pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of the Strong Hearts Urban Program
NCT Number: NCT06567184
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases
Interventions: BEHAVIORAL: Strong Hearts Urban
Sponsor: Texas A&M University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-01-05
Completion Date: 2023-08-09
Locations: West Dallas Multipurpose Center, Dallas, Texas, 75212, United States|Texas A&M AgriLife Research and Extension Center at Dallas, Dallas, Texas, 75252, United States

Summary:
The aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, American Heart Association's Life's Essential 8 (AHA Essential 8), and health behaviors among Black/African American and/or Hispanic/Latinx urban residents with overweight or obesity.

Primary Outcome Measures: Body Weight, Change in body weight, 12 weeks
Secondary Outcome Measures: Fruit and Vegetable Consumption, Dermal Carotenoid Score. As measured by Veggie Meter using a participant's index finger, the dermal carotenoid score (0-800) reflects a concentration biomarker of fruit and vegetable intake, where a higher score is correlated with higher intake., 12 weeks|Self-reported healthy eating behaviors, Healthy Eating Index (HEI) as measured by Dietary Health Questionnaire (DHQ-III). The DHQ-III is a self-administered, web-based food frequency questionnaire scored 0 to 100, where higher scores indicate closer adherence to the Dietary Guidelines for Americans., 12 weeks|Physical activity - Active Minutes, Objectively measured physical activity by Fitbit activity tracker, counted as Active Minutes, 12 weeks|Physical activity - Steps, Objectively measured physical activity by Fitbit activity tracker, counted as steps, 12 weeks|Participant Acceptability, Participant feedback from follow-up questionnaires measures acceptability on a 5-point Likert scale, where higher score indicates higher satisfaction, 12 weeks|Intervention Engagement, Engagement is assessed by attendance at study activities including intervention classes and data collection appointments, 12 weeks
How Well Ethiopian Parents Assess and Manage Their Children's Postoperative Pain: Descriptive Correlational Study
NCT Number: NCT06567171
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Parent|Pain|Ethiopia|Hospital
Interventions: PROCEDURE: This descriptive correlational study was conducted among 102 parents with children aged between 2 and 12 undergoing elective surgical procedures.
Sponsor: Wachemo University
Sex: ALL
Age: ADULT
Enrollment: 102
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-08-12
Completion Date: 2022-10-20
Locations: Mitiku Desalegn, Hosa'ina, Snnpr, 667, Ethiopia

Summary:
This study aims to evaluate the practice of mothers towards the evaluation and management of postoperative children's pain.According to this study, Parents displayed low to moderate levels of knowledge adequacy towards the use of pain relief methods in relation to their children's postoperative pain and pain management, which indicates the need to provide parents with more information regarding their children's postoperative pain management.

Primary Outcome Measures: To evaluate the quality of parents management of children's pain in postoperative period using observational tools called PURPS (Parental use of pain relief strategy) and PPPM (Parental postoperative pain measure), An observational tool was used to measure the quality of parental pain management, Oct, 2023
Evaluation of the Effect of Non-Surgical Periodontal Treatment in Women With Polycystic Ovary Syndrome
NCT Number: NCT06567132
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome|Gingivitis
Interventions: PROCEDURE: Non-surgical periodontal treatment
Sponsor: Bezmialem Vakif University
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-15
Completion Date: 2023-02-08
Locations: Bezmialem University, Istanbul, Fatih, 34080, Turkey

Summary:
The goal of this clinical trial is to compare women with polycystic ovary syndrome and systemically healthy woman in relation to their gums and gum treatment outcomes as well as to investigate the role of a new biomarker in gum disease. The main questions it aims to answer are:

1. Is gum disease more common in women with PCOS?
2. Does PCOS affect the response to gum disease treatment?
3. Is there a new marker to identify gum disease? It is known that polycystic ovary syndrome is a low-grade chronic inflammatory disease. It has been reported that this aspect may be associated with gum disease. In our study, women with polycystic ovary syndrome will be compared with systemic healthy women. Initial gum conditions and response after treatment will be investigated. Additionally, the results will be supported by gingival crevicular fluid and saliva analysis.

Primary Outcome Measures: Bleeding on probing, Bleeding on probing is an important indicator of gingivitis. Bleeding on probing less than 10% is an indicator of healthy periodontium and means that the non-surgical periodontal treatment is successful., Baseline and sixth weeks after the treatment
Secondary Outcome Measures: Interleukin-6, Comparisons between groups were made by evaluating baseline and post-treatment levels., Baseline and sixth weeks after the treatment|Interleukin-10, Comparisons between groups were made by evaluating baseline and post-treatment levels., Baseline and sixth weeks after the treatment|Annexin A1, Comparisons between groups were made by evaluating baseline and post-treatment levels., Baseline and sixth weeks after the treatment
Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects
NCT Number: NCT06567119
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Skin Aging
Interventions: BIOLOGICAL: SPOT-mRNA01|OTHER: Placebo
Sponsor: SIPO Biotechnology Co. Ltd.
Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-15

Summary:
This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.

Primary Outcome Measures: Assessment of the incidence of treatment-emergent adverse events of SPOT-mRNA01 by recording adverse events, The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01., 3 months
Secondary Outcome Measures: Assessment of changes in collagen expression level after subcutaneous injection of SPOT-mRNA01, Local collagen expression in injection area biopsy by ELISA detection, Days 4, 7 and 31|Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01, Detecting local skin thickness in injection site biopsy by Masson trichrome stain., Days 4, 7 and 31|Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01, Detecting local skin thickness by Skin ultrasound., Baseline and days 7， 15， 31， 61 and 91
Investigation of Cardiac Function With Ultrasound
NCT Number: NCT06567106
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Function
Interventions: OTHER: Ultrasound application|OTHER: No ultrasound application
Sponsor: ShanghaiTech University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2027-02-01

Summary:
The goal of this clinical trial is to learn the influence of ultrasound on the cardiac functrion.

The main question it aims to answer is:

How will ultrasound affect the cardiac function?

Researchers will apply ultrasound to the body and observe cardiac functions.

Participants will:

Receive ultrasound application and physiological signal monitoring.

Primary Outcome Measures: The change of heart rate of the participants assessed by electrocardiogram., Monitor participants' electrocardiogram before, during and after ultrasound application. Calculate heart rate from the electrocardiogram signal. Heart rate change rate is calculated as the rate of change in heart rate relative to the baseline heart rate. Aggregate the data and do statistical analysis. Data will be presented as mean with standard deviations., Throughout the trial, an average of 1 hour.|The change of left ventricular ejection fraction and shortening fraction of the participants assessed by echocardiogram., In order to evaluate cardiac function, participants will receive echocardiography examination. Left ventricular ejection fraction and shortening fraction are calculated from the echocardiogram images. Data will be reported as mean with standard deviations, and comparisons will be made to evaluate changes before and after ultrasound application., At 30 minutes before and after each trial. Each examination takes 30 minutes on average.
Effect of Leg and Heel Massage on Pain During Heel Blood Collection Newborns
NCT Number: NCT06567093
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Infant ALL
Interventions: OTHER: Baby Foot and Leg Massage
Sponsor: Bartın Unıversity
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-15
Completion Date: 2025-06-15
Locations: Bartın University, Bartın, Province, 74100, Turkey

Summary:
This study was planned to evaluate the effect of leg and heel massage on newborns, the pain experienced during heel blood collection, and the effects on physiological parameters.

H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group.

H2: Heart rates are lower in leg and heel massage group than control group. H3: Oxygen saturation levels are higher in leg and heel massage group than control group.

Primary Outcome Measures: Difference of the mean score of the "Newborn Infants Pain Scale" between intervention and control groups, Pain assessment will be made with the "Newborn Infants Pain Scale". The "Newborn Infants Pain Scale" will be measured again during the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick. At the end of the study, the change of the mean score of "Newborn Infants Pain Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program., 9 months
Secondary Outcome Measures: Difference of the mean score of the heart rate peak between intervention and control groups, Heart rate peak, which is a physiological parameter, will be evaluated. During the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick application, the heart rate will be measured again. At the end of the study, the change of the mean score of "peak heart rate" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program., 9 months|Difference of the mean score of the oxygen saturation between intervention and control groups, Oxygen saturation value, which is a physiological parameter, will be evaluated. Oxygen saturation will be measured again during the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick application. At the end of the study, the change of the mean score of "oxygen saturation" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program., 9 months
Human Factoring Validation of Pulsenmore ES Device
NCT Number: NCT06567067
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pregnancy Related
Interventions: DEVICE: Pulsenmore ES home ultrasound
Sponsor: PulseNmore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 57
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-09
Completion Date: 2023-12-21
Locations: Center for Fetal Medicine and Women Ultrasound, Los Angeles, California, 90404, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and healthcare professionals (HCP)) to evaluate whether the device/user interface can be used by the intended users without any serious issues or errors under that intended use and actual use conditions. The intended users will be qualitatively assessed via observation and cognitive debrief and usability testing methodology. Participants will be remotely observed during the video-guided fetal scanning actual process and participants and HCPs will be remotely observed during the clinician-guided fetal scanning actual process.

Primary Outcome Measures: Safety issues while using Pulsenmore ES device, Any safety issue, either serious that could cause serious injury or death to the user, or non serious, One day|User error while using Pulsenmore ES device, Any user interface issues reported by study participants and HCPs that can cause delay in diagnosis or treatment, One day
A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 Diabetes
NCT Number: NCT06567041
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes Mellitus, Type 2|Obesity
Interventions: DRUG: NNC0519-0130|DRUG: Placebo
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2025-09-08
Locations: Parexel International GmbH, Berlin, 14050, Germany

Summary:
A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.

Primary Outcome Measures: Number of adverse events, Measured in number of events., From time of first dosing (day 1) until completion of the end of study visit (day 274/253)
Secondary Outcome Measures: Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI), Measured in milliseconds (ms)., From baseline (day - 1) until completion of the end of study visit (day 274/253)|Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF), Measured in ms., From baseline (day - 1) until completion of the end of study visit (day 274/253)|Area under the NNC0519-0130 plasma concentration-time curve in steady state, Measured in hours\*nanomoles per liter (h\*nmol/L)., From pre-dose until 7 days post-dose, for third and last doses in the maintenance period|Maximum plasma concentration of NNC0519-0130 in steady state, Measured in nanomoles per liter (nmol/L)., From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
OSFound-Enhanced AI Model to Identify Premalignant and Malignant Ocular Surface Tumors
NCT Number: NCT06567028
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Performance of the Model
Interventions: DIAGNOSTIC_TEST: OSFound-Enhanced AI Model
Sponsor: Ningbo Eye Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-11-01
Locations: Ningbo Eye Hospital, Ningbo, Zhejiang, 315040, China

Summary:
An OSFound-enhanced deep learning model has been developed for identifying premalignant and malignant tumors using data retrospectively collected from the Ningbo Eye Hospital, Jiangdong Eye Hospital, and the Eye Hospital of Wenzhou Medical University. To further substantiate the model's effectiveness, we intend to evaluate it prospectively at Ningbo Eye Hospital.

Primary Outcome Measures: AUROC, area under the receiver operating characteristic curve, 3 months
BFR Training on Muscle Morphology
NCT Number: NCT06566950
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Flow Restriction Training|Eccentric Training|Muscle Morphology|Patellofemoral Pain Syndrome|Anterior Cruciate Ligament Injuries
Interventions: PROCEDURE: Low load-BFRt|PROCEDURE: Sham Low load-BFRt|PROCEDURE: High load-Eccentric training
Sponsor: Udayana University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2025-11-20

Summary:
This randomized clinical trial study compares high-load eccentric training (HL-Et), sham LL-BFRt, and low-load blood flow restriction (LL-BFRt) in sportsmen. The primary inquiries it seeks to address are:

Is LL-BFR superior to HL-Et and sham LL-BFRt in terms of improving muscle morphology? Is LL-BFR a more effective Patellofemoral Pain Syndrome and ACL injury preventive than HL-Et and sham LL-BFRt?

The three intervention groups that will be randomly assigned to participants are LL-BFRt, sham LL-BFRt, and HL-Et. Participants are expected to carry out:

Participants in LL-BFRt will be required to perform LL eccentric training at 30% of their repetition maximum (RM) and 70% of their artery occlusion pressure (AOP). This training will include stairs, single leg squat, and single leg deadlift.

Participants in HL-Et will be required to perform LL eccentric training at 70% of their maximum number of repetitions (RM).

In order to determine whether muscular morphology and the prevention of Patellofemoral Pain Syndrome and ACL injury improve following the interventions and follow-up, researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et.

Primary Outcome Measures: Muscle cross-sectional area, Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and peroneus longus muscle., 8 weeks|Vastus medial obliques fiber angle, Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle., 8 weeks|Patella position, Using a musculoskeletal ultrasonography, researchers will determine the patella position., 8 weeks
Secondary Outcome Measures: Incidence of patellofemoral pain syndrome, Researchers will determine the incidence of patellofemoral pain syndrome with the physical examination of grind test., 1 year|Incidence of anterior cruciate ligament injury, Researchers will determine the incidence of anterior cruciate ligament injury with the physical examination of Lachman's test., 1 year
The Effect of Standardised Patient Simulation in Nursing Education
NCT Number: NCT06566924
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries
Interventions: OTHER: Control|OTHER: Training Group for Standardised Patient Simulation
Sponsor: University of Beykent
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-04-15
Completion Date: 2023-08-15
Locations: Beykent Üniversity, Istanbul, Beykent, 34500, Turkey

Summary:
With the coronavirus outbreak, the experience of nursing students with personal protective equipment is one of the issues of interest. The competence of nursing students is important in terms of the fact that outbreaks will persist in the future. In this study, the effect of standardised patient method in training of isolated patient care in terms of knowledge, skills and satisfaction of nursing students was investigated. A experimental design was employed in this study, involving a total of 80 nursing university students, with 40 participants in the experimental group and 40 in the control group. In the study, pre-test-post-test knowledge exam, isolated patient care skills and training satisfaction of nursing students were evaluated. In addition to descriptive statistical methods, chi-square, fisher exact and t-tests were used in the evaluation of the data.

Primary Outcome Measures: Skill Evaluation Form for Isolated Patient Care, This form was developed in accordance with the isolation precautions guideline of the CDC. The form includes 20 skill steps to be completed regarding isolation precautions. The skills included communication, isolation measures and scenario-specific care steps. The range of points that can be obtained from the form is between 0-100., 2 months|Knowledge Test on Isolated Patient Care, There are 20 questions in the form created by the researchers in line with the literature. The scope of the questions included communication with the patient, use of protective equipment, hand washing and care practices. The range of points that can be obtained from the form is between 0-100., 2 Months
Secondary Outcome Measures: Satisfaction Survey for Training Methods, The satisfaction survey on Training Methods was developed by Gürpınar (Cronbach's alpha: 0.84) and used in his studies . The survey consists of 16 propositions. Each proposition is scored according to a 5-point Likert scale (1 - strongly disagree, 2 - disagree, 3 - undecided, 4 - agree, 5 - strongly agree). It was determined that the higher the mean score of the scale, the higher the students' satisfaction with the training method, and the lower the mean score of the scale, the lower their satisfaction with the training method. In the evaluation of the scale, students' satisfaction with the Training Methods is scored at least 16 and at most 80 points., 2 Months
Voice Analysis for Monitoring Patients With Heart Failure
NCT Number: NCT06566911
Acronym: VAMP-HF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Sponsor: Noah Labs
Collaborators: Charite University, Berlin, Germany|Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-24
Completion Date: 2024-09
Locations: Mayo Clinic, Rochester, Minnesota, 55902, United States|Deutsches Herzzentrum der Charité, Berlin, 13353, Germany

Summary:
This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Alongside voice data, additional clinical information such as left ventricular ejection fraction, NTpro-BNP levels, and ECG-data will be collected for comprehensive analysis. The study's goal is to identify voice-based indicators of heart failure progression, with the potential to enhance remote monitoring and self-management strategies for heart failure patients.

Primary Outcome Measures: Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers., The primary endpoint is the change in vocal characteristics from admission to discharge, and its correlation with clinical markers of heart failure severity, such as weight change from admission to discharge, NTpro-BNP levels, ECG-parameters, and left ventricular ejection fraction (LVEF)., Hospital stay
Monitoring of Antimicrobial Resistance Based on Metagenomics Analyses in Pneumonia Patients
NCT Number: NCT06566898
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pneumonia|Next-generation Sequencing|Microbiome|Antimicrobial Resistance
Sponsor: Shanghai General Hospital, China
Collaborators: Wuxi People's Hospital Affiliated to Nanjing Medical University|Wuhan Union Hospital, China|Huanggang Central Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-05-30
Locations: Mei Kang, Shanghai, Shanghai, 200080, China

Summary:
Monitoring of antimicrobial resistance (AMR) based on metagenomics analyses in pneumonia patients is critical for optimizing clinical diagnosis and treatment and improving clinical prognosis. This study is designed to ask the following key questions:

1. What is the microbiome maps of patients with severe pneumonia and mild pneumonia ?
2. How many pathogen resistance genes are carrying in severe pneumonia and mild pneumonia ?
3. What is the genetic diversity of key pathogens detected in severe pneumonia and mild pneumonia during 2019-2025?

Primary Outcome Measures: Microbiome composition, a collection of microbial communities detected in the biospecimen, during the study period, 2019-2025
Secondary Outcome Measures: Alpha diversity, the diversity within a particular area or ecosystem, during the study period, 2019-2025|Prevalence of bacterial resistance genes, the number of bacterial resistance genes divided by the number of biospecimen, during the study period, 2019-2025|Beta diversity, a comparison of of diversity between ecosystems, usually measured as the amount of species change between the ecosystems, during the study period, 2019-2025
Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).
NCT Number: NCT06566872
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colon Polyp
Interventions: DEVICE: ME-APDS
Sponsor: Magentiq Eye LTD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-16
Completion Date: 2025-12
Locations: Department of Gastroenterology, Shamir Medical Center, Israel, Be'er Ya'aqov, Israel

Summary:
The study shall mainly help to better evaluate the performance the ME-APDS device and secondly it may help the development of additional future versions of the ME-APDS.

Primary endpoints

* Clear video of the colon or the stomach or the esophagus achieved during the test.
* Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.

Secondary endpoints

• A recorded video of at least 80% of the actual test duration.

Primary Outcome Measures: To support the offline evaluation, in objective way, of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters., Clear video of the colon or the stomach or the esophagus achieved during the test., during colonoscopy and gastroscopy procedure|Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial., Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial., during colonoscopy and gastroscopy procedure
Secondary Outcome Measures: A recorded video of at least 80% of the actual test duration., A recorded video of at least 80% of the actual test duration., during colonoscopy and gastroscopy procedure
Lumbosacral Transitional Vertebra Prevalence Among Egypt Population and Its Association With Lumbar Degeneration
NCT Number: NCT06566846
Acronym: LSTV
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lumbosacral Anomalies
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12

Summary:
retrospective cross sectional study Study Setting: Cases will be recruited from the recorded data system at the department of diagnostic radiology, Assiut University.

Primary Outcome Measures: prevalence, prevalence of LSTV among egyptians, one year
Secondary Outcome Measures: correlation of LSTV with lumbar disc degeneration, association between LSTV and disc height ,segmental disc wedge angle and degree of disc prolapse(mild ,moderate ,severe), one year|correlation of LSTV with facet joint arthropathy, fact joint arthropathy will be assessed as unilateral ,bilateral and its degree(mild ,moderate ,severe), one year|correlation of LSTV with sacroiliac degeneration, sacroiliac joint will be assessed as unilateral ,bilateral and degree (mild ,moderate ,severe), one year|correlation of LSTV with paravertebral muscle volume, bilateral psoas muscle volume in cubic centimeter, one year
Effectiveness Of Different Remineralizing Strategies on The Management Of Early Carious Lesions In Primary Teeth
NCT Number: NCT06566833
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: White Spot Lesion
Interventions: DRUG: self assmbling peptide p11-4 combined with 0.05% fluoride|DRUG: Casein phosphopeptide amorphous calcium phosphate|DRUG: 5% sodium fluoride varnish
Sponsor: Alexandria University
Sex: ALL
Age: CHILD
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-15
Completion Date: 2024-08-15
Locations: Karin Dowidar, Alexandria, Professor, Egypt

Summary:
the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.

Primary Outcome Measures: Assessing the remineralization of early carious lesions in primary teeth, comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents, 3,6,9 and12 months
Secondary Outcome Measures: comparing the change in esthetic appearance of early carious lesion before and after treatment, comparing the change in lesion size using standardized photographs quantitatively by calculating pixel size of the lesion before treatment and after 6 and 12 months of intensive mode of application of the different remineralizing agents using ImageJ software program for image analysis. Assessing the esthetic appearance of the lesions will be done subjectively by using a visual analogue scale score from 1 to 7, 12 months|comparing the antibacterial effect of different remineralizing agents against streptococcus mutans, Supragingival plaque samples will be collected at baseline then after 48 hours, 1 months and 3 months of application of the materials in an intensive mode. log count of streptococcus mutans is determined using disk diffusion method using mitis salivaris agar plates, 3 months
Continuation Protocol for Obstructive Sleep Apnea (OSA)
NCT Number: NCT06566820
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: OSA
Interventions: DRUG: Aroxybutynin and Atomoxetine
Sponsor: Apnimed
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1280
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-03
Completion Date: 2026-06-30
Locations: Core Healthcare Group, Cerritos, California, 90703, United States|Exalt Clinical Research, Inc., Chula Vista, California, 91910, United States|Canvas Clinical Research, Lake Worth, Florida, 33467, United States|Clinical Neuroscience Solutions, Inc., Orlando, Florida, 32801, United States|Georgia Neurology and Sleep Medicine Associates, Suwanee, Georgia, 30024, United States|Centennial Medical Group Research Department, Columbia, Maryland, 21045, United States|Abington Neurological Associates, Abington, Pennsylvania, 19001, United States|FutureSearch Trials of Dallas, Dallas, Texas, 75231, United States|Huntsville Research Institute, Huntsville, Texas, 77340, United States

Summary:
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.

Primary Outcome Measures: Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs), An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. An SAE was an AE during any study phase that fulfills one or more of the following criteria: results in death, life threatening (The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity., through study completion, an average of 1 year|Number of Participants With Vital Signs Abnormalities, Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure., through study completion, an average of 1 year|Number of Participants With Concomitant Therapy (Medication or Devices), Concomitant therapy with devices (i.e., CPAP) and concomitant medications are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation., through study completion, an average of 1 year
Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma
NCT Number: NCT06566807
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Marginal Zone Lymphoma
Interventions: DRUG: Orelabrutinib, obinutuzumab
Sponsor: Huai'an First People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2028-08-10
Locations: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#, Huai'an,, Jiangsu, 210000, China

Summary:
This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.

Primary Outcome Measures: Overall response rate (ORR), The ORR is defined as the proportion of patients with a response of CR or PR, At the end of Cycle 6 (each cycle is 28 days)
Secondary Outcome Measures: the complete response rate, CRR is defined as the proportion of patients with a response of CR, (up to 2 year)|BOR, The BOR is defined as the proportion of patients with a best response of CR or PR, Up to 2 years|Duration of Response (DOR), Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause., [ Time Frame: Up to 3 years ]|TTR, TTR is defined as the time from registration to the first response., [ Time Frame: Up to 3 years ]|24-month time to CR TTCR24, TTCR24 is defined as the time from registration to the first complete response Within 24 months., Up to 2 years|CR at 24 months (CR24), CR24 is defined as the proportion of patients with a response of CR at 24 months, at 24 months|2 years progression-free survival, Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment., [Time Frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]|2 years overall survival, Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date., [Time Frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]|The occurrence of adverse events, Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0., One month after discontinuation of treatment
Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants
NCT Number: NCT06566768
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: Deucravacitinib
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-03
Completion Date: 2025-06-06
Locations: Local Institution - 0001, Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Summary:
The purpose of this study is to identify drug levels of gastro-retentive (GR) formulations which prolong retaining time in the stomach of deucravacitinib (BMS-986165) in Healthy Participants.

Primary Outcome Measures: Maximum observed plasma concentration (Cmax), Up to approximately 5 days|Concentration at 24 hours post dose (C24), Up to approximately 5 days|Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)], Up to approximately 5 days
Secondary Outcome Measures: Incidence of adverse events (AEs), Up to approximately 1 month|Incidence of serious adverse events (SAEs), Up to approximately 1 month|Incidence of AEs leading to discontinuation, Up to approximately 1 month|Incidence of participants with vital sign abnormalities, Up to approximately 1 month|Incidence of participants with electrocardiogram (ECG) abnormalities, Up to approximately 1 month|Incidence of participants with physical examinations abnormalities, Up to approximately 1 month|Incidence of participants with clinical laboratory abnormalities, Up to approximately 1 month|Time of maximum observed concentration (Tmax), Up to approximately 5 days|Apparent terminal plasma half-life (T-HALF), Up to approximately 5 days|Apparent total body clearance (CLT/F), Up to approximately 5 days
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
NCT Number: NCT06566742
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Myelodysplastic Syndromes|Chronic Myelomonocytic Leukemia|Clonal Cytopenia of Undetermined Significance
Interventions: DRUG: Olutasidenib
Sponsor: M.D. Anderson Cancer Center
Collaborators: Rigel Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02-28
Completion Date: 2029-08-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
MRD in High-risk EBC
NCT Number: NCT06566729
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2028-04

Summary:
This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.

Primary Outcome Measures: Relapse-free survival, Defined as the time from the diagnosis of the disease to the first occurrence of a local recurrence of breast cancer, distant recurrence, or death from any cause, 5 years after surgery
Secondary Outcome Measures: Overall survival, Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause, 5 years after surgery|Lead time, Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases, 2 years after surgery
Testing ANSOS for Efficacy in Multi-Tribal Urban Communities
NCT Number: NCT06566703
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smokeless Tobacco Cessation
Interventions: BEHAVIORAL: All Nations Snuff Out Smokeless|BEHAVIORAL: Healthy Living
Sponsor: Lehigh University
Collaborators: American Cancer Society, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 384
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-18
Completion Date: 2026-08-18
Locations: Lehigh University, Bethlehem, Pennsylvania, 18015, United States

Summary:
This is a wait-list control trial to test for efficacy of the All Nations Snuff Out Smokeless (ANSOS) recreational tobacco cessation program in multi-tribal American Indian (AI) communities. Participants randomized to the control arm are provided with a Healthy Living educational intervention while they wait for the program to encourage them to remain engaged with the study team during the six-month waiting period. Participants from the ANSOS arm are offered the Healthy Living educational intervention after they complete the 6-month outcome measures.

Primary Outcome Measures: Number of participants with 7-day point prevalence abstinence, 7-day point prevalence abstinence from smokeless tobacco product use, 6 months
Secondary Outcome Measures: Number of participants with continuous abstinence, Continuous abstinence from smokeless tobacco product use, 6 months, 12 months
The Association Between Sensory Block Level, Oxygen Therapy, and ORi in Varicose Vein Patients Undergoing Spinal Anesthesia (ORi: Oxygen Reserve Index)
NCT Number: NCT06566690
Acronym: ORi
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hyperoxia|Hypoxia
Interventions: DEVICE: Addition of ORi monitoring to SpO2 monitoring
Sponsor: Kocaeli University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-29
Completion Date: 2025-07-10
Locations: Kocaeli University, Kocaeli, Turkey

Summary:
The assessment of peripheral capillary oxygen saturation (SpO2) by pulse oximetry has become standard in perioperative care for the detection of hypoxaemia. The oxygen reserve index (ORI) can provide an early warning of deteriorating oxygenation long before a change in SpO2 occurs, reflect the response to oxygen administration, facilitate oxygen titration and prevent unwanted hyperoxia. The combination of ORI with pulse oximetry can help to accurately adjust inhaled oxygen concentration and prevent hypo- and hyperoxaemia. In spinal anaesthesia, neuraxial blockade can cause paralysis of accessory respiratory muscles and theoretically lead to bronchospasm. Therefore, in this study, the investigators planned to perform oxygen saturation monitoring using two modalities. The investigators wanted to investigate the correlation between ORI, SpO2, oxygen therapy and the degree of sensory block.

Primary Outcome Measures: The primary outcome of this study is to assess the correlation between the need for oxygen therapy, the ascension of sensory block level, and changes in Oxygen Reserve Index (ORi)., The primary outcome measure of this study is to evaluate the potential correlation between three variables: the need for supplemental oxygen therapy, the cephalad progression of sensory block level, and fluctuations in oxygen reserve index (ORi) values., 9 months
Point of Care Rapid STI Test Optimization and Validation Extension
NCT Number: NCT06566677
Acronym: PROVE
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Chlamydia Trachomatis Genital Infection|Gonorrhea|Trichomoniasis
Sponsor: Wits RHI Research Centre Clinical Research Site
Collaborators: University of Washington
Sex: FEMALE
Age: ADULT
Enrollment: 364
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-26
Completion Date: 2023-12-07
Locations: Wits RHI Research Centre, Hillbrow, Gauteng, 2038, South Africa

Summary:
The purpose of this sub-study (PROVE) is to support and facilitate the validation of commercially available point of care (POC) sexually transmitted infection (STI) diagnostic test kits/devices for potential on-site laboratory use as well as bedside use in parallel to gold standard established testing methodologies. A further extension of bedside testing would include self-testing.

Primary Outcome Measures: GeneXpert, A PCR instrument was used to assess the presence of chlamydia trichomatis and gonorrhea from samples taken using endocervical swabs., 1 year
Secondary Outcome Measures: Osom rapid testing kit, A rapid point-of-care test for the diagnosis of Trichomonas vaginalis in women using dacron swabs., 1 year
Other Outcome Measures: JD Biotech Trichomonas vaginalis antigen rapid test kit, Trichomonas vaginalis antigen rapid test kit, 1 year|JD Biotech C. Trachomatis/ N. Gonorrhoeae Ag combo rapid test, Urine or vaginal cavity swab or vaginal glans sample to diagnose chlamydia trichomati and gonorroea, 1 year|Cromatest Chlamydia one step rapid kit, Female cervical swab and male urethral swab specimens to diagnose chlamydia, 1 year|NADAL Chlamydia Test, Female or male urethral swab/male Urine used to diagnose chlamydia, 1 year|ACRO Biotech Gonorrhoea, Female cervical swab/ male urethral swab to diagnose gonorrhoea, 1 year|Rapid Labs Gonorrhea, Sterile Female cervical swab/ male urethral swab to diagnose gonorrhea, 1 year