pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Efficacy of Long-Course Treatment Using Vibrating Capsules for Chronic Constipation
NCT Number: NCT06553664
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Functional Constipation
Interventions: DRUG: Treat with Vibrabot capsules for at least 7 weeks
Sponsor: Beijing Tsinghua Chang Gung Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-28
Completion Date: 2023-12-02
Locations: XuanJiang, Beijing, Beijing, 102218, China

Summary:
This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).

Primary Outcome Measures: The proportions of responders during the treatment period., Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period., at least 7 weeks
Secondary Outcome Measures: The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period., Evaluating the proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period., at least 7 weeks|Number of mean weekly complete spontaneous bowel movements (CSBM)., The average number of complete spontaneous bowel movements per week for each patient during the treatment period., at least 7 weeks
Evaluation of the Prognostic Impact of Decreased Serum beta2 Microglobulin in the First Year of Follow-up of Myeloproliferative Neoplasia (PRODIGE)
NCT Number: NCT06553638
Acronym: PRODIGE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myeloproliferative Neoplasm
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2026-05-31
Locations: Chu Brest, Brest, 29609, France

Summary:
50 patients with a diagnosis of MPN will have an assessment of b2microglobuline at diagnosis and after 1 year. b2mic value decrease will be compared to treatment response.

Primary Outcome Measures: b2mic decrease level between responders and non-responders, 1 year
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS
NCT Number: NCT06553625
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease|Dystonia|Essential Tremor|Movement Disorders
Interventions: DEVICE: Radiofrequency Ablation
Sponsor: Boston Scientific Corporation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-29
Completion Date: 2035-12
Locations: Universitaetsklinikum Dusseldorf, Dusseldorf, Germany|St. Georges Hospital, London, United Kingdom

Summary:
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.

Primary Outcome Measures: Change in patient's quality of life (QoL) during the study as compared with baseline, Change in quality of life assessments during the study as compared with baseline, Up to 24-Months
Epidemiology of Road Traffic Accidents in Riyadh Region in the Last Five Years (2019-2023)
NCT Number: NCT06553586
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Epidemiology|Road (Traffic) Accident [RTA] Nos|Riyadh
Interventions: OTHER: Data collection
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2026-10-01
Locations: Assiut university, Assiut, Egypt

Summary:
The findings arising from the proposed study will spot light on the issue of road traffic accidents in Riyadh Region which will help stakeholders to design proper plans and strategies of prevention and control of this issue. This will minimize the toll and burden of road traffic accidents in Riyadh Region.

To highlight the magnitude of the problem of road traffic accidents in Riyadh Region in the last five years (2019-2023), To identify the demographic characteristics of the victims involved in accidents throughout the last five years in Riyadh Region, To estimate the trend and seasonal variations of road traffic accidents Riyadh Region.

Primary Outcome Measures: Prevalence of Road Traffic Accidents, Prevalence of Road Traffic Accidents will be recorded in the Riyadh Region in the Last Five Years., Five years from the start of the study
Secondary Outcome Measures: Causes of Road Traffic Accidents, Causes of Road Traffic Accidents will be recorded such as dangerous overtaking / lane cutting, drunken driving, over crowding and over loading, lack of driving skills and inadequate knowledge of traffic discipline., Five years from the start of the study|Complication, Complication will be recorded such as physical injuries, psychological trauma, financial strain, legal issues, and disruptions to traffic flow., Five years from the start of the study
Comparison of PSB and RIFPB Combination With PSB and ESPB Combination in Cardiac Surgery With Sternotomy
NCT Number: NCT06553573
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: OTHER: Parasternal Block and Recto-İntercostal Fascial Plane Block|OTHER: Parasternal Block and Erector Spinae Plane Block
Sponsor: Cumhuriyet University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2024-09-20

Summary:
The goal of this study is to compare the analgesic efficacy of the combination of PSB and RIFPB and the combination of PSB and ESPB in patients undergoing cardiac surgery with sternotomy.

Primary Outcome Measures: Comparing the numerical rating scale scores, Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome., Postoperative 24 hours
Secondary Outcome Measures: Comparing total morphine consumption, Postoperative analgesic need, Postoperative 24 hours
The Efficacy of PSB and Recto-intercostal Block Combination on Postoperative Pain in Patients Undergoing Cardiac Surgery Via Sternotomy: Case Series
NCT Number: NCT06553560
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: OTHER: Parasternal Block and Recto-İntercostal Fascial Plane Block
Sponsor: Cumhuriyet University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2024-09-20

Summary:
The aim of this study was to investigate the effectiveness of the combination of Superficial Parasternal Block and Recto-Intercostal Fascial Plane Block in patient groups undergoing cardiac surgery via sternotomy by evaluating postoperative pain scores and analgesic consumption.

Primary Outcome Measures: Comparing the numerical rating scale scores, Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome., Postoperative 24 hours
Secondary Outcome Measures: Comparing total morphine consumption, Postoperative analgesic need, Postoperative 24 hours
4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
NCT Number: NCT06553547
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions: DRUG: Tenapanor|DRUG: Placebo
Sponsor: Ardelyx
Sex: ALL
Age: CHILD
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2026-06
Locations: Florida Pharmaceutical Research and Associates, Inc., South Miami, Florida, 33143, United States

Summary:
This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Primary Outcome Measures: Average weekly SBM (week 4), Change from baseline in average weekly SBM frequency in Week 4, 4 weeks
Secondary Outcome Measures: Average weekly SBM (weeks 1, 2 and 3), Change from baseline in average weekly SBM frequency in Week 1, Week 2, and Week 3, 3 weeks|SBM Response, Weekly ≥3 SBM response: achieving an average weekly SBM frequency ≥3 for a given week, 6 weeks|Stool consistency, Percent change from baseline in average weekly stool consistency score in each week, 6 weeks|Abdominal Pain Score, Percent change from baseline in average weekly abdominal pain score in each week, 6 weeks|Rescue medication, Overall use of rescue medication, 6 weeks
Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU
NCT Number: NCT06553534
Acronym: SAMURAI PICU
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: In-hospital Cardiac Arrest|Cardiopulmonary Resuscitation
Interventions: OTHER: SAMURAI PICU Bundle
Sponsor: Children's Hospital Medical Center, Cincinnati
Collaborators: Children's Hospital of Philadelphia|Agency for Healthcare Research and Quality (AHRQ)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2029-01
Locations: Comer Children's Hospital, Chicago, Illinois, 60637, United States|Akron Children's Hospital, Akron, Ohio, 44308, United States|MUSC Shawn Jenkins Children's Hospital, Charleston, South Carolina, 29425, United States|Children's Hospital of Richmond, Richmond, Virginia, 23219, United States|Seattle Children's, Seattle, Washington, 98105, United States

Summary:
The goal of this pragmatic prospective Type 1 Hybrid Implementation-Effectiveness Trial study is to learn if The Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In (SAMURAI) the PICU Bundle can reduce PICU CPR events. The SAMURAI PICU Bundle includes an automated PICU warning tool, twice daily huddles and mitigation plans. The main questions it aims to answer are:

Is the adapted bundle will be acceptable, feasible, and appropriate to stakeholders prior to implementation?

Will there be at least a 30% relative reduction in PICU CPR events following successful implementation of the bundle?

Each site will:

Adapt and implement SAMURAI PICU Bundle which includes an automated PICU warning tool, twice daily huddles and mitigation plans

Primary Outcome Measures: Effectiveness - CPR Event Rate, The primary outcome is CPR Event Rate per 1000 Patient Days. CPR Events will be defined per Utstein Criteria., 2 years and 4 years
MyHEARTSMAP In-Patient Study
NCT Number: NCT06553521
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|Psychosocial Functioning
Interventions: OTHER: MyHEARTSMAP Youth Self-assessment Tool (At Admission)
Sponsor: University of British Columbia
Sex: ALL
Age: CHILD
Enrollment: 289
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2021-08-17
Completion Date: 2023-09-05
Locations: BC Children Hospital, Vancouver, British Columbia, V6H 3N1, Canada

Summary:
Often, mental health (MH) conditions are under-identified in youth with chronic health conditions, which can lead to long-term health consequences and can impact their everyday lives. Hospitalized youth often experience higher MH burdens and tend to have fewer interactions with their primary healthcare providers upon discharge, leading to overall worse health outcomes. In-hospital treatment focuses on the acute physical condition relating to the hospitalization and often neglects the mental health aspect of the patients general health problems. The American Academy of Paediatrics has advocated for the universal use of MH screening tools to detect and facilitate management of youth with psychiatric illnesses; however, this has yet to be effectively implemented. Currently, the guidelines for screening of MH related concerns in hospitalized youth vary by treating specialties. The investigators believe that having a universal psychosocial screening using an online MH self-assessment tool, MyHEARTSMAP, in hospitalized youth will allow for early screening of MH conditions and can improve their holistic biopsychosocial care.

Primary Outcome Measures: Incorporation of mental health resources during in-patient stay, The investigators will report the proportion of youth who received MH resources/consultation during their in-patient stay comparing participants in their randomized intervention group., During admission period|Incorporation of MH resources on discharge planning, The investigators will compare the proportion of youth who received MH resources and recommendations for support on their discharge plans comparing participants in their randomized intervention group. The investigators will also assess whether the care team provided verbal consultation with patients/families at the time of discharge., Time at which participant is discharged from hospital, could be up to approximately 6 weeks from date of randomization
Secondary Outcome Measures: Utilization of mental health resources following discharge, At the 3-month follow-up, all participating families will receive, by email, a link to a survey to assess whether they have accessed any psychosocial resources or therapeutics since discharge. They will also be prompted to indicate what barriers prevented them from accessing care if it was so indicated., At 3 months following discharge
Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days
NCT Number: NCT06553508
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bursa; Tuberculous|Hip Bursitis|Deep Gluteal Syndrome|Hip Disease
Interventions: PROCEDURE: Trochanteric bursa repaired|PROCEDURE: Trochanteric bursa unrepaired
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2023-01-01
Locations: Ankara Bilkent City Hospital, Ankara, 06800, Turkey

Summary:
During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is generally recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may protect against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.

Primary Outcome Measures: Rate of superficial wound problems, Wound leakage, superficial infection, wound dehiscence - Recorded as Yes / No, First postoperative 90 days|Rate of posterior gluteal pain, The condition is also refered to as Deep Gluteal Syndrome - Recorded as Yes / No, First postoperative 90 days|Rate of painful trochanteric bursitis, Recorded as pain on the trochanteric region on palpation - Recorded as Yes / No, First postoperative 90 days
Secondary Outcome Measures: Range of motion (ROM), Angular measurement of hip joint motion - minimum value:0, maximum value 130, higher values mean better outcome, First postoperative 90 days|Visual Analog Scale (VAS), minimum value:0, maximum value 10, higher values mean worse outcome, First postoperative 90 days|Harris Hip Score (HHS), minimum value:0, maximum value 100, higher values mean better outcome, First postoperative 90 days
A Comparative Analysis of Intertransverse Nerve Block and Paravertebral Nerve Block in Endoscopic Hepatectomy
NCT Number: NCT06553495
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain
Interventions: OTHER: Nerve block
Sponsor: Jie Chen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: The Second Affiliated Hospital Of Chongqing Medical University, Chongqing, Chongqing, 400000, China

Summary:
This study aims to compare the analgesic effect of intertransverse nerve block and paravertebral nerve block after endoscopic hepatectomy, evaluate its effectiveness and safety, and provide new ideas and clinical basis for postoperative pain management of liver surgery.

Primary Outcome Measures: The number of effective compressions of the analgesic pump within 24 hours after surgery, Within 24 hours after the operation
FatMax Training on Metabolic and Epigenetic Parameters
NCT Number: NCT06553482
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight and Obesity|Body Weight Changes
Interventions: OTHER: FatMAx training intervention|OTHER: FatMax and physical endurance exercise intervention|OTHER: Control
Sponsor: Universidad Autonoma de Baja California
Sex: ALL
Age: ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2025-01-01
Completion Date: 2027-01-01
Locations: Medical and Psychology School, Tijuana, California, 22390, Mexico

Summary:
Exercise is an essential pillar for the health of all individuals, as it contributes to physical, mental, and emotional well-being. Various international organizations, such as the World Health Organization, advocate for the integration of exercise into healthy lifestyles, recognizing its im-portance in disease prevention and improving quality of life. However, despite the general consensus on its value, there is no universal agreement on specific prescriptions for vulnerable groups, highlighting the need for personalized approaches that consider the unique characteristics and needs of each individual. It has been proposed that a moderate aerobic exercise training program could promote positive outcomes in individuals living with overweight and obesity, particularly with an emphasis on reducing injury risk, ensuring high adherence, and achieving favorable health changes. In this regard, the present protocol establishes the basis for a randomized clinical trial based on exercise prescription at the maximal fat oxidation rate in young individuals with overweight and obesity, with a duration of 16 weeks. Throughout the study, biochemical changes (cholesterol, glucose, triglycerides, and inflammatory markers), metabolic changes (de-termination of fat and carbohydrate utilization rates during rest and exercise), and epigenetic changes (focusing on microRNAs associated with adipogenesis, inflammation, and fat metabolism) will be monitored.

Primary Outcome Measures: Body composition change, Changes in body composition (fat mass and muscle mass) after the intervention, 16 weeks
Secondary Outcome Measures: Changes in lipid profile, Changes in total cholesterol, high-density lipoprotein cholesterol (c-HDL), low-density lipoprotein cholesterol (c-LDL), triglycerides, 16 weeks|Changes in epigenetic markers, Changes in microRNAs involved in inflammatory processes (miR-15, miR-29c, miR-30a, miR-142/3, miR-181a), adipogenesis (miR-188-5p, miR-146b-5p, miR-103, miR-107, miR-125b), and fatty acid metabolism (miR-33, miR-335, miR-370, miR-758), 16 weeks
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
NCT Number: NCT06553469
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cystometry|Sacral Neuromodulation|Ultrasound
Interventions: DEVICE: sacral neuromodulation
Sponsor: Qilu Hospital of Shandong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 41
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2025-12-31
Locations: Qilu Hospital of Shandong University, Jinan, Shandong, China

Summary:
The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury, as well as its preventive effect on complications of neurogenic lower urinary tract dysfunction. We will use urodynamic examination results such as maximum bladder capacity and detrusor leak point pressure, combined with renal function and urinary ultrasound results, as our evaluation indicators. Follow up evaluations will be conducted at 6 and 12 months after permanent implantation, and periodic comparisons will be made with baseline data to gain a more comprehensive understanding of the effectiveness and safety of sacral nerve regulation surgery.

Primary Outcome Measures: urodynamics, To examine function of bladder, 3,6,12 month|renal function, To examine function of kidney, 3,6,12 month|Urinary ultrasound, morphological change of urinary system, 3,6,12 month
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
NCT Number: NCT06553443
Acronym: RANGER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Arteriovenous Fistula|Arteriovenous Fistula Stenosis|Dialysis Access Malfunction
Interventions: DEVICE: Angioplasty of all peripheral AVF stenosis
Sponsor: Singapore General Hospital
Collaborators: Singapore Clinical Research Institute|Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-04
Completion Date: 2029-12-31
Locations: Singapore General Hospital, Singapore, Singapore

Summary:
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

Primary Outcome Measures: Access circuit primary patency, Time to next clinically-driven intervention, 6 months
Secondary Outcome Measures: Access access circuit patency, Time to next clinically-driven intervention, 12 months|Access circuit assisted primary patency, Time to next access thrombosis or surgical intervention., 6 and 12 months|Access circuit secondary patency, Time to access abandonment or surgical revision / declotting, 6 and 12 months|Procedural complication, Complication related to procedure, 12 months|Mortality, All cause mortality, 12 months and 5 years
Myoslow Lens Study to Control Myopia in Children
NCT Number: NCT06553404
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Myopia
Interventions: DEVICE: Myoslow|DEVICE: Single Vision
Sponsor: Crystal Optic
Sex: ALL
Age: CHILD
Enrollment: 125
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-24
Completion Date: 2025-11-01
Locations: Sheba MC, Ramat Gan, Israel

Summary:
A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children.

The following study measures will be assessed:

* Demographics and medical history
* Current spectacles
* Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M\&S) system
* Biometry
* Cover test
* Stereopsis
* Ocular Motility
* Pupil responses
* Cycloplegic refraction
* Fundus Examination
* Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2
* Adverse Events

Primary Outcome Measures: spherical equivalent error, Change in spherical equivalent refractive error from baseline to 24-month visit, 24 months
Secondary Outcome Measures: Axial length, Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry), 24 months
Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis
NCT Number: NCT06553391
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: DRUG: The tetralogy of medication regimen
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 106
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-09
Locations: Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen, Shenzhen, Guangdong, 518058, China

Summary:
The goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is:

Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol.

This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from March 7, 2023, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2000, and January 31, 2023, were included in the study.

Primary Outcome Measures: Sinus rhythm, Electrocardiogram monitoring, From the release of the aortic cross-clamp until 6 hours after surgery
Secondary Outcome Measures: Mean arterial pressure, Invasive arterial blood pressure test, From the release of the aortic cross-clamp until the end of surgery|the use of temporary pacemakers, Postoperative record, From the release of the aortic cross-clamp until 6 hours after surgery
The GOS-Frail (Geriatric Oncology Supportive Care for Frail Older Adults With Cancer) Study
NCT Number: NCT06553378
Acronym: GOS-Frail
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Geriatric Oncology|Supportive Care|Quality of Life
Interventions: OTHER: Geriatric Oncology Supportive Clinic
Sponsor: Tan Tock Seng Hospital
Collaborators: National University Cancer Institute, Singapore|National Medical Research Council (NMRC), Singapore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 154
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2027-08-31
Locations: Tan Tock Seng Hospital, Singapore, Singapore

Summary:
Background Cancer is more prevalent in older adults, but most cancer treatment trials have mainly involved young and healthy subjects. Among geriatric syndromes, frailty is a significant risk factor for negative outcomes such as treatment delays, discontinuation, and treatment-related side effects, as well as functional decline and poor survival. Research has shown that geriatric assessment with appropriate intervention can improve these outcomes, although the impact may be influenced by the inclusion of patients receiving palliative-intent treatment. Supportive care focuses on symptom assessment and treatment to enhance treatment tolerance and quality of life. To date, there have been no studies examining the combined benefits of geriatric oncology and supportive care clinics. We conducted a pilot study called Geriatric Oncology Supportive Clinic for Elderly (GOSPEL), which demonstrated an improved quality of life for older adults with curable cancer. Based on these results, we developed an enhanced care model.

Aim The study GOS-Frail aims to assess the effect of an integrated Geriatric Oncology Supportive Clinic on the quality of life of older adults with cancer receiving curative-intent chemotherapy and/or radiotherapy at 1 month.

Methods The GOS-Frail study is a multi-centre, open-label, parallel-arm, randomized controlled trial conducted in the specialist outpatient clinics of two university-affiliated tertiary care hospitals. 154 adults aged 65 and above, diagnosed with solid organ cancer and planned for curative-intent chemotherapy and/or radiotherapy, and with a clinical frailty scale score of 4 and above, will be recruited. Subjects will be randomized to either attend a geriatric oncology supportive clinic or receive frailty education material. Quality of life questionnaires will be administered at baseline, 2 weeks, and 1, 3, 6, and 12 months from treatment initiation.

Hypothesis:

The GOS-Frail study investigates on the role of a synergistic geriatric oncology and supportive model of care in improving quality of life in older adults undergoing curative-intent cancer treatment.

Primary Outcome Measures: EuroQoL-5 Dimension (EQ5D-5L), EuroQoL-5 Dimension (EQ5D-5L), 1 month
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
NCT Number: NCT06553365
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Nerve Sheath Tumor
Interventions: DRUG: FCN-159
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-07-31

Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors.

Primary Outcome Measures: Objective response rate (ORR) estimated by investigators, Investigator-assessed objective mitigation rate ORR (Reponse evaluation in Nerufibromatosis and Schwannomatosis, REiNS criteria and RECIST 1.1 criteria, respectively), Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Secondary Outcome Measures: Clinical benefit rate (CBR) estimated by investigators, Clinical benefit rate CBR will be assessed by the investigator (REiNS criteria and RECIST 1.1 criteria respectively), Every 4 cycles (each cycle is 28 days), assessed up to 2 years|24-week word recognition score (WRS), Hearing response changes will be assessed in patients with hearing impairment (24-week word recognition scores and pure tone audiometry)., up to 24 weeks|pain estimated by NRS, Change in pain intensity score relative to baseline will be assessed according to NRS scale., Every 4 cycles (each cycle is 28 days), assessed up to 2 years|Duration of response (DOR) assessed by investigator, Duration of response (DoR) is estimated by the investigators as the time from treatment initiation to disease progression or death in patients who achieve complete or partial response, using both RECIST V1.1 and REINS criteria., From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|progression free survival (PFS) assessed by investigator, PFS is estimated by the investigators as the time from treatment initiation to disease progression or death in patients, using both RECIST V1.1 and REINS criteria., From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Other Outcome Measures: life quality assessed by NFTI-QOL, Change in quality of life scores relative to baseline will be assessed by Neurofibromatosis type 2 impact on quality of life (NFTI-QOL) score. The higher score means worse life quality., Every 4 cycles (each cycle is 28 days), assessed up to 2 years|Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0, Adverse events during treatment of FCN-159 will be assessed by the investigators accroding to CTCAE 5.0., During the intervention
Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma
NCT Number: NCT06553352
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Follicular Lymphoma|Newly Diagnosed
Interventions: DRUG: Zanubrutinib combined with Obinutuzumab
Sponsor: The First Affiliated Hospital of Xiamen University
Collaborators: Shanxi Provincial Cancer Hospital|The First Hospital of Jilin University|Fujian Cancer Hospital|Jiangxi Provincial Cancer Hospital|The Second Affiliated Hospital of Dalian Medical University|Sun Yat-sen University|Huazhong University of Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-31
Completion Date: 2027-08-31
Locations: Bing Xu, Xiamen, Fujian, 361003, China

Summary:
To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.

Primary Outcome Measures: CR, Complete remission rate, up to 1 year
EndoStyle: Artificial Intelligence Image Transformation Tool for Colonoscopy
NCT Number: NCT06553326
Acronym: EndoStyle
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colon Cancer|Colon Rectal Cancer
Interventions: DEVICE: EndoStyle
Sponsor: Wuerzburg University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-12-31

Summary:
The study addresses the limitations of current AI systems in gastrointestinal endoscopy, which are tipically trained with data from a single type of endoscopy processor and have limited expert-annotated images. The investigators aim to develop and validate EndoStyle, an AI system that can generate images in the style of various processors from a single reference image. EndoStyle will be tested by showing endoscopists colonoscopy sequences with different image types to determine if they can distinguish AI-transformed images. Success would enhance AI training for diverse clinical setups.

Primary Outcome Measures: Perceptual Indistinguishability of AI-Transformed Endoscopic Images, Comparison of the accuracy for each study group., 5 months
Secondary Outcome Measures: Time Taken for Image Identification, Time taken to assess the different tasks according to each study group., 5 months|Influence of regularly used processor, Influence of regularly used endscopy processor during clinical work for the perceptual indistinguishability of AI-transformed endoscopic images with defined processor classes, 5 months|Influence of endoscopy experience, Influence of experience in endoscopy measured in lifetime performed colonscopies on perceptual indistinguishability of AI-transformed endoscopic images, 5 months
Analysis of Protein Expression in Serum of KOA Subjects
NCT Number: NCT06553313
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: DEVICE: Micro-Western Array
Sponsor: China Medical University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-04
Completion Date: 2025-07-23
Locations: China Medical University, Taichung, Taiwan

Summary:
In the previous study "Using omics technology to explore the mechanism of acupuncture treatment of different acupoints of knee osteoarthritis: a randomized controlled trial (CMUH109-REC3-113)", we found that acupuncture for knee osteoarthritis(KOA) significantly reduces inflammation, apoptosis, and metabolism-related serum protein profiles. However, due to the lack of serum protein data from the control group, it is impossible to establish standard values for comparison. To analyze the protein expression in the serum of KOA control group subjects, we also measured the spectral energy values of the radial artery pulse wave obtained from the pulse sphygmograph and the meridian energy values obtained from Ryodoraku. The results obtained can be compared with previous studies, thus this experiment was designed.

Primary Outcome Measures: Micro-Western Array and Enzyme-linked immunosorbent assay, Obtaining the serum protein content value, the first and the fifth weeks
Secondary Outcome Measures: pulse sphygmograph and Ryodoraku, the energy measurement of pulse and meridians, the first and the fifth weeks
Auto Transplantation of Wisdom Teeth
NCT Number: NCT06553300
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autotransplantation of Wisdom Teeth|Patelet Rich Fibrin
Interventions: PROCEDURE: Autotransplantation with PRF|PROCEDURE: Autotransplatation Only
Sponsor: Cleveland Dental Institute
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-03-31
Locations: Cleveland Dental Institute, Cleveland, Ohio, 44128, United States

Summary:
Autotransplantation emerges as a viable alternative to tooth extraction and prosthetic restoration when conventional endodontic treatments are unfeasible or contraindicated. The success of autotransplantation is influenced by diverse factors, including root development stage, tooth morphology, surgical technique, extraoral duration, recipient socket shape, recipient bed vascularity, and periodontal ligament cell vitality. Preserving periodontal ligament quality and achieving tissue adaptation are pivotal for successful tooth transplantation. Successful donor tooth replacement is influenced by variables like fitting attempts, alveolus-root distance, extra-alveolar time, surgical skill, and extraction trauma intensity.

Primary Outcome Measures: Radiographic success, The success of auto-transplanted immature third molars with and without Platelet-Rich Fibrin will be assessed over a year period., one year
Effect of Nutritional Intervention Based on Prediction Model on Adult Umbilical Cord Blood Transplantation Patients
NCT Number: NCT06553274
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Nutrition Disorders
Interventions: PROCEDURE: Individualized nutrition intervention
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital, Hefei, Anhui, 230041, China

Summary:
Based on the nutritional factor prediction model, the individualized nutritional management of patients with umbilical cord blood transplantation (UCBT) was carried out to observe the impact on the survival efficacy of patients.

Primary Outcome Measures: The body mass index, Body Mass Index (BMI) is defined as a person's weight in kilograms divided by the square of their height in meters (kg/m²)., before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.|The calf circumference, The calf circumference (cm), before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.|The thickness of skinfold, thickness of skinfold (mm), before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.|Grip strength, The grip strength (kg), before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.|Prealbumin level, The level of prealbumin (mg/L), before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.|Albumin Level, The level of Alb (g/L), before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Secondary Outcome Measures: Incidence of complications, Incidence of acute graft-versus-host disease (GVHD), incidence of chronic GVHD, incidence of oral mucositis and rate of infection., before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.|Overall survival (OS), OS was calculated from the date of transplantation to death or last follow-up., 12 months after transplantation|Disease-free survival (DFS), DFS was defined as the time from transplantation to relapse or death from any cause., 12 months after transplantation|The cumulative incidence of relapse (CIR), Relapse and death were considered to be competing events when calculating CIR and NRM ., 12 months after transplantation|Non-Relapse Mortality (NRM), Relapse and death were considered to be competing events when calculating CIR and NRM ., 12 months after transplantation|Hospitalization Duration, Hospitalization Duration, 12 months after transplantation|Hospitalization Costs, expenses of hospitalization, 12 months after transplantation
Anastomotic Leakage in Right Colectomy
NCT Number: NCT06553261
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anastomotic Leak
Interventions: PROCEDURE: suturing of leak, lavage, drainage|PROCEDURE: Formation of a new anasthomosis|PROCEDURE: Fecal diversion
Sponsor: Barmherzige Brüder Vienna
Collaborators: Barmherzige Brüder Salzburg|Kepler University Hospital|University of Salzburg|Hospital Barmherzige Schwestern Vienna|Medical University of Vienna|University Hospital, Saarland|Sigmund Freud PrivatUniversitat
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3446
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2024-12-12
Locations: Krankenhaus der Barmherzigen Brüder, Vienna, 1020, Austria

Summary:
Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.

Primary Outcome Measures: Clinical outcome, Survival or death, 2010-2019
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes
NCT Number: NCT06553248
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes
Interventions: DRUG: GZR4|DRUG: Insulin Degludec
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-22
Completion Date: 2023-11-01
Locations: Gan & Lee Pharmaceuticals Co., Ltd, Beijing, Beijing, 100000, China

Summary:
This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes

Primary Outcome Measures: Incidence of TEAE, Baseline to Week 6
Secondary Outcome Measures: AUC0-inf, Week 6|AUC0-last, Week 6|AUC0-168h, Week 1, Week 6|Tmax,GZR4, Week 1, Week 6|ADA of GZR4, Baseline to Week 10
Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty
NCT Number: NCT06553222
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Periodontal Bone Defects
Interventions: BIOLOGICAL: Putty bone - Tricalcium phosphate with Collagen gel
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-04
Completion Date: 2025-12-04

Summary:
• All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty

Primary Outcome Measures: Primary outcome, measurement (mm) in alveolar bone gain, measured at 6 and 12 months postoperative
Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis
NCT Number: NCT06553209
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Atopic Dermatitis
Interventions: BIOLOGICAL: CM512|DRUG: Placebo
Sponsor: Keymed Biosciences Co.Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-09-30
Locations: West China Hospital of Sichuan University, Chengdu, Sichuan, China

Summary:
This is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in healthy subjects and patients with moderate to severe atopic dermatitis.

Primary Outcome Measures: Adverse events, Incidence of adverse events., Up to 141 days or up to 169 days
Immersive Virtual Reality Based Exersice in Post-mastectomy Lymphedema Patients
NCT Number: NCT06553183
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lymphedema Arm
Interventions: PROCEDURE: immersive virtual reality|PROCEDURE: traditional physicaltherapy
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-02-15

Summary:
To determine the effect of immersive virtual reality on shoulder proprioception and ROM of post-mastectomy lymphedema patients.

Primary Outcome Measures: shoulder proprioception, digital goniometer, 4 weeks
Secondary Outcome Measures: shoulder ROM, all 6 motions will be measured by digital goniometer, 4 weeks
Anesthetic Management of Diabetes in Perioperative Urology and Visceral Surgery
NCT Number: NCT06553170
Acronym: DIAPRO-BREST
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus
Sponsor: University Hospital, Brest
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-12-01
Completion Date: 2019-09-01
Locations: Cadic, Brest, Bretagne, 29200, France

Summary:
It is recognized that a poor glycemic, pre- and intraoperative balance is the source of increase in morbimortality. There was no local protocol at the CHRU Brest regarding the perioperative management of the diabetic patient. This retrospective observational work aims to assess the application of the French recommendations for the perioperative management of diabetes, and compare management before and after the introduction of a protocol based on its recommendations published in 2017 by the SFAR.

The main endpoint is the percentage of patients for whom half of the patients recommendations from the local protocol were implemented for each of the recommendations evaluated and applicable to each patient, before and after protocol and staff training.

Primary Outcome Measures: follow the recommendations, The main endpoint is the percentage of patients for whom half of patients recommendations of the local protocol were implemented for each of the recommendations evaluated and applicable to each patient, before and after the application of the protocol and training staff., 1 year after
Secondary Outcome Measures: complications and mortality, Secondary endpoints are hospital mortality, the occurrence of early postoperative complications related to diabetes, the occurrence of complications post-operative surgery, and finally the occurrence of medical complications not related to Diabetes., 1 year after