pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
NCT Number: NCT06585761
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure
Sponsor: Kafrelsheikh University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-15
Completion Date: 2025-06-30

Summary:
The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.

Primary Outcome Measures: measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention, At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL., 1 year|clinical examination for the presence and extent of improvement in signs and symptoms, Clinical examination depending on NYHA classification of the participants, 1 year
Secondary Outcome Measures: measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention, At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarker

Il-6 serum concentration is measured in pg/mL, 1 year|Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention, TNF-Alpha serum concentration is measured in pg/ml, 1 year
Other Outcome Measures: measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers in heart failure patients before and after the intervention, At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers such as MDA which plasma concentration is measured in nM, 1 year
Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization
NCT Number: NCT06585748
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure
Sponsor: Ankara City Hospital Bilkent
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-01
Completion Date: 2024-12-01

Summary:
Bladder catheterization is a procedure frequently performed in emergency departments and may cause symptoms such as pain and discomfort in patients. This study hypothesizes that lidocaine spray application will improve patient compliance and comfort from the outset and facilitate smoother medical procedures. In our prospective, case-controlled study, the patients were divided into two groups: Group L (lidocaine) and Group P (placebo). Pain conditions after bladder catheterization were evaluated at 0 minutes (during the procedure) and 15, 30 and 60 minutes after the procedure. Face Legs Arm Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used. All time periods in Group L, FLACC score and Wang Baker scores were found to be statistically significantly lower.The differences between the first measurement and the measurements at 15-30-60 minutes of the FLACC score were found to be significantly higher in group P than in group L. As a result, we recommend that lidocaine spray be applied before urinary catheter insertion. This study showed that lidocaine spray increased patients\&#39; sleep at the end and reduced the feeling of restlessness by reducing pain.

Primary Outcome Measures: Lidocaine and Pain, The FLACC scale assesses acute pain based on facial expression, leg position, activity, crying, and consolability Each category is scored from 0-2, with 0 indicating a calm patient and 10 indicating a visibly distressed patient ., 0., 15., 30., and 60. minutes
Secondary Outcome Measures: Lidocaine and comfort, Wong-Baker pain scale evaluates pain based solely on facial expressions. A score of 0 represents no pain, while a score of 10 represents unbearable pain ., 0., 15., 30., and 60. minutes
Proteolytic Enzyme Fortified Protein Supplement in Chronic Pancreatitis.
NCT Number: NCT06585735
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pancreatitis|Malnutrition
Interventions: DIETARY_SUPPLEMENT: Proteolytic enzyme fortified protein supplement
Sponsor: Asian Institute of Gastroenterology, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-30
Locations: Asian Institute of Gastroenterology Hospitals, Hyderabad, Telangana, 500032, India

Summary:
A complex disease, Chronic Pancreatitis (CP) is caused by a wide range of factors, including smoking, alcoholism, autoimmune disorders, and obstruction of the major pancreatic duct. In patients who are genetically susceptible to the condition, these factors can result in damage to the acinar, ductal, and islet cells, as well as persistent inflammatory infiltration and fibrosis. Malnutrition is an ongoing concern for persons with CP, even though pain is the primary symptom in most cases. Complications that commonly arise during the disease's natural history include exocrine and endocrine pancreatic insufficiency and local changes (such as pseudocyst, biliary and duodenal blockage, splenic and portal vein thrombosis, and pancreatic cancer). Consequently, CP mortality is higher than that of the general population.

Primary Outcome Measures: Weight gain, Improvement in body weight at least by 10% of the original weight., 6 weeks
Secondary Outcome Measures: Improvement in body composition, Change in composition in medical body composition analyser (mBCA) test, 6 weeks|Improvement in body function 1, Muscle strength will be assessed by Jamar Hand grip Dynamometer at baseline and at the end of 6 weeks., 6 weeks|Improvement in body function 2, Muscle function will be assessed by SARC-F questionnaire at baseline and at the end of the 6 weeks, 6 weeks|Improvement in body function 3, Muscle performance will be assessed using a 6-minute walk test at baseline and at the end of the 6 weeks, 6 weeks|Improvement in pain, Improvement in pain (VAS 0-10), 6 weeks
Association Between Venous Excess Ultrasound Grading System and Acute Kidney Injury in the ICU Population
NCT Number: NCT06585722
Acronym: VExUS ICU
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fluid Overload|Kidney Injury|Make-30
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 136
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2024-09-05

Summary:
Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. However, fluid responsiveness does not take fluid tolerance into account. Fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. Recent developments in point of care ultrasound e.g. the Venous excess ultrasound might help identify patients at risk of fluid overload. However its association with patient relevant outcomes in the ICU remains unclear.

Primary Outcome Measures: Rate of acute kidney injury, Clinically relevant acute kidney injury in the ICU: a 200% rise in creatinine or the use of renal replacement therapy, within 30 days of admission to the ICU|Mortality, death of all causes, within 30 days of admission to the ICU|Rate of MAKE-30, a composite endpoint of mortality and acute kidney injury ( including renal replacement therapy), within 30 days of admission to the ICU
Other Outcome Measures: Lung ultrasound score, a score for lung aeration as assessed by ultrasound ranging from 0 to 36 where 0 is the normal physiological state, maximum of 3 times during the first 7 days of admission|Cardiac function as assed by ultrasound, determined by eyeballing and measurement of the tricuspid annular plane systolic excursion (\>16 is normal), maximum of 3 times during the first 7 days of admission
OUD (Opioid Use Disorder) Target Trial
NCT Number: NCT06585709
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder
Interventions: DEVICE: Active repetitive Transcranial Magnetic Stimulation (rTMS)|DEVICE: Sham repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsor: Duke University
Collaborators: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
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: 2026-10-31
Locations: Duke University, Durham, North Carolina, 27705, United States

Summary:
In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids.

The investigators are trying to learn two things:

1. Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine?
2. Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS?

In order to complete the study the investigators will ask participants to:

* Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later.
* Undergo study-treatment with 50-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks.
* Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.

Primary Outcome Measures: Number of participants with Relapse Free survival, The number of participants who have not met relapse criteria in the 12-week follow-up phase. Relapse is defined as a) any opioid use in 4 consecutive weeks, or b) any opioid use on 7 consecutive days., Up to 12 weeks
Secondary Outcome Measures: Number of participants with high ventral striatal reactivity using the Reassessment of Craving (ROC) task, Baseline|Number of participants with low ventral striatal reactivity using the Reassessment of Craving (ROC) task, Baseline
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)
NCT Number: NCT06585696
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Moderate to Severe Glabellar Striae
Interventions: DRUG: CU-20101 treatment for Moderate to Severe Glabellar Striae
Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 554
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-11
Completion Date: 2026-05-01
Locations: Peking University First Hospital, Beijing, Beijing, 200443, China

Summary:
This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines. The study consisted of a 7-day screening period, Study Part 1 (randomized double-blind controlled study) and Period 2 (open-label study). Part I was a multicenter, randomized, double-blind, single-injection, active-drug parallel-controlled, non-inferiority design clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20101 in the treatment of moderate to severe glabellar stria compared with a single injection of Botox®; part 2 was an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines.

Primary Outcome Measures: • Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection., • Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection., Stage 1: Screening period of 7 days, treatment + follow-up about 12 weeks, the longest 92 days; Stage 2: Treatment + follow-up for about 36 weeks. All together takes up to 344 days
Post-Trial Tuberculosis Case Finding: a Substudy of CoVPN 3008 (Ubuntu)
NCT Number: NCT06585683
Acronym: CoVPN3008TB
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tuberculosis
Sponsor: COVID-19 Prevention Network
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-12
Completion Date: 2025-10-05

Summary:
This substudy aims to identify cases of tuberculosis after the Ubuntu clinical trial (CoVPN 3008) is completed.

Primary Outcome Measures: Proportion of participants with TB, The 95% confidence interval on the proportion of participants with TB will be estimated using the "score" method, Measured at Day 1, Day 4 and week 26|Association parameters of each demographic variable with confirmed TB., Proportions and 95% CIs will be estimated using the score method. A multivariate analysis will also be conducted using generalized linear regression models with TB as the outcome., Measured at Day 1, Day 4 and week 26|Proportion of participants with confirmed TB at the six-month follow visit out of the total number of participants that are screened at the six-month visit and who had confirmed TB at their enrollment visit., Proportion and 95% CI will be estimated using the score method., Measured at Day 1, Day 4 and week 26|Peripheral blood biomarkers associated with diagnosis of TB, including subclinical TB., TB risk scores will be computed from RNA sequencing data generated from each participant's baseline whole-blood sample (Tempus tube) provided upon enrollment into CoVPN 3008 (Ubuntu). Association of each score with confirmed TB will be assessed using cross-validated ROC curve analysis with area under curve (AUC) 95% CI estimated using the Delong method., Measured at Day 1, Day 4 and week 26
Brain Visual Perception Training for Prevention and Control of Premyopia
NCT Number: NCT06585657
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia
Interventions: DEVICE: brain visual training
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sex: ALL
Age: CHILD
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-03-31

Summary:
The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training.

The main questions it aims to answer are:

Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children

Participants will:

The training group will receive 20 minutes of brain visual perception training once a day for a period of one year.

Follow up check ups at the hospital every 3 months. Keep a diary of the values of axial length and refractive diopter.

Primary Outcome Measures: change in axial length after 1 year, the difference in the change of axial length between the intervention group and the control group, 1 year after the baseline
Secondary Outcome Measures: change in cycloplegic spherical equivalent after 1year, the difference in the change of cyclopegic spherical equivalent between the intervention group and the control group, 1 year after the baseline
The Collaborative Care PrTNER Study
NCT Number: NCT06585631
Acronym: PrTNER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV|Substance Use Disorders|Substance Use|AIDS
Interventions: BEHAVIORAL: CC PrTNER
Sponsor: Children's Hospital of Philadelphia
Collaborators: Johns Hopkins University|Baltimore City Health Department|National Institutes of Health (NIH)|National Institute on Drug Abuse (NIDA)
Sex: MALE
Age: CHILD, ADULT
Enrollment: 275
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2028-06
Locations: Johns Hopkins Center for Adolescent and Young Adult Health, Baltimore, Maryland, 21205, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19146, United States

Summary:
A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young Black and Latino men who have sex with men (YBLMSM) aged 15 to 24 through engagement in SU treatment.

Primary Outcome Measures: PrEP uptake at 12 months, PrEP uptake from baseline to 12 month survey. Biomedical assessment of PrEP use at 12 months, Intraerythrocytic Tenofovir-Diphosphate (TVF-DP) from dried blood spot (DBS) \>700 fmol/punch (oral PrEP), 2+ on-time injections of Long-acting injectable cabotegravir (CAB-LA), 12 months|HIV virologic suppression at 12 months, Viral load \< 20 copies/mL from baseline to 12 months, 12 months|Number of days of past-28-day non-tobacco drug/alcohol use, Number of days of past-28-day non-tobacco drug/alcohol use, assessed via Timeline Followback Method Assessment (TLFB) from baseline to 12 months, 12 months
Secondary Outcome Measures: PrEP persistence, Duration of time participants maintain benchmark TFV-DP concentrations from baseline to 12 months, 12 months|Sustained viral suppression, Duration of time participants are virally suppressed from baseline to 12 months, 12 months|Uptake of HIV Antiretroviral therapy (ART) treatment, Frequency of inadequate drug measurements and drug-resistant virus in those who are not virally suppressed from baseline to 12 months, 12 months|Mean number of negative urine drug screens (UDS), Mean number of negative UDS at 12 months, 12 months|Substance-related problems, Substance-related problems as defined by Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), and Severity of Dependence Scale (SDS scores) from baseline to 12 months, 12 months
A Multicenter Pediatric Deep Brain Stimulation Registry
NCT Number: NCT06585618
Acronym: DBS-R
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dystonia|Epilepsy in Children|Cerebral Palsy|Tourette Syndrome|Obsessive-Compulsive Disorder|Neurologic Disorder|Movement Disorders in Children|Movement Disorders|Deep Brain Stimulation
Sponsor: Boston Children's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2029-07-30

Summary:
There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.

Primary Outcome Measures: Development of a Multi-Center Pediatric DBS Registry, This study will define DBS as a therapeutic option for children with dystonia, other hyperkinetic movement disorders, or epilepsy., 5 years
Secondary Outcome Measures: Data Collection, Secondary objectives will focus on using the data collected to answer important research questions such as :

1. Which patients benefit from DBS?
2. Which clinical variables contribute to the responsiveness or nonresponsivness to DBS?
3. Which implant sites are preferred?
4. What are the long-term effects of DBS in the pediatric population?
5. How does DBS affect quality of life in pediatric patients?, 5 years
A Retrospective Survey-based Multicenter Study to Delineate the Molecular and Phenotypic Spectrum of Epilepsy-dyskinesia Syndromes
NCT Number: NCT06585605
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Epilepsy in Children|Dyskinesias|Movement Disorders in Children|Neurologic Disorder|Chorea|Myoclonus|Ataxia|Epilepsy|Dystonia Disorder|Movement Disorders
Sponsor: Boston Children's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2029-12-31

Summary:
The Epilepsy-Dyskinesia Study aims to advance the understanding of the clinical and molecular spectrum of epilepsy-dyskinesia syndromes, monogenic diseases that cause both movement disorders and epilepsy. Addressing challenges in rare disease research -such as small, geographically dispersed patient populations and a lack of standardized protocols- the study employs a multinational retrospective survey endorsed by the International Parkinson and Movement Disorder Society. This survey seeks to collect comprehensive data on clinical features, disease progression, age of onset, genetic variants, and concurrent neurological conditions, standardizing data collection across countries to provide a unified understanding of these conditions. Through retrospective review and molecular data analysis, the study aims to identify patterns and correlations between movement and seizure disorders, uncovering genotype-phenotype relationships. The initiative\&#39;s goals are to enhance understanding of epilepsy-dyskinesia syndromes, inform precision medicine approaches, and foster international collaboration.

Primary Outcome Measures: Creation of a Shared Clinical Database, The primary endpoint of this multi-center study will be the creation of the Epilepsy-Dyskinesia Study and the enrollment of 350 individuals in a shared database., 1 year|Understanding of Disease Spectrum, To comprehensively understand the spectrum and association of movement and seizure disorders on both clinical and molecular levels., 1 year|Assess the Impact of Movement Disorders on Health-Related Quality of Life, To assess the impact of movement disorders on health-related quality of life specifically within the context of epilepsy-dyskinesia syndromes., 1 year|Investigate the Efficacy of Symptomatic Treatments, Investigate the efficacy of symptomatic treatments in addressing both seizure and movement disorders, aiming to identify shared therapeutic strategies., 1 year
Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy
NCT Number: NCT06585592
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Thyroid-Associated Ophthalmopathy
Sponsor: Shanghai Changzheng Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-01
Completion Date: 2024-03-31

Summary:
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.

The aim of this clinical study is to:

1. Found characteristic changes from baseline to the end of treatment.
2. Identify characteristic changes associated with treatment response.
3. Construct a multimodal and multiparameter prediction model by characteristic changes.

Primary Outcome Measures: Percentage of participants with overall response, Overall response, 1 week after the end of treatment|Percentage of participants with overall response, Overall response, 24 weeks after the end of treatment|Percentage of participants with overall response, Overall response, 52 weeks after the end of treatment|Percentage of participants with overall response, Overall response, 104 weeks after the end of treatment
Secondary Outcome Measures: Incidence and characterization of nonserious treatment emergent adverse events (TEAEs), Safety and Tolerability, 1 week after the end of treatment|Incidence and characterization of nonserious treatment emergent adverse events (TEAEs), Safety and Tolerability, 52 weeks after the end of treatment|Change of Serum TRAb, 52 weeks after the end of treatment|Change of Serum thyroid function, inculde T3、T4、TSH, 52 weeks after the end of treatment|Change of Serum lipid parameter, including TG、TC、HDL、LDL, 52 weeks after the end of treatment
Other Outcome Measures: MRI, baseline|MRI, 52 weeks after the end of treatment|MRI, 1 week after the end of treatment
The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
NCT Number: NCT06585579
Acronym: ORIGYNE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervicovaginitis
Sponsor: Biocodex
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2025-11

Summary:
This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery.

Primary Outcome Measures: To confirm the performance of Mucogyne® ovule in wound healing promotion, The primary endpoint is a composite endpoint derived with the following criteria:

* Inflammation evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed,
* Edema evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed,
* Abrasion evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed,
* Coalescence evaluated with a 3-point scale (none, partial, total) and not assessed.
* Opening of the cervix (only for cervical wound) evaluated with a 4-point scale (closed, slightly open, open, gaping) and not assessed., Day 0 to day 21(+10)
Secondary Outcome Measures: To assess the aspect of the epithelium 3(+1) weeks after surgery, Criteria assessing the aspect of the epithelium (such as presence of mucosa, stroma, presence and quality of mucus, opening of the cervix, presence or absence of inflammation, edema, vulvo-vaginal abrasions, coalescence, adherence, leucorrhoea and bleeding at contact), Day 0 to day 21(+10)|To assess the performance of Mucogyne® ovule in symptoms relief, Vaginal symptoms (dryness, itching, burning, discharge) will be assessed by the patient using a 4-point scale (1 = absent, 2 = mild, 3 = moderate, 4 = severe) at 3 (+1) weeks after surgery, Day 0 to day 21(+10)|To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications, Postoperative side-effects (i.e. postoperative bleeding, infection and impairment of daily activities, etc.) will be assessed using a questionnaire. For the assessment of hemorrhage, the amounts of bleeding will be checked with a pictorial blood assessment chart., Day 0 to day 21(+10)|To assess change in clinical status, Change in clinical status will be assessed by the Investigator using Clinical Global Impressions scale, (CGI) at 3(+1) weeks after surgery, Day 0 to day 21(+10)|To assess compliance with the Medical Device use, Compliance with the Medical Device use will be assessed by number of days of use, Day 0 to day 21(+10)|To assess the safety of Mucogyne® ovule, Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution, Day 0 to day 21(+10)
Alveolar Cleft Reconstruction With Cortical-Shells
NCT Number: NCT06585566
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alveolar Cleft
Interventions: PROCEDURE: Cortical-shell graft
Sponsor: Beni-Suef University
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-10-01

Summary:
The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.

The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.

Primary Outcome Measures: Vertical bone loss, The amplitude of radiographic vertical bone loss, 6 months consolidation period
Secondary Outcome Measures: Horizontal bone width, The amplitude of radiographic the horizontal bone width, 6 months consolidation period|Bone density, The radiographic bone density of the consolidated graft at the site of the reconstructed cleft, 6 months consolidation period
Atrophic Gastritis and OLGIM Stage
NCT Number: NCT06585553
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Intestinal Metaplasia
Sponsor: Shandong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2121
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-01
Completion Date: 2024-08-25

Summary:
Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.

Primary Outcome Measures: Diagnostic Performance of IM at Different Sites, Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of IM at different gastric sites for predicting OLGIM stage III/IV were calculated., 3 years
Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
NCT Number: NCT06585527
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Glioblastoma Multiforme|Glioma, Malignant
Sponsor: Beijing Neurosurgical Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-29
Completion Date: 2026-01-01

Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant glioma will :

* Be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.
* Be followed for 1 year after the injection to complete imaging studies, neurological function tests, and report adverse events.

Using the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.

Primary Outcome Measures: Incidence and severity of adverse events., All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to TS-2021., Up to 8 weeks|Overall survival, The overall survival for each patient receiving TS-2021 will be calculated., Up to 12 months
Secondary Outcome Measures: Objective response rate (ORR) determined by MRI scan review., Interval tumor size change will be measured., Up to 12 months|Progression Free Survival., Time after TS-2021 administration to clinical and radiographic disease progression, Up to 12 months
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
NCT Number: NCT06585514
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Systemic Lupus Erythematosus (SLE)|Lupus Nephritis (LN)
Sponsor: Beijing GoBroad Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).

Primary Outcome Measures: Phase I: Dose-limiting toxicity (DLT), The incidence and type of dose-limiting toxicity (DLT)., 28 days post infusion|Phase I: Adverse events (AEs), The incidence and severity of adverse events (AE)., 30 days post infusion|Phase II: Objective response rate (ORR), Proportions of subjects achieving SLE Responder Index (SRI)-4 response, 3 months and 6 months post infusion
Secondary Outcome Measures: Phase I: Objective response rate (ORR), Proportions of subjects achieving SLE Responder Index (SRI)-4 response., 3 months and 6 months|Phase I: Long-term Adverse events (AEs), Total number, incidence and severity of AEs from 30 days to 2 years after CD19 CAR T infusion will be recorded., From 30 days after CD19 CAR T infusion to 2 years|Phase I: Pharmacokinetics, The proliferation and survival of CD19 CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR)., Up to 2 years post infusion|Phase II: Adverse events (AEs), The incidence and severity of adverse events., 2 years post infusion|Phase II: Pharmacokinetics, The proliferation and survival of CD19 CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR)., Up to 2 years post infusion|Phase II: Overall survival (OS) and during of response (DOR), Overall survival (OS) is defined the time from the initial CD19 CAR T cell infusion to death for any cause. During of response (DOR) is defined as the date when response criteria are first met to the date of relapse or death caused by SLE in the absence of documented relapse., Up to 2 years post infusion
A Study of Treatment Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China
NCT Number: NCT06585501
Acronym: REHEARSAL
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|Gastroesophageal Junction Cancer
Interventions: OTHER: No drug
Sponsor: Daiichi Sankyo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-03-31
Locations: Beijing Cancer Hospital, Beijing, China|The First Affiliated Hospital of Fujian Medical University, Fuzhou, China|Zhejiang Provincial People's Hospital, Hangzhou, China|Harbin Medical University Cancer Hospital, Harbin, China|Affiliated Cancer Hospital of Shandong First Medical University, Jinan, China|Liaoning Cancer Hospital & Institute, Shenyang, China|The First Hospital of China Medical University, Shenyang, China|The First Affiliated Hospital of Soochow University, Suzhou, China|Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China

Summary:
This study will be conducted to retrospectively evaluate the treatment patterns in first-line, second-line, and subsequent lines of therapy for HER2-positive Gastric Cancer/Gastroesophageal Junction Cancer (GC/GEJC) patients.

Primary Outcome Measures: Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens, 72 months
Secondary Outcome Measures: Percentage of HER2 sample type and testing method among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC, 72 months|Percentage of re-biopsies and re-biopsies with HER2-positive results among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC, 72 months|Real-world Progression-Free Survival, 72 months|Real-world Time to Discontinuation, 72 months|Real-world Time to Next Treatment 1, 78 months|Overall Survival, 78 months
Investigation of the Effectiveness of Structured Education According to Premenstrual Syndrome Symptom Map
NCT Number: NCT06585475
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premenstrual Syndromes|Education|Menstrual Cycle Disorder
Interventions: BEHAVIORAL: Structured training according to premenstrual syndrome symptom map
Sponsor: Sakarya University
Sex: FEMALE
Age: ADULT
Enrollment: 101
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-11-01
Completion Date: 2024-08-05
Locations: Sakarya University, Sakarya, 54050, Turkey

Summary:
In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test.

Primary Outcome Measures: Premenstrual syndrome assessment scale, a scale used to measure the degree of premenstrual syndrome, pre-intervention, 2 month after intervention|premenstrual syndrome specific life satisfaction scale, Premenstrual syndrome specific life satisfaction scale evaluates life satisfaction of women with PMS, pre-intervention, 2 month after intervention|DAS depression stress anxiety assessment scale, DAS depression stress anxiety assessment scale, evaluates psychological symptoms, pre-intervention, 2 month after intervention|VAS pain score, 1.421 / 5.000 VAS pain score measures pain score, pre-intervention, 2 month after intervention
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
NCT Number: NCT06585462
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cardiometabolic Disease
Interventions: DRUG: AMG 513|DRUG: Placebo
Sponsor: Amgen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2026-03-17

Summary:
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

Primary Outcome Measures: Number of Participants With Treatment-emergent Adverse Events (TEAE), Approximately 178 days (Part A) and 225 days (Part B)
Secondary Outcome Measures: Maximum Observed Drug Concentration (Cmax) of AMG 513, Day 1 up to Day 57|Time to Cmax (Tmax) of AMG 513, Day 1 up to Day 57|Area Under the Concentration-time Curve (AUC) of AMG 513, Day 1 up to Day 57
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
NCT Number: NCT06585449
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Huntington's Disease
Interventions: DRUG: ALN-HTT02|DRUG: Placebo
Sponsor: Alnylam Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2028-07-05

Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose of ALN-HTT02.

Primary Outcome Measures: Frequency of Adverse Events (AEs) in the Double-blind Part of the Study, Up to 12 months|Frequency of AEs in the Open-label Part of the Study, Up to 12 months
Secondary Outcome Measures: Change from Baseline in Levels of Mutant Huntingtin (mHTT) in Cerebrospinal Fluid (CSF), Baseline up to Month 12 in the Double-blind Part of the study; Baseline up to Month 12 in the Open-label Part of the study|Concentrations of ALN-HTT02 in Plasma, Area Under the Plasma Concentration-time Curve (AUC) Maximum Observed Plasma Concentration (Cmax) Time to Maximum Plasma Concentration (Tmax), Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study|Concentrations of ALN-HTT02 in Cerebrospinal Fluid (CSF), Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study|Concentrations of ALN-HTT02 in Urine, Fractional Excretion of ALN-HTT02, Up to Month 12 in the Double-blind Part of the study; Up to Month 12 in the Open-label Part of the study
Selective Versus Stepwise Removal of Deep Carious Lesions in Permanent Teeth Using Different Medicaments
NCT Number: NCT06585436
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caries Arrested
Interventions: PROCEDURE: partial caries removal
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-01
Completion Date: 2024-08-01
Locations: Al Azhar university, Cairo, 11651, Egypt

Summary:
The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.

Primary Outcome Measures: post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 7 days|post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 3 months|post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 12 months|post operative pain, evaluation of the post operative pain following restorations using modified USPHS, 18 months
Tolerability of an Anesthesia-free Tonometer Tip
NCT Number: NCT06585423
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glaucoma
Interventions: DIAGNOSTIC_TEST: Sterile commercially available bandage contact lens|DIAGNOSTIC_TEST: Medical grade silicone of a thickness <100 µm|DIAGNOSTIC_TEST: Medical grade silicone of a thickness >100 µm
Sponsor: Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2025-10
Locations: Duke Eye Center, Durham, North Carolina, 27710, United States

Summary:
The purpose of this study is to compare the tolerability and comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.

Primary Outcome Measures: Patient tolerability rating of different tips, Tolerability of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip, Baseline|Patient comfort rating of different tips, Comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip, Baseline