pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
NCT Number: NCT06474819
Acronym: DEEP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Complete Heart Block|Second Degree Atrioventricular Block Möbitz Type II
Interventions: DEVICE: Pacemaker implant
Sponsor: Institut d'Investigació Biomèdica de Bellvitge
Collaborators: Fundació La Marató de TV3|Hospital Universitari de Bellvitge
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 326
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-12
Completion Date: 2027-01-12
Locations: Hospital Vall d'Hebrón, Barcelona, Spain|Hospital General Universitario de Castellón, Castellón De La Plana, Spain|Hospital Virgen de las Nieves, Granada, Spain|Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain|Hospital La Fe, Valencia, Spain|Hospital Lozano Blesa, Zaragoza, Spain

Summary:
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.

Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.

Primary Outcome Measures: Pacing-induced cardiomyopathy, Decrease in the left ventricular ejection fraction (LVEF) by \>10% as compared to the LVEF before pacemaker implant and final LVEF\<45%., 12 months
Secondary Outcome Measures: LVEF during follow-up, To compare the mean or median (depending on distribution) LVEF before and one year after pacemaker implant in the two groups., 12 months|Mitral and tricuspid regurgitation, To compare the degree of mitral and tricuspid regurgitation before and one year after pacemaker implant in the two groups., 12 months|New York Heart Association (NYHA) class, To compare the NYHA class one year after pacemaker implant in the two groups., 12 months|Brain Natriuretic Peptide levels, To compare the N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels one year after pacemaker implant in the two groups., 12 months|heart failure, Comparison of heart failure (HF) events in the first year after pacemaker implant in the two groups. HF events will be: hospitalizations for heart failure, emergency department or day-hospital visits for heart failure, heart failure symptoms requiring the initiation of diuretic therapy., 12 months
Other Outcome Measures: Complications, Complications related to the ventricular lead, 12 months
Evaluation of The Effect of Virtual Reality Glasses
NCT Number: NCT06474780
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anxiety|Cancer|Chemotherapy|Virtual Reality|Treatment Compliance
Interventions: DEVICE: Weight: 414g Size: 19.5cm x 14cm x 11cm Compatibility: Android and iOS VR Box 3.0 3D Virtual Reality Glasses Has the Feature of Fixation with Headband It has a lens mechanism tha
Sponsor: Gozde Oz
Sex: ALL
Age: ADULT
Enrollment: 900
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2024-08-25

Summary:
The study was planned as a randomized controlled study to evaluate the effect of virtual reality glasses used on anxiety and treatment compliance in outpatient cancer patients receiving chemotherapy. The sample of the study consisted of a total of 30 patients, including 15 experimental and 15 control groups, who received intravenous chemotherapy treatment every 21 days between April 1 and September 31, 2023, in the outpatient chemotherapy unit of a research hospital. Research data will be collected using the Patient Information Form, Beck Anxiety Scale (BAI) and Chronic Disease Adaptation Scale (CCDS). In evaluating the data, it was planned to analyze the differences between the rates of categorical variables in independent groups with Chi-Square tests. It was planned to use t tests to compare quantitative continuous data between two independent groups. Dependent groups t-test will be used to compare measurements within groups. After being informed about the research, patients in both groups will be given a pre-test. Patients in the experimental group will be shown 3 different videos with virtual reality glasses during 3 cycles of chemotherapy treatment, and a final test will be administered to both groups at the end of the 3rd cycle..

Primary Outcome Measures: Virtual Reality Glasses, Virtual Reality Glasses Used in Cancer Patients Will Reduce Anxiety Score on the Visual Analogue Scale in 3 Months, 3 month
Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery
NCT Number: NCT06474754
Acronym: EnhanceMINS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myocardial Injury After Non-cardiac Surgery|Submaximal Exercise Performance|Preoperative Period
Interventions: DIAGNOSTIC_TEST: High-sensitivity troponin, serum|DIAGNOSTIC_TEST: Submaximal Cardiopulmonary Exercise Testing|DIAGNOSTIC_TEST: Duke Activity Status Index
Sponsor: Yale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 61
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11
Completion Date: 2026-01
Locations: Yale University; Yale New Haven Hospital, New Haven, Connecticut, 06510, United States

Summary:
The goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing. The main questions are:

Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care?

And which submaximal cardiopulmonary exercise testing measure is better?

Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test, then undergo surgery. Myocardial injury will be measured on postoperative days 0, 1, 2, and 3 (during and up to 3 days after surgery). These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test.

If there is a relationship, this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery.

Primary Outcome Measures: MINS, Myocardial Injury after noncardiac surgery. Measurement: High-Sensitivity Troponin assay with an abnormal value defined as 14 nanograms per liter or greater., Operative Day 0, Postoperative Day 1, 2 or 3
Secondary Outcome Measures: 30-day Major Adverse Cardiovascular Events, 30-day recorded events of atrial fibrillation, angina, stroke, myocardial infarction, congestive heart failure as defined by International Classification of Disease (Version 10) coding., Postoperative Day 1 through Postoperative Day 30|Length of Stay, Measurement of patient inpatient status from operative day 0 through physical discharge from the hospital., From operative day 0 through hospital discharge up to postoperative day 180|Readmission, Readmission of any type from the time of surgical procedure discharge through postoperative day 60., Postoperative Day One through Postoperative Day 60.
Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly
NCT Number: NCT06474741
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Torticollis
Interventions: BEHAVIORAL: in-app notification
Sponsor: College of Staten Island, the City University of New York
Collaborators: Duquesne University
Sex: ALL
Age: CHILD
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2025-06
Completion Date: 2027-12

Summary:
The goal of this clinical trial is to test whether an app-based intervention can reduce the likelihood of a torticollis diagnosis in infants. The main question\[s\] it aims to answer are:

* whether an app can successfully deliver an intervention to parents of young infants
* whether parents who learn about torticollis will increase behaviors intended to prevent torticollis compared to parents who learn about general infant development

Participants will complete a monthly survey for 6 months asking about their parenting behaviors. Researchers will compare parents who receive notifications about torticollis with parents who receive notifications about general infant development to see if increased knowledge of torticollis leads to preventive behavior.

Primary Outcome Measures: symmetry score, extent of infant's head turn asymmetry, baseline and 4 months
Secondary Outcome Measures: gaze asymmetry score, extent of infant's eye gaze asymmetry, 6 months|time spent in focused attention, 6 months|# of bouts of focused attention, 6 months|correlation between computer vision algorithm & manual coding for infants' head turns, 4 months|Correlate computer vision score with clinical test of symmetry, 4 months
Effects of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus on Pediatric Atopic Dermatitis
NCT Number: NCT06474728
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atopic Dermatitis|Eczema|Emollient
Interventions: OTHER: Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus
Sponsor: Children's Hospital of Fudan University
Sex: ALL
Age: CHILD
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2025-12-31

Summary:
The goal of this study is to investigate whether the use of emollients containing postbiotic Saccharomyces and Lactobacillus can significantly reduce the risk of atopic dermatitis (AD) recurrence in pediatric patients aged 0-6 years during the remission phase, compared to the routine maintenance treatment with conventional emollients.

Primary Outcome Measures: Recurrence rate during the intervention phase, During the intervention phase, when the patient's Investigator's Gobal Assessment (lGA) score reaches 2 or higher, we defined it as recurrence., 12 weeks
Predicting Violent Outburst in Inpatient Pediatric Psychiatry Ward Using a Wearable Device.
NCT Number: NCT06474702
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Child Behavior Disorders
Interventions: DEVICE: 'Fitbit charge 4' 'smart-watch'-
Sponsor: Sheba Medical Center
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-07-01

Summary:
The investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. also, the investigator will try to do a characterization of those physiological measures in the prediction of aggression and violence outbursts.

Primary Outcome Measures: physiological parameter, Heart rate, 12 months (july 2024-july 2025)|physiological parameter, heart rate variability, the data of heart rate variability is based on respiratory rate (outcome 3) and heart rate (outcome 1), 12 months (july 2024-july 2025)|physiological parameter, respiratory rate, 12 months (july 2024-july 2025)|physiological parameter, sleep patterns, the data of sleep pattern is based on movements (outcome 5) and heart rate (outcome 1), 12 months (july 2024-july 2025)|movements., movements frequency of the patient, collected by the smart-watch using 3 axis-accelerometer that can detect movements in 3 dimensions. for example, number of steps taken., 12 months (july 2024-july 2025)
Secondary Outcome Measures: violence assessment with 'MOAS' score system., using 'MOAS', the Modified Overt Aggression Scale score system filled by the department staff manually on each day and outburst description. the score system is made up of four categories (verbal aggression, aggression against objects, aggression against self, and aggression against others. each category is ranked by numbers. range of total score is between 0-40. higher score usually higher than 20 indicating more aggressive behavior which means worse outcome., 12 months (july 2024-july 2025)
T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.
NCT Number: NCT06474676
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Soft-tissue Sarcoma
Interventions: DRUG: Cyclophosphamide|DRUG: T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2032-12-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To find a recommended dose of attIL2-TIL cell therapy that can be given to participant with either relapsed or metastatic sarcomas (has come back or spread to other parts of the body, respectively).

To further test the dose found in Part A to see if it can help to control liposarcoma growth.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias
NCT Number: NCT06474663
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Refractory Acute Leukemia|Relapsed Acute Leukemia
Interventions: DRUG: Cladribine|DRUG: Cytarabine|DRUG: Sorafenib|DRUG: Decitabine
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 22
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2033-12-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To find the recommended dose of the drug combination cladribine, cytarabine, decitabine, and sorafenib in participants with relapsed/refractory AML, MPAL, and ALAL.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets
NCT Number: NCT06474650
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Huntington Disease|Tardive Dyskinesia
Interventions: DRUG: LPM3770164 sustained release tablet
Sponsor: Luye Pharma Group Ltd.
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-10
Locations: Shanghai Mental Health Center, Shanghai, China

Summary:
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.

Primary Outcome Measures: Peak Plasma Concentration (Cmax), Predose and up to 240 hours postdose|Area Under the Curve from time 0 to the last measurable concentration (AUC0-t), Predose and up to 240 hours postdose|Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf), Predose and up to 240 hours postdose
Secondary Outcome Measures: Treatment-emergent adverse event, from baseline to day 25|Time to maximum concentration (Tmax), Predose and up to 240 hours postdose|Half-life (t1/2), Predose and up to 240 hours postdose
Powered Handle Primary Sleeve Gastrectomy Study
NCT Number: NCT06474637
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleeve Gastrectomy
Interventions: DEVICE: AEON Endoscopic Powered Stapler Handle and Reload
Sponsor: Lexington Medical Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-30
Completion Date: 2025-03
Locations: Gijos Clinic, Kaunas, Lithuania

Summary:
The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.

Primary Outcome Measures: Post Operative Staple Line Complications, The primary measure of effectiveness and safety will be determined by the incidence of post-operative staple line complications defined as requiring blood transfusion and revision surgery to treat staple line complications., 1 week
Secondary Outcome Measures: Hospital Stay, Average hospital stay will be measure and compared in patients without post-operative staple line complications vs. patients with post-operative staple line complications., 1 week|36-Item Short Form Health Survey (SF-36), SF-36 scores will be collected at baseline and at the 3-week follow up appointment and compared for quality-of-life changes., 3 weeks
Evaluation of a Patient 'Nudge' on Engagement in Lung Cancer Screening
NCT Number: NCT06474611
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: BEHAVIORAL: Patient nudge
Sponsor: Kaiser Permanente
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-26
Completion Date: 2024-12
Locations: Kaiser Permanente, Aurora, Colorado, 80011, United States

Summary:
The purpose of this quality improvement project is to conduct and evaluate the effect of sending an electronic reminder message to patients who qualify for lung cancer screening, haven't had a screening previously, and who have an upcoming scheduled appointment with their doctor.

Primary Outcome Measures: The proportion completed a visit with a Primary Care provider by receipt of an electronic letter or paper letter, The proportion completed a visit with a Primary Care provider by receipt of an electronic letter or paper letter, 12 months|The proportion receiving an order to get a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter, The proportion receiving an order to get a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter, 12 months|The proportion completing a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter, The proportion completing a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter, 12 months
Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table
NCT Number: NCT06474572
Acronym: IntTab
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neonatal Disease|Intubation
Interventions: DEVICE: Direct laryngoscope and table at xiphoid level|DEVICE: Videolaryngoscope and table at xiphoid level|DEVICE: Direct laryngoscope and table at umbilical level|DEVICE: Videolaryngoscope and table at umbilical level
Sponsor: University Hospital Padova
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-06

Summary:
The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated.

This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.

Primary Outcome Measures: Magnitide of applied forces (Newton), Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation, 3 minutes
Secondary Outcome Measures: Percentage of participants achieving the intubation success at the first attempt, The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer, 30 seconds|Total time of intubation, Time of device positioning will be calculated as the sum of the time of device positioning in all attempts, as the procedure will be repeated in case of incorrect positioning, 3 minutes|Participant's opinions about the procedure, Participants will report: their preference about table height and device; perceived difficulty using a Likert scale (1= not difficult, 5=very difficult), 12 hours
Comparison of Lma-Protector With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
NCT Number: NCT06474559
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mechanical Ventilation
Interventions: DEVICE: LMA Protector|DEVICE: Endotracheal tube
Sponsor: University Hospital of Patras
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-06
Completion Date: 2025-03
Locations: General Univerisity Hospital of Patras, Patras, Greece

Summary:
The aim of this prospective, randomized, comparative, controlled clinical study is to compare laryngeal mask airway ProtectorTM with the endotracheal tube, regarding to the respiratory mechanical parameters during controlled mechanical ventilation and the prevalence of aspiration. Aspiration will be evaluated by detecting and quantifying pepsin (a marker of gastric aspiration) and α-amylase (a marker of salivary aspiration) in the bronchoalveolar lavage ( mini BAL) of patients ≥18 years old, ASA 1-2, undergoing selective low-risk surgery under general anesthesia in a lithotomy position.

Primary Outcome Measures: Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients., Measured by Ventilator, Intraoperative|Assessment of aspiration risk by quantitative measurements of pepsin (ng/ml) and α-amylase (IU/ml) in BAL of patients and differences in its incidence between the two groups., Measured by ELISA method, through study completion, an average of 1 year
Secondary Outcome Measures: Differences in lung mechanics between the two patient groups, Pplat cmH20( plataeu pressure) Dynamic Compliance ml/cmH20 , MAP cmH20( Mean Airway pressure ), PEEP cmH20,( positive end-expiratory pressure VTins, VTexp ( t, Raw cmH20/ml/sec( resistance of airway), ΔP cmH20(Driving Pressure, inspired (VTinsp) and expired (VTexp) tidal volumes, VTins - VTexp., Intraoperative
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
NCT Number: NCT06474533
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intracranial Neoplasm
Interventions: DRUG: Fluorethyltyrosine (18-F)|PROCEDURE: Positron Emission Tomography (PET)
Sponsor: Thomas Hope
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 199
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-21
Completion Date: 2028-08-31
Locations: University of California, San Francisco, San Francisco, California, 94143, United States

Summary:
This is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.

Primary Outcome Measures: Maximum Intracranial lesion tumor-to-background ratio (TBRmax), The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue., Up to 3 years|Percentage of accurate prediction of presence of tumor (Population 1), The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported, Up to 3 years|Percentage of radiological read responses, The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported., Up to 3 years
Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma
NCT Number: NCT06474481
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: FL
Interventions: DRUG: Zanubrutinib|DRUG: Obinutuzumab|DRUG: Prednisone|DRUG: Cyclophosphamide|DRUG: Vincristine|DRUG: Doxorubicin
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2029-12

Summary:
:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.

Primary Outcome Measures: CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV), Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria, From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)
Secondary Outcome Measures: Objective Response rate after induction by investigator (INV), ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV according to 2014 Lugano criteria, From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)|Overall survival (OS), Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause, From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years|Progression free survival (PFS), -PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV, From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer
NCT Number: NCT06474468
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced or Metastatic Esophageal Cancer
Interventions: DRUG: SHR-A2102；Adebrelimab；Cisplatin
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 148
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2026-10
Locations: Affiliated Cancer Hospital of Shandong First Medical University, Jinan, Shandong, 250117, China

Summary:
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer

Primary Outcome Measures: RP2D, RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages；, through phase IB completion, an average of 1 years|Incidence and severity of AE(DLT)：, According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose；, from Day1 to 90 days after last dose|ORR：, efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1, 18 months after the last subject was enrolled in the group
Secondary Outcome Measures: DCR, Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；, 18 months after the last subject was enrolled in the group|DOR, Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；, 18 months after the last subject was enrolled in the group|PFS(Investigator evaluation), Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；, 18 months after the last subject was enrolled in the group|OS(Investigator evaluation), Since C1D1 and death from any cause；, 18 months after the last subject was enrolled in the group
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
NCT Number: NCT06474455
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Solid Tumors
Interventions: DRUG: SHR-9839 ；SHR-A2009|DRUG: SHR-9839 ； SHR-A1921|DRUG: SHR-9839 ； pemetrexed ；carboplatin|DRUG: SHR-9839 ； Almonertinib
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2027-06
Locations: Zhejiang Cancer Hospital, Zhejiang, HangZhou, 310005, China|HeNan CANCER HOSPITAL, Zhenzhou, Henan, 450003, China

Summary:
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

Primary Outcome Measures: Incidence of dose-limiting toxicity (DLT) (phase IB), 21 days after the first dose was administered to each subject，Up to approximately 24 months.|Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase IB), Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0), Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.|Objective Response Rate (ORR) (phase II)., Evaluated using RECIST 1.1, The first treatment lasted until disease progression，Up to approximately 24 months.
Secondary Outcome Measures: Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II), Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0), Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.
TipTraQ Home Sleep Test Validation Study, VGH
NCT Number: NCT06474390
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea
Sponsor: PranaQ Pte. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-05-31
Locations: Taipei Veterans General Hospital, Taipei, 201, Taiwan

Summary:
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test.

Primary Outcome Measures: Oxygen Desaturation Index(ODI), Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour, From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.|Apnea Hypopnea Index(AHI), The combined average number of apneas and hypopneas that occur per hour of sleep, From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.|Total Sleep Time(TST), Total sleep time during the polysomnography (PSG), From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
Phase I Clinical Trial of PCV24 in Adults
NCT Number: NCT06474377
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pneumococcal Infectious Disease
Interventions: BIOLOGICAL: Sinovac PCV24 formulation 1|BIOLOGICAL: Sinovac PCV24 formulation 2|BIOLOGICAL: Pneumovax®|BIOLOGICAL: Placebo
Sponsor: Sinovac Life Sciences Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-20
Completion Date: 2025-01-20
Locations: Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, 210009, China

Summary:
A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled Phase I clinical trial.

Primary Outcome Measures: Incidence of adverse reactions, Incidence of adverse reactions within 30 days after vaccination, 0-30 days after vaccination
Secondary Outcome Measures: Incidence of adverse reactions, Incidence of adverse reactions within 7 days after vaccination, 0-7 days after vaccination|Incidence of serious adverse events (SAE), Incidence of SAE during the period of safety monitoring, 0-6 months after vaccination|Incidence of clinically significant abnormality in laboratory examination tests, Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination, 0-3 days after vaccination|Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC), IgG GMC 30 days after vaccination, 30 days after vaccination|Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI), IgG GMI 30 days after vaccination, 30 days after vaccination|Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4, Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination, 30 days after vaccination|Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs), OPA GMT 30 days after vaccination, 30 days after vaccination|Pneumococcal serotype-specific OPA GMI, OPA GMI 30 days after vaccination, 30 days after vaccination|Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4, Proportion of OPA antibody titer increase≥four folds 30 days after vaccination, 30 days after vaccination
Developement of TipTraQ Home Sleep Test
NCT Number: NCT06474351
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea
Sponsor: PranaQ Pte. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2023-12-31
Locations: Taipei Veterans General Hospital, Taipei, 201, Taiwan

Summary:
The clinical study aims to develop and fine-tune the FingertipQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and Apnea-Hypopnea Index (AHI). This open-label, non-randomized study will recruit 240 subjects aged 20 and older from the Veteran General Hospital, Taipei.

Primary Outcome Measures: Apnea Hypopnea Index(AHI), the combined average number of apneas and hypopneas that occur per hour of sleep, From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours|Oxygen Desaturation Index(ODI), Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour, From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours|Total Sleep Time(TST), Total sleep time during the polysomnography (PSG), From the start of a single polysomnography study to the end of the recording. Usually range from 4 to 10 hours
AI Detection of Bladder Tumors Under Endoscopy
NCT Number: NCT06474338
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bladder Tumor
Interventions: DIAGNOSTIC_TEST: detection by artificial intelligence|DIAGNOSTIC_TEST: detection by urologists
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2034-12-31
Locations: Peking Union Medical College Hospital, Beijing, Beijing, China

Summary:
The goal of this clinical trial is to learn if the AI algorithm can detect bladder tumors better than urologists under cystoscopy. It will also train the AI algorithm for bladder tumor detection. The main question it aims to answer is:

Can AI algorithm achieve IOU value, precision, recall, false negative rate of bladder tumor detection similar to that of urologists? The cystoscopy video will be annotated by AI and urologists. Researchers will compare AI algorithm to urologists to see if Al algorithm has a similar capability as urologists do.

Primary Outcome Measures: intersection over union, The overlapping area of the actual bladder lesion and detected bladder lesion divided by their combined areas., From Jan 1st 2024 to Dec 31st 2033
Feasibility and Acceptability of Mobile Mental Health App for SZ and SZA
NCT Number: NCT06474325
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia|Schizo Affective Disorder
Interventions: BEHAVIORAL: Intervention via mobile application
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|Government Medical College, Palakkad-678013
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-11-01
Completion Date: 2025-09-30
Locations: Government Medical College,, Palakkad, Kerala, India

Summary:
A new mental health application will be developed for persons with schizophrenia and schizoaffective disorder. The aim is to look at whether it is feasible to use a mobile health application for improving medication adherence in persons with schizophrenia and schizoaffective disorder and whether it is acceptable to that population.

Primary Outcome Measures: Feasibility of Mobile app, To assess the feasibility and the acceptability with a mobile mental health application for medication adherence in persons with SZ and schizoaffective disorder using Acceptability Questionnaire. The scale ranges from 0 to 50., Baseline and after three months|Acceptibility of Mobile app, To assess the feasibility and the acceptability with a mobile mental health application for medication adherence in persons with SZ and schizoaffective disorder using Perception of treatment Acceptability scale (Score (0-5) 0= Not at all 5 =very much). Ranges from 0 to 50.

), Baseline and after three months|Adherence to medication, To compare the Medication adherence rating scale scores before and after using mental health application for changing medication adherence in persons with schizophrenia and schizoaffective disorder, Baseline and after three months
Reducing Suicide Ideation Among Young People
NCT Number: NCT06474312
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicidal Ideation|Suicide, Attempted
Interventions: BEHAVIORAL: Nae Disha
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|Christian Hospital Chhatarpur
Sex: ALL
Age: CHILD
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-02-02
Completion Date: 2025-06-30
Locations: Christian Hospital, Mahoba Road, Chhattarpur, Madhya Pradesh, 471001, India

Summary:
It is Cluster Randomized Control Trial research to examine feasibility and relevance of the modified tool Nae Disha for Life, which will incorporate suicide prevention and resilience to reduce suicide ideation among young people in Bundelkhand region of Madhya Pradesh, India. This intervention will build on existing relationships with at least four Government Middle Schools in Nowgong block of Chhatarpur district, Madhya Pradesh. This preliminary research will develop relationships and evidence for implementation scale-up research.

Primary Outcome Measures: Suicide ideation, To study change in suicide ideation in intervention group measured by Beck Suicidal Ideation Scale as compared to control group. The total score ranges from 0 to 38.More score means higher suicide ideation., Baseline and after 18 weeks of intervention|Hopelessness, To study change in hopelessness in intervention group measured by Beck Hopelessness Scale as compared to control group. The score ranges from 0 to 20., Baseline and after 18 weeks of intervention|Generalized anxiety, To study change in generalized anxiety in intervention group measured by Generalized Anxiety Disorder Scale as compared to control group, Baseline and after 18 weeks of intervention|Resilience, To study change in resilience in intervention group measured by Connor-Davidson Resilience Scale as compared to control group, Baseline and after 18 weeks of intervention
The Avenues Study: Dual Use Cessation
NCT Number: NCT06474299
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Smoking Cessation|Electronic Cigarette Use
Interventions: DRUG: Varenicline|DRUG: Nicotine patch|BEHAVIORAL: Dual Focused Cessation Counseling|BEHAVIORAL: Smoking Focused Cessation Counseling|OTHER: Counseling Intensity: 1 Session|OTHER: Counseling Intensity: 4 Sessions
Sponsor: University of Wisconsin, Madison
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-07
Locations: University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, 53792, United States

Summary:
The overarching goal of this research is to determine the most effective approach for helping dual users of cigarettes and electronic nicotine delivery systems (ENDS) quit smoking. 500 participants will be enrolled and can expect to be on study for 12 months.

Primary Outcome Measures: 52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes, 52-week biochemically confirmed (CO\<6ppm) 7-day point-prevalence abstinence from cigarettes, up to 52 weeks
Secondary Outcome Measures: 26-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes, 26-week biochemically confirmed (CO\<6ppm) 7-day point-prevalence abstinence from cigarettes, up to 26 weeks|7-day point-prevalence abstinence from smoking and vaping at Weeks 26 and 52 post-TQD, Biochemically confirmed with saliva cotinine \<30 ng/mL, up to 52 weeks
Other Outcome Measures: Number of Participants Achieving Initial Smoking Abstinence, Measured by self-reported 24-hours of cigarette abstinence within the first 2 weeks of the target quit day, up to 2 weeks|12-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes, 12-week biochemically confirmed (CO\<6ppm) 7-day point-prevalence abstinence from cigarettes, up to 12 Weeks (end of treatment)|7-day point-prevalence abstinence from smoking and vaping at Week 12, Biochemically confirmed with saliva cotinine \<30 ng/mL, up to 12 Weeks (end of treatment)|Number of Participants Achieving Initial Abstinence from Smoking and Vaping, Measured by self-reported 24-hours of cigarette and ENDS abstinence within the first 2 weeks of the target quit day, up to 2 weeks|Number of days until first cigarette following initial cessation, Latency to lapse (number of days until first cigarette following initial cessation) computed over the full 52 weeks post-TQD, up to 52 weeks post-TQD|Number of days until 7 consecutive days of smoking following initial cessation, Latency to relapse (number of days until 7 consecutive days of smoking following initial cessation) computed over the full 52 weeks post-TQD., up to 52 weeks post-TQD
Prucalopride for Cognitive Functioning in Schizophrenia
NCT Number: NCT06474286
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia
Interventions: DRUG: Prucalopride 1 MG
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|K S Hegde Medical Academy
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-09-30
Locations: K S Hegde Medical Academy,, Mangalore, Karnataka, 575018, India

Summary:
A core component of schizophrenia is neurocognitive impairment. The cognitive deficits are prominently seen in memory, attention, working memory, problem solving, processing speed and social cognition. Atypical antipsychotics continue to be the mainstay of treatment in schizophrenia.

Promising areas for future research include search for new compounds for cognition enhancement. Prucalopride, a highly selective 5HT4 receptor agonist is a potential drug and its effect on cognition in patients with schizophrenia needs to be studied.

An open label, pilot study involving 34 patients with schizophrenia diagnosed as per DSM 5 criteria. The participants will receive Tab. Prucalopride one milligram (1 mg) for a duration of four weeks along with their existing treatment regimen with antipsychotics.

Assessments includes PANSS and BACS at baseline and at the end of 4 weeks. The effect of prucalopride on cognitive functioning in patients with schizophrenia is studied.

Primary Outcome Measures: Positive and Negative Syndrome Scale for Schizophrenia (PANSS )Score, There will be change is PANSS score at the end of the study. The score is to assess symptoms. Lowest score is 30 and highest is 210., PANSS scores measured at baseline and at the end of 4 weeks|Cognitive Functioning (List learning), To study the change in the cognitive functioning as measured by list learning after intervention. Scores range between 0 and 30., Baseline and and at the end of 4 weeks|Cognitive Functioning (Digit sequencing task), To study the change in the cognitive functioning as measured by Digit sequencing task after intervention, It ranges from 0 to 28 points, Baseline and and at the end of 4 weeks|Cognitive Functioning (Token motor task), To study the change in the cognitive functioning as measured by Token motor task after intervention. It ranges from 0 to 100 points,, Baseline and and at the end of 4 weeks|Cognitive Functioning (Tower test), To study the change in the cognitive functioning as measured by Tower test after intervention, Baseline and and at the end of 4 weeks|Cognitive Functioning (Symbol coding), To study the change in the cognitive functioning as measured by Symbol coding after intervention. It ranges from 0 to 22 points., Baseline and and at the end of 4 weeks