Nodule|Cytologic Atypia
Sponsor: Saglik Bilimleri Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2024-08-15
Locations: Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, 34000, Turkey

Summary:
The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology.

The secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology.

Primary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity.

Primary Outcome Measures: Mean Platelet Volume (MPV) (fL), Mean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients., 1 week|Neutrophil/lenfosit Ratio (NLR)(103/µL), Neutrophil/lymphocyte ratio (NLR) will be calculated by taking the Neutrophil (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients., 1 week|Platelet/Lenfosit Ratio (PLR)(103/µL), Platelet/lymphocyte ratio (PLR) will be calculated by taking the Platelet (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients., 1 week|Lenfosit/Monosit Ratio (LMR)(103/µL), Lymphocyte/Monocyte Ratio (LMR) will be calculated by taking the Lymphocyte (103/µL) and Monocyte (103/µL) values in the preoperative hemogram parameters of all patients., 1 week
Secondary Outcome Measures: BRAF molecular test, Pathological molecular test (25 patients), 1 week
A Study to Compare Nighttime Aligners to Daytime Aligners
NCT Number: NCT06539676
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Teeth Straightening|Aligner Therapy|Orthodontic Aligner
Interventions: DEVICE: Nighttime Aligners|DEVICE: Daytime Aligners
Sponsor: Dentsply Sirona Implants and Consumables
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12

Summary:
The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per day), in adults and children from 12 years of age and older.

It will investigate the efficacy and performance of the treatments, as well as the safety of the investigational device and comparator.

The main objectives are:

* Comparison between the two groups concerning actual vs planned tooth movements (measured by changes in tooth position)
* Comparison between the two groups concerning the incidence of device or dental related AEs.
* Overall dentist and participant satisfaction with the treatment.

Participants will:

* Be given orthodontic aligner therapy with the Daytime (20-22h/day) or Nighttime (10-12h/day) Aligners (randomly assigned)
* Attend approximately 5 study during approximately 8-10 months

Primary Outcome Measures: Peer Assessment Rating (PAR) index, Comparison between actual vs planned tooth movements, compared between the investigational treatment and the control device, From day 0 (Treatment start) up to 8 months post treatment start (Final visit)
Secondary Outcome Measures: Subject satisfaction with the treatment, Overall subject satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied)., At the final visit (2-8 months post day 0)|Dentist (Investigator) satisfaction with the treatment, Overall dentist (investigator) satisfaction with the treatment assessed by a questionnaire using a rating scale from 1 to 10 (1 very satisfied - 10 very unsatisfied)., At the final visit (2-8 months post day 0)|Occurrence of Adverse Events (AEs), Incidence of (device or dental) related AEs associated with the planned investigational treatment, compared to the incidence from treatment with the control device, Continuously collected and reported AEs at each visit from day 0 up to 8 months post treatment start (Final visit)|Subject self-reported pain/discomfort, The subject self-reported values pertaining to pain/discomfort during treatment and comfort in wearing the aligners captured in a questionnaire with Visual Analogue Scale (VAS) with a Wong Baker face scale (score 0-10), where a higher score corresponds to a higher level of pain/discomfort., At each follow-up visit and at the final visit (1-8 months post day 0)
The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients
NCT Number: NCT06539663
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Corneal Perforation|Exposure Keratitis|Infectious Keratitis
Interventions: COMBINATION_PRODUCT: OmniLenz®
Sponsor: Farwaniya Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-04-10
Completion Date: 2024-04-10
Locations: Farwaniya Hospital, Kuwait, 81004, PO Box 13372, Kuwait

Summary:
Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024.

The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. The inclusion criteria were corneal perforation less than 1mm in size, positive culture \& sensitivity results and showing initial improvement on topical antibiotic eye drops.

Primary Outcome Measures: Size of corneal perforation, Size of corneal perforation will be measured in mm using slit lamp examination, one week
Secondary Outcome Measures: size of epithelial defect, Size of epithelial defect will be measured in mm using slit lamp examination, one week
Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3%
NCT Number: NCT06539637
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Cataract
Interventions: COMBINATION_PRODUCT: OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}|OTHER: Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop
Sponsor: DHS Consulting
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2026-02
Locations: Ophthalmic Consultants of Long Island, Westbury, New York, 11590, United States

Summary:
This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.

Primary Outcome Measures: Concentration of ketorolac in the vitreous humor, Vitreous samples taken from vitrectomy at the beginning of the procedure for all patients., The day of surgery
Evaluate the Safety and Preliminary Efficacy of EXG110 in Subjects With Fabry Disease
NCT Number: NCT06539624
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fabry Disease
Interventions: GENETIC: EXG110 injection
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-04-09
Locations: Shanghai Children's Medical Center, Shanghai, Shanghai, China|Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Summary:
Objective: To explore the safety and tolerability of different doses of EXG110 with Fabre disease

Primary Outcome Measures: Incidence and severity of adverse events, Safety and tolerability of EXG110 following a single IV dose, as assessed by incidence and severity of adverse events, serious adverse events and dose limiting toxicities, including clinically significant changes from baseline to scheduled time points in safety parameters, 52 weeks following EXG110 administration
Secondary Outcome Measures: eGFR change from baseline in mL/min/(1.73m^2);, eGFR change from baseline in mL/min/(1.73m\^2), 52 weeks following EXG110 administration|NYHA cardiac function grade changed from baseline;, NYHA cardiac function grade changed from baseline;, 52 weeks following EXG110 administration|Changed from baseline: region and area in mm^2 of skin angiokeratoma The number of Gb3 deposition in skin biopsy under the microscope, Changed from baseline: region and area in mm\^2 of skin angiokeratoma The number of Gb3 deposition in skin biopsy under the microscope, 52 weeks following EXG110 administration|Change from baseline in serum AGA activity, Change from baseline in serum AGA activity, 52 weeks following EXG110 administration|Change from baseline serum lysoGb3, Change from baseline serum lysoGb3, 52 weeks following EXG110 administration
Respiratory Training in Friedreich's Ataxia
NCT Number: NCT06539598
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Friedreich Ataxia
Interventions: OTHER: Respiratory Strength Training (RST)
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-03

Summary:
This is a prospective interventional study of patients with Friedreich's Ataxia that receive respiratory strength training for a period of 12 weeks with two research visits at the beginning and at the end of the study period. Visits include swallowing evaluation with fiberoptic endoscopic evaluation of swallowing, pulmonary function testing, surface electromyography and patient surveys.

Primary Outcome Measures: Force Vital Capacity, Forced Vital Capicity will be measured before and after the 12 week intervention, Through study completion (4 months)|Maximal Inspiratory Pressure (MIP), Maximal Inspiratory Pressure (MIP) will be measured before and after the 12 week intervention, Through study completion (4 months)|Maximal Expiratory Pressure (MEP), Maximal Expiratory Pressure (MEP) will be measured before and after the 12 week intervention, Through study completion (4 months)|Sniff Nasal Inspiratory Pressure (SNIP), Sniff Nasal Inspiratory Pressure (SNIP) will be measured before and after the 12 week intervention, Through study completion (4 months)|Swallowing, Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be measured before and after the 12 week intervention., Through study completion (4 months)|Surface Electromyography (sEMG), sEMG will be placed on the skin to measure muscle activity involved in breathing and swallowing, Through study completion (4 months)|Diaphragm Ultrasound, Diaphragm movement will be measured through an ultrasound probe positioned on the skin before and after the 12 week intervention., Through study completion (4 months)
Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality
NCT Number: NCT06539585
Acronym: SMART
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility|Infertility, Male|Infertility, Female
Interventions: PROCEDURE: Meiotic spindle status observation in polarized light|PROCEDURE: ICSI
Sponsor: Charles University, Czech Republic
Collaborators: Czech Academy of Sciences|Czech Technical University in Prague|General University Hospital, Prague
Sex: FEMALE
Age: ADULT
Enrollment: 164
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-18
Completion Date: 2028-03-31
Locations: General University Hospital in Prague, Prague, 128 08, Czechia

Summary:
The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation and the optimal time of oocyte fertilization by intracytoplasmic sperm injection (ICSI). A new accurate and non-invasive method for selecting quality maturated oocytes based on meiotic spindle imaging is for women over 35 years of age will be introduced. The evaluation of efficiency using meiotic spindle visibility in polarized light and its relative position to the polar body as indicator of oocyte maturity will be monitored and the optimal time for ICSI will be defined.

Primary Outcome Measures: Clinical pregnancy rate of patients whose ICSI time was established according to MS state, The percentage of all attempts that leads to pregnancy of patients whose ICSI fertilization was done according MS status. Meiotic spindle visibility in polarized light and its relative position to the polar body as indicator of oocyte maturity will be monitored and the optimal time for ICSI will be defined., 6-8 weeks
Secondary Outcome Measures: clinical pregnancy rate of patients whose ICSI time was not established according to measured MS state, The percentage of all attempts that leads to pregnancy of patients whose ICSI fertilization was not done according MS status. But the meiotic spindle visibility in polarized light and its relative position to the polar body was measured., 6-8 weeks
Other Outcome Measures: Clinical pregnancy rate of patients with standard ICSI time, The percentage of all attempts that leads to pregnancy of patients whose ICSI was standard., 6-8 weeks
Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence
NCT Number: NCT06539572
Acronym: Cleft social
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cleft Lip and Palate|Social Isolation
Interventions: PROCEDURE: Cleft lip repair; palatoplasty; alveolar bone grafting
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: CHILD
Enrollment: 91
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-14
Completion Date: 2023-08-03
Locations: Chang Gung Memorial Hospital, Taoyuan, Taiwan

Summary:
Background: Using three-dimensional (3D) surface imaging, this study aims to understand the differences in perception between schoolchildren with and without cleft lip and palate (CLP), as well as to explore peer awareness and acceptance of children with craniofacial abnormalities post-surgery.

Methods: This cross-sectional study utilized three-dimensional surface images of early adolescent patients with CLP post-repair and without CLP for examination by schoolchildren (with CLP and without). Both groups assessed the images and responded to a questionnaire eliciting perceptions of facial appearance and social acceptance of children with craniofacial abnormalities, rating each question on a Likert scale of one to five. The results were presented using bar graphs, and the Item Response Theory-Graded Response Model was employed to estimate the latent ability (θ) of each participant. The reliability of the questionnaire was assessed with Cronbach's alpha test.

Primary Outcome Measures: Facial appearance, based on 3dMD image, 6 months after alveolar bone grafting
Shade Matching and Patient Satisfaction of Yttria Stabilized Multilayered Zirconia and Lithium Disilicate Restorations
NCT Number: NCT06539546
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mutilated Teeth|Endodontically Treated Teeth
Interventions: OTHER: Yttria stabilized multilayered (YML) zirconia restorations|OTHER: Lithium disilicate restorations
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
The aim of the study is to determine whether Yttria stabilized multilayered zirconia restorations will differ from lithium disilicate restorations in shade matching and patient satisfaction in patients requiring full coverage restorations.

Primary Outcome Measures: Color difference, By Intraoral Spectrophotometer, color difference between the restoration and the adjacent or contralateral natural tooth will be measured by the unit (ΔE), (ΔE) will be measured for each sample., immediate after cementation
Secondary Outcome Measures: Patient satisfaction, By Visual Analogue Scale, with score range from 1 to 10 , where 1 is the worst (lowest satisfaction) and 10 is the best (highest satisfaction)., immediate after cementation
Pilates on Dynamic Balance in Flexible Flat Feet
NCT Number: NCT06539533
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Flexible Flatfoot
Interventions: OTHER: pilates training
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-04
Locations: Faculty of Physical Therapy, Cairo, Egypt

Summary:
Flexible flatfoot is one of the most common types of flatfeet. It has an arch that is present in open kinetic chain and lost in closed kinetic chain Balance is defined as the process that maintains the center of gravity within the body's support base.

Pilates exercises is a whole body conditioning program which was initially used for managing low back pain and improving balance in elderly. Now-a-days it is used for posture correction and fitness training.

Primary Outcome Measures: dynamic balance, is the ability to remain standing and stable while performing movements or actions that require displacing or moving oneself. In this way, each time that we take a step in any direction, we will be testing this type of balance. And, of course, the ability to walk requires its continuous use.

Balance check 636 device (Dr Wolff, Arnsberg, Germany)for assessment of dynamic balance in each subject individually, 6months
Secondary Outcome Measures: quialty of life, sense of wellbeing embracing the physical, psychological, social, and spiritual state. • Foot Health Status Questionnaire (FHSQ) for quality of life assessment., 6months