pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Rapid-Response EEG in Children With Suspected Status Epilepticus
NCT Number: NCT06564662
Acronym: RECS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Status Epilepticus|Coma
Interventions: DEVICE: Rapid Response EEG
Sponsor: Children's Hospital at Montefiore
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-12-09
Completion Date: 2026-12-08
Locations: Children's Hospital at Montefiore, Bronx, New York, 10467, United States

Summary:
Seizures are common in children (\~350 per 100,000 patients per year) and require immediate medical attention. If the seizure is prolonged (\> 5 minutes) it is called status epilepticus and delayed treatment leads to higher risk in drug resistance and brain injury. The current standard of care for children admitted to the ICU with established or suspected status epilepticus is to start a conventional continuous EEG study that helps diagnosing seizures by typical electro graphic patterns. It takes on average 4 hours to start and another two hours to obtain a reading by epileptologists. This is far beyond the time window of starting an EEG study (60 minutes) as recommended by the neurocritical care society. In adult ICUs, point of care "Rapid Response EEG" are becoming a new standard of care and our ICU adopted this practice in 2020. It can be easily placed by the ICU staff rather than a specifically trained EEG technician but has a lower resolution due to fewer leads (10 vs. 20). The purpose of this study is to determine wether and by how much time RR-EEG yields faster preliminary EEG reports that the previously available conventional EEG (cEEG) and wether the detection of electro graphic seizures is comparable. This is a retrospective cohort study following patients who are admitted to the PICU and are placed on either cEEG or RR-EEG for status epilepticus.

Primary Outcome Measures: Time from order of electroencephalogram (EEG) to EEG reading, EMR order placement as a surrogate for decision making to obtain an EEG. Report time of EEG was considered the time relevant information was available to the ICU team., up to 24 hours
Secondary Outcome Measures: Time from EEG order to start of EEG recording, time from EEG order to actual EEG start as time stamped in the EEG record, up to 24 hours|Time from EEG start to first EEG reading report as documented in the electronic medical record, time from EEG start to available EEG report, up to 24 hours|EEG description, Electrographic seizures (and burden = time spent in electro graphic seizure), brief (ictal) rhythmic discharges (BIRDs), sporadic epileptiform discharges, generalized or lateralized rhythmic delta activity (GRDA/LRDA), generalized, lateralized or bilateral independent periodic discharges (GPD/LPD/BIPD) and background reactivity, frequency, and superimposed rhythmic, fast or sharp activity ("plus factors"), up to 24 hours
Urinary CXCL10 Pilot Implementation Trial
NCT Number: NCT06564649
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Transplant Rejection
Interventions: DIAGNOSTIC_TEST: CXCL10 Monitoring at clinical frequency
Sponsor: University of British Columbia
Collaborators: University of Toronto|University of Manitoba
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-15
Completion Date: 2027-05

Summary:
Kidney transplantation is considered the best option to treat end-stage kidney disease, but the recipient's immune system may respond with rejection to the transplanted organ, leading to permanent kidney damage and failure.

The current standard for rejection monitoring in transplanted recipients is regular blood creatinine testing and kidney biopsies. Creatinine doesn't detect rejection until damages had occurred, causing some amount of kidney failure, and kidney biopsies are only done at set timepoints.

A new test called CXCL10 is shown to be more effective in detecting rejection from previous research and can be done as often as needed. Therefore, The investigators are doing this randomized trial to test CXCL10 as part of clinical care and to help design a larger national clinical trial in the future.

Primary Outcome Measures: Capacity of Recruitment for future definitive trial, Demonstrate capacity to recruit, randomize and retain 60 participants, 8 months
Secondary Outcome Measures: Study Protocol Feasibility, 2) Identify and resolve challenges in executing the study protocol regarding sample acquisition, CXCL10 testing, and adherence to the mandated trial protocols, 2 years|Trial Cost and logistical support evaluation, 3) Comparison of cost and logistical supports needed for local vs. central CXCL10 testing options, 2 years
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
NCT Number: NCT06564623
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pancreatic Cancer
Interventions: DRUG: mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)]|DRUG: Durvalumab|DRUG: Tremelimumab
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: AstraZeneca|Private Philanthropic Funds
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-09
Locations: SKCCC Johns Hopkins Medical Institution, Baltimore, Maryland, 21231, United States

Summary:
The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.

Primary Outcome Measures: Number of participants experiencing grade 3 or above drug-related toxicities, When calculating the incidence of Adverse Events (AE), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject., 20 Months|Maximum percentage change in interferon-producing mutant-specific cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) T cells., Evaluated by the maximal percent change in interferon-producing mutant-specific CD8 and CD4 T cells within 20 weeks post-vaccination compared to pre-vaccination baseline., Baseline to 20 weeks post vaccination (baseline, 20 weeks)
Secondary Outcome Measures: Progression Free Survival (PFS), PFS is defined as the number of months from the date of first vaccine dose until the date of disease progression using RECIST 1.1 criteria or death due to any cause, whichever occurs first, for BTC patients. PFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis. Per RECIST 1.1 criteria, Complete Response (CR) = disappearance of all target lesions, Partial Response (PR) is =\>30percent decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20percent increase in sum of diameters of target lesions, Stable Disease (SD) is \<30percent decrease or \<20percent increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve., 4 years|Overall Survival (OS), OS will be defined as the number of months from the date of first vaccine dose until date of death due to any cause. OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at time of analysis. Estimation based on the Kaplan-Meier curve., 4 years
Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Bariatric Surgery
NCT Number: NCT06564610
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Postoperative|Obesity|Analgesia
Interventions: PROCEDURE: Transversus abdominis block|PROCEDURE: Erector spinae block|PROCEDURE: Bariatric surgery|DEVICE: Endotracheal intubation|DRUG: Propofol
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-22
Completion Date: 2024-12-20
Locations: Faculty of medicine, Cairo University., Cairo, 11432, Egypt

Summary:
The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.

Primary Outcome Measures: Numerical rating scale, This is a scale for pain assessment which ranges between 0 and 10 with the highest level of pain having score 10 and lowest level of pain having score 0, 24 hours after surgery
Secondary Outcome Measures: Consumption of analgesia, This is the total consumption of nalbuphine by the patient measured in milligrams, 24 hours after surgery|Heart rate, This is the number of heart beats measured as frequency of heart beats in one minute., 24 hours after surgery|Systolic blood pressure, This is the systolic arterial blood pressure measured in mmHg., 24 hours after surgery|Vomiting, This is the incidence of vomiting after surgery measured as the frequency of patients with vomiting., 24 hours|Diastolic blood pressure, This is the diastolic arterial blood pressure measured in mmHg., 24 hours
Activity-based Training After Myocardial Infarction
NCT Number: NCT06564597
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myocardial Ischemia|Activities of Daily Living
Interventions: OTHER: Patient education
Sponsor: Pamukkale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-04-01
Completion Date: 2023-12-20
Locations: Pamukkale University, Merkez, Deni̇zli̇, Turkey

Summary:
Cardiovascular diseases cause high morbidity and mortality, resulting in disability, medical complications and comorbidities. Patients who have MI experience motor, cognitive and sensory impairments, reduced quality of life and burdened the national economy. Cardiac rehabilitation aims to optimize patients' health services, reduce physical and psychological effects and increase activity return performance. The rehabilitation process includes physical activities and patient education starting in the early stages after MI. Psychosocial support and occupational therapy can accelerate patients' recovery and return to daily activities. Since there are inadequacies in the literature on this subject, this study aims to provide an effective educational intervention for patients who have MI and to examine a safe return to activity.

Primary Outcome Measures: Canadian Occupational Performance Measure, The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time., The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.|Katz Index of Independence in Activities of Daily Living, The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently., The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.|Lawton Brody Instrumental Activities of Daily Living Scale, The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs., The evaluation were completed after discharge. The exact time is post-operative 2nd week, 3th month and 6th month.
Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD
NCT Number: NCT06564584
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hypertriglyceridemia|Nonalcoholic Fatty Liver Disease
Interventions: DRUG: TLC-2716 Dose 1|DRUG: TLC-2716 Dose 2|DRUG: Placebo
Sponsor: OrsoBio, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2025-02
Locations: OrsoBio Research Site, Guadalajara, Jalisco, 45116, Mexico|OrsoBio Research Site, Zapopan, Jalisco, 45170, Mexico|OrsoBio Research Site, Ciudad de México, 06700, Mexico|OrsoBio Research Site, Ciudad de México, 14080, Mexico

Summary:
This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.

Primary Outcome Measures: Change in fasting triglycerides, Relative (%) change in fasting triglycerides at Week 4 from baseline, Through study completion, up to Day 28 of the study|Incidence of TLC-2716 treatment-emergent adverse events, Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related., Through study completion, up to Day 28 of the study
Artificial Inteligence in Endoscopic Ultrasound
NCT Number: NCT06564571
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatic Cancer|Pancreas Disease|Pancreatic Cyst
Interventions: DEVICE: Patients undergoing endoscopic ultrasound procedures
Sponsor: Orlando Health, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-19
Completion Date: 2027-12
Locations: Orlando Health, Orlando, Florida, 32806, United States

Summary:
The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.

Primary Outcome Measures: Rate of detection pancreatic abnormalities by AI, Ability of AI to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas., 1 day
Secondary Outcome Measures: Rate of detection pancreatic solid mass lesions by AI, Ability of AI to detect pancreatic solid mass lesions as identified by an endoscopist during EUS examination of the pancreas., 1 day|Rate of detection pancreatic cystic lesions by AI, Ability of AI to detect pancreatic cystic lesions as identified by an endoscopist during EUS examination of the pancreas., 1 day
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL
NCT Number: NCT06564545
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Lymphoblastic Leukemia, Adult
Interventions: RADIATION: TBI|RADIATION: TMLI|DRUG: Cyclophosphamide
Sponsor: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 276
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-12-31

Summary:
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for haplo-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.

Primary Outcome Measures: Relapse-free survival (RFS), RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint., 2 years|acute Graft Versus Host Disease (aGVHD), The incidence of aGVHD within 100 days post-transplant., 100 days|Overall Survival (OS), OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint., 2 years
Secondary Outcome Measures: Transplantation Related Mortality (TRM), The incidence of TRM in 2 years., 100 days|Relapse Rate (RR), The incidence ratio of leukemia relapse in 2 years., 2 years|Conditioning-related Adverse Events (CRAE), Based on CTCAE v5.0., 30 days
Evaluative Conditioning and Relationship Satisfaction
NCT Number: NCT06564532
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Relationship, Marital
Interventions: BEHAVIORAL: Evaluatively conditioning participant to like partner|BEHAVIORAL: Evaluatively conditioning partner to like participant
Sponsor: Florida State University
Collaborators: United States Naval Medical Center, Portsmouth
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-22
Completion Date: 2025-08-31
Locations: Florida State University, Tallahassee, Florida, 32306, United States

Summary:
The overall objective is to evaluate the efficacy of a novel computerized learning procedure to enhance marital well-being among military members and their partners.

Primary Outcome Measures: Partner Evaluative Priming Procedure (McNulty et al., 2013), Modeled after the evaluative priming task developed by Fazio et al. (1995), the task implicitly measures participants' automatically activated partner attitudes by measuring RTs to positive and negative words following exposure to primes of the partner. Primes will be photos primes of the partner appearing in one of four orientations in each photo: (a) a frontal view of the face, (b) a profile view of the face, (c) a frontal view of the entire body while standing, and (d) a frontal view of the entire body while sitting., Every two weeks for eight weeks|Couples Satisfaction Index (Funk & Rogge, 2007), Questionnaire to assess self-reported satisfaction with the relationship, Every two weeks for eight weeks|Verbal Tactics Coding Scheme (Sillars, 1982), Qualitative coding scheme designed to identify direct and indirect oppositional statements during problem-solving discussions, Eight weeks|Suicidality subscale of the Depressive Symptom Index (Metalsky & Joiner, 1997, a well-validated measure that assesses the fre- quency and controllability of suicidal thoughts as agreement with four sets of four statements that increase in severity, Every two weeks for eight weeks
Resident Posture Biofeedback Study
NCT Number: NCT06564519
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postural; Strain|Healthy
Interventions: DEVICE: Posture Biofeedback Device
Sponsor: Wake Forest University Health Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-06
Locations: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States

Summary:
While a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. Biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in turn lead to longer and more fulfilling careers.

Primary Outcome Measures: Time spent in upright vs non-upright position, proportion (percentage) of time (minutes) in the upright position relative to the non-upright position during laparoscopic procedures, week 1 to week 4]
Secondary Outcome Measures: Change in Self-reported musculoskeletal pain score, Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) - measures self-reported musculoskeletal discomfort for all body segments. 1 = low (score 1-2) 2 = moderate (score 3-4) 3 = high (score 5-7) 4 = very high (score 8-10 - higher scores meaning more discomfort, baseline to week 4
A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
NCT Number: NCT06564493
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Interventions: RADIATION: TBI|RADIATION: TMLI|DRUG: Cyclophosphamide
Sponsor: The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: CHILD
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-12-31

Summary:
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.

Primary Outcome Measures: Relapse-free survival (RFS), RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint., 2 years|acute Graft Versus Host Disease (aGVHD), The incidence of aGVHD within 100 days post-transplant., 100 days|Overall Survival (OS), OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint., 2 years
Secondary Outcome Measures: Transplantation Related Mortality (TRM), The incidence of TRM in 2 years., 2 years|Relapse Rate (RR), The incidence ratio of leukemia relapse in 2 years., 2 years|Conditioning-related Adverse Events (CRAE), Based on CTCAE v5.0., 30 days
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JMT202
NCT Number: NCT06564467
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Subjects
Interventions: DRUG: JMT202|DRUG: Placrbo
Sponsor: Shanghai JMT-Bio Inc.
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2025-07-10
Locations: Peking University First Hospital, Beijin, China

Summary:
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JMT202 in Healthy Participants.

Primary Outcome Measures: The Number of adverse events (AEs) electrocardiograms, To investigate the safety and tolerability by assesment of AEs following administration., Pre-dose and multiple timepoints no less than 50 days|Number of participants with clinically significant change from baseline in vital signs, Pre-dose and multiple timepoints no less than 50 days|Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings, Pre-dose and multiple timepoints no less than 50 days|Number of participants with clinically significant abnormalities in physical examination, Pre-dose and multiple timepoints no less than 50 days
Secondary Outcome Measures: Area under the concentration-time curve from 0 to the collection time t (AUC0-t), Pre-dose and multiple timepoints no less than 50 days|Area under the concentration-time curve from 0 to infinity (AUC0-∞), Pre-dose and multiple timepoints no less than 50 days|Time to maximum concentration (Tmax), Pre-dose and multiple timepoints no less than 50 days|Serum Maximum concentration (Cmax), Pre-dose and multiple timepoints no less than 50 days|Half-Life (t1/2), Pre-dose and multiple timepoints no less than 50 days|Anti-drug antibody (ADA) prevalence in blood before study treatment and at the Follow-up Visit, Pre-dose and multiple timepoints no less than 50 days|Absolute change in High molecular weight adiponectin, Pre-dose and multiple timepoints no less than 50 days|Absolute change in weight, Pre-dose and multiple timepoints no less than 50 days|Absolute change in glycosylated hemoglobin, Pre-dose and multiple timepoints no less than 50 days|Absolute change in fasting insulin level, Pre-dose and multiple timepoints no less than 50 days|Absolute change in fasting glucose, Pre-dose and multiple timepoints no less than 50 days|Absolute change in blood lipoprotein, Pre-dose and multiple timepoints no less than 50 days
Knowledge, Attitude and Practices Regarding Green Eco-Friendly Dentistry Among a Group of Dentists
NCT Number: NCT06564454
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Knowledge, Attitudes, Practice
Interventions: OTHER: No intervention
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 272
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-16
Completion Date: 2024-09-02
Locations: Faculty of Dentistry, Cairo, 11559, Egypt

Summary:
Global warming, reduction in resources, increase in prices are all factors leading to more direction towards reuse, recycling, and reduction in use of materials. The World Dental Federation (FDI) considers sustainability to be an indispensable principle of Dentistry, which "must be practiced ethically, with high levels of quality and safety, in the pursuit of optimal oral health. Sustainability requires more attention from dental health professionals to reduce, recycle and reuse available resources.

Primary Outcome Measures: Knowledge, attitude, and practices regarding green eco-friendly Dentistry., Knowledge, attitude, and practices of dentists regarding green eco-friendly Dentistry using a validated questionnaire, the unit is percentage of participants answering each question., Immediately after the dentists complete the questionnaire
A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity
NCT Number: NCT06564441
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Overweight|Obesity
Interventions: DRUG: Survodutide|DRUG: Bupropion|DRUG: Caffeine|DRUG: Midazolam
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-05
Completion Date: 2025-11-12

Summary:
This study is open to adults with overweight or obesity who are otherwise healthy. People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion, caffeine, and midazolam in the blood.

The study has 2 treatment periods. In Period 1, participants take 1 dose each of midazolam, caffeine, and bupropion as tablets or oral solution on separate days. In Period 2, participants get BI 456906 as an injection under the skin once a week. At 2 selected timepoints in Period 2, participants also take midazolam, caffeine and bupropion as tablets or oral solution on separate days.

Participants are in the study for about 13 months. They visit the study site up to 45 times. At 3 of those visits, participants stay for 5 or 6 days at the study site. During the visits, doctors collect information about participants' health and take blood samples from the participants. They compare the amounts of midazolam, caffeine, and bupropion in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.

Primary Outcome Measures: Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞), Up to week 32|Area under the concentration-time curve of the caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞), Up to week 32|Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞), Up to week 32|Maximum measured concentration of bupropion in plasma (Cmax), Up to week 32|Maximum measured concentration of caffeine in plasma (Cmax), Up to week 32|Maximum measured concentration of midazolam in plasma (Cmax), Up to week 32
A Cohort Study of Genetic Ovarian Cancer Risk Prediction Models and Pathogenesis Exploration
NCT Number: NCT06564428
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Neoplasms
Interventions: GENETIC: Suspective gene mutations and family history
Sponsor: Peking University Third Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2026-12-31
Locations: Peking University Third Hospital, Beijing, Beijing, 100000, China

Summary:
The aim of this project is to establish a bidirectional multicenter cohort of hereditary ovarian cancer and to describe the clinicopathologic features of hereditary ovarian cancer patients in our country. The risk prediction model of ovarian cancer for Chinese was established by following-up analysis of clinical and pathological information, genetic test results and detailed family history, to predict the risk of cancer in first-degree relatives of carriers of pathogenic/suspected pathogenic mutations, and to guide the intervention management of high-risk population of cancer.

The study will identify novel tumor-causing mutations/predisposing genes by gene sequencing in a special family with hereditary tumor.

Primary Outcome Measures: The clinicopathological features and gene mutation characteristics of hereditary ovarian cancer, * personal history (age, BMI, oral contraceptive use, hormone replacement therapy use, tubal ligation)

  * menstrual marriage and childbearing history (whether or not menopause, menopausal age, menarche age, the number of births)

    * personal history of tumor (history of malignant tumor, tumor type, pathological type, tumor stage, age of onset) ④family history of cancer (family history of cancer or not, number/person of cancer in first/second/third degree relatives, relationship with patients, tumor type, pathological type, tumor stage, age of onset, gene detection) ⑤results of gene detection (detection items, specimen type, mutation, mutated gene, cDNA change, amino acid change, mutation type, mutation significance), 2024-2026
Secondary Outcome Measures: Newly diagnosed ovarian cancer in a first-degree relative, The pathological diagnosis was epithelial ovarian cancer, 2024-2026
Tailored MgSO4 Supplementation to Reduce Complications in Pediatric Heart Surgery
NCT Number: NCT06564376
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: AKI - Acute Kidney Injury|Arrythmia|Congenital Heart Disease
Interventions: DIAGNOSTIC_TEST: total magnesium|DEVICE: ionized magnesium
Sponsor: West Virginia University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-20
Completion Date: 2027-06
Locations: West Virginia University, Morgantown, West Virginia, 26506, United States

Summary:
Lay Summary

This study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems after surgery. The right amount of magnesium in blood reduces this risk. This study will test the best way to measure magnesium. This will let doctors choose the right dose of MgSO4. MgSO4 is a magnesium supplement. Taking MgSO4 after heart surgery helps children. For each child, it is best to personalize MgSO4 dose. This is based on the amount of magnesium in blood. This study will test two ways of personalizing MgSO4 dose.

In the blood, there are two kinds of magnesium. Usually, blood magnesium tests measure both forms together. This does not say anything about active magnesium. This study will measure the two forms separately. Then, MgSO4 will be given based on either the active or whole magnesium. Measuring active magnesium is good. Active magnesium levels change faster than total. That means active magnesium tests may better protect children. Also, active magnesium has more of an impact on heart and kidney function. Focusing on the active form will help these organs stay healthy.

To test how well the MgSO4 is working, heart and kidneys will be examined. After surgery, certain harmful heart rhythms can occur. The types and number of harmful rhythms will be studied. Kidney problems can also happen after heart surgery. Kidney health will be studied. To help understand how active magnesium works, further tests will be done. These tests will look for evidence of poor health in the cells that make up the heart, kidney, and blood.

Primary Outcome Measures: Duration from reanimation to sinus rhythm, 48 hours after reanimation|Time in non-sinus rhythms: within 24h of removing aortic cross-clamp, first 24 hours after reanimation|Time in non-sinus rhythms: 24-48h after removing aortic cross-clamp, 24-48 hours after reanimation|Presence of any arrhythmia, Defined as any non-sinus rhythm, 48 hours after reanimation|Urine NGAL concentration, Sensitive marker of acute kidney injury, 48 hours after reanimation|Urine Creatinine concentration, The combination of NGAL/Creatine increases sensitivity marker of acute kidney injury, 48 hours after reanimation
The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma
NCT Number: NCT06564363
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urothelial Carcinoma
Interventions: DIAGNOSTIC_TEST: IUrisure test
Sponsor: Wuhan Ammunition Life-tech Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 148
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2025-12-31
Locations: Peking University First Hospital, Beijing, China

Summary:
The clinical trial was designed to determine the efficacy (sensitivity and specificity) of the IUrisure test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of urothelial carcinoma.

Primary Outcome Measures: Specificity of IUrisure test, The proportion of negatives that are correctly identified as such by the gold standard, Day 1|Sensitivity of IUrisure test, The proportion of positives that are correctly identified as such by the gold standard, Day 1
Digitalization of Measuring Physical Performance
NCT Number: NCT06564350
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Physical Performance
Interventions: DEVICE: IMU (Inertial Measurement Unit) sensors
Sponsor: Yale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-27
Completion Date: 2023-08-11
Locations: Yale New Haven Hospital Rehabilitation and Wellness center, New Haven, Connecticut, 06520, United States

Summary:
Investigators will test the validity and reproducibility of the measurement of motor performance using wearables and the correlation of this measurement with function and mobility.

Primary Outcome Measures: Digitalized scores of physical performance, A percentage score, which determines how well a participant can do motor tasks for strength, balance, mobility, range of motion and tasks of activities of daily life. Computer software will be used to evaluate the test score of the patient using information from the wearable sensors. The resulting score will be evaluated with the help of a Regression Machine Learning Algorithm. These results will be compared to the assessment and scoring of physical performance by rehabilitation therapists that is based on observation. Higher percentage indicates better performance., up to 5 weeks
A Prospective Clinical Trial Evaluating Outcomes of Surveyed Zirconia Crowns
NCT Number: NCT06564337
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Removable Partial Denture|Dental Crown
Interventions: DEVICE: Surveyed zirconia crown
Sponsor: Neena DSouza
Collaborators: University of Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-06
Completion Date: 2031-12-31

Summary:
Zirconia has shown to be a suitable substitute for metal ceramic crowns when comparing survival, biological and technical complications. Evidence demonstrating the outcomes of surveyed zirconia crowns on removable partial denture abutments is unavailable. Zirconia as a substitute for metal ceramic is being currently used for fabricating surveyed crowns although quantitative data evaluating its efficacy is sparse. The purpose of this prospective clinical trial is to evaluate clinical outcomes when zirconia is used as a full coverage restoration on removable partial denture abutments. The study will be designed as a 3-5 year prospective observational trial in the University of Toronto undergraduate clinic in a controlled environment. Outcomes measures will include survival, biological and technical complications. Descriptive statistics will be used to summarize patient characteristics and outcomes and for categorical variables frequency and percentages will be reported. A level of significance 0.05 will be used for inferential analysis, with p-values \< 0.05 reported as statistically significant. It is expected that zirconia will demonstrate similar outcomes to traditional metal ceramic surveyed crowns.

Primary Outcome Measures: Survival, A. Survival will be recorded as the tooth with the crown still in function with or without 'clinical complications' during and up to the end of follow up. These will include but are not limited to

* occlusal adjustments,
* follow up sensitivity,
* open margins,
* recurrent decay,
* infection,
* endodontic treatment or retreatment,
* chipping of ceramic,
* recementation,
* non healing endodontic lesion,
* bone loss and associated periodontal problems., study follow up- every year for 3-5 years|Biological Complications, Biological failures will be recorded when the tooth is no longer present in the mouth either because of

* tooth or core fracture rendering the tooth non restorable,
* or the tooth extracted because of caries, infection or periodontal disease., study follow up- every year for 3-5 years|Technical Complications, Technical failures will be recorded when

* the zirconia crown fractures or
* needs to be replaced because of inadequate fit., study follow up- every year for 3-5 years|Success, Success will be recorded as all surviving crowns with no clinical complications., study follow up- every year for 3-5 years|Other complications, Not listed above, study follow up- every year for 3-5 years
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
NCT Number: NCT06564311
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Relapsing Multiple Sclerosis
Interventions: DRUG: Obexelimab|DRUG: Placebo
Sponsor: Zenas BioPharma (USA), LLC
Sex: ALL
Age: ADULT
Enrollment: 93
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: Aqualine Clinical Research, Naples, Florida, 35105, United States|MS Center for Innovations in Care, Saint Louis, Missouri, 63131, United States|Boster Center for MS, Columbus, Ohio, 43235, United States|MS Center of Greater Washington, Vienna, Virginia, 22182, United States

Summary:
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis

Primary Outcome Measures: Cumulative number of new GdE T1 hyperintense lesions, Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI, Week 8 and Week 12
Secondary Outcome Measures: Number of T2 Lesions, cumulative number of new and/or enlarging T2 weighted hyperintense lesions, Week 8 and Week 12|Number of GdE T1 lesions, number of new GdE T1 hyperintense lesions, Week 4, Week 8, and Week 12|Volume of T2 lesions, change from baseline in volume of T2 lesions, Week 12|Serum NfL, serum NfL, Week 12|Incidence of Adverse Events, injection site reactions and hypersensitivity reactions, Incidence of Adverse Events, injection site reactions and hypersensitivity reactions, serious adverse events, and adverse events of special interest, as defined by the CTCAE v5.0, 24 weeks
A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis
NCT Number: NCT06564298
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Stomach Neoplasms
Interventions: DRUG: Sintilimab|DRUG: Ramucirumab|DRUG: SOX/XELOX
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-06

Summary:
The goal of this clinical trial is to observe the efficacy and safety of Sintilimab (a PD-1 inhibitor) combined with Ramucirumab (a VEGFR-2 antagonist) and chemotherapy as a first-line treatment for patients with advanced gastric cancer with liver metastasis.

* Can the combination of Sintilimab, Ramucirumab, and chemotherapy improve the prognosis of patients with AGC and liver metastases?
* What are the adverse events (AEs) associated with the use of the combination regimen of Sintilimab, Ramucirumab, and chemotherapy in patients with AGC and liver metastases?

Participants will:

* Receive a combined treatment regimen of Sintilimab, Ramucirumab, and chemotherapy (SOX (oxaliplatin and S-1) or XELOX (oxaliplatin and capecitabine)), administered every 21 days for up to 6 cycles. Following the completion of 6 cycles, maintenance therapy with Sintilimab and oral chemotherapy agents (capecitabine or S-1) with or without Ramucirumab will be administered until disease progression.
* Imaging assessments will be performed at baseline, after every 2 cycles of treatment, and every 3 months following the completion of 6 cycles of treatment.

Primary Outcome Measures: Objective Response Rate (ORR), ORR was defined as the proportion of participants whose tumor volume decreases to a predefined value and can maintain the minimum duration requirements, which is the sum of the rates of Complete Response (CR) and Partial Response (PR) according to RECIST 1.1 based on investigator assessment., Up to approximately 12 months
Secondary Outcome Measures: Disease Control Rate (DCR), DCR was defined as the percentage of the participants who achieve either a response (PR + CR) or Stable Disease (SD) after treatment and can maintain the minimum duration requirements according to RECIST 1.1 based on investigator assessment., Up to approximately 12 months|Progression-free Survival (PFS), PFS was defined as the time from the start of treatment to disease progression according to RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first., Up to approximately 16 months|Overall Survival (OS), OS was defined as the time from enrollment to death due to any cause., Up to approximately 16 months|Incidence of adverse events and serious adverse events (AEs), Categorized according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0). Descriptive statistical analysis is primarily used to list and describe the AEs that occurred during this trial., Up to approximately 16 months
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Adults With Occasional Gastrointestinal Issues
NCT Number: NCT06564285
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Microbiome|Nutrition, Healthy|Exercise
Interventions: DIETARY_SUPPLEMENT: AG1 - Nutritional Supplement|DIETARY_SUPPLEMENT: Placebo
Sponsor: Athletic Greens International
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-28
Completion Date: 2025-03-31
Locations: Citruslabs, Santa Monica, California, 90404-3727, United States

Summary:
This study is a randomized, double-blind, placebo-controlled study of N=40 adult men and women with occasional GI issues. This study to assess the effect of a novel dietary supplement on improving nutrient gaps, Gastrointestinal (GI) symptoms, and the gut microbiome.

Primary Outcome Measures: Gut Microbiome, Examine changes in the gut microbiome via fecal polar metabolomics measured by LC/MS, 14 days|Nutrient Gaps, Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool, 14 days|Digestive Measures, A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life, 14 days|GI Symptoms, The Gastrointestinal Symptom Rating Scale will be provided to assess the effect of the intervention on GI symptoms. Scores range from 1 to 7 with a higher score indicating a higher level of discomfort, 14 days