pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Safety and Pharmacokinetics Study of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function
NCT Number: NCT06496217
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Renal Impairment
Interventions: DRUG: MBX 2109|DRUG: MBX 2109|DRUG: MBX 2109|DRUG: MBX 2109
Sponsor: MBX Biosciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-24
Completion Date: 2024-10-12
Locations: MBX Biosciences Investigational Site, Miami, Florida, 33136, United States|MBX Bioscience Investigational Site, Tampa, Florida, 33603, United States|MBX Biosciences Investigational Site, Minneapolis, Minnesota, 55101, United States

Summary:
Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function

Primary Outcome Measures: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞), Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose, Baseline through Day 36|Maximum observed concentration (Cmax), Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose, Baseline through Day 36|Area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC0-T), Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose, Baseline through Day 36|Apparent clearance (CL/F) (MBX 2109 only), Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose, Baseline through Day 36|Time to maximum concentration (Tmax), Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose, Baseline through Day 36|Terminal elimination half-life (t1/2), Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose, Baseline through Day 36|Apparent volume of distribution (Vz/F) (MBX 2109 only), Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose, Baseline through Day 36
Swedish Physical Activity and Fitness Longitudinal Study
NCT Number: NCT06496204
Acronym: SPAF
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Sarcopenia
Sponsor: Karolinska Institutet
Collaborators: Swedish Research Council for Sport Science|The Swedish Research Council
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 429
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-22
Completion Date: 2022-06-08
Locations: Karolinska institutet, Stockholm, 14152, Sweden

Summary:
Aging means loss of strength, which can affect the ability to lead an active life and be independent. Physical activity can counteract the loss of strength to some extent, but individual differences are large and the mechanisms are partly unknown. The hypothesis is that changes in the innervation and composition of the muscle may explain the individual differences in strength loss. A group of Swedish men and women have participated in this study of physical performance for almost 50 years, since they were 16 years old. The project will improve the understanding of muscle aging. The findings may help to develop strategies to counteract muscle loss and enable healthy aging and to promote physical activity throughout life

Primary Outcome Measures: Physical fitness, Handgrip strength (kg), benchpress (number), curlups (number), back enduarance (seconds), aerobic capacity (L/min), flexibility of the hips and neck (degrees), balance (seconds), vertical jump (seconds), through study completion, an average of 70 year|Skeletal muscle fiber characteristics, Fiber type distribution (%), fibre type clustering (number/cluster), muscle mass (kg), motor units (n), neuromuscular function (Volt Amp, sec), through study completion, an average of 70 year
Secondary Outcome Measures: Questionnaire physical activity, amount of physical activity (Metabolic equivalens), through study completion, an average of 70 year|Questionnaire regarding health and lifestyle, Self reported pain and complaints, through study completion, an average of 70 year
FMT for Alcohol Use Disorder in Cirrhotics.
NCT Number: NCT06496191
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Cirrhosis
Interventions: BIOLOGICAL: FMT|OTHER: SMT|OTHER: Placebo
Sponsor: Institute of Liver and Biliary Sciences, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-27
Completion Date: 2025-06-30
Locations: Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, 110070, India

Summary:
* Title "FMT for Alcohol Use Disorder in cirrhotics: A Randomized Controlled Trial"
* The aim of the study is to study the efficacy of Fecal microbiota transplantation in patients with Alcohol liver disease over a 6 month duration without liver related side effects. The project will be conducted at ILBS over the period of 1 year.
* The concept is to test the efficacy of FMT in alcohol related cirrhotics by its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.

Primary Outcome Measures: Proportion of patients achieving and maintaining alcohol abstinence at 4 weeks, 4 weeks
Secondary Outcome Measures: Gut microbiome alterations and relative abundance of gut associated bacteria., Gut microbiome composition will be assessed by 16s Metagenomics, 12 weeks|Proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo., 12 weeks|Proportion of patients maintaining abstinence from alcohol at 3 & 6 months., 3 and 6 months|Craving measures will be assessed based on pre-existing structured and validated questionnaires (Obsessive Compulsive Drinking Scale (OCDS) and Visual Analog Scale (VAS)., VAS ranges from 0 to 10, where 0 means no craving and 10 means most craving or strongest drive to consume alcohol, in our thesis), 4,12 weeks and 6 months|Proportion of patients developing lapse and relapse at 4,12 weeks and 6 months., 4,12 weeks and 6 months.
Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients
NCT Number: NCT06496165
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease
Interventions: DRUG: Remimazolam|DRUG: Propofol
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 338
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2026-12-31
Locations: Zhongshan Hospital Fudan university, Shanghai, Shanghai, 200032, China

Summary:
In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.

Primary Outcome Measures: rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery, Within 8 hours of study drug used
Secondary Outcome Measures: RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery, Within 8 hours of study drug used
Other Outcome Measures: rate of delirium during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery, Within 8 hours of study drug used
Knowledge, Attitude, and Perceptions Towards Artificial Intelligence Among Dental Students
NCT Number: NCT06496152
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Artificial Intelligence
Interventions: OTHER: questionnaire
Sponsor: Tanta University
Sex: ALL
Age: ADULT
Enrollment: 371
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-09-02

Summary:
The aim of this study will be to assess knowledge, attitudes, and perceptions towards Artificial intelligence among dental students of Faculty of Dentistry, Tanta University

Primary Outcome Measures: The online form by questionnaire, Knowledge, Attitude, and Perceptions Towards Artificial Intelligence Among Dental Students, Two months
Clinical Comparison of Resin-hybrid Ceramic Restorations Produced Using a Computer-aided Design/Computer-aided Manufacturing (CAD/CAM) System With Fiber-reinforced Composite Restorations
NCT Number: NCT06496126
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries
Interventions: DEVICE: Cerasmart 270 (GC Coop, Tokyo, Japonya)|DEVICE: EverX Flow (GC Coop, Tokyo, Japonya)|DEVICE: : G-CEM ONE (GC Coop, Tokyo, Japonya)|DEVICE: G-Premio Bond (GC Coop, Tokyo, Japonya)|DEVICE: G-ænial A'CHORD
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-01-12
Completion Date: 2025-04-12
Locations: Hacettepe University, Ankara, 06100, Turkey

Summary:
The aim of this clinical study was to compare the clinical performance of CAD/CAM endochrone and fibre-reinforced composite restorations in root canal treated teeth with excessive loss.

Primary Outcome Measures: Retention, Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorations materyal.

Charlie: Any loss of restorative material, [Time Frame: From baseline to 24 month]|Marginal discoloration, Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding Marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scorsese: Alfa: No discoloration. Bravo: Discoloration without. Charlie:Discoloration with penetration in pulpal direction, [Time Frame: From baseline to 24 month]|Marginal Adaptation, Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate.

Charlie: Crevice in which dentin is exposed, [Time Frame: From baseline to 24 month]|Seconder Caries, Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries presented. Charlie Caries present, [Time Frame: From baseline to 24 month]
Robotic Versus Laparoscopic Liver Resection for Hepatocellular Carcinoma
NCT Number: NCT06496113
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Interventions: PROCEDURE: Minimally invasive liver resection
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-01
Completion Date: 2024-06

Summary:
The objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage BCLC 0-A. Data from two tertiary centers for liver surgery will be retrospectively reviewed. Patients will be divided in two cohorts (robot; laparoscopy). The primary endpoint will be recurrence-free and overall survival; secondary endpoints were incidence, pattern, and treatment of recurrences.

Primary Outcome Measures: Recurrence-free survival, Recurrence was dated at the first HCC detection on follow-up imaging., From the date of liver resection until the first documented HCC progression on follow-up imaging, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.|Overall survival, From the date of liver resection until the date of death for any cause or the last follow-up available whichever came first, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
Effect of Triticum Aestivum on Appetite, Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
NCT Number: NCT06496100
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Obesity|Leptin Deficiency|Ghrelin|Adiponectin
Interventions: DRUG: Triticum Aestivum|DRUG: Placebo (calcined magnesia)
Sponsor: Coordinación de Investigación en Salud, Mexico
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-03
Completion Date: 2024-12-24
Locations: Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute., Guadalajara, Jalisco, 44380, Mexico

Summary:
Obesity represents one of the major health problems worldwide; it is clear that current approaches to address obesity are largely unsuccessful. The endocrine axis of leptin and ghrelin acts as the critical link between adipose tissue and hypothalamic centers that regulate food intake, satiety, energy expenditure and weight.

Despite being a highly prevalent disease with major complications, current therapeutic options are not sufficient, as they are not ideal for the entire population. The importance of new pharmacological interventions that can be evaluated in the population at risk as an early form of treatment to avoid the development of chronic diseases with high morbidity and mortality.

Natural products such as Triticum aestivum and their high content of bioactive principles have been described for their pharmacokinetic functions in weight reduction, insulin resistance and modulation of neuropeptides involved in food intake.

Primary Outcome Measures: To evaluate the effect of Triticum aestivum on leptin in patients with obesity., To quantify the serum concentrations of leptin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo., 120 days|To evaluate the effect of Triticum aestivum on ghrelin in patients with obesity., To quantify the serum concentrations of ghrelin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo., 120 days|To evaluate the effect of Triticum aestivum on adiponectin in patients with obesity., To quantify the serum concentrations of adiponectin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo., 120 days|To evaluate the effect of Triticum aestivum on satiety regulation, To evaluate the effect on satiety by the visual analog scale for satiety and appetite, 120 days|To evaluate the effect of Triticum aestivum on appetite regulation, To evaluate the effect on satiety by the visual analog scale for satiety and appetite, 120 days
Heart Rate Variation in Females Predicts Tilt Test Results
NCT Number: NCT06496074
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Syncope, Vasovagal
Interventions: DIAGNOSTIC_TEST: Head-up Tilt Test
Sponsor: Federal University of Piaui
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 149
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-02
Completion Date: 2024-08-02
Locations: Carlos Eduardo Batista de Lima, Teresina, Piauí, 64048-350, Brazil

Summary:
Head-up tilt test (HUTT) is widely used to evaluate patients with unexplained syncope, but data on clinical predictors of HUTT results are limited. The investigators aim to evaluate heart rate (HR) variations and blood pressure (BP) changes associated with the HUTT results and the difference according to the gender. For this, a cross-sectional study will be performed with patients attended with unexplained syncope submitted to HUTT (70-degree angle), from January/2011 to April/2015. The investigators will analyze BP changes and Receiver-Operating Characteristics (ROC) curves for the maximum interval in HR variation from the first minute to tenth minute (delta-HR 10) after tilting. The significance level will be considered at 5%.

Primary Outcome Measures: Positive diagnostic correlation, Positive diagnostic correlation of the data obtained in group 1 (positive head-up tilt test) in relation to group 2 (negative head-up tilt test)., 30 days
Secondary Outcome Measures: Blood pressure variation in the head-up tilt test, Accuracy, sensitivity, and specificity of blood pressure values as predictors of outcome in the head-up tilt test, 30 days|Heart rate variation in the head-up tilt test, Accuracy, sensitivity, and specificity of heart rate values as predictors of outcome in the head-up tilt test, 30 days
Blood Flow Restriction Training in Patients With Lower Extremity Fractures
NCT Number: NCT06496035
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tibial Fractures|Lower Extremity Fracture
Interventions: DEVICE: Blood Flow Restriction with low load exercise|OTHER: Therapeutic Exercise
Sponsor: Denver Health and Hospital Authority
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-01-31
Locations: Denver Health Medical Center, Denver, Colorado, 80204, United States

Summary:
This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.

Primary Outcome Measures: Fracture healing, Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures, 6 weeks, 12 weeks, 6 months
Secondary Outcome Measures: Muscle strength, Knee extension and ankle plantarflexion strength measured with a dynamometer, 2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months|Muscle girth, Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line, 2, 4, 6, 12 weeks and 6 months|Physical function, Subjective measure of function measured by Lower Extremity Functional Scale (LEFS), 2, 6,12 weeks and 6 months
Comparative Analysis of Risk Factors and Prediction of Frailty Syndrome
NCT Number: NCT06496022
Acronym: FRAILTY-KZ
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Frail Elderly Syndrome
Interventions: DIAGNOSTIC_TEST: Frail scale|DIAGNOSTIC_TEST: Barthel scale|DIAGNOSTIC_TEST: SARC-F|DIAGNOSTIC_TEST: FRAX|DIAGNOSTIC_TEST: Mini-Cog scale|DIAGNOSTIC_TEST: dynamometry
Sponsor: Asfendiyarov Kazakh National Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2025-03-01
Locations: Kazakh National Medical University, Almaty, Tole Bi 94, 050012, Kazakhstan

Summary:
Assessing frailty syndrome in elderly patients in Almaty To study the features of the clinical course in the group of patients with a pre-frailty and in the group with frailty syndrome

Primary Outcome Measures: frailty prevalence, A FRAIL scale or Fried frailty criteria is used (weight loss, exhaustion, low physical activity, slowness, weakness). The participants were divided into three stages: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5)., 1 March 2024 - 31 December 2024
The Clinical Characteristics and Efficacy of Immunotherapy in First-line PD-L1-negative Advanced NSCLC Patients
NCT Number: NCT06496009
Acronym: LungCadX-RW
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: NSCLC
Interventions: DRUG: PD-1 Inhibitors
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 845
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-08
Completion Date: 2027-04-28

Summary:
This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice.

Primary Outcome Measures: 1-year Progression-Free Survival (PFS) rate, The 1-year Progression-Free Survival (PFS) rate is a clinical metric used to measure the percentage of patients who are still alive and have not experienced disease progression one year after the start of treatment., up to 12 month
Secondary Outcome Measures: Progression-Free Survival, PFS is the length of time during and after treatment that a patient lives with the disease but it does not get worse. It is a standard measure used in clinical trials to evaluate the effectiveness of a treatment., up to 24 months|Overall Survival, OS refers to the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with a disease are still alive, up to 36 months|Objective Response Rate, Objective Response Rate (ORR) refers to the proportion of patients whose cancer shrinks (partial response) or disappears (complete response) after treatment., up to 9 month
The Protrieve PROTECTOR Study
NCT Number: NCT06495996
Acronym: PROTECTOR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Venous Thromboembolism|Deep Venous Thrombosis
Interventions: DEVICE: Percutaneous mechanical thrombectomy (PMT)
Sponsor: Inari Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10-31
Completion Date: 2025-12-31

Summary:
The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.

Primary Outcome Measures: Primary Effectiveness Measure:, a. Clinically significant PE, 24 Hours (+-12 Hours)|Primary Safety Measure:, 1. Protrieve device-related Major Adverse Events (MAEs)
2. Major Protrieve access site complications, 24 Hours (+-12 Hours)
Secondary Outcome Measures: Secondary Outcome Measure:, a. Capture and removal of thromboembolic material in the Protrieve funnel, Index Procedure
Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
NCT Number: NCT06495983
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mineralocorticoid Excess|Primary Aldosteronism|Hypercortisolism
Interventions: DEVICE: dynamic microdialysis sampling
Sponsor: Haukeland University Hospital
Collaborators: University of Bergen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2028-12
Locations: Haukeland University Hospital, Bergen, 5021, Norway

Summary:
This study is a observational study applying 24-hour microdialysis methodology to perform dynamic multisteroid adrenal hormone profiling of patients with suspected or confirmed PA. Simultaneous registration of blood pressure, tissue glucose, sleep pattern, activity level and food intake registration may be performed. The overall objective is to develop a novel, sensitive, fast and user-friendly diagnostic procedure for PA, using multimodal data capture including dynamic multisteroid hormone profiling from microdialysis fluid.

Primary Outcome Measures: Multisteroid rhythmicity of mineralocorticoids and glucocorticoids in primary aldosteronism, Assess multisteroid rhythmicity measured in microdialysis fluid of aldosterone, precursors and metabolites of the mineralocorticoid and glucocorticoid pathway, compared to standard diagnostic work-up in patients with suspected or confirmed PA., 2024-2028
Secondary Outcome Measures: Effect of saline infusion test on multisteroid rhythmicity of mineralocorticoids and glucocorticoids, Influence of diagnostic saline infusion test on multisteroid adrenal rhythmicity will be assessed by performing 24h microdialysis before and during saling infusion testing, 2024-2028|Effect of exogenous glucocorticoid suppression on aldosterone rhythmicity, Influence of exogenous administered glucocorticoids on aldosterone and related adrenal hormone rhythmicity will be assessed by performing 24h microdilays without and during suppression with exogenous glucocorticoids, 2024-2028|cortisol co-secretion in primary aldosteronism, determine and quantify the presence of cortisol co-secretion in primary aldosteronism assessed by dynamic microdialysis compared with conventional cortisol co-secretion testing, 2024-2028|Blood pressure, glucose and sleeep pattern correlation to dynamic hormone rhythmicity in primary aldosteronism, Correlate continous blood pressure and glucose variations, sleep, food intake and movement to variations in multisteroid hormone rhythmicity in primary aldosteronism., 2024-2028
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
NCT Number: NCT06495970
Acronym: PreVailPH2 OUS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Hypertension
Interventions: DEVICE: Gradient Denervation System
Sponsor: Gradient Denervation Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-26
Completion Date: 2026-06-30
Locations: Hospital Clínico Universitario de Valencia, Valencia, Spain

Summary:
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Primary Outcome Measures: Device related serious adverse events, Number of device related SAEs, 30-days post-procedure
Secondary Outcome Measures: Procedure related adverse events, Number of procedure related AEs, 30 days post-procedure
Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants
NCT Number: NCT06495944
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Adults
Interventions: DRUG: Dazucorilant|DRUG: Itraconazole
Sponsor: Corcept Therapeutics
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-31
Completion Date: 2024-07-28
Locations: Site 01, Baltimore, Maryland, 21201, United States

Summary:
This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults.

Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Those participants who can participate will be admitted to the clinical pharmacology center (CPC) and complete pretreatment tests. Those participants will stay at the CPC for the duration of the study. On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, after eating. On Days 5-11, all participants will receive once daily, oral doses of itraconazole 200 mg, after eating. Blood and safety assessments will continue for 96-hours after dosing on Day 1 and Day 8. Participants will leave the CPC following completion of all procedures on Day 12.

Participants will return to the CPC for a final visit 7 (±1) days after their final dose of study medication.

Primary Outcome Measures: Maximum observed plasma concentration (Cmax) of dazucorilant, Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8|Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) of plasma dazucorilant, Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8|Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of plasma dazucorilant, Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
Secondary Outcome Measures: Number of Participants with 1 or More Adverse Events, Up to Day 18|Number of Participants with 1 or More Clinically Significant Abnormal ECG Result, Up to Day 18|Number of Participants with 1 or More Clinically Significant Abnormal Vital Signs, Up to Day 18|Number of Participants with 1 or More Clinically Significant Abnormal Physical Examination Finding, Up to Day 18|Number of Participants with 1 or More Clinically Significant Abnormal Clinical Laboratory Test Result, Up to Day 18
Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human
NCT Number: NCT06495931
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: HRS-1780 tablets|DRUG: HR20033 tablets|DRUG: HRS-7535 tablets
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-07-31
Locations: Xuanwu Hospital ,Capital Medical University, Beijing, Beijing, 100032, China

Summary:
This study was designed as a single-center, single-arm, open, fixed-sequence, self-controlled trial in healthy subjects.

Primary Outcome Measures: PK parameters：Cmax, 0 hour to 24 hours after the last dosing|PK parameters：AUC0-t, 0 hour to 24 hours after the last dosing|PK parameters：AUC0-∞, 0 hour to 24 hours after the last dosing
Secondary Outcome Measures: PK parameters：Tmax, 0 hour to 24 hours after the last dosing|PK parameters： t1/2, 0 hour to 24 hours after the last dosing|PK parameters： CL/F, 0 hour to 24 hours after the last dosing|PK parameters： Vz/F, 0 hour to 24 hours after the last dosing|Incidence and severity of adverse events (AEs), from screening to 24 hours after the last dosing
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
NCT Number: NCT06495918
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Interventions: DRUG: OTX-TKI|DRUG: Aflibercept|DRUG: Aflibercept
Sponsor: Ocular Therapeutix, Inc.
Collaborators: Fortrea|Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 825
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2027-01-08
Locations: Retina Vitreous Associates of Florida- Saint Petersburg, Saint Petersburg, Florida, 33711, United States|Cumberland Valley Retina Consultants, Hagerstown, Maryland, 21740, United States|Sierra Eye Associates, Reno, Nevada, 89502, United States|The Retina Center Of New Jersey, LLC - Bloomfield, Bloomfield, New Jersey, 07003, United States|Erie Retina Research, Erie, Pennsylvania, 16507, United States

Summary:
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration

Primary Outcome Measures: Best Corrected Visual Acuity (BCVA), Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48, Week 48
Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis
NCT Number: NCT06495905
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Mucormycosis
Interventions: PROCEDURE: transbronchoscopic interventional debridement
Sponsor: Beijing Tsinghua Chang Gung Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-12-30
Locations: Beijing TsingHua ChangGung hospital, Beijing, Beijing, China

Summary:
Evaluation of the effectiveness and safety of transbronchoscopic local precision infusion of amphotericin B + transoral nebulized inhalation of amphotericin B + transbronchoscopic interventional debridement + liposomal amphotericin B + posaconazole or Isavuconazole multimodal treatment of pulmonary mucormycosis

Primary Outcome Measures: the rate of complete or partial response at 4 weeks, * Complete response: Resolution of all clinical signs and symptoms and more than 90% of lesions visible on radiology
* Partial response: Clinical improvement and \>50% improvement in findings on radiology, 4 weeks
Secondary Outcome Measures: the rate of complete or partial response at 12 weeks, * Complete response: Resolution of all clinical signs and symptoms and more than 90% of lesions visible on radiology
* Partial response: Clinical improvement and \>50% improvement in findings on radiology, 12 weeks|Survival rate at 6 months, estimates using all-cause mortality at 12 months, 6 months|the incidence of adverse reactions related to this comprehensive treatment at 4 weeks, The adverse reactions were assessed based on the Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0), 4 weeks
Association Between Triglyceride Glucose Index and Severity of Coronary Artery Disease
NCT Number: NCT06495879
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-01-01

Summary:
Coronary artery disease (CAD) is a chronic cardiovascular disease occurring due to atherosclerotic occlusion of the coronary arteries (1).

Acute coronary syndrome (ACS) is the most severe type of Coronary artery disease including unstable angina(UA) , St -elevation myocardial infarction (STEMI) Non ST elevation mayocardial infarction (NSTEMI) (2).

Despite the use of current guidline-recommended therapeutics including Percutaneous coronary intervention (PCI) or coronary Artery bypass Grafting (CABG) and optimal drug treatments some patients with ischemic heart disease (IHD) remain at high risk for recurrent Cardio vascular events(3).

Triglyceride glucose index (TYG) has a good potential in predicting poor cardiovascular prognosis in patients with IHD (4).

Primary Outcome Measures: Triglyceride glucose index, Association between Triglyceride glucose index and severity of coronary artery disease, 6 months
Postoperative Anxiety and Depression Among Older Chinese Patients
NCT Number: NCT06495840
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Depression|Anxiety|Elderly Patients|Non-cardiac Surgery
Interventions: OTHER: no intervention
Sponsor: Chinese PLA General Hospital
Collaborators: Beijing Tiantan Hospital|Peking University First Hospital|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|Xiangya Hospital of Central South University|Beijing Anzhen Hospital|Central South University|Peking University People's Hospital|Zhejiang University|Fudan University|Sun Yat-sen University|Wuhan Union Hospital, China|China-Japan Friendship Hospital|The Affiliated Hospital Of Guizhou Medical University|First Affiliated Hospital of Xinjiang Medical University|First Affiliated Hospital of Guangxi Medical University|Taihe Hospital|Zhejiang Provincial People's Hospital|Shanghai Zhongshan Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 8525
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-04-01
Completion Date: 2022-04-30
Locations: First Medical center of Chinese PLA General Hospital, Beijing, China

Summary:
A multicenter, prospective observational study to describe the socioeconomic characteristics and the occurrence of postoperative anxiety and depression in the Chinese old population.

Primary Outcome Measures: Anxiety, The GAD-7 is a seven-item questionnaire for screening on the presence of generalized anxiety disorder and assessing its severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-one. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe anxiety. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of anxiety. Higher scores mean more anxiety., within 7 days after surgery|Depression, Primary outcomes were depression Patient Health Questionnaire 9 (PHQ-9).The PHQ-9 is a nine-item questionnaire for screening on the presence of depressive symptoms and monitoring depression severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-seven. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe level of depression. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of depression. The higher the score, the worse the situation. The total score ranges from 0 to 27, and higher scores indicate more depressive symptoms., within 7 days after surgery
Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils
NCT Number: NCT06495827
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Tumor Associated Neutrophils
Interventions: OTHER: No different intenvention
Sponsor: Fudan University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 653
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-07
Completion Date: 2023-08

Summary:
A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.

Primary Outcome Measures: PFS, From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months, From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Characterization and Mechanism Research of the Pre-disease State of Obese Type 2 Diabetes Mellitus
NCT Number: NCT06495814
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obese Impaired Glucose Tolerance|Newly Diagnosed Obese Type 2 Diabetic Patients
Interventions: DRUG: 1/bag of Jinlida granules, 3 times/day, taken with hot water.
Sponsor: Fengmei Lian
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 380
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-30

Summary:
Establish a comprehensive evaluation system for the progression of obese impaired glucose tolerance (IGT) to type 2 diabetes mellitus (T2DM) through cross-sectional studies; Constructing and validating a T2DM risk prediction model for obese IGT population through observational research; Through open-label clinical research, we applied Jinlida granules to intervene in high-risk obese IGT population and clarify its protective effect on this population.

Primary Outcome Measures: incidence of diabetes, During the follow-up period, when the subjects measured abnormal fasting blood glucose, venous blood was collected and OGTT was measured. Subjects who were diagnosed with type 2 diabetes according to the OGTT results and who were still diagnosed with type 2 diabetes by OGTT one week later were defined as the occurrence of diabetes., Both the observation group and the intervention group were followed up for 12 months, once a month.
Effectiveness of a Mobile Application in Improving Employees' Social Well-being.
NCT Number: NCT06495801
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Loneliness|Social Isolation|Social Support|Depressive Symptoms
Interventions: BEHAVIORAL: Frendie PRO mobile application
Sponsor: University of Eastern Finland
Collaborators: Finnish Work Environment Fund|Social Welfare Consulting Oy
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1012
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-05-20

Summary:
The goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are:

Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO mobile application at work for 6 months reduce social isolation in employees?

Researchers will compare employees from workplaces that use the Frendie PRO mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms).

Participants will be given access to the Frendie PRO mobile application and encouraged to use it by employers.

Primary Outcome Measures: Loneliness, University of California, Los Angeles (UCLA) Loneliness Scale, Will be measured three times: baseline, 3-month follow-up and 6-month follow-up|Social Isolation, A scale composed for this study based on previous literature, Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Secondary Outcome Measures: Social support, Oslo Social Support Scale, Will be measured three times: baseline, 3-month follow-up and 6-month follow-up|Depressive symptoms, Patient Health Questionnaire-9 (PHQ9), Will be measured three times: baseline, 3-month follow-up and 6-month follow-up|Workplace loneliness, Specific scale regarding loneliness experienced at workplaces, Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Other Outcome Measures: Activity and behavior on the application, Each individual user's activity on the mobile application will be measured. The data will be used for additional analyses., 6 months
Stool Sampling in the Acute Isolated Patient , Efficient Acquiring With a Novel Device
NCT Number: NCT06495775
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Feasibility Study
Interventions: DEVICE: quickfact
Sponsor: Zealand University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-11-26
Completion Date: 2024-12-02
Locations: Zealand University Hospital, Roskilde, Zealand Region, 4000, Denmark

Summary:
stool sample device tested on patients admitted to oncological dept. with diarrhea, in order to shorten time in isolation and time to relevant treatment.

Primary Outcome Measures: acquiring of stool sample with experimental device, in order to prove feasibility, instant acquiring of stool sample from acute admitted patients with diarrhea, the stool sample is collected bedside, and there after analysed with standard analysis for infectious pathogenes., the sample is intended to be collected in an expected time range is within 1-2 hours after admission|safety of device, sampling with out harm to patient, 5 minutes
Early Diagnosis of Pancreatic Cancer Via Deciphering Multi-modal Immunological Signatures
NCT Number: NCT06495749
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatic Cancer Resectable
Sponsor: Zhejiang University
Collaborators: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences|Nanjing Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-12-31
Locations: First Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, Zhejiang, 310003, China|the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, China

Summary:
Prospective inclusion of 1000 patients with pancreatic cancer (early-stage pancreatic cancer accounts for approximately 75% of cases), 1000 patients with benign pancreatic diseases, and 1000 healthy individuals as controls. Peripheral blood samples were collected from newly diagnosed pancreatic cancer patients and healthy individuals. Using techniques such as plasma TCR/BCR-seq, CyTOF, and plasma proteomics, multi-modal individual immune characteristics were obtained and analyzed along with clinical information. An artificial intelligence predictive model was built based on these multi-modal individual immune characteristics to establish an early screening technique for pancreatic cancer. The sensitivity and specificity of this artificial intelligence model for early pancreatic cancer diagnosis were evaluated using an external multicenter sample test set.

Primary Outcome Measures: Peripheral blood mononuclear cell, Using RNA seq technology to analyze differentially expressed genes in peripheral immune cells, During the 1-7 day period before surgery|Peripheral blood mononuclear cell, TCR/BCR-seq:Using multiple amplification to obtain the CDR3（complementarities determining region3） region of TCR and BCR and analyzing the VDJ rearrangement pattern, During the 1-7 day period before surgery|Peripheral blood mononuclear cell, Analyzing RNA expression in individual cells using scRNA-seq, During the 1-7 day period before surgery|Peripheral blood mononuclear cell, scTCR/BCR-seq:Using multiple amplification to obtain the CDR3（complementarities determining region3） region of TCR and BCR and analyzing the VDJ rearrangement pattern in individual cells, During the 1-7 day period before surgery|Peripheral blood mononuclear cell, Identification of open chromatin regions in individual cells using scATAC-seq technology, During the 1-7 day period before surgery|Peripheral blood mononuclear cell, Detecting the abundance and type of some markers for peripheral blood mononuclear cell using CYTOF technology, During the 1-7 day period before surgery|CT, Imaging data from the patient's initial visit, Within 1 month before surgery|MRI, Imaging data from the patient's initial visit, Within 1 month before surgery
Application of Rapid On-site Evaluation in Lymph Node Biopsy of Breast Cancer
NCT Number: NCT06495736
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: DIAGNOSTIC_TEST: Experimental: ROSE technique stain
Sponsor: Yunnan Cancer Hospital
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-02-01
Completion Date: 2026-02
Locations: Yunnan Cancer Hospital, Kunming, Yunnan, China

Summary:
The goal of this clinical trial is to evaluate the value of rapid on-site evaluation（ROSE） in lymph node biopsy of breast cancer. The main question it aims to answer is:The ROSE technique was applied to breast cancer lymph node biopsy to improve the diagnostic efficiency and accuracy.

Participants underwent routine lymph node biopsy, and the test personnel conducted routine disease examination and rose technique evaluation on the removed ly

Primary Outcome Measures: The number of positive and negative lymph nodes diagnosed by ROSE technique, up to 2 years
Secondary Outcome Measures: The time taken to diagnose using the ROSE technique, up to 2 years