pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Integrating Whole Genome Sequencing and Digital Twins Into the Management of Hypercholesterolemia in Emiratis
NCT Number: NCT06535542
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypercholesterolemia, Autosomal Dominant|Hypercholesterolemia, Autosomal Recessive|Familial Combined Hypercholesterolemia
Interventions: GENETIC: Whole Genome Sequencing
Sponsor: Abu Dhabi Health Services Company
Collaborators: Predictiv Care, Inc.
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-29
Completion Date: 2025-07-15
Locations: Abu Dhabi Health Research Center, Abu Dhabi, United Arab Emirates

Summary:
This pilot study investigates integrating whole genome sequencing and digital twin technology for managing hypercholesterolemia in Abu Dhabi clinics. It aims to establish protocols for larger future studies and incorporate genomic insights into routine medical care.

Primary Outcome Measures: Diagnostic capabilities, Diagnostic yield of standard-of-care (based on medical and family history) versus whole genome sequencing (WGS) for identifying monogenic and polygenic familial hypercholesterolemia., From consent date until first documented report, up to 6 months
Secondary Outcome Measures: Prognostic capabilities of standard-of-care, Prognostic capabilities of standard-of-care (based on medical and family history) versus whole genome sequencing for predicting outcomes and management in monogenic and polygenic familial hypercholesterolemia., Baseline to End of Study, up to 12 months|Resources Implementation for WGS in a clinical setting, Assessed by documenting resources necessary for each phase, including execution of WGS, reporting of results, and overall evaluation,, Baseline to End of Study, up to 12 months|Participant characteristics, Age, sociodemographic, personal and family history, Baseline|Change in Perceived Utility, Assessed using novel participant surveys via questions including: attitudes towards DNA testing and results, understanding of results, change in expectations, confidence, concerns., Baseline, post-disclosure of results (approximately 2-3 months after enrollment), 6 months post-enrollment|Changes in Health Care Utilization, Assessed by reviewing medical records comparing number of services and procedures received related to the diagnosis., Baseline to End of Study, up to 12 months|Clinician Attitudes About WGS, A self-built survey was created to assess physicians' perspective and attitude toward WGS, Baseline
Clinical Characteristics and Outcomes Among STEMI Patients With Cardiogenic Shock at Abu Dhabi City
NCT Number: NCT06535503
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ST Elevation Myocardial Infarction|Cardiogenic Shock
Sponsor: Abu Dhabi Health Services Company
Collaborators: Sheikh Shakhbout Medical City|Sheikh Khalifa Medical City
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-05-30
Locations: Sheikh Khalifa Medical City (SKMC), Abu Dhabi, 11001, United Arab Emirates|Sheikh Shakhbout Medical City (SKMC), Abu Dhabi, 11001, United Arab Emirates

Summary:
A retrospective study on the clinical characteristics and treatment outcomes of patients admitted with ST-elevation Myocardial Infarction (STEMI) complicated with cardiogenic shock (CS) during admission or CS development during their hospital stay for two tertiary hospitals in Abu Dhabi, UAE, from 2020-2024.

Primary Outcome Measures: Analyze STEMI patient with CS disease profile, Comorbidities, demographical information, past medical history, morbidity, 5 years|Incidence of CS-complicated AMI events, The incidence of CS-complicated AMI events will show an increase over the years because of advanced diagnostic modalities and a clearer definition of CS., 5 years|Analyze treatment outcomes in the targeted population as per the patient profile, Incidence of Mortality, 5 years|Analyze STEMI patient with CS disease profile, Incidence of Morbidity, 5 years|Analyze treatment outcomes, % of patients who were discharged, 5 years
Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions
NCT Number: NCT06535490
Acronym: PrePaCyst
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatic Cystic Lesion
Interventions: PROCEDURE: EUS-FNA|DRUG: ATBp
Sponsor: Société Française d'Endoscopie Digestive
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1702
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2027-10-15
Locations: Clinique Paris-Bercy, Charenton-le-Pont, 94220, France

Summary:
Large prospective comparative observational study in numerous reference centers in France, comparing infectious complications in patients admitted for pancreatic cystic lesions (PCL) aspiration performed with or without antibiotic prophylaxis (ATBp) according to the usual practices.

This is a prospective, comparative, observational, multicenter study, with the primary objective of comparing the infection rates in pancreatic cystic lesions (PCL) aspirated under EUS, with and without the administration of ATBp.

A sample size of 1702 patients will be needed over a 3-year study period.

Primary Outcome Measures: Post EUS-FNA PCL infection rate, Post-EUS-FNA infection rate of PCL (patients exhibiting clinical and biological signs - fever \>38.5°C, neutrophilic leukocytosis, elevated CRP, pathogen identification in blood cultures - indicative of sepsis requiring prolonged antibiotic therapy). The occurrence of the aforementioned clinical and biological signs, along with imaging evidence (such as cyst wall thickening or presence of intracystic air images) and the absence of another infection source (urinary, pulmonary, venous, etc.) will lead to the diagnosis of post-FNA infection. Centralized validation of infection cases will be conducted by an expert panel based on clinical, biological, and imaging findings., 30 days
Secondary Outcome Measures: Rate of urinary infectious complications, Number of patients with at least one urinary infection within 21-30 days after EUS-FNA, 30 days|Rate of post-ATBp allergic reactions, Number of patients with at least one allergic reaction within 21-30 days after EUS-FNA, 30 days|Duration and extension of hospitalization, Number of hospitalization days per stay within 30 days following EUS-FNA, 30 days|Diameter of the needle used for EUS-FNA, 25G, 22G, 20G, or 19G, 1 days|Associated procedures (confocal endomicroscopy or intracystic biopsy), Yes or No, 1 days|Appearance of the fluid, Thin, thick, hemorrhagic, 1 day|Complete aspiration of the cyst fluid, Yes or No, 1 day|Nature of the PCL, mucinous vs. non-mucinous, 30 days|Age, Years, 1 day|Gender, Male or female, 1 day|Diabetes, Yes or No, 1 day|Immunosuppression, Yes or No, 1 day|BMI, Weight/(size)2 expressed in in kg/m\^2, 1 day|history of aspiration of the same lesion, Yes or No, 1 day|Rate of pulmonary infectious complications, Number of patients with at least one pulmonary infection within 21-30 days after EUS-FNA, 30 days
Hypotension Prediction Index (HPI) in Patients Undergoing Robotic Assisted Radical Prostatectomy
NCT Number: NCT06535464
Acronym: HPI in RARP
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypotension During Surgery
Interventions: DEVICE: Hypotension Prediction Index|DEVICE: No Hypotension Prediction Index
Sponsor: University of Foggia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2022-01-01
Completion Date: 2023-09-01
Locations: Ospedali Riuniti, Foggia, Puglia, 71100, Italy

Summary:
Robot assisted radical prostatectomy (RARP) is the leader in robotic treatment for prostate cancer. Goal-directed therapy (GDT) is the approach used, but HPI, a machine learning algorithm analysing arterial waveforms, might offer additional benefits. The aim of this prospective randomised study is to evaluate the cumulative amount of intraoperative arterial hypotension episodes in patients undergoing RARP managed by GDT protocol guided or not by HPI algorithm

Primary Outcome Measures: cumulative amount of time spent in Hypotension, the cumulative amount of intraoperative hypotension, measured by Time Weighted Average (TWA) of Mean Arterial Pressure (MAP) below 65 mmHg, intraoperative
Lung Cancer Screening Program in Mexico
NCT Number: NCT06535451
Acronym: DETECTO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: OTHER: Screening
Sponsor: Instituto Nacional de Cancerologia de Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-24
Completion Date: 2027-03-24
Locations: Instituto Nacional de Cancerologia (INCan) Mexico, Mexico City, Tlalpan, 14080, Mexico

Summary:
This prospective study aims to detect early-stage lung cancer using low-dose computed tomography (LDCT) in Mexicans aged 50 or older who are current or former heavy smokers, non-smokers exposed to significant wood smoke, or diagnosed with COPD. Annual LDCT, spirometry, and serum biomarker tests will be conducted over 3 years, and a follow-up lasting up to 10 years.

Primary Outcome Measures: Lung cancer incidence in Mexican population, Assess the number of lung cancer detections after each round of screening., Annually over 3-year from inclusion
Secondary Outcome Measures: Lung cancer survival, Assess lung cancer mortality in participants included in the screening protocol and outside the protocol., 10-year follow-up or death from lung cancer|All-cause mortality, Asses all-cause mortality related to risk factors at the 3-years of LDCT screening and follow-up, 10-year follow-up or death from lung cancer
Other Outcome Measures: Lung cancer clinical stage, Assess stage of the disease in patients detected by LDCT screening program, Annually over 3-year from inclusion|Serum immunological biomarkers, Assess Inflammatory cytokines, Annually over 3-year from inclusion|Nodule detection rate, Assess nodule detection rate, characteristics and outcomes detected at the screening protocol., Annually over 3-year from inclusion|Chronic Obstructive Pulmonary disease (COPD) incidence rate, Detect participants with a positive spirometry test that covers COPD diagnosis, Annually over 3-year from inclusion|Anxiety/Depression rate, Asses psychological diagnosis (anxiety/depression) related to a lung cancer screening program., Annually over 3-year from inclusion
The Role of Noncontrast Computed Tomography Markers in Predicting the Clinical Outcome of Cerebral Hemorrhage
NCT Number: NCT06535438
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intracerebral Hemorrhage
Sponsor: Jin Hu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-08-31

Summary:
The goal of this observational study is to To investigate the ability of Noncontrast Computed Tomography to predict clinical prognosis in Intracerebral Hemorrhage.

The main question it aims to answer is:How to judge the prognosis of patients with cerebral hemorrhage by CT image reading at admission.

Primary Outcome Measures: The prognosis of cerebral hemorrhage at 90 days, The Modified Rankin Scale was used to evaluate the prognosis of the patients, and MRS Score \>2 indicated poor prognosis, 90 days
A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
NCT Number: NCT06535412
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Systemic Lupus Erythematosus
Interventions: DRUG: IMC-002 + SOC|DRUG: Placebo + SOC
Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 218
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-10
Completion Date: 2026-06-10

Summary:
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.

Primary Outcome Measures: SLE Responder Index (SRI-4), Proportion of patients achieving a response in SRI-4, week 52
Secondary Outcome Measures: SLE Responder Index (SRI-4), Proportion of patients achieving a response in SRI-4, week 24|achieve and sustain a low dose of corticosteroid, Proportion of patients who achieve or maintain prednisone \</= 7.5 mg/d or equivalent, week 52|achieve low level of urine protein, Proportion of patients who achieve to reduce urine protein level, week 52
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
NCT Number: NCT06535399
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatic Impairment|Healthy Volunteers
Interventions: DRUG: BMS-986369
Sponsor: Celgene
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2025-10-11

Summary:
The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with moderate and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.

Primary Outcome Measures: Maximum observed plasma concentration (Cmax), Up to approximately 44 days|Time of maximum observed plasma concentration (Tmax), Up to approximately 44 days|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)], Up to approximately 44 days
Secondary Outcome Measures: Incidence of adverse events (AEs), Up to approximately 44 days|Incidence of serious adverse events (SAEs), Up to approximately 44 days|Number of participants with physical examination abnormalities, Up to approximately 44 days|Number of participants with vital sign abnormalities, Up to approximately 44 days|Number of participants with electrocardiogram (ECG) abnormalities, Up to approximately 44 days|Number of participants with clinical safety laboratory test abnormalities, Up to approximately 44 days
Polyuria Associated With Dexmedetomidine in Operating Room
NCT Number: NCT06535386
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Polyuria
Interventions: DRUG: Dexmedetomidine 0.004 MG/ML
Sponsor: Hospital Privado de Comunidad de Mar del Plata
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-10
Completion Date: 2025-01-10

Summary:
Dexmedetomidine is an a2-adrenergic receptor agonist drug, widely used in intensive care for the sedation of patients on mechanical ventilation, as well as in the operating room during invasive procedures and during general anesthesia. It also has anti-inflammatory properties and reduces the need for opioids and benzodiazepines, which leads to a lower incidence of delirium associated with these drugs.

Among the frequent adverse effects associated with the administration of dexmedetomidine we can find bradycardia and hypotension, while some studies carried out in animals have shown that it can increase the diuretic rate.

Polyuria related to pharmacological agonism of a2-adrenergic receptors has been described in vitro and in studies performed in animal models, and is believed to be the result of functional antagonism of arginine vasopressin. Despite its widespread use as a sedative and adjunctive anesthetic, there are very few reports in the literature of dexmedetomidine-related polyuria in humans.

Currently there are no reports in the literature on the incidence of polyuria induced by the intraoperative administration of dexmedetomidine.

Primary Outcome Measures: Incidence of polyuria associated with the administration of dexmedetomidine, Determine the incidence of polyuria defined as urine output greater than 150 ml/h or 3 ml/kg/h associated with the administration of dexmedetomidine during the intraoperative period in patients scheduled for highly complex surgery, 3 hours
Secondary Outcome Measures: determine if the appearance of polyuria is associated with other factors, Determine if there is any correlation between the appearance of polyuria associated with the administration of dexmedetomidine and age, sex, type of surgery, other anesthetic drugs, and esophageal temperature., 3 hours
Blood Flow Restriction Training on Upper Extremity Grip Strength
NCT Number: NCT06535373
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Volunteers
Interventions: OTHER: Blood flow restriction
Sponsor: Casa Colina Hospital and Centers for Healthcare
Collaborators: Azusa Pacific University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2025-12
Locations: Casa Colina Healthcare and Hospital, Pomona, California, 91767, United States

Summary:
The primary objective of this prospective study is to investigate the effects of Blood Flow Restriction (BFR) training compared to traditional low-weight resistance training on grip strength in young adults.

Despite the growing interest in BFR training and its potential benefits, there is limited research specifically investigating its impact on grip strength. Understanding the effects of BFR training on grip strength could have significant implications for individuals seeking to optimize their grip performance, rehabilitation settings, and sports performance enhancement. Additionally, examining the safety and efficacy of BFR training for this specific outcome will contribute valuable insights to the scientific community.

Primary Outcome Measures: Grip Strength, Isometric grip strength will be assessed in the dominant arm after the intervention using the Jamar hydraulic hand dynamometer (Lafayette Instruments, Lafayette, IN). Participants will be positioned in sitting with the knees and hips flexed to 90 degrees and feet flat on the floor. The shoulder will be in a neutral position with the elbow flexed to 90 degrees and the forearm in neutral pronation-supination. (Crotin \& Ramsey, 2021) The participant will be instructed to squeeze the dynamometer with maximal effort for 3 seconds while receiving verbal encouragement. A total of three repetitions will be completed with a 30 second rest between trials to reduce fatigue. (Crotin \& Ramsey, 2021) The peak grip strength value of all three trails will be used for baseline strength and 30% of the peak value will be used to calculate the resistance (in lbs.) for the exercise protocol., baseline, post-intervention (6 weeks), and follow-up (6 weeks)
Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion
NCT Number: NCT06535360
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Cardiopulmonary Bypass Surgery
Interventions: BIOLOGICAL: Platelet transfusion
Sponsor: University of Maryland, Baltimore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-01
Completion Date: 2023-05-31
Locations: University of Maryland Medical Center, Baltimore, Maryland, 21201, United States

Summary:
This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.

Primary Outcome Measures: Change in Maximum Amplitude (MA) of thromboelastography (TEG), ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion), within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion
Secondary Outcome Measures: Chest Tube Drainage, The volume in ml of chest tube drainage during the first 24 hours post surgery, 24 hours|Red blood cell units Transfused, number of red blood cell units transfused, Within the first 24 Hrs Following Surgery|Platelet Units Transfused, number of platelet units transfused, Within the first 24 Hrs Following Surgery|Cryoprecipitate Units Transfused, number of Cryoprecipitate Units Transfused, Within the first 24 Hrs Following Surgery|Plasma Units Transfused, number of plasma units transfused, Within the first 24 Hrs Following Surgery
Nudging High-acuity Emergency Department Patients to Schedule a Follow-up Visit
NCT Number: NCT06535347
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emergency Service, Hospital
Interventions: BEHAVIORAL: Information about scheduling a follow-up appointment
Sponsor: Geisinger Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-09
Completion Date: 2025-04-09
Locations: Geisinger Health System, Danville, Pennsylvania, 17822, United States

Summary:
The goal of this campaign is to reduce unnecessary emergency department (ED) visits by encouraging patients with high acuity visits to follow up with an appropriate primary care provider (PCP) or specialist and therefore obtain appropriate care outside of the ED. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message and information added to the patient's after visit summary, and will include a contact number to schedule and hyperlink to allow self-scheduling. The study will assess whether ED use differs across patients in different outreach conditions. It will also examine whether patients followed through on the calls to action in the messages differently across conditions.

Primary Outcome Measures: Return to ED, ED visit (yes/no), within 120 days following day of discharge
Other Outcome Measures: PCP/specialist appointment scheduled, PCP or specialist appointment scheduled, within 7 days following day of discharge|PCP/specialist appointment scheduled, PCP or specialist appointment scheduled, within 14 days following day of discharge|PCP/specialist appointment scheduled, PCP or specialist appointment scheduled, within 30 days following day of discharge|PCP/specialist appointment scheduled, PCP or specialist appointment scheduled, within 60 days following day of discharge|PCP/specialist appointment attended, PCP or specialist appointment attended, within 7 days following day of discharge|PCP/specialist appointment attended, PCP or specialist appointment attended, within 14 days following day of discharge|PCP/specialist appointment attended, PCP or specialist appointment attended, within 30 days following day of discharge|PCP/specialist appointment attended, PCP or specialist appointment attended, within 60 days following day of discharge
Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
NCT Number: NCT06535334
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
Interventions: DRUG: Chemotherapy
Sponsor: Far Eastern Memorial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2026-05
Locations: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, 22050, Taiwan

Summary:
This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.

Primary Outcome Measures: RFS, Recurrence free survival, the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up|OS, Overall Survival, the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or last follow-up
BnH-015B Clinical Trial in Moderate Alzheimer's Disease
NCT Number: NCT06535308
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Alzheimer Disease
Interventions: DRUG: BnH-015B 5 mg|DRUG: BnH-015B 10 mg|DRUG: BnH-015B 20 mg|DRUG: BnH-015B 40 mg (Dietary impact)|DRUG: BnH-015B 40 mg|DRUG: BnH-015B 80 mg|DRUG: BnH-015B 160 mg|DRUG: BnH-015B 40 mg (MAD)|DRUG: BnH-015B 80 mg (MAD)|DRUG: BnH-015B 40 mg (Part II)|DRUG: BnH-015B 80 mg (Part II)|DRUG: BnH-015B Placebo (Part II)
Sponsor: BnH Research
Sex: ALL
Age: ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-06

Summary:
BnH-015B is a small molecule compound that targets the GluN2B binding site on NMDA receptors and positively modulates. BnH-015B has shown, through nonclinical trials, to improve symptoms of cognitive decline by regulating the BDNF/TRKβ and microglia-mediated IL-33/OPN signaling pathways; therefore, it is expected to be a promising new drug that can significantly improve symptoms associated with Alzheimer's disease, including memory loss.

Primary Outcome Measures: Number of occurrences, affected participants with adverse events, Safety/tolerability evaluation, Through study completion, an average of 14 days|Pharmacokinetic (PK) plasma concentration of BnH-015B, 0 hours(pre-dose), 15 minutes, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post-dose
Secondary Outcome Measures: Changes in serum biomarker concentration, Baseline and 14 days after administration
Other Outcome Measures: Changes in the metabolites of BnH-015B, 0 hours(pre-dose), 15 minutes, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post-dose
Physical Activity, Functional Capacity and Quality of Life in Older Patients With Chronic Comorbidities
NCT Number: NCT06535295
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Obesity|Hypertension|Type 2 Diabetes
Sponsor: Biruni University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 148
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-06-30
Locations: Istanbul Atlas University, Istanbul, Kaguthane, 34408, Turkey

Summary:
The prevalence of obesity, hypertension (HT) and type 2 diabetes (T2D) is increasing. The adoption of an increasingly sedentary lifestyle is one of the main factors contributing to the increased incidence of chronic diseases such as obesity, cardiovascular diseases, HT and T2D. Furthermore, lack of physical activity leads to a decline in functional capacity in these individuals, which facilitates the progression of HTN, T2D and obesity. The presence of multiple chronic comorbidities can exacerbate the negative impact on health-related quality of life. The main aim of this study was to compare the levels of physical activity, functional capacity and quality of life between elderly individuals with chronic comorbidities such as HTN, T2D and obesity and their healthy peers. Quality of life, functional capacity , and physical activity level will be assessed by SF-36 questionnaire, 6-minute walk test, and the International Physical Activity Questionnaire-short form, respectively.

Primary Outcome Measures: Level of Physical Activity, Physical activity will be assessed by SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability., 10-15 minutes|Level of Functional Capacity, The 6-minute walking test will be used to assess the functional capacity. Participants will be recorded in a 30-meter straight corridor for 6 minutes at their own walking speed, as fast as possible but without running. The walking distance will be recorded in meters., 15-20 minutes|Level of Quality of Life, Quality of life will be assessed by the International Physical Activity Questionnaire-short form. (IPAQ-SF). The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. If the participants reported at least 150 min/wk of walking, moderate, or vigorous intensity physical activity., 8-10 minutes
Brain Mechanism and Outcome of Surgical Intervention of Conductive Hearing Loss.
NCT Number: NCT06535282
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Conductive Hearing Loss|Tinnitus|Surgery
Interventions: OTHER: surgery
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT
Enrollment: 26
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-01-01
Completion Date: 2023-12-31
Locations: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510000, China

Summary:
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data.

Primary Outcome Measures: pure tone audiometry, The air- conducted threshold, bone-conducted threshold and air- bone gap of each frequency of pure tone audiometry were used to compare pre - and post-operative hearing level., 3-7 days before surgery, 1-12 months after surgery|speech test, Speech audiometry was mainly used to analyze the speech recognition rate of patients before and after surgery, 3-7 days before surgery, 1-12 months after surgery|EEG activation, EEG signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed., 3-7 days before surgery, 1-12 months after surgery|tinnitus handicap inventory scores, The total score of the THI scale and the scores of the three subscales(functional, emotional, and catastrophic) were collected before and after surgery for data analysis., 3-7 days before surgery, 1-12 months after surgery
Secondary Outcome Measures: tinnitus function index scores, The total score of the TFI scale were collected before and after surgery for data analysis., 3-7 days before surgery, 1-12 months after surgery|visual analogue scale, The total score of the VAS were collected before and after surgery for data analysis. VAS scale 0-10. A score of 0 means that tinnitus has no impact on daily life, and a score of 10 means that tinnitus has an intolerable, fatal level of impact on daily life., 3-7 days before surgery, 1-12 months after surgery|fNIRS activation, fNIRS signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed., 3-7 days before surgery, 1-12 months after surgery
Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)
NCT Number: NCT06535269
Acronym: TAUHEMOR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemorrhoid Pain|Hemorrhoidectomy
Interventions: PROCEDURE: Monopolar Hemorroidecotmy|PROCEDURE: Caiman Hemorroidectomy
Sponsor: Corporacion Parc Tauli
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-02
Completion Date: 2025-07
Locations: Laura Mora López, Sabadell, Barcelona, 08208, Spain

Summary:
To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.

Primary Outcome Measures: Visual analogue scale (VAS), Postoperative pain: value 0 (no pain) - 10 (maximum pain), 6 hours of post-operative period (before hospital discharge performed); within 2 days with telephone control; at 7 days control at external consultations; at 30 days control at external consultations
Secondary Outcome Measures: Wound healing time, A healed wound is considered when all post-hemorrhoidectomy wounds of 2-3 bundles are epithelialized, 7 days postoperative control at external consultations; 30 days postoperative control at external consultations|Post-surgery satisfaction survey, Phone checklist survey, 30 days postoperative control at external consultations|Wexner scale, Assessment of fecal incontinence o a scale from 0 (never incontinence) to 4 (always), obtaining a score between 0 and 20., in pre-operative visit, on the 7th and 30th postoperative clinical control|Number of emergency consultations, revision of Database, in 30 days post-surgery|Collection of adverse effects from patients, revision of Database, in 30 days post-surgery
Compare Intraperitoneal Instillation of Bupivacaine+Dexmedetomidine Versus Bupivacaine+Dexamethasone on Postoperative Pain After Lap Cholecystectomy
NCT Number: NCT06535256
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain
Interventions: DRUG: bupivacaine with dexamethasone|DRUG: bupivacaine with dexmedetomidine
Sponsor: Aswan University Hospital
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-12-01
Locations: Zaher, Cairo, Egypt

Summary:
Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy

Primary Outcome Measures: incidence and severity of postoperative pain for 24 hours, using VAS pain score, severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hrs. postoperatively, using Visual Analogue Scale
Evaluation of the Efficacy of "Lifespan Integration" (LI) Therapy in Patients With Complex Post-Traumatic Stress Disorder
NCT Number: NCT06535243
Acronym: EVALI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-Traumatic Stress Disorder Complex|Psychiatric Disorder|Abuse Neglect|Abuse Physical|Abuse, Sexual|Abuse Domestic|Abuse Verbal
Interventions: BEHAVIORAL: Lifespan Integration Therapy (LI)
Sponsor: Centre Hospitalier St Anne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-01
Completion Date: 2027-04-01
Locations: CHU St Anne, Paris, Ile De France, 75014, France

Summary:
The study aims to evaluate the efficacy of a relatively new type of psychotherapy called Lifespan Integration (LI) in patients suffering of complex PTSD

Primary Outcome Measures: change of the scores of International Trauma Questionnaire, International Trauma Questionnaire measures subscores of simple and complex PTSD, the score is calculated using an algorithm, a minimum score of 8 for the PTSD simple part and of 8 for PTSD complex part is needed in order to diagnose a complex PTSD; the maximum score for simple PTSD is 16, same for complex PTSD., maximum one year
Secondary Outcome Measures: Difficulties in Emotion Regulation Scale (DERS) Score, the DERS scale (Gratz and Roemer, 2004) contains 36 Likert Scale questions with scores from 1 to 5; the scale can generate a total score and six underscores (assessing nonacceptance, goals, impulse, awareness, strategies, clarity); in a general population cohort the mean score was of 77.99 (SD= 20.72) for N=260 women and 80.66 (SD= 18.79) for N=97 men, maximum one year
Other Outcome Measures: Rosenberg Self - Esteem Scale (RSES) (Rosenberg, 1965), RSES is one of the most widely used measures of global self esteem; it contains 10 questions with answers ranging from 0 (poor) to 3 (excellent); five questions are positively worded and five questions are negatively worded. Sinclair and colleagues, 2010 reported a mean score of 22.62 (SD=5.80) in a general population cohort from the US of N=503 individuals, maximum one year
Explainable Machine Learning for the Assessment of Donor Grafts in Liver Transplantation
NCT Number: NCT06535217
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Liver Transplant; Complications
Interventions: PROCEDURE: Liver transplantation
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Collaborators: the China Liver Transplant Registry
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5636
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-01
Completion Date: 2024-06-30
Locations: The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Summary:
Clinically, organ evaluation generally performed by the senior surgeons based on their experience and the visual and tactual inspection of the graft during procurement. However, it is proved that transplant surgeons intuition in the evaluation of donor risk and the estimation of steatosis is inconsistent and usually inaccurate. Besides, graft assessment is a dynamic process refer to amount of complex factors, which is considered to be an incredibly complicated relationship that is nonlinear in nature. Unfortunately, the classical statistic techniques in vogue such as multiple regression require the statistical assumption of independent and linear relationships between explanatory and outcome variables, and fail to analyse a large number of variables. We attempted to develop liver graft assessment models by predicting postoperative DGF using several ML techniques. Secondly, the best prediction model was selected by comparing the performance of different AI algorithms and logistic regression. Finally, we sought to explain the decision made by AI algorithms using a visualization algorithm based on the best prediction model, helping clinicians evaluate specific organ and whether to receive that may develop DGF postoperatively.

Primary Outcome Measures: Delayed Graft Function (DGF), defined as early graft dysfunction without the need for a second liver transplant or death, Within 7 days after liver transplantation
Effect of Red Beetroot Juice Intake in Adults With Long COVID-19
NCT Number: NCT06535165
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long COVID
Interventions: DIETARY_SUPPLEMENT: Red Beetroot Juice|OTHER: Placebo
Sponsor: Catholic University of the Sacred Heart
Sex: ALL
Age: ADULT
Enrollment: 31
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-03-01
Completion Date: 2021-07-31
Locations: Center for Aging and Geriatrics Research - UCSC, Rome, 00168, Italy

Summary:
Red beetroot juice may have positive effects on multiple pathways involved in long COVID. The aim of this pilot study was to explore the impact of beetroot juice supplementation on physical function, gut microbiota, and systemic inflammation in adults with long-COVID

Primary Outcome Measures: Fatigue resistance, The time (in seconds) when the pressure dropped to 50% of the maximum grip strength, 14 days
Secondary Outcome Measures: Six-minute walk test, The distance walked (in meters) on the 6-min walk test, 14 days|Flow-mediated dilation, the dilation of the brachial artery after a transitory bout of forearm ischemia, 14 days|Changes in the concentration of gut microbial species, Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis, 14 days|Fecal water metabolomics, Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy, 14 days|Changes in the concentration of circulating inflammatory mediators, Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles, 14 days
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
NCT Number: NCT06535152
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: DEVICE: Lifelight|DEVICE: Manual sphygmomanometer
Sponsor: Xim Limited
Collaborators: Element Materials Technology|Mind Over Matter Medtech Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-05-18
Completion Date: 2023-08-03
Locations: Element Materials Technology, Louisville, Colorado, 80027, United States

Summary:
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard smartphone or tablet camera.

By conducting this validation study we aimed to demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive and demonstrate its accuracy for measuring pulse rate and the blood pressure of people with blood pressures relevant to Stage 1 hypertension.

Primary Outcome Measures: Blood Pressure Classification Accuracy, Demonstrate the accuracy of Lifelight for classifying the full range of clinically relevant blood pressures as hypertensive or non-hypertensive., Up to 3 Months|Pulse Rate Measurement Accuracy (relevant to Stage 1 hypertension, Demonstrate its accuracy for measuring pulse rate (bpm), Up to 3 Months|Blood Pressure Measurement Accuracy (relevant to Stage 1 hypertension, the blood pressure (mmHg) of people with blood pressures relevant to Stage 1 hypertension, Up to 3 Months
Decoding the Inflammasome Influence on Treatment Response in Acute Myeloid Leukemia
NCT Number: NCT06535113
Acronym: Inflamm-AML
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myeloid Leukemia
Interventions: OTHER: Clinical Practice
Sponsor: Ciceri Fabio
Collaborators: Azienda Ospedaliera Bianchi-Melacrino-Morelli
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2026-08-31
Locations: GOM Bianchi Melacrino Morelli, Reggio Calabria, Calabria, 89133, Italy|IRCCS Ospedale San Raffaele, Milan, 20132, Italy

Summary:
The study is designed as a collection of biological samples of newly diagnosed acute myeloid leukemia (AML) patients treated in the clinical units involved. Samples of peripheral blood (PB) and bone marrow (BM) will be analyzed to determine the Inflammasome profile before and after a first-line chemotherapy treatment.

Primary Outcome Measures: Inflammasome Activity, The outcome variable is the inflammasome activation in AML blasts (PB e BM), At diagnosis, in case of treatment failure and at 6 months after first line chemotherapy initiation
Secondary Outcome Measures: Correlation Inflammasome and Therapy, To evaluate the correlation between inflammasome activity and response to chemotherapy in patients with AML, At diagnosis, in case of treatment failure and at 6 months after first line chemotherapy initiation
Strong Mother Strong Special Individual
NCT Number: NCT06535100
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Behavior Problem
Interventions: BEHAVIORAL: Art therapy
Sponsor: Kastamonu University
Collaborators: The Scientific and Technological Research Council of Turkey
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-03
Completion Date: 2024-10-17
Locations: Kastamonu University, Kastamonu, 37300, Turkey|Kastamonu Üniversity, Kastamonu, 37300, Turkey

Summary:
Special needs individuals with mental disabilities and other special conditions accompanying mental needs (hearing disability, visual disability, physical disability, autism spectrum disorder, multiple disabilities, language and speech disorder, learning disability and emotional/behavioral disorder) are diagnosed with special needs individuals. It includes mothers who are in service. Caregivers of children with mental special needs may experience mental problems such as anxiety, hopelessness and depression, which negatively affects the caregiver's mental resilience and increases their care burden. In order to reduce the care burden, artistic activities will be organized to express the emotions of caregivers.

Primary Outcome Measures: increasing mental well-being, enabling mothers to take a positive path in communication, seven weeks apply
Lung Function Monitoring During Hypoxemia Episodes
NCT Number: NCT06535074
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypoxemia of Newborn
Interventions: OTHER: Detecting changes in lung volume with hypoxemia episodes
Sponsor: Rutgers, The State University of New Jersey
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-04
Completion Date: 2026-08-04
Locations: Bristol Myers Squibbs Childrens Hospital, New Brunswick, New Jersey, 08901, United States

Summary:
Premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. As we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.

Primary Outcome Measures: Frequency of hypoxemia episodes of each subtype, Hypoxemia episodes classified into 4 subtypes of Apnea, forced exhalation, mixed and unclassified according to changes in lung volume parameters., 6 hour
Secondary Outcome Measures: Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia, Severe HEs defined as SpO2\<80, Prolonged HEs duration\>=30s, Bradycardia HR\<100 for \>=5s, 6hr|Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes, Episodes meeting the EIT criteria for FE and apnea but not associated with HEs, 6hr|Mean highest change in CrSO2 and cFToE during HEs and each subtype, Change in CrSO2 from baseline and fTOE during HEs, 6hr