pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
NCT Number: NCT06494761
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: zongertinib|DRUG: midazolam|DRUG: omeprazole|DRUG: repaglinide
Sponsor: Boehringer Ingelheim
Sex: MALE
Age: ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-10-08
Locations: Humanpharmakologisches Zentrum Biberach, Biberach, 88397, Germany

Summary:
The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.

Primary Outcome Measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), Up to 15 days|Maximum measured concentration of the analyte in plasma (Cmax), Up to 15 days
Secondary Outcome Measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), Up to 15 days
Evaluating the Efficacy of Artificial Intelligence Models in Predicting Intensive Care Unit Admission Needs
NCT Number: NCT06494748
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intensive Care Unit
Interventions: OTHER: Follow up Decision
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 398
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-12-02

Summary:
This study aims to evaluate the efficacy of two artificial intelligence (AI) models in predicting the need for ICU admissions. By comparing the AI models' predictions with actual clinical decisions, we aim to determine their accuracy and potential utility in clinical decision support.

Primary Outcome Measures: Intensive Care Unit Need, The primary outcome measure of this study is the accuracy of the predictions made by the artificial intelligence (AI) models, ChatGPT and Gemini, regarding the need for ICU admissions. This will be evaluated by comparing the AI model predictions to the actual clinical decisions made regarding ICU admissions., 1 day
Expansion of the T1DES Pilot to a Public Hospital
NCT Number: NCT06494722
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: BEHAVIORAL: Diabetes Education|BEHAVIORAL: T1DES
Sponsor: Kaiser Permanente
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust|Emory University|Grady Memorial Hospital
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-25
Completion Date: 2025-04-30
Locations: Grady Health System, Atlanta, Georgia, 30303, United States

Summary:
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

Primary Outcome Measures: Diabetes Distress, Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100., 3 months|Diabetes Distress, Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100., 6 months|Diabetes Distress, Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6., 3 months|Diabetes Distress, Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6., 6 months|A1C, Point of Care A1C, 3 months|A1C, Point of Care A1C, 6 months
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
NCT Number: NCT06494696
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DIAGNOSTIC_TEST: Ga-68 PSMA PET/MRI
Sponsor: Chang Gung Memorial Hospital
Collaborators: National Science and Technology Council
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 71
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2027-05-31
Locations: Chang Gung Memorial Hospital ,Linkou, Taoyuan City, 333, Taiwan

Summary:
The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are:

1. Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer?
2. Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy?

Participants will:

1. Undergo a Ga-68 PSMA PET/MRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan.
2. Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.

Primary Outcome Measures: PPV of concordant PET/MRI lesion plus PI-RADS score 4~5, Comparing positive predictive values (PPV) of using concordant PET/MRI lesion plus PI-RADS score 4\~5 as positive test with PPV of using PI-RADS 4\~5 alone as positive test to predict diagnosing prostate cancer within 2 years., 2 years after PSMA PET/MRI scan|NPV of using negative PET lesion plus PI-RADS score 1~3, Comparing negative predictive values (NPV) of using negative PET lesion plus PI-RADS score 1\~3 as negative test with NPV of using PI-RADS 1\~3 alone as negative test to predict diagnosing prostate cancer within 2 years., 2 years after PSMA PET/MRI scan
Trends in Prevalence of 11 Site-specific Musculoskeletal Pain Among U.S. Adults, 1999-2018
NCT Number: NCT06494670
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Musculoskeletal Pain|Neck Pain|Low Back Pain|Joint Pain|Shoulder Pain
Interventions: OTHER: No intervention
Sponsor: Fan luying
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 565219
Study Design: Observational Model: |Time Perspective: p
Start Date: 1999-01-01
Completion Date: 2024-12-31

Summary:
The goal of this observational study is to explore the prevalence trends of 11 site-specific musculoskeletal pain from 1999 to 2018. The main question it aims to answer is:

Does the prevalence of musculoskeletal pain among U.S. adults changed from 1999 to 2018? What are the trends?

Participants will answer survey questions about their musculoskeletal pain on the past three months.

Primary Outcome Measures: Musculoskeletal pain, Participants aged 18 years or older were asked the following questions: "During the past three months, did you have \[neck pain, low back pain, or jaw/front of ear pain\]?" and "During the past 30 days, did you have joint pain?". Participants who answered affirmatively to joint pain were then asked to report the site of their joint pain. The options included shoulder, elbow, hip, wrist, knee, ankle, toes, and Participants aged 18 years or older were asked the following questions: "During the past three months, did you have \[neck pain, low back pain, or jaw/front of ear pain\]?" and "During the past 30 days, did you have joint pain?". Participants who answered affirmatively to joint pain were then asked to report the site of their joint pain. The included shoulder, elbow, hip, wrist, knee, ankle, toes, and fingers/thumb., 1999-2018
A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants.
NCT Number: NCT06494644
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: AZD6793|DRUG: Itraconazole|DRUG: AZD6793+ Itraconazole
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-23
Completion Date: 2024-09-23
Locations: Research Site, Berlin, 14050, Germany

Summary:
The study will evaluate the pharmacokinetics (PK) of AZD6793 when administered alone and in combination with itraconazole in healthy adult participants.

Primary Outcome Measures: Maximum plasma drug concentration (Cmax), The effect of itraconazole on the single-dose Cmax of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast), The effect of itraconazole on the single-dose AUClast of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Area under plasma concentration-time curve from time 0 to infinity (AUCinf), The effect of itraconazole on the single-dose AUCinf of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Apparent total body clearance (CL/F), The effect of itraconazole on the single-dose CL/F of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Terminal elimination half-life (t1/2λz), The effect of itraconazole on the single-dose t1/2λz of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Time to reach maximum observed concentration (tmax), The effect of itraconazole on the single-dose tmax of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Apparent volume of distribution during the terminal phase (Vz/F), The effect of itraconazole on the single-dose Vz/F of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Ratio Area under plasma concentration-time curve from time 0 to infinity (RAUCinf), The effect of itraconazole on the single-dose RAUCinf of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Ratio Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (RAUClast), The effect of itraconazole on the single-dose RAUClast of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11|Ratio Maximum plasma drug concentration (RCmax), The effect of itraconazole on the single-dose RCmax of AZD6793 will be evaluated in healthy participants., Day 1, Day 8, and Day 11
Secondary Outcome Measures: Number of participants with adverse events, The safety and tolerability after administration of AZD6793 with itraconazole will be evaluated., From first dose (Day 1) until Follow-up (10-15 days post last itraconazole dose)
Effects of Botulinum Toxin Injection Combined With rESWT in Lower Extremity Spasticity in Children With Cerebral Palsy
NCT Number: NCT06494618
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy, Spastic
Interventions: DEVICE: Radial Extracorporeal Shockwave Therapy
Sponsor: Istanbul Medeniyet University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2025-01-15
Locations: Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, Kadikoy, 34722, Turkey

Summary:
This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy

Primary Outcome Measures: Modified Aschworth Scale, Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4., 3 months (before injection, first week, first month and third month after injection.)|Modified Tradiue Scale, Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4., 3 months (before injection, first week, first month and third month after injection.)|Modified Timed Up and Go Test, The test for evaluate the functionality of pediatric patients with cerebral palsy. Only one chair and a surface for the patient to walk three meters are required. The time it takes for the patient to get up from the chair, walk the specified distance and sit back in the chair is recorded., 3 months (before injection, first week, first month and third month after injection.|Facies Pain Scale Revised, The scale for evaluate the pain level of pediatric patients. Chosen faces are scored 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain.", 3 months (before injection, first week, first month and third month after injection.)|Passive Range of Motion, Goniometric measurement of the range of motion of the joint of the injected muscle, 3 months (before injection, first week, first month and third month after injection.)|Goal Attaintment Scale, The method of scoring the extent to which patient's individual goals are achieved in the course of intervention. GAS comprises of goals divided into a 5-point scale from -2 to +2.

Achievement of goal = 0 Achieved somewhat more than expected outcome = +1 Achievement of much more than expected goal = +2 Achievement of somewhat less than expected goal = -1 Achievement of much less than expected goal = -2, 3 months (before injection, first week, first month and third month after injection.)
Omega-3 Supplementation After Surgical Treatment of Obesity
NCT Number: NCT06494566
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Obesity
Interventions: DIETARY_SUPPLEMENT: Omega-3|DIETARY_SUPPLEMENT: Mineral Oil
Sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2019-04-10
Completion Date: 2023-12-04
Locations: Irmandade Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, 90035-072, Brazil|Instituto de Cardiologia, Porto Alegre, Rio Grande Do Sul, 90040-371, Brazil

Summary:
The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.

Primary Outcome Measures: Weight, Measurement with digital scale, patient standing, barefoot. kilograms (kg), Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.|Height, Height measurement, patient standing, barefoot. Unit of measurement: meters (m)., Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
Secondary Outcome Measures: Manual Grip Strength, Best of three handgrip strength measurements, patient seated, arm supported. Unit of measurement: kilograms-force (kgf)., Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.|6-Minute Walk Test, Walking with measurements of distance covered. Units of measurement: meters., Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.|Electrical Bioimpedance - Percentage of muscle mass, Electrical bioimpedance scale measurement. Unit of measurement: percentage (%)., Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.|Electrical Bioimpedance - Body fat percentage, Electrical bioimpedance scale measurement. Unit of measurement: percentage (%)., Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.
A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults
NCT Number: NCT06494527
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Safety Issues
Interventions: DRUG: RG002C0106
Sponsor: Rigerna Therapeutics, Beijing； Rigerna Therapeutics, Suzhou； Rigerna OA Therapeutics Pty Ltd
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2025-12-31

Summary:
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:

Part A, conducted : SAD stage Part B, conducted: MAD stage

Primary Outcome Measures: Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug, Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug, up to 169 days
NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer
NCT Number: NCT06494514
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Locally Advanced Pancreatic Cancer
Interventions: DRUG: nal-IRI+Oxaliplatin+5-FU/LV+PD-1|DRUG: Gemcitabine + albumin-paclitaxel+PD-1
Sponsor: Du Juan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2027-04-01
Locations: FirstNanjingMU, Nanjing, Jiangsu, 025, China|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 025, China

Summary:
The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.

Primary Outcome Measures: mPFS, Time from randomization to disease progression and/or death., Up to 12 months
Secondary Outcome Measures: mOS, Time from randomization to death, Up to 24 months|ORR, According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement., Up to 12 months|DCR, According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) and stable lesion (SD) after treatment and maintained the minimum time-frame requirements., Up to 12 months
The Prevent Coronary Artery Disease Trial
NCT Number: NCT06494501
Acronym: PRECAD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Atherosclerotic Cardiovascular Disease
Interventions: DRUG: Inclisiran
Sponsor: Icahn School of Medicine at Mount Sinai
Sex: ALL
Age: ADULT
Enrollment: 1600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2032-06-30
Locations: Mount Sinai Fuster Heart Hospital, New York, New York, 10029, United States

Summary:
Despite increasing evidence that exposure to cardiovascular risk factors (CVRF) at an early age increases the prevalence of subclinical atherosclerosis and is associated with a greater risk of cardiovascular events later in life, there is a lack of randomized trial evidence to support primary prevention strategies in adults aged 30-50 years. The researchers have designed a randomized controlled trial to evaluate whether strict control of CVRF in young adults without known cardiovascular disease, will reduce the progression of total atherosclerosis burden, a surrogate endpoint for symptomatic cardiovascular disease, compared with usual care.

The researchers propose a randomized controlled trial enrolling 1,600 healthy young adults who meet the inclusion criteria and who do not meet any exclusion criteria. Eligible study participants will be randomized, in a 1:1 ratio, to either the intervention group (active treatment strategy) or to the control group (guideline-directed medical therapy). Randomization will be stratified by the presence or absence of atherosclerotic plaque in vascular ultrasound.

Primary Outcome Measures: Change in atherosclerotic plaque burden from baseline, Change in atherosclerotic plaque burden at 2.5 years and the last year of follow up from baseline as measured by the 3D vascular ultrasound. Atherosclerotic plaque burden is amount of plaque in the arteries., Baseline, 2.5 years and 5 years after randomization
Secondary Outcome Measures: Change in Number of participants with Cardiovascular Disease (CVD), Change in Number of participants with Cardiovascular Disease (CVD) at 5 years as compared to baseline. CVD includes myocardial infarction, stroke, revascularization), cardiovascular death and all cause death., Baseline and 5 years after randomization
Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL).
NCT Number: NCT06494488
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Lipid Metabolism Disorders
Interventions: DRUG: EPA|DRUG: DHA
Sponsor: The Miriam Hospital
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08-01
Completion Date: 2028-03-31

Summary:
Epidemiological studies suggest that consumption of omega-3 polyunsaturated fatty acids (n-3 PUFAs) derived from fish oil, mainly consisting of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is associated with lower cardiovascular risk. However, interventional clinical trials aimed at reducing cardiovascular incidents by n-3 PUFAs supplementations have yielded inconsistent results. An intriguing fact is that only the outcome trials using EPA, but not those testing EPA/DHA mixed regimens, showed beneficial results. This discrepancy begs the question of whether EPA and DHA have differential effects and whether DHA blunts the cardiovascular benefits of EPA. However, no head-to-head clinical trial comparison of the biological effects of EPA and DHA in the hyperlipidemia patients has been reported. Hence, a well-designed, controlled, proof-of-concept clinical study testing EPA versus DHA in a relevant population is urgently required. In this study, the human subjects with atherogenic dyslipidemia will be randomized to dietary supplementation with four grams of either EPA or DHA n-3 PUFAs for eight weeks. At baseline and after the supplementation, various markers of thrombogenesis will be assessed, including biomarkers of the clotting cascade, thromboelastography, urinary thromboxane metabolites, whole blood aggregation, platelet aggregation, and flow cytometry analysis of platelets and platelet-leukocyte aggregates will also be performed.

Primary Outcome Measures: Platelet function., Platelet aggregation area under the curve will be used as primary endpoint. Specifically, the percentage of platelet aggregation multiple time will be calculated to get area under the curve as a comprehensive marker for platelet aggregation response., 8 weeks
Secondary Outcome Measures: Platelet function., Secondary endpoints include platelet activation measured as P-selectin level by flow cytometry, urinary thromboxane metabolite, PFA-100 function, inflammation markers and SPM levels., 8 weeks
GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age
NCT Number: NCT06494475
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Streptococcus Agalactiae Infection
Interventions: DRUG: GBS-NN/NN2 vaccine|DRUG: Tdap vaccine|DRUG: Placebo
Sponsor: Minervax ApS
Sex: FEMALE
Age: ADULT
Enrollment: 564
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-12-17
Completion Date: 2025-06-21

Summary:
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration of GBS-NN/NN2 and Tdap, to evaluate the reactogenicity of GBS NN/NN2 when administered alone or in combination with Tdap, and to evaluate the safety of GBS-NN/NN2 when administered alone or in combination with Tdap in terms of serious adverse events (SAEs) and unsolicited adverse events (AEs).

Primary Outcome Measures: Number of Participants Expressing Anti-tetanus Toxoid Antibody Concentration ≥0.1 IU/mL, Day 85|Number of Participants Expressing Anti-diphtheria Toxoid Antibody Concentrations ≥0.1 IU/mL, Day 85|Number of Participants Expressing Anti-pertussis Toxin Antibodies, Day 85|Number of Participants Expressing Anti-filamentous Hemagglutinin (FHA) Antibodies, Day 85|Number of Participants Expressing Anti-pertactin (PRN) Antibodies, Day 85|Number of Participants Expressing RibN Antibody, Day 85|Number of Participants Expressing Alp1N Antibody, Day 85|Number of Participants Expressing Alp2N Antibody, Day 85|Number of Participants Expressing AlpCN Antibody, Day 85|Number of Participants Experiencing Solicited Local Adverse Events (AEs), Day 63|Number of Participants Experiencing Solicited Systemic AEs, Day 63|Number of Participants Experiencing Unsolicited AEs, Day 85|Number of Participants Experiencing SAEs, An SAE is any occurrence that results in death, poses a life-threatening situation, necessitates inpatient hospitalization or the extension of an existing hospital stay, leads to persistent or significant disability or incapacity, involves a congenital anomaly or birth defect, or is considered an important medical event that, while not resulting in death, being life-threatening, or requiring hospitalization, still warrants serious concern., Day 85
Secondary Outcome Measures: Number of Participants Experiencing Medically-attended Adverse Events (MAAEs), A MAAE is defined as an AE that leads to an unscheduled visit to a health care professional., Day 85
Effect of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on DIT
NCT Number: NCT06494449
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy|Overweight and Obesity
Interventions: OTHER: Higher protein|OTHER: Lower protein
Sponsor: Midwest Center for Metabolic and Cardiovascular Research
Collaborators: General Mills
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2024-11

Summary:
The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity.

Primary Outcome Measures: Diet Induced Thermogenesis (DIT) AUC, Change in DIT assessed as the area under the curve (AUC), Pre-consumption (0 minutes) to 300 minutes
Secondary Outcome Measures: DIT niAUC, Change in DIT assessed as the net incremental area under the curve (niAUC), Pre-consumption (0 minutes) to 300 minutes|Carbohydrate oxidation, Change in carbohydrate oxidation assessed as the AUC and niAUC, Pre-consumption (0 minutes) to 300 minutes|Fat oxidation, Change in fat oxidation assessed as the AUC and niAUC, Pre-consumption (0 minutes) to 300 minutes|Respiratory Exchange Ratio (RER), Change in RER assessed as the AUC and niAUC, Pre-consumption (0 minutes) to 300 minutes
Microvention AnEurysm & STroke Real-life Data cOllection
NCT Number: NCT06494436
Acronym: MAESTRO-1
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intracranial Aneurysm|Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion|Aneurysmal Subarachnoid Hemorrhage
Interventions: DEVICE: All Microvention Class III implantable device CE marked
Sponsor: Microvention-Terumo, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-30
Completion Date: 2030-06-30

Summary:
The MAESTRO-1 registry is a post-market, single-arm, non-interventional, multicenter registry

Primary Outcome Measures: Proportion of aneurysms with complete occlusion, based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory, 18 (±6) months
Effect of High Versus Low Fraction of Inspired Oxygen During Alveolar Recruitment
NCT Number: NCT06494410
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bariatric Surgery Candidate|Atelectasis
Interventions: PROCEDURE: High versus Low Fraction of Inspired Oxygen
Sponsor: Egymedicalpedia
Collaborators: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-07
Completion Date: 2024-07-10
Locations: Ain Shams University Hospitals, Cairo, Abbasia, Egypt

Summary:
Intraoperative absorption atelectasis is associated with decreased lung compliance, impaired oxygenation, increased pulmonary vascular resistance, and lung injury.

The alveolar recruitment maneuver (RM) with positive-end expiratory pressure (PEEP) has been advocated as efficient for absorption atelectasis treatment.

During general anesthesia, absorption atelectasis reportedly occurs in most patients especially during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance

Primary Outcome Measures: Modified Lung Ultrasound Score (LUSS), 1. Modified LUSS at surgery completion compared to baseline preoperative modified LUSS, reflecting any aeration loss during general anesthesia., from 0 hours to 6 hours after the procedure
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
NCT Number: NCT06494397
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Schizophrenia|Bipolar I Disorder
Interventions: DRUG: VHX-896 and iloperidone|DRUG: Iloperidone and VHX-896
Sponsor: Vanda Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-09
Locations: Vanda Investigational Site, Los Alamitos, California, 90720, United States|Vanda Investigational Site, Gaithersburg, Maryland, 20877, United States|Vanda Investigational Site, Marlton, New Jersey, 08053, United States

Summary:
Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state conditions.

Primary Outcome Measures: Bioequivalence between VHX-896 tablets relative to iloperidone tablets, As measured by plasma concentrations, 12 hours
Secondary Outcome Measures: Assessment of safety and tolerability of VHX-896 and iloperidone, As measured by spontaneous reporting of adverse events (AEs)., 24 days
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
NCT Number: NCT06494345
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Allergic Asthma
Interventions: BIOLOGICAL: Genolair, solution for subcutaneous administration, 150 mg|BIOLOGICAL: Genolair, lyophilisate for the preparation of solution for subcutaneous administration|BIOLOGICAL: Xolair®, solution for subcutaneous administration, 150 mg
Sponsor: AO GENERIUM
Sex: ALL
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-01-15
Completion Date: 2024-06-09
Locations: State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department", Moscow, 117556, Russian Federation

Summary:
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in healthy volunteers

Primary Outcome Measures: Pharmacokinetics: Peak Plasma Concentration (Cmax), Analysis of equivalence of Cmax, Day 85|Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity, Day 85
Secondary Outcome Measures: Proportion of participants with Adverse Events (AE), The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\]), Day 85|Area under the curve "Relative difference in the free IgE concentration compared to the initial value - time", Time-points: 5-15 minutes before drug administration, in 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 984, 1344, 1680, 2016 hours after drug administration, 2016 hours
Characterization of Olfactory Perception in Post-Traumatic Stress Disorder
NCT Number: NCT06494306
Acronym: TRAUMODO
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Post Traumatic Stress Disorder
Interventions: BEHAVIORAL: European Test of Olfactory Capabilities (ETOC)|BEHAVIORAL: Standardized Hedonicity Test|BEHAVIORAL: Questionnaires|BEHAVIORAL: Odor / trauma association questionnaire
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-26
Completion Date: 2026-08-25
Locations: Auvergne-Rhône-Alpes Regional Center for Psychotrauma, Lyon, 69003, France

Summary:
The core symptoms of post-traumatic stress disorder (PTSD) include flash backs, intrusive pictures and thoughts related to the traumatic event, hyperalertness, avoidance of traumatic relevant environmental triggers and emotional dysregulation. Some studies suggest that PTSD is also associated with impaired olfactory perception, which seems quite intuitive regarding the close anatomical-functional connections between olfactory and emotional circuits. Furthermore, some studies reported that olfactory stimuli can trigger flashbacks in subjects with PTSD. However, up to know available data is scarce and heterogeneous concerning that topic. The goal of the study is to determine the olfactory phenotype of subjects with PTSD. More precisely, this project aims at filling the above mentioned gap by systematically assessing the olfactory perception of subjects with PTSD along five dimensions: olfactory identity, hedonic value, familiarity, desirability and edibility. As a secondary goal, the relative weight of olfaction compared to the other senses in the relived memories of subjects with PTSD will be assessed.

The investigators here hypothesize a global impairment in olfactory processing (intensity, hedonicity, familiarity and edibility judgments) in PTSD subjects, compared with healthy subjects.

Primary Outcome Measures: Standardized Hedonicity Test score, Results obtained in patients will be compared to those obtained in control group, at inclusion
Secondary Outcome Measures: Effects of potential moderators on odor judgement, Analysis of covariance (ANCOVA) to determine the effect of different moderators (age, gender, type of trauma, time elapsed since trauma, type of treatment received, symptom intensity) on olfactory perception, at inclusion|Evaluation of sensory impressions of memories evoked by certain odors., Sensory impressions: Nature and frequency of sensory descriptions associated with odor-evoked memories, at inclusion|Evaluation of emotional valence of memories evoked by certain odors., Language analysis: Use of Natural Language Processing (NLP) techniques to assess the emotional valence of odor-evoked memories and recurrent themes in oral responses concerning evoked memories. Analysis of the association of trauma-related odors with the 5 senses, at inclusion
Post-Operative Prediction of PulmonarY Function
NCT Number: NCT06494254
Acronym: POPPY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Sponsor: University of Sydney
Collaborators: Royal North Shore Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-12

Summary:
Prediction of postoperative lung function is currently based on anatomical segment counting (ASC), which incorporates pulmonary function test (PFT) results. Standard PFTs such as spirometry can only measure pulmonary capacity as an average over the entire lung and do not take regional function differences into account. Nuclear medicine is recommended where regional functional imaging is required to inform surgical decisions. However, nuclear medicine scans are expensive, time consuming and not available in all institutions. CT-ventilation imaging is a cheaper and more accessible alternative to nuclear medicine for informing lung cancer patient treatment choices.

The primary aim is to quantify the difference between predicted postoperative values of pulmonary function metrics derived from CT ventilation imaging and standard anatomical segment counting method.

Primary Outcome Measures: The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1, The accuracy of CT ventilation imaging compared to ASC in predicting postoperative values of the pulmonary function metric FEV1 will be assessed via a comparison with actual postoperative values measured from PFTs. CT ventilation images will be used to produce regionally-informed ppoFEV1 by proportionally reducing the pre-surgery FEV1 by the proportion of ventilation lost by removal of the surgical target section of lung. As this is an investigative study, it is not powered for a statistical analysis. Bland-Altman analysis will be used to quantify the ability of ASC and CT ventilation to predict ppoFEV1, 1 week
Secondary Outcome Measures: The accuracy of CT ventilation imaging in predicting ppoFEV1, The accuracy of CT ventilation imaging in predicting ppoFEV1will be compared to that of SPECT ventilation imaging. Bland-Altman analysis will be used to quantify the ability of SPECT and CT ventilation to predict ppoFEV1, 1 week|The regional pattern of ventilation from CT ventilation imaging will be compared to ventilation from SPECT using Spearman correlation., The average Spearman correlation across all patients will be \> 0.6., 1 week|The regional pattern of perfusion from CT perfusion imaging will be compared to perfusion from SPECT using Spearman correlation., The average Spearman correlation across all patients will be \> 0.6., 1 week
Comparison of Diagnostic Performances of 3D FLAIR, DIR and PSIR Sequences in Optic Neuritis
NCT Number: NCT06494228
Acronym: Optic-Neuritis
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis|Demyelinating Diseases
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-19
Completion Date: 2025-01-19
Locations: Service de Radiologie II, CHU de Strasbourg, Strasbourg, Les Hôpitaux Universitaires De Strasbourg, 67091, France

Summary:
Ultimately improve the care of patients suffering from multiple sclerosis (1st cause of acquired non-traumatic disability in adults) and NMO spectrum diseases by using more efficient MRI sequences than the FLAIR sequence commonly used in detection of optic neuritis.

In the literature, many studies have already focused on comparing the sensitivity of detection of white matter demyelination plaques using FLAIR, PSIR or DIR sequences.

Some authors have shown better sensitivity of the PSIR sequence in the detection of demyelinating lesions of the marrow in multiple sclerosis compared to conventional sequences.

Others have shown better performance of the combined use of PSIR and DIR sequences compared to the FLAIR sequence in the detection of cortical lesions in multiple sclerosis.

However, in the context of optic neuritis, few comparative studies comparing these three sequences have been carried out:

A 2022 study showed better diagnostic sensitivity of optic neuritis of the DIR sequence compared to the FLAIR sequence.

A possible better diagnostic performance of a sequence not used in current practice in the detection of optic neuritis (PSIR and DIR sequences), would be possible to justify their use on a larger scale and ultimately improve patient care.

Primary Outcome Measures: Comparison of the radiologist's degree of diagnostic confidence based on the three sequences (3D FLAIR, 3D DIR and 3D PSIR sequences)., During their analysis, each investigator fills out an interpretation grid for each series, where they indicate the presence or absence of optic neuritis and the degree of confidence they attribute to it on a scale of 1 to 5.

During their analysis, each investigator fills out an interpretation grid for each series, where they indicate the presence or absence of optic neuritis and the degree of confidence they attribute to it on a scale of 1 to 5.

A score of 5 shows that the level of confidence is very good., One month after brain MRI
Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Patients
NCT Number: NCT06494215
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asynchrony, Patient-Ventilator|ARDS|Respiratory Insufficiency|Respiratory Effort-Related Arousal &#X7C; Patient &#X7C; Respiratory Measures and Ventilator Management
Interventions: OTHER: Pressure Support Variation and Calculation of Respiratory Mechanics
Sponsor: University of Sao Paulo General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-11
Completion Date: 2025-06-11
Locations: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo, 05403-900, Brazil

Summary:
The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. The measurement of Pendelluft is still uncertain in the literature, and although various methods have been proposed, not all have the same meaning in terms of pulmonary overstress and overstrain. This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography.

Primary Outcome Measures: 1. Magnitude of Pendelluft, Three differents methods of estimating magnitude of Pendelluft shall be compared using a software based on electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil), During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS|2. Magnitude of Pendelluft during inspiratory pause, One of the methods of Pendelluft measurement shall be performed during an inspiratory pause for comparison with a normal cycle (without pause)., During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS|3. Magnitude of respiratory effort, Respiratory effort shall be estimated through expiratory pauses and though recording of esophageal pressure at different pressure support levels. These data shall be compared to Pendelluft magnitude according to the different methods of calculation, During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS
Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma
NCT Number: NCT06494189
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Head and Neck Cancer
Interventions: BIOLOGICAL: Tislelizumab|DRUG: Afatinib|RADIATION: Low dose radiotherapy
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-12-31
Locations: West China Hospital, Sichuan University, Chengdu, Sichuan, 610000, China

Summary:
The purpose of this study was to evaluate the safety and tolerability of low-dose radiotherapy plus tislelizumab in combination with afatinib neoadjuvant therapy for patients with surgically resectable squamous carcinoma of the head and neck.

Primary Outcome Measures: The incidence of dose-limiting toxicity (DLT) Incidence., Dose-Limiting Toxicity (DLT) is the maximum safe dose of radiotherapy that a patient can tolerate in an experiment., Intraoperative
Secondary Outcome Measures: Major Pathologic Response, Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells., Intraoperative|Pathologic Complete Response, Pathologic Complete Response (pCR) was defined as the absence of viable tumor cells., Intraoperative|Objective Response Rate, Objective Response Rate (ORR) was defined as the percentage of participants with a best overall response of CR or PR using RECIST Criteria, Up to 8 weeks|Adverse events, Adverse events were defined as the number of participants with adverse events using CTCAE Criteria or with an unplanned surgery delay., Up to 12 weeks|Disease-free Survival, Disease-free Survival (DFS) was defined as the time from the administration of the first dose to first disease progression or death., 1 year