pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth
NCT Number: NCT06581536
Acronym: Yes and Know
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Related|Sexually Transmitted Diseases|Adolescent Behavior
Sponsor: ETR Associates
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-01-06
Completion Date: 2027-08-31

Summary:
This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.

Primary Outcome Measures: Rates of unprotected vaginal or anal sex, Single measure constructed from the number of times had vaginal sex without a contraceptive method in the past 3 months; number of times had anal sex without a condom in the past 3 months., 12 months post-intervention
Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners
NCT Number: NCT06581523
Acronym: SKYforiPD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson's Disease
Interventions: BEHAVIORAL: SKY Breath and Meditation
Sponsor: Nova Southeastern University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-04
Locations: Raw Kickboxing and Fitness, Coral Springs, Florida, 33071, United States|David Posnack Jewish Community Center, Davie, Florida, 33328, United States|Nova Southeastern University, Fort Lauderdale, Florida, 33328, United States

Summary:
The goal of this feasibility study and clinical trial is to learn if an evidenced-based breathwork and meditation intervention (SKY Breath) will improve the mental and physical well-being of individuals with Parkinson's Disease (iPD) in stages 1, 2, and 3, under the age of 75 and their care partners. The main questions it aims to answer are:

* Objective 1: Can the SKY Breath practice be designed and implemented to specifically cater to the unique needs of individuals with Parkinson's Disease and their care partners.
* Objective 2: Will the SKY Breath practice decrease stress levels (a contributor to increasing PD symptoms) for individuals with Parkinson's Disease (iPD) and their care partners as measured through self-reported surveys to improve overall well-being and quality of life.
* Objective 3: Will the SKY Breath practice in part alleviate the emotional stress and physical burden experienced by care partners of PD patients, promoting their resilience and well-being.

Participants will be asked to learn the SKY Breath and Meditation practice over the course of 4 days (2.25 hours each morning), practice SKY every day for 4 weeks and keep a log of time spent doing SKY. The participants will complete a series of surveys before learning the practice and then after at weeks 1, 4 and 8. The series of surveys will take about 20 minutes.

Primary Outcome Measures: Stress, Feelings of pressure and overwhelm as measured before and after intervention from self reported stress scales, Pre-intervention, and at 2 weeks, 4 weeks and 8 weeks post intervention|Psycho-social well-being, The general perceived mental health and well-being of individuals as measured from self reported scales, Pre-intervention, and at 2 weeks, 4 weeks and 8 weeks post intervention|Symptom management, Symptoms of gait, balance, energy levels in individuals with Parkinson's Disease as heasured from the Hoehne and Yahr Scale, Pre-intervention, and at 2 weeks, 4 weeks and 8 weeks post intervention
Custom-Made Zirconia Crowns and 3D-Printed Resin Crowns Versus Ready-Made Zirconia Crowns in Primary Molars
NCT Number: NCT06581510
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Crowns
Interventions: PROCEDURE: esthetic dental crowns|PROCEDURE: control group
Sponsor: British University In Egypt
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-25
Completion Date: 2026-02-23
Locations: The British university in Egypt, Cairo, Egypt|The British university in Egypt, Cairo, Egypt

Summary:
The main problem introduced in this study is the aggressive reduction needed for ready-made zirconia crowns to be passively fitted. In addition, its relatively expensive cost and wear of the opposing tooth structure. In this study, different crown materials will be introduced, such as customized zirconia crowns and novel 3D printed resin crowns who may offer better adaptability and gingival health and are relatively cost effective. The proposed study will help in increasing studies of different crown materials for primary teeth

Primary Outcome Measures: Functional, biological , and esthetic performance according to FDI clinical criteria, FDI World Dental Federation scores from 1-5 (highest score 1 and lowest score 5 ), 3,6,9 months|Measure amount of reduction done after preparation, Using superimposition technique, During procedure|Measure time taken during preparation, Stopwatch / timer from start of preparation till the end of preparation, During procedure|Measure amount of bleeding during preparation, Gravimetric method by weighing pre and post procedure gauze on scale, immediately after completion of the procedure (after reduction and cementation of dental crown)
Secondary Outcome Measures: Patient's satisfaction while restoring primary molars, Wong baker Faces scale ( 0 least indication no pain and 5 highest indicating pain), During procedure|Measure cost-effectiveness of each crown material, Compare costs between different crown materials, through study completion, an average of 1 year
ICIs With and Without MWA in Advanced Hepatocellular Carcinoma
NCT Number: NCT06581497
Acronym: IMI-aHCC
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HCC|Therapy Adverse Effect
Interventions: DRUG: ICIs|PROCEDURE: ICIs+MWA
Sponsor: The First People's Hospital of Neijiang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-01-01
Locations: The First People's Hospital of Neijiang City, Neijiang, Sichuan, 641000, China

Summary:
Immunotherapy has become the main treatment recommendation for HCC. MWA treatment induces peripheral immune response, which may enhance the effectiveness of immunotherapy for advanced HCC. This study aims to compare the efficacy and safety of ICIs combined with MWA compared to ICIs alone.

The study will compare two groups: ICIs and ICIs+MWA. Main objectives: OS, PFS Secondary objectives: CR PR、SD、PD、ORR、DCR、AEs This study addresses the efficacy and safety of using ICIs in combination with MWA compared to ICIs alone for advanced HCC patients.

Our study aims to evaluate the necessity of immunotherapy combined with targeted drugs or microwave ablation in patients with advanced hepatocellular carcinoma in the real world, providing relevant clinical data for the treatment selection of HCC patients.

Primary Outcome Measures: Progression-Free Survival (PFS), Time from treatment initiation to disease progression or death from any cause., Progression-Free Survival was assessed from the date of treatment initiation until the date of first documented disease progression or death from any cause, whichever occurred first, assessed up to 24 months.|Overall Survival (OS), Time from treatment initiation to disease progression or death from any cause., Overall Survival was measured from the date of treatment initiation until death from any cause or patients who were still alive at the last follow-up were censored at that time point, assessed up to 36 months.
Secondary Outcome Measures: objective response rate (ORR), According to the mRECIST criteria, the proportion of patients who achieve complete response (CR) or partial response (PR)., Objective response rate was measured from baseline to 24 months, every 8 weeks or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first.
The TRICURE EU Pivotal Study
NCT Number: NCT06581471
Acronym: TRICURE EU
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tricuspid Valve Regurgitation|Heart Valve Disease|Cardiovascular Diseases
Interventions: DEVICE: Transcatheter Tricuspid Valve Replacement
Sponsor: TRiCares
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2030-12-30
Locations: Algemeen Stedelijk Ziekenhuis, Aalst, 9300, Belgium

Summary:
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Primary Outcome Measures: Composite of MAE, Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications., 30 day post-intervention|Investigational Device Success, Device success defined as a reduction in tricuspid regurgitation immediately post-intervention, immediately post-intervention
Secondary Outcome Measures: Six minute walk test, Change in distance (m) compared to baseline assessment, 30 days, 6 months, annual for five years post-intervention|Reduction in Tricuspid Regurgitation (TR) Grade, Number of patients presenting with reduction in TR grade compared to baseline assessment, 30 days, 6 months, annual for five years post-intervention|New York Heart Association (NYHA) Function Class, Number of patients presenting with improvement in NYHA classification, 30 days, 6 months, annual for five years post-intervention
A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
NCT Number: NCT06581406
Acronym: RP2-202
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Metastatic Uveal Melanoma
Interventions: BIOLOGICAL: RP2|BIOLOGICAL: Ipilimumab|BIOLOGICAL: Nivolumab
Sponsor: Replimune Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 280
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-27
Completion Date: 2031-10

Summary:
The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.

Primary Outcome Measures: Overall Survival (OS), OS is the time from the date of randomization to death from any cause., From Day 1 up to 3 years after last dose.|Progression Free Survival (PFS), PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause., From Day 1 up to 3 years after last dose.
Secondary Outcome Measures: Number of patients with treatment-emergent adverse events (TEAEs), The incidence of all TEAEs., From first dose up to 100 days after last dose.|Overall Response Rate (ORR), ORR is the proportion of patients with a confirmed best overall response of complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1., Every 12 weeks from Day 1 up to 3 years after last dose.|Disease Control Rate (DCR), DCR is the proportion of patients with a confirmed best overall response of CR, PR, or Stable Disease (SD), as assessed by BICR per RECIST 1.1., Every 12 weeks from Day 1 up to 3 years after last dose.
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
NCT Number: NCT06581393
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End Stage Renal Disease|End Stage Renal Disease on Dialysis|End Stage Kidney Disease
Interventions: DEVICE: Moda-flx Hemodialysis System
Sponsor: Diality Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2024-11
Locations: North America Research Institute, Ontario, California, 91762, United States

Summary:
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center Hemodialysis) setting.

Primary Outcome Measures: Single-Pool Standardized Dialysis Adequacy, Single-pool standardized dialysis adequacy (spKt/V) will be measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. spKt/V values of ≥ 1.2 are regarded as being adequate., Samples will be collected before and after each dialysis treatment at Visit 1, Visit 2, Visit 3 and at Visit 4 over a two week period|Changes in Blood Chemistry, Changes in overall blood chemistry laboratory levels from Visit 1 to Visit 4., Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period|Changes in Complete Blood Count, Changes in overall complete blood count levels from Visit 1 to Visit 4., Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period|Changes in Iron Studies, Changes in overall iron studies levels from Visit 1 to Visit 4., Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period
Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care
NCT Number: NCT06581367
Acronym: STORM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Respiratory Tract Infection
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 474
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-10-01
Completion Date: 2027-04-30

Summary:
The rise of drug-resistant organisms and the need to minimize side effects calls for a new approach to antibiotic therapy duration. This study explores tailoring the length of antibiotic treatment to patient recovery, focusing on whether adjusting therapy based on when the patient feels better is as effective as completing the prescribed course for acute respiratory tract infections (RTIs). The investigators will enroll 474 outpatients aged 18-75 with acute RTIs across 25 Spanish healthcare centers. Patients will be randomized into two groups: one following standard full-course antibiotic therapy, and another receiving a tailored approach, where treatment may be shortened based on clinical assessments. The primary outcome is clinical efficacy at day 14. Secondary outcomes include antibiotic duration, complications, and quality of life.

Primary Outcome Measures: Clinical resolution, Number of patients with disappearance of fever, disappearance or improvement in overall condition (all scores \<2), such that no additional antimicrobial treatment is necessary., Day 14
Secondary Outcome Measures: Duration of antibiotic therapy, Number of patients discontinuing treatment in both groups and what day they discontinue recorded, Day 14|Doses taken, Number of doses of antibiotic taken, Day 14|Duration of severe symptoms, Number of days until the last day the patient scores 5 in any of the symptoms in the RTI diary symptom, Day 14|Duration of moderate symptoms, Number of days until the last day the patient scores 3 in any of the symptoms in the RTI symptom diary., Day 14|Total resolution of symptoms, Number of days until the last day the patient scores 0 in any of the symptoms in the RTI symptom diary., Day 14|Re-attendance rate, Number of re-attendances to any doctor for new or worsening symptoms regarding the RTI regarding the infection, Day 28|Complication rate, Number of complications related to the infection, such as visits to emergency departments and/or hospital admissions regarding the RTI, Day 28|Absenteeism, Number of days of work absenteeism due to the infectious disease, Day 14|Adverse events, Drug-associated adverse events related to the antibiotic and antibiotics changed, Day 14|Use of other medication, Number of participants using antibiotics others than the study medication and other symptomatic therapies within the first two weeks, Day 14|Health quality of life, Variation of the score of the health-related quality of life on days 14 and 28, compared to baseline, measured using the EuroQol instrument, including visual analogical scale, ranging from 0 (worst health condition) to 100 (best health condition), Day 28
GFRC Enhance Patient Satisfaction and Reduce Complications in Maxillary Implants With Pekkton Frameworks
NCT Number: NCT06581354
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Edentulous Alveolar Ridge
Interventions: PROCEDURE: PROVISIONALIZATION
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-11-01

Summary:
This study aims to evaluate the effect of provisionalization with a glass fiber composite framework on patient satisfaction and prosthetic complications before the insertion of a definitive PEKKTON framework when used under the screw-retained maxillary implant-supported prostheses at a one-year follow-up period.

Primary Outcome Measures: patient satisfaction, During the 12-month follow-up period as follows (3 months after delivery, 6 months after delivery, and 12 months after delivery), Patient satisfaction for Implant-supported screw-retained full arch maxillary provisional prosthesis with early loading protocol utilizing 6 implants for constructing a resin glass fiber composite followed by (PEKKTON) framework will be registered and calculated by Questionnaire, one year
Secondary Outcome Measures: prosthetic complications, During the 12-month follow-up period as follow( 3 months after delivery, 6 months after delivery, and 12 months after delivery), Prosthetic complications for Implant-supported screw-retained full arch maxillary provisional prosthesis with early loading protocol utilizing 6 implants for constructing a (PEKKTON) framework will be registered and calculated according to the following events: screw loosening of the abutment, screw loosening of the prosthesis, fracture of the screw of the abutment, fracture of the screw of the prosthesis, abutment fracture, framework fracture, fracture of acrylic resin denture, loss of cover of access hole, prosthetic teeth fracture and remake of the prosthesis, occlusal discrepancies, maxillary and mandibular denture relining if needed, pain., one year
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
NCT Number: NCT06581315
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatocellular Carcinoma|Adjuvant Therapy
Interventions: DRUG: Donafenib
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 204
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2032-08-30
Locations: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510120, China

Summary:
This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.

Primary Outcome Measures: One year recurrence-free survival (RFS) rate, The proportion from randomization to 1 year without recurrence., 1 year
Secondary Outcome Measures: Recurrence-Free Survival (RFS ), The time from randomization to disease recurrence, or death from any cause (whichever occurs first)., 6 years|Recurrence-Free Survival rate (RFS rate), The proportion from randomization to 2 years, 3 years or 5 years without recurrence., 5 years|Overall Survival (OS), The time from randomization to death from any cause., 6 years
Magnetic Seizure Therapy for Psychotic Disorders
NCT Number: NCT06581302
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychotic Disorders
Interventions: DEVICE: Magnetic seizure therapy by Magnetic stimulator|DRUG: Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-30
Locations: Shanghai Mental Health Center, Shanghai, Shanghai, 200030, China

Summary:
This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.

Primary Outcome Measures: Changes in Positive and Negative Symptom Scale (PANSS), measured by Positive and Negative Symptom Scale (PANSS), Baseline, 1 weeks, 2 weeks, 6 weeks
Secondary Outcome Measures: Changes in cognition, measured by MCCB cognition tests, Baseline, 1 weeks, 2 weeks|Changes of ictal EEG feature, measured by electroencephalogram (EEG), during each treatment|Changes of cortical inhibition, measured by TMS evoked potentials (TEP), baseline, 2 weeks|Changes of brain grey matter, measured by structural MRI images of brain, baseline, 2 weeks|Changes in 24-item Hamilton Depression Rating Scale (HAM-D), measured by 24-item Hamilton Depression Rating Scale (HAM-D), Baseline, 1 weeks, 2 weeks, 6 weeks|Changes in Hamilton Anxiety Scale (HAMA), measured by Hamilton Anxiety Scale (HAMA), Baseline, 1 weeks, 2 weeks, 6 weeks|Changes in Clinical Global Impression (CGI) scale, measured by Clinical Global Impression (CGI) scale, Baseline, 2 weeks, 6 weeks|Changes in Global Assessment of Functioning (GAF) scale, measured by Global Assessment of Functioning (GAF) scale, Baseline, 2 weeks, 6 weeks|Changes in brain gamma band signal, Gamma band signal will be measured by magnetoencephalogram (MEG), Baseline, 2 weeks
Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome
NCT Number: NCT06581289
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Anaesthesia
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2034-09-30
Locations: Severance Hospital, Seoul, Korea, Republic of

Summary:
AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. Collecting perioperative biosignal data and studying their association with renal outcomes can help improve kidney injury, mortality, and morbidity in cardiac surgical patients. Furthermore, the occurrence of AKI, length of hospital stay, and recovery of renal function after discharge are closely associated with the development of chronic kidney disease (CKD). Therefore, regular monitoring of renal function and related indicators in cardiac surgical patients can help improve long-term outcomes.

Primary Outcome Measures: post-operative AKI incidence within 1 week after cardiac surgery with CPB, The definition of AKI refers to Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury., within first 7 days after surgery
Secondary Outcome Measures: MAKE 30 (Major adverse kidney event within 30 days), death, starting dialysis, or decrease in eGFR of 25 % or more within 30 days after surgery, within 30 days after surgery|MAKE 90 (Major Adverse kidney event within 90 days), death, starting dialysis, or decrease in eGFR of 25 % or more within 90 days after surgery, within 90 days after surgery|incidence of CKD (chronic kidney disease) within 1 year, at least one of the following criteria is met, with structural or functional abnormalities of the kidney persisting for at least 3 months within 1 year

* urine albumin/creatinine ratio ≥ 30 mg/g
* abnormality in urine sediment test or persistent hematuria
* renal structural abnormalities found in image study
* eGFR \< 60 ml/min/1.73m2 (GFR category G3a-G5), within 1 year after surgery|1 year mortality, death due to any cause within 1 year, within 1 year after surgery|in-hospital mortality, death which occurs during the hospitalization, from day of hospitalization for surgery until discharge after surgery 1year
Psychedelic Virtual Reality
NCT Number: NCT06581263
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Psychedelic Experiences|Virtual Reality|Healthy Volunteer
Interventions: DEVICE: Meta Quest 3
Sponsor: Yale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-03-31
Locations: Yale University School of Medicine, New Haven, Connecticut, 06510, United States

Summary:
The purpose of this study is to evaluate a novel VRP.

Primary Outcome Measures: Assess subjective experience of novel VRP (DeepDream) comparable to a standard dose of psychedelics., Subject experience will be assessed by scores on the Altered States of Consciousness Questionnaire (ASC)., Day 0 through Day 30|Assess subjective experience of novel VRP (DeepDream) comparable to a standard dose of psychedelics., Subject experience will be assessed by scores on the Mystical Experience Questionnaire (MEQ-30)., Day 0 through Day 30|Assess subjective experience of novel VRP (DeepDream) comparable to a standard dose of psychedelics., Subject experience will be assessed by scores on the Ego-Dissolution Inventory (EDI)., Day 0 through Day 30
Secondary Outcome Measures: Assess the incidence of VRP adverse effects, principally virtual reality sickness (VRS) and neck and upper back pain., The number of adverse events will be assessed through qualitative interviews following VRP viewing., Day 0 through Day 30
Pseudotumor Cerebri Headache Ten Years Outcome
NCT Number: NCT06581185
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Pseudotumor Cerebri
Sponsor: Bnai Zion Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-08-31
Locations: Bani Zion, Haifa, Israel

Summary:
Telephone interview on patient who suffered from PTC ten years ago regarding their headache status

Primary Outcome Measures: headache outcome HIT-6, How many patients will suffer from headache after recovery from PTC measured by HIT 6 questionnaire, 5-10 years
Secondary Outcome Measures: Quality of life (QOL), Is the QOL of patients recovering from PTS related to their headache measured by WHO QOL questionnaire, 5-10 years
Significance of Disseminated Intravascular Coagulation Score in Mortality for Children With Shock
NCT Number: NCT06581172
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Shock, Septic
Interventions: DIAGNOSTIC_TEST: D_dimer
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2026-01-01

Summary:
Evaluates whether the DIC score, as defined according to the International Society of Thrombosis and Hemostasis guidelines is associated with mortality in Children with shock and DIC

Primary Outcome Measures: Evaluates whether the DIC score, as defined according to the International Society of Thrombosis and Hemostasis guidelines is associated with mortality in Children with shock and DIC, Data of the patients will be collected in the

form of:

* Personal history (age, sex), demographics including residence.
* Clinical history and examination including diagnoses, vital signs and signs of shock, cause of shock if detected.
* Therapeutic history including the use of continuous vasoactive medications, volume of blood products transfused and the presence of mechanical ventilation

Laboratory investigation:

The four laboratory components of the DIC score were determined from

1. Complete blood count (CBC).
2. Prothrombin time (PT)
3. Platelet count
4. FDP titer Scoring systems The score was determined within the first 12 h of admission, at this time the patient was on the highest cumulative dose of these medications and used as a marker for hemodynamic instability. DIC scores were computed when all four-laboratory component, Baseline|Scoring system, Component of the score 0 1 2 3 Max points possible

Platelet count (/mm3 ) \>100,000 100,000_51 ≤50,000 2 Fibrinogen (mg/dl) ≥100 \<100 1 FDP titer (mg/ml) ≤5 6_40 \>40 3 prolonged PT (s)\<3 3_6 \>6 2 Total score 8 All individual components are summed for a total of eight possible points. If d-dimer is used instead of FDP titer, then cutoff values for the DIC score are (0: ≤2 mg/l), (2: 2.1-8 mg/l) and (3: \>8 mg/l)

Interpretation of total score:

≥5 points positive for DIC \<5 points: negative, but patients could still have "on_ overt DIC" which could evolve into Frank DIC .If there is ongoing concern for DIC, Coagulation labs may be repeated in 12_24 hours., Baseline
Secondary Outcome Measures: Sample size, Eighty (80) children with shock will be included in this study during the period from 1-1-2025 to 31-12-2025. Sample size was calculated by Open Epi Info version (3) according to previous study conducted by Robinder., et al (2008), by comparing two related means using confidence level 85%., Baseline
Sleep Disruption Pattern - Epilepsy Monitoring Unit
NCT Number: NCT06581133
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Epilepsy Intractable
Interventions: DEVICE: Alarm system
Sponsor: Duke University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2025-12-01

Summary:
Epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. This process, however, is resource-intensive, with lengthy hospital stays. The investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. Building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units.

Primary Outcome Measures: Seizure frequency during EMU (epilepsy monitoring unit) stay, Average number of seizures per day, recorded daily during the patient's EMU stay. Measured for all groups of patients., 1 month after the EMU stay (up to 9 weeks)|Duration of EMU (epilepsy monitoring unit) admission, Overall duration (in days) of the EMU admission. Measured for all groups of patients., 1 month after the EMU stay (up to 9 weeks)|Average interictal spike rates, Average number of spike rates, taken from a random segment for each day and night. Measured for all groups of patients., 1 month after the EMU stay (up to 9 weeks)|Change in sleep quality, As determined by changes in Pittsburgh Sleep Quality Index scores. A higher score indicates increased sleep disturbances., Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks)
GLP_1 RA Ultrasound Study
NCT Number: NCT06581120
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Glucagon Like Peptide-1 (GLP-1|Delayed Gastric Emptying|Risk of Aspiration|Diabetes|Morbid Obesity
Sponsor: Children's Hospital Medical Center, Cincinnati
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-08
Completion Date: 2026-07

Summary:
The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.

Primary Outcome Measures: Aspiration Risk determined by POGUS, Difference between control group and GLP-1 group. Measured by Gastric contents during Point of Care Gastric Ultrasound., Two years
Effects of UC-II, Glucosamine and Curcumin Supplementation on Knee Pain and Inflammation.
NCT Number: NCT06581094
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammation|Knee Pain Chronic
Interventions: DIETARY_SUPPLEMENT: UCII, glucosamine and curcumin
Sponsor: Taipei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-11-30
Locations: Taipei medical university, Taipei, Taiwan

Summary:
This research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.

Primary Outcome Measures: Pain evaluation scale, Self-assess pain using a visual analog scale (VAS), which is a straight line 10 cm in length, with 0 cm on the left representing no pain and 10 cm on the right representing extreme pain. Explain to the subjects that the pain intensity increases from left to right. Ask the subjects to mark the point on the line that corresponds to their pain level, and then record the distance in centimeters from the 0 cm mark., 12 weeks|Up-and-go test, A professional physical therapist marked a distance of 3 meters on the ground and placed an armless chair at one end. The subject sat on the chair with a straight back, and the time was measured from when the subject stood up and walked to the 3-meter mark at their usual speed, turned around, walked back, and sat down again., 12 weeks|Range of motion (ROM), A professional physical therapist tested the active flexion and extension of the knee joint (range of motion, ROM) as the subjects attempted to achieve maximum active flexion and extension., 12 weeks|Serum inflammatory factors, IL-6、IL-1β、TNF-α, 12 weeks
Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cell Acute Lymphoblastic Leukemia, a Prospective, Open, Multicenter, Randomized, Control Study
NCT Number: NCT06581081
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Relapsed Adult ALL|B-cell Acute Lymphoblastic Leukemia|Refractory Acute Lymphoblastic Leukemia|Relapsed Pediatric ALL
Interventions: BIOLOGICAL: Senl_B19 autologous CAR-T (S1904) treatment
Sponsor: Peking University People's Hospital
Collaborators: The First Affiliated Hospital of Soochow University|Nanfang Hospital, Southern Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-08-31

Summary:
Traditional salvage chemotherapy has low efficacy and poor long-term prognosis for relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Targeted CD19 CAR-T cell immunotherapy is an effective means of treating R/R B-ALL. Several clinical studies have shown that its remission rate for R/R B-ALL can reach 68-93%. However, long-term follow-up found that the remission time after CD19 CAR-T treatment is short and the relapse rate is high. Therefore, how to ensure the long-term survival of R/R B-ALL patients after remission by CAR-T therapy is an urgent problem to be solved. Some studies have shown that timely bridging allo-HSCT after CAR-T treatment can overcome the risk of relapse and further improve the long-term survival of patients. However, there is currently no randomized controlled study on whether to bridge transplantation after CAR-T. The purpose of this study is to evaluate the efficacy and safety of S1904 in the treatment of relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia with or without bridging to allogeneic hematopoietic stem cell transplantation after remission.

Primary Outcome Measures: 2-year event-free survival after randomization, The time from randomization to MRD positive or relapse or death due to non-relapse causes (whichever occurs first), Participants will be followed for an expected average of 2 years
Secondary Outcome Measures: 2-year relapse-free survival after randomization, Time from randomization to relapse or death from any cause (whichever occurs first), Participants will be followed for an expected average of 2 years|Cumulative incidence of relapse, Time from randomization to relapse, Participants will be followed for an expected average of 2 years|2-year overall survival after randomization, Time from randomization to death from any cause, Participants will be followed for an expected average of 2 years
A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes
NCT Number: NCT06581055
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myelodysplastic Syndromes (MDS)
Interventions: DRUG: Luspatercept|DRUG: Epoetin Alfa
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-30
Completion Date: 2025-03-30
Locations: National Taiwan University Hospital (NTUH), Taipei, 10040, Taiwan

Summary:
This study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records.

Primary Outcome Measures: Participant treatment patterns: Type of treatment received, Up to 24 months|Participant treatment patterns: Duration of treatment received, Up to 24 months|Participant treatment patterns: Dosage of treatment received, Up to 24 months|Participant treatment patterns: Dosing route of treatment administration, Up to 24 months|Participant treatment patterns: Reason for treatment administration, Up to 24 months|Participant treatment patterns: Time to next line of therapy (LoT), Up to 24 months|Participant treatment patterns: Reason for treatment discontinuation, Up to 24 months|Participant treatment patterns: Type of concomitant medications received, Up to 24 months|Participant treatment patterns: Start and end dates of concomitant medications received, Up to 24 months
Secondary Outcome Measures: Participant clinical outcomes: Number of units of red blood cell transfusions received, Up to 24 months|Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category, Category 1: Transfusion dependent (at least 4 units of red blood cell (RBC) with 8 weeks for hemoglobin (Hb) \<9g/dL) Category 2: Transfusion independence (\<4 units of RBC with 8 weeks for Hb \<9 g/dL), Up to 24 months|Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018, IWG 2028 criteria:

1. Non-transfused (0 Red Blood Cells \[RBC\] in 16 weeks)
2. Low-transfusion burden (3-7 RBCs in 16 weeks in at least 2 transfusion episodes, maximum 3 in 8 weeks)
3. High-transfusion burden (≥8 RBCs in 16 week, ≥4 in 8 weeks), Up to 24 months|Participant clinical outcomes: Blood test results, Up to 24 months|Participant clinical outcomes: Number of participants that progressed to acute myeloid leukemia (AML) status, Up to 24 months|Number of participants that progressed to high-risk myelodysplastic syndromes (MDS), Up to 24 months|Participant clinical outcomes: Participant survival status, Up to 24 months|Participant clinical outcomes: Date and primary cause of death, Up to 24 months|Participant clinical characteristics, Up to 24 months
Study to Assess Treatment Patterns and Outcomes With Upadcitinib in Adult Participants With Inflammatory Bowel Disease in Belgium
NCT Number: NCT06581042
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ulcerative Colitis|Crohn's Disease
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 280
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-02
Completion Date: 2029-09-28

Summary:
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD).

Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice

Primary Outcome Measures: Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis, Clinical remission is defined as: stool frequency (SF) score \< = 1 and not greater than baseline and Rectal bleeding (RB) score = 0, Up to approximately 52 weeks|Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease, Clinical remission is defined as stool frequency (SF) score \< =3 and not worse than baseline and Abdominal Pain (AP) score \< =1 and not worse than baseline, Up to approximately 52 weeks
Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers
NCT Number: NCT06581029
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: SLE
Interventions: OTHER: The multidimensional peer victimization scale (PVS)
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 62
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2025-12-30

Summary:
assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.

Primary Outcome Measures: Evaluating mental health challenges in juvenile SLE and their caregivers, The aim of the present study is to evaluate and assess psychiatric problems in juvenile systemic lupus erythematosus patients and their caregivers. Also, to evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life., baseline
Performance Characteristics and Technical Outcomes of Single-use Vs. Reusable Gastroscopes Evaluated in the or
NCT Number: NCT06581016
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Upper Gastrointestinal Disorder
Sponsor: Zealand University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31

Summary:
The goal of this clinical trial is to investigate whether single-use gastroscopes are as good as reusable gastroscopes when used in the operation theater in all patients where gastroscopy in the operation theater is indicated. The main question it aims to answer is:

- Is the technical success and performance characteristics the same for single-use and reusable gastroscopies?

Researchers will compare single-use gastroscopes with reusable gastroscopes to see if the technical success and performance characteristics are the same in the to groups.

Participants will in the first period have gastroscopy with a single-use gastroscope. In the second period participants will have gastroscopy with a reusable gastroscope.

Primary Outcome Measures: Technical success of single-use gastroscopes vs reusable gastroscopes, Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines., From admission to discharge, up to 3 months
Secondary Outcome Measures: Complications, Complications to gastroscopy, 24 hours and 72 hours follow-up after procedure|30th day mortality, Mortality after 30 days after procedure, 30 days|Endoscopist's rating of gastroscope, The endoscopist's rating of the gastroscope, Right after procedure|Duration of procedure, The time from intubation of gastroscope until gastroscope removed from esophagus., During the procedure|Time from procedure to discharge, Time from procedure to discharge, From procedure to discharge, up to 3 months|Success of specific therapeutic procedures, E.g. success in treating ulcers, banding or stenting, During the procedure|Need of new gastroscopy, Need of new gastroscopy during admission, During admission, up to 3 months|Readmission, Does the patient need readmission after discharge, 30 days after procedure|Sufficient ability to target the biopsy if taken, Successful biopsy which the pathologist can use to either diagnose the patient or to reject a diagnose., During procedure