pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of the Relationship Between Missed Appointments and Adherence to Medical Indications
NCT Number: NCT06501456
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: No-Show Patients|Therapeutic Adherence and Compliance|Type 2 Diabetes Mellitus|COVID-19
Sponsor: Hospital Italiano de Buenos Aires
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-01
Completion Date: 2020-08-01
Locations: Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aire, Caba, C1199ABB, Argentina

Summary:
We will conduct a cross-sectional study involving adults with type 2 diabetes mellitus. Our primary objective is to evaluate the association between nonattendance and participants' adherence to both pharmacological and non-pharmacological medical recommendations, as well as COVID-19 prevention measures. Additionally, we will assess the adherence rates to these medical recommendations, COVID-19 prevention protocols, and the recommended health care practices and controls for patients with type 2 diabetes mellitus.

Primary Outcome Measures: Association between non-attendance to scheduled outpatient shifts and adherence to doctor's instructions in adult patients, Measured the association between absenteeism from outpatient visits and adherence to medical indications in adults with type 2 diabetes mellitus., 2020 - 2021
Secondary Outcome Measures: Adherence of patients with type 2 diabetes mellitus to medical indications during the pandemic, Report the adherence of patients with type 2 diabetes mellitus to medical indications during the pandemic, July 2020
PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis
NCT Number: NCT06501404
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature Infants|Necrotizing Enterocolitis
Interventions: DIETARY_SUPPLEMENT: High dose group|DIETARY_SUPPLEMENT: Low dose group
Sponsor: José Antonio Hurtado Suazo
Collaborators: University Hospital Virgen de las Nieves|Hospital Regional de Malaga|Hospital of Jaen|Hospital Costa del Sol|Hospital Universitario Torrecárdenas|Hospital Universitario Virgen Macarena|Complejo Hospitalario de Especialidades Juan Ramón Jimenez|Hospital Universitario de Valme|Hospitales Universitarios Virgen del Rocío|Hospital Universitario Puerta del Mar|Hospital General Universitario Santa Lucia|Hospital del SAS de Jerez
Sex: ALL
Age: CHILD
Enrollment: 583
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2015-01-10
Completion Date: 2020-03-20
Locations: Hospital Virgen de las Nieves, Granada, 18012, Spain

Summary:
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.

Primary Outcome Measures: Incidence of necrotizing enterocolitis and all-cause mortality, The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups., From birth until three months
Secondary Outcome Measures: Intestinal colonization by administered strains, From birth until three months|Incidence of Late Onset Sepsis, Incidence of Late Onset Sepsis. In accordance with the criteria used by the Castrillo Group for neonatal infections in Spain (compatible clinical symptoms, elevation of water-phase reactants and positive blood culture), From birth until three months|Time to complete enteral nutrition, Time to reach complete enteral nutrition 140 ml/kg/day, From birth until three months|Days of Central Vascular Catheter, From birth until three months|Length of hospital stay, Days of hospital stay, From birth until three months|Weight change, From birth until three months|Incidence of Bronchopulmonary Dysplasia, From birth until three months|Incidence of patent ductus arteriosus, From birth until three months
Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries
NCT Number: NCT06501352
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Vitreoretinal Surgeries|Local Anesthesia
Interventions: DRUG: Dexmedetomidine|DRUG: Neostigmine|DRUG: Saline
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 81
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-01-20
Completion Date: 2024-03-30
Locations: Ain Shams University Hospitals, Cairo, Egypt

Summary:
The majority of patients undergoing ophthalmic surgeries are elderly, with multiple chronic diseases, with increased risk of morbidity and mortality under general anesthesia.

Peribulbar anesthesia is widely practiced now as a first-choice local block for ophthalmic surgeries.

Dexmedetomidine is a highly selective alpha-2 adrenoceptor. It increases central and peripheral nerve blockade and when added to local anesthetic as an adjuvant, it will provide better anesthetic quality as well as prolongation of postoperative analgesia .

Neostigmine is a parasympathomimetic drug that increase the level of acetylecholine at peripheral muscarinic receptors present in the peripheral nerve endings .

Many researches examined the analgesic effects of peripherally administered neostigmine as in intravenous regional anesthesia reporting that addition of neostigmine to the local anesthetic solution accelerated the onset of anesthesia

\& prolong duration .

Primary Outcome Measures: Onset & Duration of sensory and motor block, By minutes , Refers to the time from injection till patient will feel nothing in his eyes , then the time when he regain feeling again, 12 hours
Secondary Outcome Measures: Systolic & Diastolic Arterial Blood Pressure, measuring it pre-operative , intra-operative \& post-operative, 12 hours|Heart rate, measuring HR per minute pre \& intra \& post operative, 12 hours|Patient & Surgeon satisfaction, No pain by VAS score ( from 0 to 10 as 0 no pain \& 10 maximum pain ) VAS score intraoperative to assess patient satisfaction \& surgeon satisfactory by longer duration of motor \& sensory block ., 12 hours
Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia
NCT Number: NCT06501339
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Clozapine Resistant Schizophrenia
Interventions: PROCEDURE: maintenance ECT|DRUG: Aripiprazole tablet
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2026-03-31

Summary:
The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.

Primary Outcome Measures: Change in Positive And Negative Syndome Scale score, Change from baseline in Total, Positive, negative and general scores with treatment. Minimum value: 30; maximum value: 210. Higher score means worsening of symptoms, Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary Outcome Measures: Change in regional cerebral blood flow by the SPECT-CT brain, Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment, Baseline, 24 weeks|change in the Monteal Cognitive Assessment scores, change from baseline in the Monteal Cognitive Assessment scores with treatment. Minimum Value: 0 Maximum Value: 30: Higher score indicate better cognitive function, Baseline,6 weeks, 12 weeks, 24 weeks|change in the Global Assessment of Functioning scores, change from baseline in the Global Assessment of Functioning scores with treatment Minimum Value: 0 Maximum Value: 100: Higher score indicate better global functioning, Baseline, 6 weeks, 12 weeks, 24 weeks|Safety evaluation, Number of events observed in each patient and patients with at least one adverse event, Baseline,6 weeks, 12 weeks, 24 weeks
Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease
NCT Number: NCT06501326
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Non-alcoholic Fatty Liver Disease|Obesity
Interventions: DRUG: Liraglutide|DRUG: Orlistat
Sponsor: Affiliated Hospital of Nantong University
Collaborators: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2025-02-28
Locations: Affiliated Hospital of Nantong University, Nantong, Jiangsu, China

Summary:
STUDY OBJECTIVE: To explore the clinical efficacy and safety of liraglutide in obesity combined with metabolism-associated fatty liver disease (MAFLD).

INTERVENTION PROGRAM: All subjects underwent dietary control and exercise therapy, and controlled smoking and alcohol consumption. During the 3 months of the trial, men were instructed to follow a diet of 1,500 to 1,800 kcal per day and women followed a diet of 1,200 to 1,500 kcal per day. All three diets included 40 to 55 percent carbohydrates, 15 to 20 percent protein and 20 to 30 percent fat. During the 3-month trial period, subjects performed at least 150 minutes of moderate-intensity exercise per week with an energy expenditure of 1500 kcal/week or more. Other medications containing the same ingredients as orlistat and liraglutide were prohibited during the trial period. After randomization, the control group was treated with lifestyle intervention + orlistat until the end of follow-up. Trial group 1 was treated with lifestyle intervention + liraglutide. Trial group 2 was treated with lifestyle intervention + liraglutide + orlistat for a total treatment and follow-up period of 3 months.

Primary Outcome Measures: Body weight, Body weight, Three months|FABP4, fatty acid-binding protein-4, Three months|BMI, body mass index, Three months|lipid indices, TC, TG, HDL-C, LDL-C, Three months|LSM, liver stiffness measurement, Three months|CAP, Controlled attenuation parameters, Three months
Secondary Outcome Measures: Waist circumference,, Waist circumference, Three months|hip circumference, hip circumference, Three months
PhotobiomoduLation for pAtientS With Advanced hEart failuRe
NCT Number: NCT06501313
Acronym: LASER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure With Reduced Ejection Fraction|Heart Failure, Systolic
Interventions: DEVICE: Photobiomodulation
Sponsor: Semmelweis University Heart and Vascular Center
Collaborators: Laser Light Medical Innovations Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-05-01

Summary:
The objective of the study is to examine the effectiveness of photobiomodulation therapy in patients with advanced-stage heart failure with reduced ejection fraction (HFrEF), who have been referred but ineligible for a heart transplantation. The primary endpoint is a 15% relative reduction in left ventricular end-systolic volume (LV ESV) as determined by echocardiography over a 12-month follow-up period. The secondary objective is to determine the change in NT-proBNP, a biomarker for heart failure, the change in heart failure symptoms based on the NYHA functional classification, the change in quality of life questionnaire (KCCQ), additional echocardiographic parameters, and the detection of changes in heart failure and fibrosis biomarkers. Additionally, the study aims to examine hospitalization due to heart failure and overall mortality.

Primary Outcome Measures: Echocardiographic response, At least 15% reduction of end-systolic volume, 12 months
Secondary Outcome Measures: Other echocardiographic response, strain alanysis, LVEF, EDV, ESV, 12 months|Biomarker changes, NT-proBNP decrease, 12 months|Symptomes, NYHA change, 12 months|Qulaity of Life, KCCQ change, 12 months|All-cause mortality or HF hospitalisation, 12 months
Postprandial Triglyceride Impact on Coronary Atherosclerosis in Non-Diabetic Patient in Sohag University Hospital
NCT Number: NCT06501287
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Atheroscleroses
Interventions: DIAGNOSTIC_TEST: Postprandial triglyceride
Sponsor: Fatma Madhy Eissa
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-12-25
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
INTRODUCTION Cardiovascular diseases, including coronary artery disease (CAD), are the leading cause of mortality worldwide. Despite remarkable advancements in diagnostic and therapeutic approaches, CAD continues to pose formidable challenges. Atherosclerosis, characterized by the deposition of lipids, inflammatory cells, and fibrous tissue within the arterial walls, is the fundamental pathology underpinning CAD. Atherosclerosis development and progression are closely intertwined with lipid metabolism, particularly elevated levels of low-density lipoprotein cholesterol (LDL-C) and reduced levels of high-density lipoprotein cholesterol (HDL-C) \*1+. However, emerging evidence suggests that postprandial triglyceride levels, the transient increase in triglycerides following a meal, may play a pivotal role in atherosclerotic processes \*2+. Postprandial hypertriglyceridemia has been linked to various cardiovascular risk factors, including inflammation, endothelial dysfunction, oxidative stress, and altered hemostasis \*3+. cardiovascular disease (CVD) causes death for 4 million subjects in Europe every year. It causes death for women \*2.2 million (55%)+ than men \*1.8 million (45%)+, and cardiovascular (CV) deaths under 65 years more prevalent in men (490 000 versus 193 000) \*4+. Endothelial dysfunction was the main cause of vascular atherosclerosis. The damage of Endothelium cause lipids and macrophages accumulation (mostly lowdensity lipoprotein) in vessel injury site \*5+. Lipids considered the major cause of atherosclerosis \*6+. The increase of blood cholesterol (especially LDL) considered the main cause of the disease. High levels of triglycerides could be independent risk factor for coronary artery disease (CAD), particularly in women. Although, it was suggested that high level of density lipoproteins (HDLs) can prohibit these risk factors. Extensive examinations showed that lipid decrease the prevention of CAD in primary and secondary cases \*7+. The level \> 90% of total glyceride and/or LDL and level \> 10% of HDL confirm dyslipidemia \*8+

Primary Outcome Measures: impact of postprandial triglyceride level on coronary atherosclerosis in non diabetic patients, impact of postprandial triglyceride concentration measured by chemistry analyzer on coronary atherosclerosis (assassed by plaque volume and luminal narrowing in coronary angiography )in non-diabetic patients, 7 months
CALM Psychotherapy in Patients With Metastatic Cancer in Chile
NCT Number: NCT06501261
Acronym: CALM-Ch
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Cancer
Interventions: BEHAVIORAL: CALM psychotherapy
Sponsor: Fundacion Arturo Lopez Perez
Collaborators: University of Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-10-14
Completion Date: 2025-10-31
Locations: Fundacion Arturo Lopez Perez, Providencia, Santiago, 7500921, Chile

Summary:
Patients with metastatic cancer experience multidimensional challenges that increase the risk of emotional distress, which must be addressed by the health team. Chile lacks evidence on effective therapeutic interventions in this population. CALM is a brief, individual (with the presence of a caregiver in one or more sessions) and evidence-based psychotherapy developed at The Princess Margaret Cancer Center. It consists of an intervention of 3 to 6 psychotherapy sessions over a period of 3 to 6 months. The Global CALM program aims to expand CALM research around the world, a program to which FALP has subscribed. Objective: To evaluate the preliminary efficacy of CALM in a sample of patients with metastatic cancer in Chile.

Phase 2 study of preliminary, pseudo-experimental efficacy, without a control group. The study will be carried out in Falp and Corporación Valientes.

Primary Outcome Measures: depressive symptoms, Patient Health Questionnaire 9- Higher score means higher depression, 3 months|depressive symptoms, Patient Health Questionnaire 9- Higher score means higher depression, 6 months|Death anxiety, Death and Dying Distress Scale- Higher score means higher depression, 3 months|Death anxiety, Death and Dying Distress Scale- Higher score means higher depression, 6 months
The Renal Protective Effects of Remote Ischemic Preconditioning in Patients With Chronic Kidney Disease
NCT Number: NCT06501222
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Diseases
Interventions: DEVICE: Remote ischemic conditioning
Sponsor: Yuanjun Yang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-03-01
Completion Date: 2027-03-30
Locations: chinese PLA general hospital, Beijing, Beijing, 100853, China

Summary:
The incidence of Chronic kidney disease (CKD) is showing an upward trend, but the therapeutic effect of treatment is limited. Remote ischemic conditioning (RIC) has the potential to safeguard remote organs via the repeated application of brief ischemic stimuli. the aim of our study is to investigate whether RIC can protect the renal function in patients with CKD.

Primary Outcome Measures: change in eGFR, eGFR is calculated using the CKD-EPI formula, eGFR in mL/min/1.73m², 3 months and 12 months
Secondary Outcome Measures: Changes in renal tissue oxygen saturation (SrtO2) compared to baseline., SrtO2 is measured by Near Infrared Spectroscopy, 3 months and 12 months|Changes in blood pressure, blood pressure in mmHg, 3 months and 12 months
Other Outcome Measures: 24-hour urine protein quantitation compared to baseline., The 24-hour urine protein quantitation is monitored through urine., 3 months and 12 months|change in Pulse Wave Velocity compared to baseline., brachial-ankle Pulse Wave Velocity in cm/s, 3 months|change in Flow-mediated vasodilation compared to baseline., FMD in %, 3 months
Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors
NCT Number: NCT06501183
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: CDH17-positive Advanced Malignant Solid Tumors
Interventions: BIOLOGICAL: Anti-CDH17 CAR-T cells
Sponsor: Shanghai Pudong Hospital
Collaborators: UTC Therapeutics Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-08
Completion Date: 2026-05-30
Locations: Shanghai Pudong hospital, Shanghai, Shanghai, China

Summary:
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-CDH17 CAR-T cell injection in patients with CDH17-positive advanced malignant solid tumors.

Primary Outcome Measures: Adverse Events (AEs), Incidence and severity of adverse events., 2 years|Serious Adverse Events (SAEs), Incidence and severity of serious adverse events., 2 years|Adverse Events of Special Interest (AESI), Incidence and severity of adverse event of special interest., 2 years|Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs), Incidence and severity of dose-limiting toxicities (DLTs) following infusion of CAR-T cell injection, at each dose level tested in dose escalation phase., 4 weeks after the CAR-T cells infusion
Secondary Outcome Measures: Objective Response Rate (ORR), The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1., 2 years|Disease Control Rate (DCR), Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1., 2 years|Progression-Free Survival (PFS), PFS is defined as the time from CAR-T infusion to the date of the disease progression or death from any cause., 2 years|Overall Survival (OS), OS is defined as the time from CAR-T infusion to the date of death due to any cause., 2 years|Bio-distribution of CAR-T cells, CAR copies will be measured by qPCR to evaluate the expansion and persistence of CAR-T cells in vivo. Cmax, Tmax, AUC0-tlast and AUC0-inf of CAR copies will be analyzed., 2 years|Cytokine Level in Peripheral Blood, Level of cytokines (IL-2、IL-6、IL-8、IL-10、TNF-α and IFN-γ, etc.) in serum., 2 years|Anti-drug Antibodies, Number of participants with anti-drug antibodies., 2 years
Risk Stratification for Abdominal Emergency Surgery: a Cohort Study
NCT Number: NCT06501170
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Emergency Surgery
Interventions: OTHER: Retrospective Data Analysis of Emergency Abdominal Surgery Outcomes
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-12-01
Locations: Lu Che, Beijing, Beijing, 100073, China

Summary:
The goal of this retrospective observational study is to identify risk factors of unwanted outcomes (in-hospital morbidity and mortality) among patients undergoing emergency abdominal surgery.

Primary Outcome Measures: in-hospital mortality, documented in-hospital mortality, From date of surgery until discharge day, assessed up to 4 weeks|in-hospital morbidity, in-hospital postoperative complications classified using Clavein-Dindo score, From date of surgery until discharge day, assessed up to 4 weeks
Secondary Outcome Measures: postoperative length of hospital stay, postoperative length of hospital stay assessed by days, From date of surgery until discharge day, assessed up to 4 weeks|Health care costs, Health care costs in RMB assessed using hospital billing records, From date of admission until discharge day, assessed up to 4 weeks
Establishment of Emergency Surgery Triage and Checklist Management System
NCT Number: NCT06501157
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Emergency Surgery|Triage|Checklist|Perioperative/Postoperative Complications
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-06-01
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
The goal of this observational study is to develop and test a system for managing emergency surgery patients at Beijing Union Medical College Hospital. The main questions it aims to answer are:

What information is necessary for effective patient triage and handovers between the emergency department, anesthesia, and ICU for surgical patients? How effective and feasible is a standardized handover process in improving patient outcomes and safety?

Participants will:

Be observed and have their handovers documented to identify key information required.

Participate in implementing a new handover checklist and triage system.

Researchers will compare the periods before and after implementing the new system to see if it:

Reduces missed critical information during handovers. Decreases pre-surgery waiting times for critically ill patients. Improves overall patient safety and outcomes, including reducing postoperative complications, mortality rates, length of hospital stay, and medical costs.

Primary Outcome Measures: The number of omitted information, The number of omitted information items during the emergency-anesthesia handover., Outcome will be assessed on the operative day
Secondary Outcome Measures: Patient waiting times, including time to theatre and time to incision., Time to Theatre (TTT): This is defined as the duration from when it is determined that the patient needs surgery to the time the patient arrives at the operating theatre. Time to Knife (TTK): This is defined as the duration from when the patient enters the operating theatre to the time the first incision is made., Outcome will be assessed on the operative day|Feasibility of handover checklist, Staff satisfaction with the new handover process across the emergency department, general surgery, anesthesia, and ICU. Whether the handover checklist is considered necessary will and feasible will be assessed using a 5 point Likert scale., Outcome will be assessed on the operative day|In-hospital mortality, In-hospital mortality, From date of admission until discharge, assessed up to 4 weeks|In-hospital morbidity, In-hospital morbidity will be documented and rated using Clavein-Dindo classification system, From date of admission until discharge, assessed up to 4 weeks
A Self-controlled Study of the Effect of Partial Spectral Absence of Visible Light on the Pupil
NCT Number: NCT06501131
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Full Spectrum
Interventions: OTHER: full-spectrum light exposure|OTHER: specific spectrum absence light exposure
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-24
Completion Date: 2024-09-30

Summary:
Previous studies have shown that the spectrum of light influences myopia. LED lights with a partially absent light spectrum increase the risk of myopia progression compared to LEDs with a full spectrum, potentially mediated by the excitability of the parasympathetic nervous system. This study intends to compare pupil size and area, as well as parameters regulated by the autonomic nervous system (such as skin bioelectrical activity and heart rate), between LEDs with a full visible spectrum and LEDs with a partially absent spectrum around 470nm and 730nm. We aim to elucidate the physiological mechanism underlying the effect of light spectrum on pupil changes and myopia.

Primary Outcome Measures: pupil size, The pupil diameter is measured in real-time using the Eyelink Portable Duo eye tracker., 5 minutes
Secondary Outcome Measures: Skin conductance response, Rapidly changing and short-duration skin surface potentials measured in real-time using the Biopac MP160 multi-channel physiological recorder., 5 minutes|Respiratory movement, The amplitude of respiratory movements measured in real-time using the Biopac MP160 multi-channel physiological recorder., 5 minutes|Pulse pressure waveform, The amplitude of respiratory movements measured in real-time using the Biopac MP160 multi-channel physiological recorder., 5 minutes|Spherical equivalent refraction, Measured with autorefractor and defined as the sum of spherical power and half of the cylinder power., 5 minutes|Uncorrected visual acuity, Visual acuity without refractive correction., 5 minutes|Axial length, Uncorrected visual acuity: Visual acuity without refractive correction., 5 minutes|Corneal curvature, Anterior corneal curvature measured by the Pentacam corneal topographer, 5 minutes
Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients
NCT Number: NCT06501118
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Failure|Acute Hypoxemic Respiratory Failure|Acute Hypoxic Respiratory Failure|Hypoxemia|Hypoxia|Hypoxic Respiratory Failure
Interventions: OTHER: Education
Sponsor: University of Colorado, Denver
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3600
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2026-08-01

Summary:
A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.

Primary Outcome Measures: Ventilator Free Days, The number of days the patient will be free of mechanical ventilation, 30 Days
Secondary Outcome Measures: instances of occult hypoxemia, arterial oxygen saturation below 88% when the Sp02 is 92-96% within 10 minutes identified among patients who identify as their race as Black or White, and ethnicity as Hispanic or Non-Hispanic, 30 days|ICU free days, Number of days patients are not in the ICU, 90 days|Hospital free days, number of days patients are not hospitalized, 90 DAYS|90 Day in hospital mortality, Patients that die in the hospital before day 90, 90 days|Time to Mortality to day 90, Patients that die within 90 days, 90 Days|Oxygen status at discharge, What if any oxygen the patient is on at discharge, 90 days|Incidence of needing high level 02 support, The number of times that the patients is in need of heated-high flow nasal cannula (HHFNC) / non-invasive positive pressure ventilation (NIPPV)) after extubation, 90 days|Discharge disposition, Place the patient is discharged to, 90 days
Performance of WOUNDCHEK Bacterial Status
NCT Number: NCT06501105
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Wound Heal
Interventions: DEVICE: WOUNDCHEK Bacterial Status
Sponsor: Woundchek Laboratories BV
Collaborators: Northwell Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-18
Completion Date: 2024-12
Locations: Northwell Health Comprehensive Wound Healing & Hyperbaric Center, Lake Success, New York, 11042, United States

Summary:
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) when the test result is used to inform treatment decisions.

Primary Outcome Measures: Healing rate and mean percent wound area reduction, Rate of healing and/or mean percent wound area reduction for WOUNDCHEK Bacterial Status positive wounds will be higher than obtained in the clinical study PROT-2023-001, 12 weeks
Secondary Outcome Measures: WOUNDCHEK Bacterial Status negative wound healing rate, The pre-test non-healing rate (i.e., \[Non-Healed wounds/Total wounds\]\*100) minus the WCBS Negative wound non-healing rate (i.e. \[Non-healed wounds with a negative WCBS result/Total wounds\]\*100) will be less than or equal to zero., 12 weeks|Adverse events, There will be no device related serious adverse events (SAE) or unanticipated adverse device effects (UADE)., 12 weeks
Dexamethasone Versus Mg Added to Bupivacaine Used in ESPB for Perioperative Pain Control in Patients Undergoing Unilateral Nephrectomy
NCT Number: NCT06501079
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Renal Neoplasm
Interventions: PROCEDURE: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%
Sponsor: National Cancer Institute, Egypt
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-01
Completion Date: 2024-12-01
Locations: National Cancer institute - Cairo University, Cairo, Egypt

Summary:
Aim of the study:

The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain.

Primary Objectives:

- To compare the effect of ESPB without additives to the effect of adding dexamethasone and to the impact of adding magnesium sulfate in the form of post-operative morphine consumption

Primary Outcome Measures: postoperative opioid consumption, total postoperative rescue analgesia be by Morphine, 24 hours post-operatively
Secondary Outcome Measures: time of first rescue analgesia, Ketorolac 30 mg I.V infusion if VAS is between 3 to 6, and Morphine 3 mg I.V if VAS equals or greater than 6, during 1st 24 postoperatively.|Intraoperative opioid consumption, total Intraoperative rescue analgesia will be done by giving fentanyl at dose of 1 mic/Kg, intraoperative|visual analogue scale 30 hours post-operatively at rest, visual analogue scale from 0 to 10 as 0 no pain and 10 worst pain, 24 hours post-operatively at rest
Mesenchymal Stem Cells for Frailty Syndrome
NCT Number: NCT06501066
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Pathologic Processes
Interventions: BIOLOGICAL: umbilical cord mesenchymal stem cells
Sponsor: Meribank Biotech Co., Ltd.
Sex: ALL
Age: OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2027-12
Locations: National Taiwan University Hospital, Taipei city, 100229, Taiwan|Taipei Veterans General Hospital, Taipei City, 11217, Taiwan

Summary:
This Phase I/II study is designed to evaluate the efficacy and safety of UMC119-06-05, an allogeneic umbilical cord mesenchymal stem cells, in older adults with frailty syndrome. This study will also seek to determine the long-term safety and clinical outcomes of UMC119-06-05 in subjects with frailty syndrome, which will provide information for subsequent clinical trials with UMC119-06-05.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)/ Serious Adverse Events (SAEs)., Phase I : Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities., Up to 12 months through study|Incidence of withdrawals due to adverse events, Phase I: Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities., Up to 12 months through study|vital signs, Phase I: change in vital signs, Up to 12 months through study|physical examination, Phase I: change in physical examination, Up to 12 months through study|clinical laboratory test results, Phase I: change in clinical laboratory test results, Up to 12 months through study|electrocardiogram, Phase I: change in electrocardiogram, Up to 12 months through study
Secondary Outcome Measures: Mean change from baseline in frailty status (Cardiovascular Health Study [CHS] frailty score, CHS scale consists of five components-unintentional weight loss, exhaustion, low activity, weakness, and slowness, change from baseline to Day 91, Day 181, and Day 361|Mean change from baseline in grip strength, Hand grip strength as assessed by a dynamometer. Grip strength is recorded (in mmHg) three times for each hand., change from baseline to Day 91, Day 181, and Day 361|Mean change from baseline in chair-stand test, a subject is able to transfer from a seated to a standing position and back to sitting five times, change from baseline to Day 91, Day 181, and Day 361|Mean change from baseline in muscle mass and bone density, muscle mass and bone density will be measured using DXA, change from baseline to Day 91, Day 181, and Day 361|Mean change from baseline in quality of life measured by change in SF-12, a quality of life measure, change from baseline to Day 91, Day 181, and Day 361
Increasing Knowledge and Interest in Cancer Clinical Trials
NCT Number: NCT06501040
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm|Malignant Solid Neoplasm
Interventions: OTHER: Web-based Educational Intervention|OTHER: Questionnaire Administration
Sponsor: Hayley Thompson
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 460
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2020-06-12
Completion Date: 2025-03
Locations: Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States

Summary:
This trial investigates how well a video-based clinical trial education session works in increasing knowledge and interest in cancer clinical trials among individuals in the metropolitan Detroit region of the Karmanos Cancer Institute (KCI) catchment area. This educational activity may help researchers learn more about individuals' awareness of clinical trials, knowledge, and intention to participates in a clinical trial.

Primary Outcome Measures: Increase in Clinical Trial Awareness and Knowledge, An 11-question true and false questionnaire regarding Knowledge will be administered prior to and immediately after a video-based educational session on Clinical Trials, Baseline and immediately post intervention up to 1 day
Secondary Outcome Measures: Increase in intentions to participate in cancer clinical trials., A 6-question standard Likert scale questionnaire regarding Intention will be administered prior to and immediately after a video-based educational session on Clinical Trials., Baseline and immediately post intervention up to 1 day
Mindfulness-Based Self-Compassion and Vagal Nerve Stimulation on Heart Rate Variability, Psychological Resilience, and Sleep Quality
NCT Number: NCT06501027
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Rate Variability|Psychological Resilience|Sleep Quality
Interventions: BEHAVIORAL: Mindfulness Based Self Compassion
Sponsor: İstanbul Yeni Yüzyıl Üniversitesi
Sex: ALL
Age: ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-12
Completion Date: 2024-10-01

Summary:
This study was conducted to determine the effects of a mindfulness-based self-compassion intervention and vagal nerve stimulation on heart rate variability, psychological resilience, and sleep quality in earthquake victims.

Design: "The study was designed as a randomized experimental research, where pre- and post-intervention measurements were administered to Intervention I and Intervention II groups."

Primary Outcome Measures: Heart Rate Variability, Heart Rate Variability (HRV) refers to the variation in the time interval between heartbeats. It is a measure of the slight differences in timing between successive heartbeats, often measured in milliseconds. HRV is regulated by the autonomic nervous system, which controls involuntary bodily functions, including heart rate., up to 4 weeks
Secondary Outcome Measures: Psychological Resilience, Psychological Resilience Scale for Adults: The scale consists of 33 items; it includes 6 sub-dimensions: The structural style (3,9,15,21) and perception of future (2,8,14,20) subdimensions were measured by 4 items each, the family cohesion (5,11,17,23,26,32), perception of self (1,7,13,19,28,31,), and social competence (4,10,16,22,25,29) subdimensions were measured by 6 items each, and the social resources (6,12,18,24,27,30,33) sub-dimension was measured by 7 items. The score that can be obtained from the scale varies from 33 to 165., up to 4 weeks|pittsburgh sleep quality index, It's a self-rated questionnaire that assesses sleep quality and disorders over a one-month period. Seven "component" scores are derived from nineteen separate items. These components include: a) subjective sleep quality, b) sleep latency, c) sleep duration, d) habitual sleep efficiency, e) sleep disorders, f) use of sleeping pills, and g) daytime dysfunction. The sum of these seven component scores yields the index score, with a total score ranging between 0 and 21. A pittsburgh sleep quality index total score of five or higher indicates poor sleep quality., up to 4 weeks
Mobile Health Technology-Enabled AFib Management
NCT Number: NCT06500988
Acronym: mTECH Afib
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Behavior
Interventions: COMBINATION_PRODUCT: Corrie Virtual Atrial Fibrillation Management Program
Sponsor: Johns Hopkins University
Collaborators: PhRMA Foundation|Apple Inc.|Itamar-Medical, Israel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 248
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12
Completion Date: 2027-06

Summary:
The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.

Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)

Primary Outcome Measures: Quality of Life as measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey, Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life., 6 months
Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program
NCT Number: NCT06500962
Acronym: SUPeRFOOD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Rehabilitation|Nutrition, Healthy|Nutrition Poor
Interventions: BEHAVIORAL: Usual Care|BEHAVIORAL: Navigation|BEHAVIORAL: Text Messaging
Sponsor: University of California, San Francisco
Collaborators: American Heart Association|Project Open Hand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-12
Completion Date: 2025-12
Locations: University of California, San Francisco, San Francisco, California, 94143, United States

Summary:
The purpose of this research is to see if offering more navigation and text-message support will help increase participation and engagement in a Food is Medicine program. The study will recruit people currently participating in cardiac rehabilitation. People will be randomly assigned to 1 of 4 study groups: navigation, text-messaging, both, or neither. People will complete surveys at the start of the study and after 3 months. After 3 months, we will compare how many Food is Medicine meals or groceries people in each group received.

Primary Outcome Measures: Participant reported satisfaction, Scale of 1 \[Quite dissatisfied\] to 5 \[Very satisfied\], 3 months
Secondary Outcome Measures: Number of food is medicine meal or grocery distributions received, 3 months|Proportion of participants initiating the food is medicine program, Numerator = number of participants who received at least 1 meal or grocery distribution; Denominator = number of participants in study arm, 3 months|Proportion of participants engaged in the food is medicine program, Numerator = number of participants who received at least 8 meal or grocery distributions; Denominator = number of participants in study arm, 3 months
Evaluation of an mHealth Intervention to Promote Participation in Breast Cancer Screening in Argentina
NCT Number: NCT06500936
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Screening
Interventions: OTHER: SMS
Sponsor: Centro de Estudio de Estado y Sociedad
Collaborators: Instituto Nacional del Cáncer, Argentina
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 248
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2021-12-05
Completion Date: 2023-08-01
Locations: Agencia del Control del Cáncer Santa Fe, Santa Fe, Argentina

Summary:
We carried out with a mixed-method study including a pragmatic randomized controlled trial to evaluate effectiveness of the intervention and quantitative and qualitative evaluation of the implementation from women and stakeholders' perspective. In this report, we present results of the pragmatic randomized control trial and implementation evaluation from women´s perspective guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, specifically developed to assess interventions beyond efficacy across multiple public health criteria. RE-AIM framework was integrated in all stages of the research process, including conceptualization (e.g., selecting implementation processes that would be evaluated), data collection and analysis. Following Proctor´s Taxonomy of Implementation Outcomes \[34\], we also measured acceptability and appropriateness, which are essential to understand the success (or failure) of the implementation of an intervention from users' perspective. This approach is the same as we used to evaluate implementation in our previous study (The ATICA study).

Primary Outcome Measures: Effectiveness outcome, Percentage of women with a mammography recorded in SITAM within105 days from recruitment., 105 days from recruitment.|Effectivenes outcome, Percentage of women with a mammography recorded in SITAM within 45 days from, 45 days from recruitment.
Narrow-diameter Implants Replacing Maxillary Lateral Incisors
NCT Number: NCT06500923
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dental Implant Failed
Interventions: OTHER: Oral rehabilitation by means of implant-supported single unit crowns
Sponsor: University of Bern
Collaborators: Copenhagen University Hospital, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-08-01
Completion Date: 2024-06-15
Locations: University Hospital Copenhagen, Copenhagen, Denmark

Summary:
To present the 5-year clinical, radiographic, and aesthetic outcomes in patients with congenitally missing lateral incisors (MLIs) rehabilitated with two narrow-diameter implants (NDIs).

Primary Outcome Measures: Peri-implant marginal bone level changes, Changes in mm at the 1-year follow-up visit, 1 year
Secondary Outcome Measures: Implant Survival rate (%), Number of implants in situ over the number of placed implants, 1-3-5 year|Aesthetic outcomes, Evaluation of the aesthetic outcomes by means of a dedicated Index (Copenhagen Index Score CPI) (Score 1-4 / Score 1: best outcome; 4 : worst outcome), 1-3-5 year|PROMs, OHIP - 49 Scale (Score 1-3) (Score 1: best outcome; 3 : worst outcome), 1-3-5 year