pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Oxford Pleural Infection Endotyping Study
NCT Number: NCT06513689
Acronym: TORPIDS-2
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pleural Infection|Pleural Diseases|Pleural Effusion|Pleural Empyema|Pleural Infection Bacterial|Pleural Infections and Inflammations
Sponsor: University of Oxford
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-20
Completion Date: 2024-06-20
Locations: Laboratory of Pleural Translational Research, Nuffield Department of Medicine, University of Oxford, Oxford, Oxfordshire, OX3 7FZ, United Kingdom

Summary:
Pleural infection is a severe disease with increasing incidence worldwide. The subphenotypes of pleural infection remain unknown.We designed a study to endotype the disease and assess the association between patient phenotype, microbiology and clinical outcome.

We subjected 80 pleural fluid samples to unlabelled mass spectrometry.

Pathway analysis of the differentially expressed proteins identified the neutrophil degranulation, glycolysis, pentose phosphate pathway, and the liver and retinoid X receptors (LXR-RXR) activation. Higher neutrophil degranulation was associated with increased glycolysis and pentose phosphate activation.

Pleural infection patients exhibit proteomic signatures indicating diverse responses of neutrophil mediated immunity, glycolysis, and pentose phosphate activation.

Primary Outcome Measures: Pleural infection endotypes, Discovery of pleural infection biological endotypes, 12 months|Association between endotypes and microbiology, Investigate the association between pleural infection endotypes and microbiology, 12 months|Association between endotypes and one-year survival, Investigate the association between pleural infection endotypes and one-year survival, 12 months
Secondary Outcome Measures: Association between endotypes and need for surgical treatment, Investigate the association between pleural infection endotypes and need for surgical treatment, 12 months|Association between levels of pleural fluid plasminogen and neutrophil elastase, Investigate the association between pleural fluid plasminogen and neutrophil elastase protein levels, 12 months
Exercise as Maintenance Therapy in Advanced Lung Cancer
NCT Number: NCT06513663
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer|Non Small Cell Lung Cancer|Metastatic Lung Cancer
Interventions: BEHAVIORAL: Exercise Intervention
Sponsor: Indiana University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2029-12
Locations: Indiana University Health Methodist Hospital, Indianapolis, Indiana, 46202, United States|Indiana University Melvin & Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, 46202, United States|Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, 46202, United States

Summary:
The purpose of this study is to examine how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer.

Primary Outcome Measures: Change in patient-reported fatigue, Measured by FACT-F survey, baseline, week 12, and week 24
Secondary Outcome Measures: Change in cardiorespiratory fitness, Measured by VO2peak, estimated as time on the treadmill, baseline, week 12, and week 24|Change in physical performance battery, total score on short physical performance battery, baseline, week 12, and week 24|Change in muscle mass, measured by mg/kg2 on HU on CT scans, baseline, and week 12|Change in muscle density, measured by mg/kg2 on HU on CT scans, baseline, and week 12|Change in depression, measured by total score of HADS survey, baseline, week 12, and week 24|Proportion of patients who are "fatigued", measured by FACT-F score of \<43, baseline, week 12, and week 24|Uptake of the study, the proportion of total patients approached, screened, and ultimately completing the baseline assessments, date open to accrual until closed to accrual, up to 5 years|Adherence with the intervention defined, the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm, baseline to post 12-week intervention
Mechanism-based Therapy of Hypotensive Syncope
NCT Number: NCT06513650
Acronym: 2STEPtherapy
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Syncope, Vasovagal, Neurally-Mediated
Sponsor: Istituto Auxologico Italiano
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2026-05-31
Locations: University of marseille Aix en Provence, Marseille, France|IRCCS Istituto Auxologico Italiano, Milan, MI, 16149, Italy|IRCCS Istituto Auxologico Italiano, Milan, MI, 16149, Italy|University of Florence, Florence, Italy|ospdali del Tigullio, Lavagna, Italy|Università della Campania Vamvitelli, Naples, Italy|AMC Universisty of Amsterdam, Amsterdam, Netherlands|University of Barcelona Vall d'Ebron, Barcelona, Spain|Karolinska Institut, Stockholm, Sweden

Summary:
The aim of this study is to assess the efficacy of a therapeutic strategy aimed to increase 24-hour systolic blood pressure (SBP) values, assessed by 24-hour ambulatory blood pressure monitoring (ABPM), in reducing syncope recurrences in patients affected by hypotensive syncope during one year of follow-up.

Primary Outcome Measures: Time to first syncope recurrenceSyncope, • The primary endpoint of the Drug-deprescribing subgroup is the comparison of syncopal recurrences (time to first recurrence and syncope burden) at one year in patients who achieved a mean absolute value of ≥134 mmHg and/or an increase ≥12 mmHg of 24-hour SBP on ABPM2 (Target) with those of patients who did not (No target). • The primary endpoint of the Drug-addition subgroup is the comparison of syncopal recurrences (time to first recurrence and syncope burden) at one year in patients who achieved a mean absolute value of ≥116 mmHg and an increase of ≥9 mmHg of 24-hour SBP on ABPM2 (Target) with those of patients who did not (No target)., 4 months
12 Lead ECG Database
NCT Number: NCT06513637
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arrhythmias, Cardiac
Interventions: DIAGNOSTIC_TEST: 12-Lead ECG and home sleep study (HST) diagnostics
Sponsor: Huxley Medical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-19
Completion Date: 2025-12-31

Summary:
The purpose of this investigation is to collect a database of simultaneous electrocardiogram (ECG) recordings from the SANSA device and a reference 12-lead ECG recording device.

The purpose of this database is to aid development and evaluation of algorithms to detect cardiac arrhythmias and other parameters from the electrocardiogram. Example analyses that may utilize this database are ECG vector transformations and ECG waveform timing analyses.

The study is for scientific purposes and does not intend to diagnose, cure, mitigate, treat, or prevent any disease and does not involve any medical procedures.

Primary Outcome Measures: No specified primary endpoint, This data collection protocol does not have any specific data analysis endpoints. Its purpose is to collect data to be included in an ECG database that may be used for various future analyses.

The number, severity, and device/comparator relatedness of AEs reported while subjects undergo study procedures will be reported., Subjects will participate in a single visit. Subjects will be considered enrolled upon signing the informed consent. The entire duration of enrollment is expected to be less than one hour and no more than six hours
ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers
NCT Number: NCT06513624
Acronym: ETC-159-02
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: With MSS/pMMR Advanced, Platinum-resistant Ovarian Cancer
Interventions: DRUG: ETC-159|DRUG: Pembrolizumab|DRUG: Denosumab / Zoledronic Acid
Sponsor: National University Hospital, Singapore
Collaborators: EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-30
Completion Date: 2027-06-30
Locations: National University Hospital, Singapore, Singapore

Summary:
This is an open-label, single-arm, investigator-initiated study conceived as a dose expansion cohort of the study D3-002, which evaluated ETC-159 in combination with pembrolizumab in solid tumors.

Primary Outcome Measures: Disease Control Rate (DCR), is defined as percentage of subjects with best overall response as (Complete Response (CR) + Partial Response (PR) + Stable disease ≥12 weeks) evaluated by RECIST v1.1 criteria measured by CT or MRI, 1 Year|Objective Response Rate (ORR), is defined as percentage of subjects with best overall response as (Complete Response (CR) + Partial Response (PR)) evaluated by RECIST v1.1 criteria measured by CT or MRI, 1 Year
Cellular Immunity, Neuroendocrine, and Inflammatory Factors for Clinical Prognosis in Acute Coronary Syndrome
NCT Number: NCT06513611
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Coronary Syndrome|Stress Hyperglycemia|Cortisol; Hypersecretion|Inflammatory Response|Coagulation
Interventions: DIAGNOSTIC_TEST: Serum cortisol.
Sponsor: Hospital de Clinicas José de San Martín
Collaborators: University of Buenos Aires
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2026-07-01
Locations: Hospital de Clinicas Jose de San Martin, Buenos Aires, Argentina

Summary:
In acute coronary syndrome (ACS), there is an increase in cortisol levels, as an expression of the stress response, and C-reactive protein, as an expression of the inflammatory response, which are in turn associated with changes in the components of cellular immunity, and ultimately are predictors of clinical events. The objective of this study is to demonstrate that, within the frame of reference of ACS, beyond the thrombotic phenomenon that leads to ischemia and myocardial necrosis, there is an activation of an inflammatory and stress response, evidenced by an elevation of CRP and cortisol, respectively, and sequentially modifications in the components of cellular immunity in peripheral blood that convey prognostic value during hospitalization and after discharge. A prospective, observational, analytical, unicentric study of consecutive patients with ACS, with telephone follow-up to 6 months, will be carried out. For 2 years, all eligible patients admitted with a diagnosis of ACS to the Coronary Care Unit of the Hospital de Clínicas José de San Martín in Buenos Aires will be registered consecutively.

Primary Outcome Measures: Cardiovascular Death, Death caused by heart-related conditions., 1 year
Secondary Outcome Measures: Myocardial Infarction, The occurrence of a Myocardial Infarction (4th International Definition)., 1 year|Stroke, The occurrence of a cerebrovascular event such as ischemic or hemorrhagic stroke., 1 year|Revascularization Procedures, Including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)., 1 year|Hospitalization for Unstable Angina, Admission to the hospital due to chest pain or other symptoms indicative of unstable angina., 1 year
Other Outcome Measures: Correlation of the leukocyte, neutrophil, lymphocyte, and eosinophil counts with maximum levels of high-sensitivity troponin., 1 week|Correlation the leukocyte, neutrophil, lymphocyte, and eosinophil counts with total serum cortisol levels, 1 week|Correlation the leukocyte, neutrophil, lymphocyte, and eosinophil counts with CRP levels., 1 week
Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices
NCT Number: NCT06513572
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hydrocephalus
Interventions: DEVICE: FlowSense
Sponsor: Rhaeos, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2024-12-31
Locations: CHOC Commerce Tower, Orange, California, 92868, United States|Cedars-Sinai Accelerator, West Hollywood, California, 90048, United States|Tampa Marriott Water Street, Tampa, Florida, 33602, United States|MATTER, Chicago, Illinois, 60611, United States|Industrious, Evanston, Illinois, 60201, United States|Northwest Special Recreation Association, Rolling Meadows, Illinois, 60008, United States|Texas Medical Center Innovation, Houston, Texas, 77021, United States|Industrious, Seattle, Washington, 98015, United States

Summary:
This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

Primary Outcome Measures: Correlation of measurement data, Correlation between measurements from flowing shunts, non-flowing shunts, and off-shunt locations., Approximately 1 hour
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis
NCT Number: NCT06513559
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glenohumeral Osteoarthritis
Interventions: DEVICE: Anatomic total shoulder replacement|DEVICE: Reverse total shoulder replacement
Sponsor: University of Utah
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-02
Completion Date: 2029-08
Locations: University of Utah Orthopedics, Salt Lake City, Utah, 84108, United States

Summary:
The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.

The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.

The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

In all cases, a deltopectoral incision will be used as the procedure type.

Primary Outcome Measures: American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., date of surgery|American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., 6 months after date of surgery|American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., 12 months after date of surgery|American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., 24 months after date of surgery
Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in Geriatric Service
NCT Number: NCT06513520
Acronym: SENIOR HLA DR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Immune System
Interventions: BIOLOGICAL: Blood sampling
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-09
Locations: Dugoujon Hospital, Caluire-et-Cuire, 69300, France|Croix Rousse hospital, Lyon, 69004, France

Summary:
The acceleration of population aging and the improved management of comorbidities lead to an increase in the number of multi-pathological elderly patients admitted to geriatric services. This is an extremely specific population in terms of immunology due to the presence of immunosenescence (physiological aging of the immune system) and the potential additional effect of multiple chronic pathologies (comorbidities) presented by these patients.

The specific effect of multiple chronic pathologies on the immune status of elderly patients is currently underexplored because most studies on immune system aging only include elderly patients who do not have comorbidities or treatments that could impact the immune system (e.g. SENIEUR protocol). Therefore, their results are not applicable to patients in geriatric services.

The decrease in monocyte expression of HLA-DR (mHLA-DR) has been studied as a marker of immune alteration in intensive care units in the context of sepsis, but also in chronic pathologies (e.g. cancer, diabetes, renal insufficiency). These chronic pathologies are frequently found in elderly subjects.

The objective of the study would therefore be to investigate the relative contribution of age (immunosenescence) and comorbidities to the alteration of the immune status of geriatric patients through the measurement of mHLA-DR.

To date, no study has explored mHLA-DR in a population of multi-pathological geriatric patients. Our work aims to generate initial data through a pilot study in hospitalized multi-pathological subjects over 75 years old in geriatric services.

Primary Outcome Measures: mHLA DR expression, Expression of mHLA DR assessed by flow cytometry and expressed as the number of antibodies bound per monocyte., up to 72 Hour
A Clinical Study to Assess the Efficacy of Cannabigerol in Patients With Active Rheumatoid Arthritis.
NCT Number: NCT06513507
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rheumatoid Arthritis|Inflammatory Disease
Interventions: DIETARY_SUPPLEMENT: Cannabigerol (CBG)
Sponsor: Raphael Pharma
Collaborators: Citruslabs
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2024-08-03
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.

Primary Outcome Measures: Change in inflammatory markers from Baseline to Week 8, Measurement of blood levels of ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein), IL6 (Interleukin 6), and TNFa (Tumor Necrosis Factor-alpha) at Baseline, Week 2, Week 4, Week 6, and Week 8., Baseline, Week 2, Week 4, Week 6, and Week 8
Secondary Outcome Measures: Change in self-reported symptoms and quality of life from Baseline to Week 8, Evaluation of participant perceptions of the product's effect on symptoms of rheumatoid arthritis and quality of life using a study-specific questionnaire., Baseline, Week 4, and Week 8
Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
NCT Number: NCT06513494
Acronym: EDUCAVAC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaccine Refusal|Vaccine Hesitancy
Interventions: BEHAVIORAL: Active Students Education plus Teacher Training|BEHAVIORAL: Active Students Education|BEHAVIORAL: Basic Health Unit Active Orientation|OTHER: Usual care
Sponsor: Hospital Israelita Albert Einstein
Collaborators: Ministry of Health, Brazil
Sex: ALL
Age: CHILD
Enrollment: 5000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-11-01
Completion Date: 2026-12-01

Summary:
This study aims to evaluate the impact of active health education methodologies on increasing adherence to the HPV vaccine among schoolchildren. The project will involve 80 schools across Brazil, encompassing a total of 5,000 students.

A stepped-wedge implementation design will be applied, with clusters being randomized every two months to one of four interventions.

Each intervention will be implemented in 20 schools.

Primary Outcome Measures: Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention, Rate of HPV vaccination among childrens and adolescents, 12 months
Secondary Outcome Measures: Proportion of children and adolescents with complete HPV vaccination, Rate of complete HPV vaccination scheme (two doses) among childrens and adolescents, 12 months|Proportion of teachers with complete HPV vaccination (two doses), Rate of complete HPV vaccination scheme (two doses) among teachers, 12 months|Proportion of vaccination refusal among children and adolescents, Rate of HPV vaccination refusal, 12 months|Proportion of vaccination refusal among teachers, Rate of teacher HPV vaccination refusal, 12 months
A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery
NCT Number: NCT06513481
Acronym: E-DISTANCE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Interventions: DRUG: Nardraparin calcium injection|DRUG: Nardraparin calcium injection
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 914
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-16
Completion Date: 2024-08-31

Summary:
This project intends to conduct a multicenter, prospective, observational cohort study, aiming to explore the impact of the timing of pharmacological thromboprophylaxis initiation on postoperative bleeding risk and the effectiveness of venous thromboembolism (VTE) prevention in Chinese patients after colorectal cancer (CRC) surgery. The research outcomes of this project could provide valuable insights for optimizing the prevention and management of VTE after CRC surgery.

Primary Outcome Measures: VTE events within 28 days after surgery, Patients were followed up for VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), within 28 days after surgery. Diagnosis of DVT: The lower limb is examined based on clinical symptoms (swelling and pain in the lower limb, tenderness in the back of the lower limb and/or in the inner thigh) and/or by color ultrasound or venography. The diagnosis of PE is based on clinical findings (dyspnea and shortness of breath), laboratory tests (plasma D-dimer), and CT pulmonary angiography (CTPA). Vte events were evaluated at 7 and 28 days after surgery. If a patient develops a VTE event, the patient is treated with VTE and assessed for thrombotic progression by ultrasound in both lower limb veins after 2 weeks., 7 and 28 days after surgery
Secondary Outcome Measures: Any bleeding event within 28 days after surgery, Patients were followed up for any bleeding events within 28 days after surgery, including major and minor bleeding events. According to the International Society of Thrombosis and Hemostasis Standards (ISTH standards). All patients were followed up at 1, 7, and 28 days after surgery through inpatient or outpatient follow-up and bleeding investigation., 1，3，7 and 28 days after surgery
The Value of Adding Group Education (DESMOND Method) to the Standard Primary Care Education Practices in Changing Glycemic Control and Self-care Practices in Adults With Type II Diabetes Mellitus: A Randomized Controlled Intervention Study.
NCT Number: NCT06513468
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2
Interventions: OTHER: Group education session by DESMOND Program
Sponsor: Primary Health Care Corporation, Qatar
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2025-10
Locations: Primary Health Care Corporation, Doha, 26555, Qatar

Summary:
The goal of this clinical trial is to assess the outcome of delivering the health education in a group format using the DESMOND program compared to the standard health education in newly diagnosed adults with type 2 diabetes mellitus . The main questions it aims to answer is:

Does adding group education (DESMOND method) to the standard primary care education practices is effective in changing glycemic control and self-care practices in adults with Type II Diabetes Mellitus .

The enrolled study participants will be randomized to receive either the standard personal health care or group health education (DESMOND) session. questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.

Primary Outcome Measures: Blood HbA1C %, before starting the diabetes standard care , after 3, and 6 months of follow up for both arms, before starting the diabetes standard care , after 3, and 6 months of follow up for both arms|The Diabetes self-management score using the (DSMQ), The Diabetes self-management score (DSMQ) at baseline , after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method, before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer
NCT Number: NCT06513455
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Pancreatic Cancer
Interventions: DRUG: Irinotecan liposome（40mg/m2）|DRUG: Nab-paclitaxel|DRUG: Gemcitabine|DRUG: Irinotecan Liposome（60mg/m2）
Sponsor: Harbin Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-12-31

Summary:
This is a Phase I/II , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.

The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxel，gemcitabine and liposomal irinotecan at different dose Levels(40 mg/m2, iv. q2w or 60 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .

This study aims to evaluate the safety and efficacy of liposomal irinotecan，nab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer.

Primary Outcome Measures: MTD /DLT (phase I), Maximum Tolerated Dose/Dose Limiting Toxicity, Within four weeks after administration|ORR(phase II), Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1., 6 months
Secondary Outcome Measures: Progression free Survival, Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause., 1 year|Overall survival, Defined as the time between signing the informed consent form to death due to various causes., 2 years|Disease Control Rate, Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1., 6 months|Incidence of adverse events, Use NCI-CTCAE version 5.0 for classification and grading, 6 months
The Added Value of Bone Microstructure Assessment in the Management of Osteoporotic Bone
NCT Number: NCT06513442
Acronym: ADVANTAGE BONE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoporosis
Interventions: OTHER: Trabecular bone score software
Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2034-08-01

Summary:
1. To assess the clinical utility of trabecular bone score (TBS) on fracture risk prediction including the new version (TBS V4) and future TBS versions at the spine and hip.
2. To assess the clinical utility of TBS software as a potential treatment outcome: sensitivity to change over time and following osteoporosis therapy.
3. To compare TBS to other imaging modalities of bone structure such as quantitative computed tomography (QCT) in fracture risk prediction and response to osteoporosis therapy.

Primary Outcome Measures: To assess the newest version of TBS software on fracture prediction, 10 years
IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)
NCT Number: NCT06513429
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Refractory Systemic Lupus Erythematosus
Interventions: BIOLOGICAL: IM19 CAR-T cells
Sponsor: Peking University Third Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-12-31

Summary:
The study is a single-arm, open-label clinical trial intended to recruit 3 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10\^6/kg CAR-T cells. The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the study aims to assess long-term efficacy, specifically achieving the treatment endpoint of lupus low disease activity state (LLDAS) at 360 days post-infusion, and long-term improvement in disease activity as measured by SLEDAI-2K at 360 days. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.

Primary Outcome Measures: Change from baseline of SLEDAI-2K score at 90 days after IM19 CAR T cell transfusion., Change from baseline of SLEDAI-2K score at 90 days after IM19 CAR T cell transfusion. Range \[0,105\], higher values indicate worse disease activity., 90 days|Adverse events related to IM19 CAR-T cell therapy within 28 post-infusion., The occurrence of adverse events related to IM19 CAR-T cell therapy within 28 post-infusion., 90 days
Secondary Outcome Measures: Change from baseline of SLEDAI-2K score at 360 days after IM19 CAR T cell transfusion., Change from baseline of SLEDAI-2K score at 360 days after IM19 CAR T cell transfusion. Range \[0,105\], higher values indicate worse disease activity., 360 days|Achieving low disease activity status (LLDAS) at 360 days post IM19 CAR-T cell infusion., Achieving low disease activity status (LLDAS) at 360 days post IM19 CAR-T cell infusion., 360 days|The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects., The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects., 360 days
Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
NCT Number: NCT06513416
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Preoperative Oral Pharyngeal and Intestinal Microbiota Spectrum; Postoperative Pulmonary Complications
Interventions: PROCEDURE: Elective upper abdominal surgery
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2024-12-31
Locations: Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
This study adopts a combination of retrospective and prospective cohort research methods to explore the composition of preoperative oropharyngeal and gut microbiota in elderly patients undergoing elective upper abdominal surgery, aiming to analyze the correlation between preoperative oropharyngeal and intestinal microbiota composition and metabolite levels and the occurrence of postoperative pulmonary complications (PPCs). The research subjects of the retrospective cohort study were participants (ClinicalTrials.gov No. NCT05679661) included in the prospective RCT on the effects of perioperative immune nutrition intervention and oral hygiene on postoperative complications in elderly patients, which was conducted at Peking Union Medical College Hospital from January 2023 to present. The prospective cohort study plans to continue enrolling elderly patients aged ≥ 65 who underwent elective upper abdominal surgery.

This study collects preoperative oropharyngeal and fecal samples, as well as preoperative plasma from patients for microbial sequencing and untargeted metabolomics analysis. The main outcome measurement is PPCs, which include pneumonia, atelectasis, and hypoxemia within 7 days after surgery. Inflammatory cells and cytokines in peripheral blood are secondary outcomes.

Primary Outcome Measures: Postoperative pulmonary complications, Including pneumonia, atelectasis, and hypoxemia, Within 7 days after surgery
Secondary Outcome Measures: Inflammatory cells and cytokines in peripheral blood before and after surgery, Inflammatory cells include white blood cells, neutrophil count (proportion), and lymphocyte count (proportion), while inflammatory factors include high-sensitivity C-reactive protein (CRP) and procalcitonin (PCT), Before and within 7 days after surgery
Preliminary Study Using Artificial Intelligence Technology to Identify Differences in Facial Expressions Between Healthy People, Patients With Cognitive Decline, and Patients With Dementia
NCT Number: NCT06513403
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Artificial Intelligence Technology|Identify Facial Expressions|Cognitive Decline|Dementia
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-10-31
Locations: NTUH, Hsinchu, 300, Taiwan

Summary:
Through artificial intelligence technology, we have conducted a preliminary study aimed at identifying differences in facial expressions among healthy individuals, patients with cognitive decline, and dementia patients. This research offers a novel method and tool for dementia screening, contributing to effective strategies for dementia prevention in our country. By utilizing this approach, we can effectively delay the onset of disability, promote healthy aging among our elderly population, reduce the caregiving burden on individuals, families, and society, and lower medical expenses.

Primary Outcome Measures: Facial Expression Test, (A) Participants will sit in front of a computer screen and watch videos depicting positive (happy) or negative (sad) emotional stimuli. Each video will be less than 60 seconds long. (B) Participants will undergo the memory recall and calculation ability tests included in the MMSE. (C) While participants are undergoing the tests, video recording equipment will be used to observe and record the facial expression responses of the three groups., 2024/8/1-2025/10/31
Complement C5 mAb in the Treatment of Anti-GBM Disease
NCT Number: NCT06513338
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Autoimmune Diseases
Interventions: DRUG: Eculizumab
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: Peking University First Hospital, Beijing, 100038, China

Summary:
Anti-GBM disease is the most severe form of glomerulonephritis. Despite of the standard treatment including plasmapheresis and immunosuppressant, 70% of the patients still go into end-stage kidney disease. Complement has been shown to participate in the pathogenesis of anti-GBM disease. This study aims to the investigate the therapeutic effects and safety of C5 monoclonal antibody in the treatment of anti-GBM disease.

Primary Outcome Measures: kidney prognosis, dialysis dependent or kidney translation, 12 months after the last infusion of eculizumab
Secondary Outcome Measures: side effects of eculizumab, side effects of eculizumab, 12 months after the last infusion of eculizumab
Association of Perceived Occupational Performance and Satisfaction, Balance, Gait, and Fear of Falling in Older Adult With Mild Cognitive Impairment
NCT Number: NCT06513325
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Mild Cognitive Impairment|Gait|Balance|Occupational Problems
Interventions: OTHER: Canadian Occupational Performance Measure
Sponsor: Gulhane School of Medicine
Sex: ALL
Age: OLDER_ADULT
Enrollment: 36
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-01
Completion Date: 2024-06-03
Locations: University of Health Sciences, Ankara, 06018, Turkey

Summary:
This study was designed to investigate the occupational performance and balance, gait, and fear of falling in older adults with MCI. Balance and gait of the older adults were assessed with the Tinetti balance and gait test, fear of falling with the Tampa Scale for Kinesiophobia and occupational performance with the Canadian Occupational Performance Measure (COPM). The relationship between COPM and other parameters was analysed by Spearmen's test.

Primary Outcome Measures: Canadian Occupational Performance Measure, It is a semi-structured scale that helps to identify problematic areas of performance experienced by individuals and to measure their perceived occupational performance and satisfaction. This scale assesses the level of performance of self-care, productivity and leisureoccupations and satisfaction with these performances as perceived by the individual., 10 minutes
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
NCT Number: NCT06513312
Acronym: PURPOSE 5
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pre-Exposure Prophylaxis of HIV Infection
Interventions: DRUG: Lenacapavir Injection|DRUG: Lenacapavir Tablet|DRUG: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Sponsor: Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 262
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2029-07

Summary:
The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP).

The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.

Primary Outcome Measures: Percentage of Participants with LEN and F/TDF Persistence through 52 Weeks, This outcome measure will compare LEN and F/TDF persistence through 52 weeks, where persistence is defined by On-time LEN Injection at Day 1/Baseline and Week 26 and On-time Follow-up Visit at Week 52 for LEN arm and by Adherence Levels Based on tenofovir diphosphate (TFV-DP) concentrations in red blood cells consistent with ≥ 4 doses/week (≥ 700 fmol/punch) in dried blood spot (DBS) at Weeks 13, 26, 39, and 52 for F/TDF arm., Up to Week 52
Secondary Outcome Measures: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), First dose date up to 30 days post last dose at Week 78|Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities, First dose date up to 30 days post last dose at Week 78|Overall acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with responses to Question on Acceptability, To assess the acceptability of the study drug, participants will complete the questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale with a response of: Completely unacceptable, Unacceptable, No opinion, Acceptable, or Completely acceptable., Up to Week 52|Pharmacokinetic (PK) Parameter: Ctrough for LEN at Week 26, Ctrough is defined as the concentration at the end of the dosing interval., Week 26|PK Parameter: Ctrough for LEN at Week 52, Ctrough is defined as the concentration at the end of the dosing interval., Week 52
Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients
NCT Number: NCT06513299
Acronym: avengARDS
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypoxemia|Ards
Interventions: DEVICE: low tidal volume|DEVICE: high tidal volume|DEVICE: low driving pressure|DEVICE: high driving pressure
Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Collaborators: Istituto di Ricerche Farmacologiche Mario Negri IRCCS|University of Bari Aldo Moro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2008-01-01
Completion Date: 2024-12-31

Summary:
The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings.

Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg PBW vs 8.1 to 11.9 ml/kg PBW) and low driving pressures (10.0-15.0 cmH2O vs 15.1-18.0 cmH2O), respectively. Data will be used to obtain the dose-response curve of lower VT and lower ∆P in mechanically ventilated patients with acute severe hypoxemia.

Primary Outcome Measures: ICU all-cause mortality, All patients will be classified as either alive if "alive at ICU discharge" or dead if "dead at ICU discharge", 14 days from assignment to intervention arm
Secondary Outcome Measures: Ventilator-free days, Number of ventilator-free days (VFDs) during the 14 days in ICU, 14 days from assignment to intervention arm
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
NCT Number: NCT06513273
Acronym: Box
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myeloid Leukemia|AML, Adult|Acute Myeloid Leukemia, Adult
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 397
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2029-12

Summary:
This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.

Primary Outcome Measures: New therapies efficacy in terms of Overall survival, evaluation of the efficacy of the new therapies or their combinations in the real-life for AML patients in terms of Overall Survival, at 24 months
Effect of Virtual Reality Distraction on Anxiety Control During Impacted Molar Tooth Surgery
NCT Number: NCT06513260
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dental Anxiety|Impact Molar|Virtual Reality
Interventions: PROCEDURE: Surgical extraction of impacted lower third molars.
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-11-01

Summary:
The goal of this clinical trial is to investigate the effectiveness of virtual reality distraction therapy using virtual reality glasses in reducing dental anxiety during the surgical extraction of impacted lower third molar teeth.The main questions it aims to answer are:

* Is the use of the virtual reality distraction during the procedure effective on perceived pain and anxiety?
* Evaluation of the effectiveness of the virtual reality distraction based on initial anxiety test scores.
* Does the use of the virtual reality headset cause difficulties for the clinician in performing the procedure?

Patients will undergo anxiety tests before surgery.

Pre-operative vital signs will be recorded.

The procedure will be performed either with or without virtual reality glasses, according to the randomly assigned groups.

Post-operative vital signs will be recorded.

At the end of the procedure, all patients will undergo anxiety tests and verbal rating scales.

Primary Outcome Measures: Modified Dental Anxiety Scale Scores, In patients with and without the use of virtual reality glasses, the dental anxiety scale and verbal rating scales evaluating their experience during the treatment will be applied., Baseline|Heart rate measurements, In patients with and without the use of virtual reality glasses, heart rate will be monitored before, during, and after the treatment., During the operation|Blood pressure measurements, In patients with and without the use of virtual reality glasses, blood pressure will be monitored before, during, and after the treatment., During the operation|Oxygen saturation measurements, In patients with and without the use of virtual reality glasses, saturation will be monitored before, during, and after the treatment., During the operation
Secondary Outcome Measures: Dentist feedback, Verbal rating scales will be applied to the dentist to evaluate the potential difficulties associated with the use of virtual reality distraction., Baseline