pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
NCT Number: NCT06493253
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Interventions: DIAGNOSTIC_TEST: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
Sponsor: PharmaNest, Inc
Collaborators: Nonalcoholic Steatohepatitis Clinical Research Network (NASH)|Virginia Commonwealth University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1700
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-08-01
Locations: Virginia Commonwealth University, Richmond, Virginia, 23284, United States

Summary:
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Primary Outcome Measures: Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS, Area under Receiver Operating Characteristic Curve (AUROC) of the FibroNest PT-Ph-FCS, as a prognostic/diagnostic biomarker for liver related events in patients with MASH., Time-to-event analysis between 2 and 10 years
Secondary Outcome Measures: Performance of Hepatic Decompensation Event predictive value of the NASH-CRN Fibrosis Stage, Area under Receiver Operating Characteristic Curve (AUROC) of the NASH-CRN Fibrosis Stage, as a prognostic/diagnostic biomarker for liver related events in patients with MASH., Time-to-event analysis between 2 and 10 years|Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test, Area under Receiver Operating Characteristic Curve (AUROC) of the elastography (Fibroscan) biomarker, as a prognostic/diagnostic biomarker for liver related events in patients with MASH., Time-to-event analysis between 2 and 10 years
Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer
NCT Number: NCT06493240
Acronym: NLCCRIT-LARC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced Rectal Cancer
Interventions: RADIATION: radiation|DRUG: PD-1 Monoclonal Antibody|PROCEDURE: TME surgery
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2025-04-01
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China

Summary:
The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.

Primary Outcome Measures: pCR rate, pathological complete response rate, within 1 week after surgery
Secondary Outcome Measures: sphincter preserving rate, proportion of patients with preserved anal sphincter, instantly after surgery|immune-related adverse event rate, adverse event rate that is deemed to be associated with PD-1 inhibition, from commencing of PD-1 inhibition to the 30th day after surgery|treatment-related adverse event rate, adverse event rate that is deemed to be associated with all treatments, from commencing of treatment to the 30th day after surgery|incidence rate of surgical complications, incidence rate of surgical complications within 30 days after surgery, within 30 days after surgery
Postoperative Infusion of Fibrinolysis Inhibitors After Cardiac Surgery
NCT Number: NCT06493227
Acronym: PRIORITY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thoracic Surgery|Heart Diseases|Fibrinolysis Shutdown
Interventions: OTHER: No routine fibrinolysis inhibitors after surgery|OTHER: Routine fibrinolysis inhibitors after surgery
Sponsor: Saint Petersburg State University, Russia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1373
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-20
Completion Date: 2026-06-01
Locations: St. Petersburg State University Hospital, Saint Petersburg, Russian Federation

Summary:
PRIORITY is a pragmatic, multi-center, cluster crossover trial that aims to evaluate whether implementing a policy of routine intraoperative and postoperative use of fibrinolysis inhibitors leads to a decrease in post-operative blood transfusion compared to a policy that only involves intraoperative use.

Primary Outcome Measures: RBC transfusion, The rate of red blood cells transfusion during the hospitalisation., From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Secondary Outcome Measures: Hospital stay, Duration of stay in the hospital, days, From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months|Redo surgery requirement, Rate of reexplorations during the initial hospitalisation, From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months|Haemoglobin on discharge, The last available blood haemoglobin level before the discharge, From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months|Total blood products requirement, Number blood products transfused, units, From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Research Into Risk Factors for Hospitalization Following a Fall in Older Patients
NCT Number: NCT06493201
Acronym: FDR-HPC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Accidental Falls
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-08
Completion Date: 2025-03-08
Locations: Service de Gériatrie Aigue - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
Every year, a considerable number of older people fall, with a variety of consequences. These falls can lead to hospitalization, with consequent adverse effects on these people, as well as a significant cost to society. The risk factors for falls themselves are well identified, but not those that lead to hospitalizations in older people who all fall. Some risk factors, such as age, cannot be modified. With a view to preventing hospitalizations in older patients who fall, The investigators aimed to identify functional, and therefore modifiable, risk factors for hospitalizations in patients who fall, such as gait parameters. The investigators hope that the results of this study will lead to early identification of the risk of hospitalization in these patients and thus to appropriate rehabilitation as early as possible to limit this risk.

Primary Outcome Measures: Gait parameters assessed using the GAITrite® mat, The recorded GAITrite® data consisted of:

* gait speed : in (cm/s)
* cadence: in (steps/min)
* step time and cycle time : in (s)
* step length and stride length : in (cm), The outcome measure is assessed at inclusion
Low VS High-fidelity Interprofessional Simulation for ABG Skills Acquisition
NCT Number: NCT06493188
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Interprofessional Relations|Self Efficacy|Knowledge, Attitudes, Practice
Interventions: OTHER: High-fidelity interprofessional simulation|OTHER: Low-fidelity interprofessional simulation
Sponsor: University of Turin, Italy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-05-28
Completion Date: 2024-11-30
Locations: University of Torino - Department of Clinical and Biological Sciences, Orbassano, Torino, 10043, Italy

Summary:
This randomized clinical trial aims to determine whether a high-fidelity interprofessional simulation laboratory can improve interprofessional collaboration, attitudes, and knowledge regarding arterial blood gas (ABG) tests in medical and nursing students. The key questions it seeks to address are:

1. Does high-fidelity interprofessional simulation help in developing better technical skills for ABG testing?
2. Does high-fidelity interprofessional simulation lead to greater satisfaction with the experience, readiness for interprofessional simulation, and better perceptions of interprofessional education?
3. Does high-fidelity interprofessional simulation lead to greater self-efficacy and self-confidence?

The researchers will compare high-fidelity interprofessional simulation to low-fidelity interprofessional simulation (a structured clinical case analysis) to assess whether high-fidelity simulation effectively enhances interprofessional collaboration, attitudes, and knowledge on arterial blood gas tests.

Participants will:

* Attend brief interactive lessons on the principles, technique, and interpretation of arterial blood gas tests.
* Participate in a series of clinical-based interprofessional simulation scenarios delivered in low- or high-fidelity.

Primary Outcome Measures: Evaluation of Attitudes and Practices during the simulation, Purposefully Developed 30-item Checklist, 10 minutes - During the simulation scenarios|Interdisciplinary Education Perception Scale - IEPS, A 18-item questionnaire targeted at evaluating the perception of interprofessional education, 10 minutes Pre-intervention and post-intervention, after 2 hours|Readiness for Interprofessional Learning Scale - RIPLS, A 19-item questionnaire targeted at evaluating the readiness for interprofessional education, 10 minutes Pre-intervention and post-intervention, after 2 hours
Secondary Outcome Measures: General Self Efficacy Scale - GSE, A 10-item questionnaire assessing the level of self-efficacy, 10 minutes Pre-intervention and post-intervention, after 2 hours|Student Satisfaction and Self-Confidence in Learning - SCLS, A 13-item questionnaire assessing the self-confidence acquired in learning, Post-intervention, after 2 hours|Satisfaction with simulation experience - SSE, A 18-item questionnaire to assess the perceived satisfaction with simulation, Post-intervention, after 2 hours
The Application of Large Language Model in Emergency Chest Pain Triage
NCT Number: NCT06493175
Acronym: ALERT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chest Pain
Interventions: DIAGNOSTIC_TEST: Application of large language model in emergency chest pain triage.|DIAGNOSTIC_TEST: According to the normal procedures to receive medical treatment
Sponsor: Peking University Third Hospital
Collaborators: Jinan Central Hospital|Qingdao Municipal Hospital|Tianjin Medical University General Hospital|The First Hospital of Hebei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-12-20
Completion Date: 2024-12-20
Locations: Peking University Third Hospital, Beijing, Beijing, China

Summary:
This study will evaluate the accuracy and efficiency of large language model in emergency triage.

Primary Outcome Measures: The Diagnostic Accuracy Rate of MedGuide-V5, To assess the consistency of the diagnosis of chest pain made by physicians with the assistance of large language models with the actual diagnosis made by patients after all examinations were completed., through study completion, an average of 10 months
Secondary Outcome Measures: The Satisfaction of Medical Personnel, To evaluate the satisfaction and acceptance of medical personnel with the use of large language models in assisting triage systems through methods such as questionnaire surveys. The name of this questionnaire is: Researcher Evaluation Form, with scores ranging from 1 to 10. The higher the score, the more helpful the large language model is to researchers., during evaluation|Medical Personnel Treatment Plan Adjustment Rate, The number of times medical personnel adjust treatment plans after receiving feedback from MedGuide V5's results and referring to the suggestions provided by the large language model., during evaluation|Emergency Department Revisit Rate within 30 Days, Evaluate the occurrence of patients revisiting the emergency department or being readmitted within 30 days after large language model-assisted triage and traditional triage., during evaluation
Etude de l'ANesthésie Par Gel de Lidocaïne Pour Les Injections IntrA vitréennes
NCT Number: NCT06493136
Acronym: ANGLIA
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Retinal Diseases - AMD - PAIN - Intravitreal Injection
Interventions: DRUG: lidocaine gel
Sponsor: Institut Ophtalmologique de l'Ouest Jules Verne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-13
Completion Date: 2023-02-05
Locations: Institut Ophtalmologique de l'Ouest Jules Verne, Nantes, Loire Atlantique, 44300, France

Summary:
Purpose To assess the efficacy of preservative-free Lidocaine gel 2% (LG) in patients complaining of pain during intravitreal injection (IVI) despite standard topical anaesthesia.

Methods First phase: prospective selection of a group of painful patients (score pain ≥ 4 on Visual Analogic Scale) during IVI with anaesthetic drops. Determination of the anxiety score before IVI, the overall pain score and pain score related to the speculum after IVI. Painful patients were proposed to enter the second phase of the study and have the next IVI with LG. Pain scores and anxiety score after each method of anaesthesia were compared.

Results In a group of 240 patients, 62 (25%) described pain≥4 despite anaesthetic drops. 39 patients (16.3%), accepted anaesthesia with LG for the next IVI. During IVI with LG, 27 patients (69%) had pain\<4 (P\<0.001). The average pain score for IVI with LG was 3.32+/-2.45 versus 5.71 +/-1.45 for anaesthetic drops (P\<0.001). Pain score due to speculum placement was 1.54+/-1.96 for LG versus 2.66+/-2.57 for drops (P=0.02). Anxiety score before IVI was 8.08+/-3.63 for LG versus 7.84+/-3.84 with drops (P=0.4). 27 patients (69%) wanted to have subsequent IVIs with LG.

Conclusion In a selected group of painful patients, anaesthesia with Lidocaine gel provided a statistically significant decrease of the pain score during IVI and the speculum placement pain score. The similarity of anxiety score before each method of anaesthesia, suggests that the reduction of pain score was truly due to a superior anaesthetic effect of LG.

Primary Outcome Measures: Visual Analog Scale : pain score, VAS score: The figure should be rounded to the nearest millimetre. Comparison of the pain felt during the injection during the 1st evaluation (with conventional anaesthesia) to the pain score pain score obtained with improved anaesthesia., 5 minutes after IVT
Secondary Outcome Measures: Pain score on simple verbal scale, Confirmation of pain relief with the simple verbal scale score, 5 minutes after IVT|Hospital Anxiety and Depression Scale - Auteurs : A.S. Zigmond et R.P. Snaith, Description of the patient's psychological state during an iVT and validation of score stability, Before the IVT
Gastric Ultrasound in Term Pregnants
NCT Number: NCT06493110
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy|Diabetes
Interventions: PROCEDURE: Gastric ultrasound
Sponsor: Kahramanmaras Sutcu Imam University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-12
Completion Date: 2025-03-12
Locations: KahramanmarasSIU, Kahramanmaraş, 46100, Turkey|Kahramanmaraş Sutcu Imam University, Kahramanmaraş, 46100, Turkey

Summary:
In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. The primary aim was qualitative assessment, while secondary objectives included quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

Primary Outcome Measures: Gastric Antrum Quality, Qualitative evaluation of the gastric antrum using ultrasound: For the qualitative evaluation of the gastric antrum, we used a grading scale where the gastric antrum is classified as Grade 0, 1, or 2. The grading criteria are as follows:

Grade 0: The stomach appears empty in both supine and right lateral decubitus positions.

Grade 1: The stomach appears empty in the supine position but shows clear fluid in the right lateral decubitus position.

Grade 2: Clear fluid is seen in the stomach in both supine and right lateral decubitus positions., 12 months
Secondary Outcome Measures: Gastric Volume, Quantitative measurement of gastric volume in milliliters., 12 months|Aspiration Risk, Number of participants with a high aspiration risk based on gastric volume., 12 months|Preoperative Anxiety Effect, Measurement of stomach content volume related to preoperative anxiety levels., 12 moths
Evaluate LAE102 in Healthy Subjects and Subjects With Overweight Obesity
NCT Number: NCT06493084
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity
Interventions: DRUG: LAE102 injection|OTHER: Saline
Sponsor: Laekna Limited
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-06-30

Summary:
The goal of this clinical trial is to learn the safety and tolerability of LAE102 injection in healthy subjects. It will also learn about the PK,ADA and PD status. The main questions it aims to answer are:

what dose level is safe tolerance and effective in human? What medical problems do participants have when taking LAE102? Researchers will compare LAE102 to a placebo (saline as placebo) to see if LAE102 is safe works to treat obesity in future.

Participants will:

Receive LAE102 injection or a placebo once in part A\& part B. Expect 6 dose levels for part A and 3 dose levels for part B Be in hospital for 7 days for checkups and blood tests, then visit clinic in D11,D15,D29

Primary Outcome Measures: Number & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0, Findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0, From Day1 to Day29
Secondary Outcome Measures: characterize the peak of serum concentration (Cmax) of LAE102 injection in healthy subjects, For both intravenously guttae \& subcutaneous injection, to evaluate the maximum observed serum concentration(Cmax), Pre-dose, immediately at the end of the infusion (time 0, only for I.V.gtt), at 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 24hour, 36hour, 60hour, 72hour, 96hour, 120hour, 144hour, 240hour, 336hour after the end of dosing, and on 672hour|characterize the area under the serum concentration versus time curve (AUC) of LAE102 injection in healthy subjects, For both intravenously guttae \& subcutaneous injection, to evaluate the area under the serum concentration versus time curve (AUC), Pre-dose, immediately at the end of the infusion (time 0, only for I.V.gtt), at 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 24hour, 36hour, 60hour, 72hour, 96hour, 120hour, 144hour, 240hour, 336hour after the end of dosing, and on 672hour|evaluate the expression levels of Activin A in blood samples, The validated methodology was employed to assay plasma levels of Activin A in biological samples., Pre-dose, at 4 hour after the end of dosing, and on Day2, Day4, Day7, Day15, Day29.|Incidence of positive Anti-drug antibody(ADA) after administration, Test ADA status in biological sample via validated methodology, Pre-dose on Day1, and on Day7, Day15, Day29.
First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers
NCT Number: NCT06493045
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Not Determined
Interventions: DRUG: IRL757|DRUG: Placebo
Sponsor: Integrative Research Laboratories AB
Collaborators: Michael J. Fox Foundation for Parkinson's Research
Sex: ALL
Age: ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-16
Completion Date: 2024-12
Locations: CTC Clinical Trial Consultants AB, Uppsala University Hospital, Uppsala, Sweden

Summary:
This is a Phase 1, First-In-Human study evaluating the safety and tolerability of single and multiple ascending oral doses of IRL757 in healthy volunteers.

Primary Outcome Measures: Evaluation of frequency, seriousness and intensity of adverse events, Until 5-10 days after IMP administration|Description of physical examination findings, Until 5-10 days after IMP administration|Description of electrocardiogram findings, Until 5-10 days after IMP administration|Description of vital signs findings, Until 5-10 days after IMP administration|Description of safety laboratory measurements, Until 5-10 days after IMP administration|Description of C-SSRS (Columbia Suicide Severity Rating Scale) findings, Until 5-10 days after IMP administration
Secondary Outcome Measures: Determination of Maximum Plasma Concentration [Cmax] of IRL757 and its 3 main metabolites, Until 48 hours post-dose|Determination of the AUC of IRL757 and its 3 main metabolites after single and multiple dose, Until 48 hours post-dose|Determination of the time for maximum concentration [Tmax] of IRL757 and its 3 main metabolites, Until 48 hours post-dose|Determination of the half-life [t1/2] of IRL757 and its 3 main metabolites, Until 48 hours post-dose|Determination of the renal clearance (CLr) of IRL757 and its 3 main metabolites, Until 48 hours post-dose
The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM
NCT Number: NCT06493032
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastroparesis
Interventions: DEVICE: Gastric Alimetry System
Sponsor: Indiana University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-30
Completion Date: 2026-09-01
Locations: Indiana University Health University Hospital, Indianapolis, Indiana, 46202, United States

Summary:
The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms. the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis and/or G-POEM procedure.

Primary Outcome Measures: Body Surface Gastric Mapping Rhythm IndexTM (GA-RI), A measure of the concentration of amplitude in the gastric frequency band over time (between 0 and 1), which characterizes the rhythmic stability of the recorded gastric activity; also adjusted for BMI., Baseline, 3 months,6 months, up to 5 hours.|Principal Gastric Frequency, Characterizes the frequency associated with stable, persistent gastric activity as defined by GA-R, Baseline, 3 months,6 months, up to 5 hours.|BMI-Adjusted Amplitude (μV), characterizes the strength of the recorded gastric activity as an average of the whole-test amplitude, adjusted for BMI, Baseline, 3 months,6 months, up to 5 hours.|Fed: Fasted Amplitude Ratio (ff-AR), characterizes the responsiveness to a meal stimulus, which is calculated as a ratio of the maximal 1-h average postprandial amplitude to the amplitude in the preprandial period., Baseline, 3 months,6 months, up to 5 hours.|SF-36, a set of generic, coherent, and easily administered quality-of-life measures, Baseline, 3 months,6 months, up to 5 hours.
Secondary Outcome Measures: Body surface gastric mapping (BSMG), enables accurate cutaneous gastric bioelectrical recording and provides valuable insights into the pathophysiology of gastric dysmotility in addition to gastric emptying measurements, Baseline, 3 months,6 months, up to 5 hours.
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
NCT Number: NCT06493019
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Anal Cancer
Interventions: DRUG: Pembrolizumab|DRUG: Paclitaxel|DRUG: Carboplatin|RADIATION: Radiation|DRUG: Pembrolizumab
Sponsor: Dustin Deming
Collaborators: Merck Sharp & Dohme LLC|University of Wisconsin, Madison
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-04-14
Locations: University of Wisconsin, Madison, Wisconsin, 53705, United States

Summary:
A single arm phase II study of pembrolizumab, carboplatin, paclitaxel, and radiation for the treatment of early-stage anal cancer. There are 2 treatments phases and then surveillance. The first treatment phase is the chemoradiation phase (Cycle 1-6, weekly cycles) which is followed by the maintenance phase (Cycle 7-14, 6 week cycles).

Primary Outcome Measures: Clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer., Meets both of the following criteria:

1. There is no documented residual cancer on anoscopy. If residual cancer is suspected, a biopsy must be obtained.
2. No documented residual cancer or new metastatic disease on PET/CT, or if a PET/CT cannot be obtained, CT or MR imaging with contrast can be used. Physiologic PET avidity in the anal canal without evidence of cancer on anoscopy is still consistent with a clinical complete response., 6 months
Secondary Outcome Measures: Percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5., Safety and tolerability will be measured as a percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5., 3 years|Assess the overall response rate of weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of anal cancer., Overall response rate as defined by RECIST 1.1, 3 years|Assess tumor downstaging, Changes in T or N staging per the AJCC V9.0 staging with be assessed comparing pre and post treatment imaging studies., 3 years|Disease-free survival of patients undergoing this treatment strategy., Disease free survival is defined as the time from completion of treatment until recurrence of disease as defined by RECIST 1.1 or death as a result of any cause, 3 years
Promoting Sustainable and Active Mobility Among Employees and Students
NCT Number: NCT06493006
Acronym: DiNaMo-active
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mobility on the Way to Work and Health-related Outcomes
Sponsor: Hannover Medical School
Collaborators: Gottfried Wilhelm Leibniz Universität Hannover|Hochschule Hannover|Leibniz Information Centre for Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-06-30
Locations: Hannover Medical School, Hannover, Lower Saxony, 20625, Germany

Summary:
The aim of the study is to assess health data (heart rate variability, blood pressure, blood glucose, particulate matter pollution) and travel characteristics (length, duration and type of commute) on the way to and from work from members of the universities in Hannover (Germany).

Primary Outcome Measures: Heart rate variability (HRV), HRV measured during the way to work, at the workplace and leisure time, as recorded by a wearable activity tracker, 24 hours
Secondary Outcome Measures: Blood glucose concentration, Intraindividual difference in blood glucose concentration between active and passive commuting as assessed with continuous blood glucose monitoring (Freestyle Libre 3), 24 hours on two separate days|Work-Ability-Index, Interindividual difference between work ability as assessed with the Work-Ability-Index-Questionnaire.

By adding up the points obtained from the questionnaire, scores can range from 7 to 49 points. The lower the score, the greater the discrepancy between the job demands placed on the respondent and their individual ability to cope with them., Once at baseline|24 hour blood pressure, Intraindividual difference in 24 hour arterial blood pressure between active and passive commuting as assessed with 24 hour systolic and diastolic blood pressure monitoring (Boso TM-2450), 24 hours on two separate days|Daily moderate to vigorous physical activity (MVPA) duration, Interindividual difference in MVPA as assessed with a wearable activity tracker (Garmin Smartwatch Forerunner 55), 5 consecutive days|Health-related quality of life, Interindividual difference between health-related quality of life as assessed with the Short Form 36 questionnaire. The possible score ranges from 0 to 100 points, with 0 points representing the greatest health impairment, while 100 points indicate no health impairment., Once at baseline|Particulate matter, Intraindividual difference in particulate matter concentration between active and passive commuting as assessed with a particulate matter measuring module, 24 hours on two separate days
Community Health Navigator Program to Promote Cancer Screenings Among DDBHH People
NCT Number: NCT06492993
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Deafness
Interventions: OTHER: Education
Sponsor: Gallaudet University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SCREENING
Start Date: 2023-09-30
Completion Date: 2026-08-31
Locations: Gallaudet University, Washington, District of Columbia, 20002, United States

Summary:
Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.

Primary Outcome Measures: Number of participants who are adherent to cancer screening, Completion of at least one recommended cancer screening as measured by documentation of the actual screening, 9 months
Secondary Outcome Measures: Percent of participants who demonstrate high cancer knowledge and high perceived patient centered care, Positive change in patient-physician communication and cancer knowledge from baseline to closeout as defined by the participating patient., 9 months
A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery
NCT Number: NCT06492980
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Aortic Dissection
Interventions: PROCEDURE: triple-branched stent graft
Sponsor: Fujian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-27
Completion Date: 2025-10-10
Locations: Department of Cardiovascular Surgery, Fuzhou, Fujian, 350001, China

Summary:
Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection

Primary Outcome Measures: Mortality within 30days post-operation, Mortality within 30days post-operation, 30 days
Secondary Outcome Measures: Aortic dissection-related death occurred within 12 months after surgery, Aortic dissection-related death occurred within 12 months after surgery, 12 month|Thrombosis of the false lumen of the arch and proximal descending aorta, Thrombosis of the false lumen of the arch and proximal descending aorta, 12 month|Technical success, Successful insertion, successful positioning, and patency of the lumen were used as indicators, 12 month
Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma
NCT Number: NCT06492954
Acronym: AflacST2301
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Osteosarcoma|Pulmonary Recurrence of Osteosarcoma
Interventions: PROCEDURE: Surgical Resection|RADIATION: Stereotactic Body Radiation Therapy (SBRT)|DRUG: Atezolizumab
Sponsor: Emory University
Collaborators: Genentech, Inc.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2027-06
Locations: Chilldren's Healthcare of Atlanta, Atlanta, Georgia, 30322, United States

Summary:
This study aims to determine the safety and tolerability of combined Atezolizumab, stereotactic body radiation therapy (SBRT), and surgical resection of pulmonary metastases in patients with pulmonary recurrence of osteosarcoma

Primary Outcome Measures: Number of participants with Dose limiting toxicity at Dose Level 1, If 6 participants have been enrolled and evaluated, and only 0 or 1 have experienced a DLT, the next participant will be enrolled at Dose Level 2, Baseline, end of 1 year|Number of participants with Dose limiting toxicity at Dose Level 2, If 6 participants have been enrolled and evaluated, and only 0 or 1 have experienced a DLT, enrollment will be terminated, and accrual determined complete., Baseline, end of 1 year
Secondary Outcome Measures: Disease Control Rate, The DC rate is defined as the number of patients without disease progression during the first 12 months after enrollment., Baseline, at 12 months|Progression-free survival (PFS), PFS is defined as the time from first dose of Atezolizumab to disease relapse, disease progression, or death from any cause, Baseline, through study completion (an average of 1 year)|Overall Survival, Overall survival is defined as the time from first dose of Atezolizumab to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up, Baseline, through study completion (an average of 1 year)
A Study of Docetaxel for Injection (Albumin Bound) in Patients With Advanced Pancreatic Cancer
NCT Number: NCT06492941
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Advanced Pancreatic Cancer
Interventions: DRUG: Docetaxel for Injection (Albumin bound)|DRUG: Placebo|DRUG: Best supportive care
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2026-11-21

Summary:
This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin Bound) in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received gemcitabine-containing and fluorouracil-containing regimens.

Primary Outcome Measures: OS, The overall survival (OS) of the two groups. All the participants received tumor assessment every 6 weeks according to RECIST1.1., Up to approximately 2 years
Secondary Outcome Measures: PFS, All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the progression-free survival (PFS) ., Up to approximately 2 years|ORR, All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the objective response rate (ORR)., Up to approximately 2 years|DCR, All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the disease control rate (DCR)., Up to approximately 2 years|DOR, All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the duration of response (DOR)., Up to approximately 2 years|Incidence of AE and SAE, Incidence of AE and SAE, Up to approximately 2 years|PK, Plasma concentration of docetaxel (free and total), At the end of Cycle 1(each cycle is 21 days)
Attentionnal Performance of Shift Health Workers in Emergency Department
NCT Number: NCT06492928
Acronym: Emerg-APoSHeW
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Work-Related Condition
Interventions: OTHER: Psychomotor Vigilance Task
Sponsor: Centre Hospitalier de Roubaix
Collaborators: Boulogne sur Mer Hospital Center|Centre Hospitalier de l'Arrondissement de Montreuil-sur-mer|Centre Hospitalier Saint-Omer|Centre Hospitalier de Bethune|Centre Hospitalier de Lens|Polyclinique de la Clarence|Centre hospitalier de Dunkerque|Centre Hospitalier de Douai|Centre Hospitalier de Valenciennes|Centre Hospitalier d'Hazebrouck|Centre Hospitalier de Watrelos|Centre Hospitalier de Denain|Tourcoing Hospital|GHICL|Polyclinique de Grande Synthe
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-12
Completion Date: 2024-07-30
Locations: Emergency Department, General Hospital, Armentières, Nord, France|Emergency Department, General Hospital, Hazebrouck, Nord, France|Emergency Department, GHICL Saint-Philibert, Lomme, Nord, France|Emergency Department, General Hospital, Tourcoing, Nord, France

Summary:
Atypical working hours can be a risk factor for workers. In fact, the body is subject to a circadian rhythm, which affects numerous physiological activities. These biological rhythms reflect the need for certain physiological activities to occur at a specific time of day. This cycle can be disrupted and shifted by external factors. This disruption of biological rhythms can manifest itself in the appearance of health effects.

The innovative nature of our work lies in the search for an alteration in psychomotor functions in nursing staff (subject to atypical working hours). To this end, we decided to study the concentration of care workers using a reflex-based psychomotor test, the Psychomotor Vigilance Test (PVT). Other factors will be studied in order to assess the factors that may affect this test.

Primary Outcome Measures: Evaluation of concentration in medical/non-medical staff at the start and end of a work shift., To this end, we will evaluate the Psychomotor Vigilance Test (PVT) and its variation at the start and end of a shift in these personnel.

The endpoint is the difference in reflex time to a visual stimulus performed at the beginning and end of the shift with a 3-minute PVT Test., Day 1
Secondary Outcome Measures: The first secondary objective is to analyze the number of PVT errors., The criterion defining an error is a reaction time greater than 500ms., Day 1|Sub-group analysis, The second secondary objective is to compare the PVT and its variation in certain subgroups. The subgroups compared will be defined according to the following criteria Shift duration: Non-medical staff (\<10h, \>10h), Medical staff (6 to 10h, 10 to 15h, 15 to 24h) Staggered shift: start before 6h or end after 22h, Type of service: acute care, MCO, SSR (or emergency sector) Sleep quality (Pittsburgh Sleep Quality Index), Professional fatigue (Maslach Burnout lnventory), Anxiety (French official version of the PSS-14), Chronotype (Morningness-Eveningness Questionnaire)., Day 7
Chiauranib in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
NCT Number: NCT06492915
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma
Interventions: DRUG: Chiauranib|DRUG: Albumin-paclitaxel Injection|DRUG: Gemcitabine Injection
Sponsor: Chipscreen Biosciences, Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-07-01

Summary:
Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.

Primary Outcome Measures: PFS, Progression free survival, From the first dose to disease progression or end of study, an average of 1 year
Secondary Outcome Measures: ORR, Objective Response Rate, From the first dose to disease progression or end of study, an average of 1 year|DCR, Disease control rate, From the first dose to disease progression or end of study, an average of 1 year|DoR, Duration of Response, From the first dose to disease progression or end of study, an average of 1 year|TTR, Time to Response, From the first dose to disease progression or end of study, an average of 1 year|OS, Overall survival, From the first dose to death or end of study, an average of 1.5 years|Adverse events, Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEV5.0)), From the enrollment until 28 days after the last dose|Time to maximum concentration (Tmax), PK Profile, Days 15, 28 during Cycle 1, thereafter once every 8 weeks subsequent cycles, an average of 1 year|Maximum plasma concentration (Cmax), PK Profile, Days 15, 28 during Cycle 1, thereafter once every 8 weeks subsequent cycles, an average of 1 year|Area under the plasma concentration-time curve (AUC0-t), PK Profile, Days 15, 28 during Cycle 1, thereafter once every 8 weeks subsequent cycles, an average of 1 year
Adding Auricular Acupuncture to Xiao-Feng-San Decoction for Treating Atopic Dermatitis
NCT Number: NCT06492902
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atopic Dermatitis
Interventions: OTHER: Auricular acupuncture|OTHER: Sham auricular acupuncture
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-03-15
Locations: University of Medical Center HCMC - Branch no.3, Ho Chi Minh City, 700000, Vietnam|Traditional Medicine Hospital of Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

Summary:
This study aims to compare the efficacy of adding auricular acupuncture to Xiao-Feng-San decoction versus Xiao-Feng-San decoction in treating atopic dermatitis. The trial is a multi-center, double-blinded, randomized, sham-controlled study.

Primary Outcome Measures: Changes in Scoring Atopic Dermatitis (SCORAD) score, The SCORAD index is a tool used to assess atopic dermatitis (AD) severity. It combines objective measures of lesion extent and intensity with subjective evaluations of symptoms like pruritus and sleep loss. Calculated using the formula: A/5 + 7B/2 + C, where A represents lesion extent (0-100 points), B rates six objective symptoms (0-18 points), and C measures subjective symptoms on a 10-cm scale (0-20 points), the total score ranges from 0 to 103 with higher scores indicating more severe AD., At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
Secondary Outcome Measures: Changes in Dermatology Life Quality Index (DLQI) Score, The DLQI consists of 10 questions assessing patients' perceptions of how skin diseases have affected various aspects of their health-related quality of life over the past week. Each question is scored from 0 to 3 points, resulting in a total DLQI score ranging from 0 to 30. Higher scores indicate a greater impact on quality of life., At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)|Change in the Number of Antihistamine Tablets Used, The number of antihistamine tablets used per week by patients, as needed to relieve pruritus, is recorded., Weekly throughout the four-week period (Week 1, Week 2, Week 3, Week 4)|Changes in Total Serum Immunoglobulin E (IgE) Levels, Total serum IgE levels are collected in the morning, measured in IU/ml., At randomization and after four weeks (Week 0, Week 4)|Proportion of intervention-related adverse effects (AEs), Expected AEs for auricular acupuncture include pain at the insertion site, local discomfort, local skin irritation (itching and redness), local inflammation and bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions. Additionally, any unexpected AEs associated with this procedure will also be documented and monitored., Up to four weeks
Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens
NCT Number: NCT06492889
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Pregnancy Early|Pregnancy Related
Interventions: DRUG: Levonorgestrel|DRUG: Mifepristone
Sponsor: Gynuity Health Projects
Collaborators: Cuidado Integral de la Mujer, Gineclinic, S.C.|Servicios de Salud Medieg, A. C
Sex: FEMALE
Age: ADULT
Enrollment: 286
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2025-06-30

Summary:
The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.

The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)

Primary Outcome Measures: Efficacy of the missed period pills regimen, Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment, Two weeks|Effectiveness of the missed period pills regimen, Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment, Two weeks
Secondary Outcome Measures: Effectiveness at inducing return of menses within 10 days of missed menses, Proportion of participants who experience menstrual bleeding after taking the study medications, One to two weeks|Safety/side effects, Incidence of side effects and complications, Two weeks|Acceptability, Proportion of participants who report that the missed period pills service was acceptable or highly acceptable, Two weeks
Gene Therapy for DME
NCT Number: NCT06492876
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Diabetic Macular Edema
Interventions: GENETIC: FT-003
Sponsor: Frontera Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-15
Completion Date: 2028-11-15
Locations: Tianjin Medical University Eye Hospital, Tianjin, Tianjin,China, 300392, China

Summary:
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Primary Outcome Measures: Safety and tolerability after FT-003 injection, Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0), At Week 12
Secondary Outcome Measures: To evaluate the efficacy after FT-003 injection, the BCVA /CST change from baseline, At Week 24