pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
NCT Number: NCT06511323
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Brain Metastases
Interventions: DIAGNOSTIC_TEST: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases
Sponsor: Lawson Health Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2027-08

Summary:
The purpose of this study is to evaluate the clinical usefulness of dynamic \[18F\]FDG PET imaging in assessing brain metastasis post stereotactic radiotherapy to separate true progression from the treatment-related changes.

Primary Outcome Measures: Diagnostic accuracy of dynamic PET, Diagnostic accuracy will be calculated and compared based on the index lesion., 12-month follow-up.
Secondary Outcome Measures: Clinical outcomes, Clinical outcomes such as local recurrence., 24-month follow-up|Clinical outcomes, CNS progression-free survival and overall survival will be analyzed, 24-month follow-up|Clinical outcomes, Factors impact on these outcomes will be explored., 24-month follow-up|Diagnostic imaging outcomes, GMR-to-perfusion ratio., 24-month follow-up|Diagnostic imaging outcomes, Blood-brain barrier permeability to glucose., 24-month follow-up|Diagnostic imaging outcomes, Glucose Metabolic Rate., 24-month follow-up|Diagnostic imaging outcomes, Magnetic resonance spectroscopy data., 24-month follow-up|Diagnostic imaging outcomes, Other ancillary clinical data will be explored., 24-month follow-up|Cost-effectiveness analysis, A decision analysis model coupled with Markov model will be constructed to estimate the incremental cost-effectiveness ratio (ICER) of performing dynamic PET in this setting from the Canadian health-care system perspective., 24-month follow-up
Exercise, Brain Activity, and Weight Maintenance
NCT Number: NCT06511310
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Weight Gain|Bariatric Surgery Candidate|Appetitive Behavior
Interventions: OTHER: Exercise
Sponsor: Joslin Diabetes Center
Collaborators: Nutrition Obesity Research Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2027-07-01

Summary:
This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research.

Primary Outcome Measures: Changes in connectivity between brain areas following exercise training by using resting state functional MRI., Evaluation of changes in brain function by fMRI before and after 12 weeks of exercise training.
Secondary Outcome Measures: Changes in appetitive behavior., Subjects will be evaluated with Three Factor Eating Questionnaire (TFEQ)., Evaluation of changes in hunger before and after 12 weeks of exercise training.|Changes in mood., Subjects will be evaluated with Beck Depression Inventory II (BDI-II) to assess for depressive symptoms., Evaluation of changes in mood before and after 12 weeks of exercise training.|Degree of changes in miRNA profiling of circulating exosomes in blood samples., Changes in circulating exosome miRNAs will be measured using next-generation sequencing (NGS) and reported as normalized counts or fold changes relative to baseline., Evaluation of changes in miRNA before and after 12 weeks of exercise training.|Changes in cognitive function., Evaluation using mini cognitive test., Changes in cognition function before and after 12 weeks of HIIT.
Metabolic Control of Aging and Disease - the MetAGE Deep Phenotyping Cohort
NCT Number: NCT06511297
Acronym: Pro-Metage
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity|Aging|Aging Problems|Metabolic Syndrome
Interventions: DIAGNOSTIC_TEST: comprehensive metabolic phenotyping
Sponsor: Thomas Scherer
Collaborators: Medical University of Graz|University of Graz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 650
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2036-01-01
Locations: Medical University of Graz, Graz, Styria, Austria|Medical University of Vienna, Vienna, Austria

Summary:
The goal of this prospective observational study is to identify and validate blood based aging biomarkers in relation to cardiometabolic phenotypes of young and old, female and male subjects with or without obesity.

The main question is to gain insights into the interaction of obesity related metabolic alteration and aging, and the relevance of loss of metabolic control in the development of age-related diseases in order to build a foundation for targeted drug- and lifestyle interventions in future studies.

Primary Outcome Measures: Epigenetic clocks, Epigenetic clocks be measured assessing DNA methylation in whole blood. The investigators speculate that the biological age is accelerated in obesity/overweight persons independent of chronological age., every 3 years
Secondary Outcome Measures: Magnetic resonance spectroscopy, Hepatic lipid content, every 3 years|Magnetic resonance imaging, Whole body fat distribution, every 3 years
Other Outcome Measures: Vibration-controlled transient elastography, Liver stiffness, Hepatic lipid content, every 3 years|Body composition, Air Displacement Plethysmograph with BodPod, every 3 years|Continuous glucose monitoring, Continuous blood glucose monitoring over 2 weeks will be performed, every 3 years|Retina scans, Optical coherence tomography angiography, every 3 years|Physical activity, Wrist-based actigraphy will be used to assess physical activity, every 3 years
Nutritional Therapy in Patients With Post-extubation Dysphagia
NCT Number: NCT06511284
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dysphagia
Interventions: OTHER: High protein dose|OTHER: Usual protein dose
Sponsor: National Institute of Respiratory Diseases, Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-12-01
Locations: National Institute of Respiratory Diseases, Mexico City, 14080, Mexico

Summary:
The aim of this study is to evaluate the impact of the prescription of two doses of protein on the amount in kilograms of muscle mass and on the clinical evolution (time until safe swallowing, time until removal of the feeding stoma, number of hospital readmissions, feeding stoma infections, incidence of pneumonia, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.

Primary Outcome Measures: Muscle mass changes, Changes of muscle mass in kilograms measured by impedance bioelectric, From randomization to 6 months
Secondary Outcome Measures: Swallow recovery, Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months, From randomization to 6 months|Duration of enteral nutrition indication, Time from discharge to feeding tube removal, From randomization to 6 months|Feeding tube complications, Number of feeding tube infections, dysfunctions and oclusions during study period, From randomization to 6 months|Muscle functionality changes, Changes in functionality measured by medical research council scale in a scale of 0-60 points, From randomization to 6 months|Handgrip strenght changes, Changes in functionality assessed by handgrip strenght in kilogramos using a digital dynamometer, From randomization to 6 months|Frailty complications, Number of falls and fractures during study period, From randomization to 6 months|Hospital readmissions associated to dysphagia complications, Number of hospital readmissions assocciated to feeding tube infections, dysfunctions and oclusions during study period, From randomization to 6 months|6-month mortality, All-cause mortality during study period, From randomization to 6 months|Aspiration pneumonia incidence, Number of hospital readmissions due to aspiration pneumonia, From randomization to 6 months
European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.
NCT Number: NCT06511245
Acronym: WAVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ruptured Aneurysm
Interventions: OTHER: Randomisation
Sponsor: Microvention-Terumo, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-06

Summary:
Comparison of efficacy and safety between WEB and other endovascular techniques

Primary Outcome Measures: As exploratory design, one of the outcome will be the assessment of aneurysm occlusion at 12 months using Raymond-Roy scale., Raymond-Roy Classification is an angiographic classification including 3 classes, from class 1 (complete obliteration) to class 3 (aneurysm remnant)., 12 months (-3/+6 months)
Maxillary Segmental Distalization Using Digitally Printed Appliances
NCT Number: NCT06511219
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Class II Malocclusion
Interventions: DEVICE: maxillary segmental distalization
Sponsor: Mansoura University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-12
Completion Date: 2026-04-12
Locations: Dentistry, Mansoura, 35516, Egypt

Summary:
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.

Primary Outcome Measures: Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances., this study includes 40 patients with class II molar and canine relation the study aimes to investigate the effect of the skeletal anchored digitally printed distalizers on the distal movement of the maxillary posterior segment in millimeters, 10 months
Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
NCT Number: NCT06511206
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight and Obesity
Interventions: DIETARY_SUPPLEMENT: 25g MCT-based nutrient mix|DIETARY_SUPPLEMENT: 25g MCT-based nutrient mix + cofactors|DIETARY_SUPPLEMENT: non-ketogenic control
Sponsor: Maastricht University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 11
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2025-09-30

Summary:
This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.

Primary Outcome Measures: Plasma ketone levels, The primary outcome is plasma ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as area under the curve (AUC)., Testday 1, 2, and 3
Other Outcome Measures: Whole-body fat oxidation, An exploratory outcome is the whole-body fat oxidation / substrate utilization determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as g/min and respiratory exchange ratio., Testday 1, 2, and 3|Energy expenditure, An exploratory outcome is the energy expenditure determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as kJ/min., Testday 1, 2, and 3|Metabolites in the blood, An exploratory outcome is the plasma metabolite levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as i.e. glucose in mmol/L, insulin in pmol/L., Testday 1, 2, and 3|Interstitial ketone levels, An exploratory outcome is the interstitial ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as μM., Testday 1, 2, and 3
Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]
NCT Number: NCT06511193
Acronym: CHRONICLES
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: DRUG: Budenoside/Glycopyrronium/Formoterol
Sponsor: AstraZeneca
Collaborators: Asthma Research Group Inc.|University Health Network, Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2025-08-29

Summary:
The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol \[BGF\] in a real-world setting.

Primary Outcome Measures: Mean change from baseline in the COPD Assessment Test (CAT) score, To estimate the change in COPD health status in patients initiating BGF after 12 weeks, 12 weeks after treatment initiation
Secondary Outcome Measures: Demographic and clinical characteristics at baseline, To describe the demographic and clinical characteristics of patients in the study, At baseline|Change from baseline in CAT score after 24 weeks of treatment, To estimate the change in COPD health status after 24 weeks from treatment initiation, 24 weeks from treatment initiation|Change in patient quality of life as measured by EQ-5D-5L at 12 and 24 weeks post-treatment initiation, To estimate the change in patient quality of life after 12 and 24 weeks of treatment initiation, 12 and 24 weeks after treatment initiation|Change in measures of sleep quality using CASIS (COPD and Asthma Sleep Impact Scale) at weeks 12 and 24, To estimate change in sleep quality following introduction of BGF, 12 and 24 weeks of treatment initiation|Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline, To describe the Responder Rate based on the CAT after 12 weeks of initiating treatment with BGF, 12 weeks treatment compared to baseline|The annualized rate of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit, To describe and compare the rate of moderate and severe exacerbations, Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months))
Post-market Surveillance Study to Evalute the Quality of Life and the Safety and Effectivness of the TIGR® Matrix After Reconstructive Breast Surgery
NCT Number: NCT06511167
Acronym: TIGR-Matrix
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Implant Based Breast Reconstruction
Interventions: DEVICE: TIGR® Matrix
Sponsor: AWOgyn
Collaborators: Esculape GmbH
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2029-01

Summary:
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.

Primary Outcome Measures: Quality of Life 12 months after surgery (BREAST-Q), Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities, 12 months after surgery
Secondary Outcome Measures: Quality of Life 6, 24, 36 months after surgery (BREAST-Q), Quality of Life will be assessed using the validated Breast-Q patient-reported outcome measure in order to compare the presence, severity and impact of the participants' symptoms on their quality of life and daily activities, 6, 24, 36 months after surgery|Complication rate, The number and rate of occurrence of major complications, minor complications; SAEs and AEs, minimum of 3 years and a maximum of 5 years after surgery|Complication rate of specific complications, Complication rate of:

* Seroma-Volume (Sum of fluid-volume during the drainage-time)
* Need for aspiration in symptomatic patients, number of aspirations in postoperative follow up
* Reconstructive failure (defined as unplanned implant loss), minimum of 3 years and a maximum of 5 years after surgery|Days with drain(s), The number of days between placement of drain system and removal of the drain, during hospital stay after surgery|Days of hospital stay, The number of days the participant spend in hospital after surgery, surgery to discharge from hospital|Cosmetic outcome, Domains of cosmesis of BREAST-Q as perceived by the participant as well as perceived by the physician, 6, 12, 24 ,36 month after surgery|Rate of unplanned conversion operations, Rate of unplanned conversion operations (to mastectomy without reconstruction; to mastectomy with reconstruction; to autologous reconstruction), minimum of 3 years and a maximum of 5 years after surgery
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
NCT Number: NCT06511141
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overactive Bladder|Urinary Urgency Incontinence|Benign Prostatic Hyperplasia|Prostate Cancer|Prostatectomy
Interventions: DEVICE: Axonics SNM System
Sponsor: Axonics, Inc.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12

Summary:
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).

Primary Outcome Measures: Adverse event reporting (Safety), Device related, procedure-related and all serious adverse events, 6 months, 1 year|Performance/Effectiveness - Improvement in Qualify of Life scoring, International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement., 6 months, 1 year|Performance/Effectiveness - Reduction in UUI episodes, Demonstrate a ≥ 50% reduction in the number of UUI episodes on a 3-day diary, 6 months, 1 year
Evaluation of the Depth of Anesthesia With 4-Channel EEG in Patients Undergoing Drug-Induced Sleep Endoscopy (DISE)
NCT Number: NCT06511128
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Seeing the Benefits of Using 4 Channel EEG During the DISE Procedure With Sedation
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-05
Completion Date: 2024-12-30
Locations: Ankara Bilkent City Hospital, Ankara, Çankaya, 06530, Turkey

Summary:
You will undergo a drug-induced sleep endoscopy procedure. The drugs we use to create routine sedation will be used as medication. During the procedure, your pulse, blood pressure, respiratory rate, blood oxygen level, and alertness will be monitored. Your values will be closely monitored and recorded before, during and after the procedure.

Our study is a study that will not require any changes in the drug-induced sleep endoscopy (DISE) procedure and treatment plan you will undergo. During drug-induced sleep endoscopy (DISE), your measurement values, which we follow in every patient, will be recorded. An adhesive tape will be attached to your forehead area, especially to determine your sleep depth. It will be removed at the end of the procedure.

Primary Outcome Measures: Determination of sedation range in 4-channel EEG, Determining the ideal PSI value in the 4-channel EEG we use in sedation-induced sleep endoscopy, from March 2024 to December 2024
Secondary Outcome Measures: Evaluating the effectiveness of different sedation techniques,Snoring situation in the shortest time and effectively,Intraoperative drug consumption,Hemodynamic changes, Evaluating the effectiveness of different sedation techniques,Snoring situation in the shortest time and effectively,Intraoperative drug consumption,Hemodynamic changes, from March 2024 to December 2024
A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants
NCT Number: NCT06511076
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: Zilucoplan
Sponsor: UCB Biopharma SRL
Sex: ALL
Age: ADULT
Enrollment: 14
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-05
Completion Date: 2024-11-25
Locations: DV0012 Site 1, Groningen, Netherlands

Summary:
The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants

Primary Outcome Measures: AUC area under the plasma concentration-time curve from time 0 to infinity), AUC: Area under the plasma concentration-time curve from time 0 to infinity, From Day 1 (Predose) up to Day 35 of each treatment period|AUC0-t (area under the plasma concentration-time curve from time 0 to time t), AUC0-t: Area under the plasma concentration-time curve from time 0 to time t, From Day 1 (Predose) up to Day 35 of each treatment period|Cmax (maximum observed plasma concentration), Cmax: Maximum observed plasma concentration, From Day 1 (Predose) up to Day 35 of each treatment period
Secondary Outcome Measures: Occurrence of treatment-emergent adverse events (TEAEs) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit, Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment., From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)|Occurrence of serious adverse events (SAEs) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit, A SAE is defined as any untoward medical occurrence that, at any dose:

* Results in death
* Is life-threatening
* Requires inpatient hospitalization or prolongation of existing hospitalization
* Results in persistent disability/incapacity
* Is a congenital anomaly/birth defect
* Important medical events, From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)|Occurrence of serious adverse device effects (SADE) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit, A serious adverse device effect (SADE) is defined as an adverse device effect that has resulted in any of the consequences characteristic of a SAE., From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)|Occurrence of nonserious adverse device effects (ADE) from Day 1 up to the end of study (EOS) visit or early termination (ET) visit, A nonserious adverse device effect (ADE) is defined as an adverse event related to the use of an investigational medical device., From Day 1 up to the end of study (EOS) visit or early termination (ET) visit (up to Day 77)
Antiviral Clinical Trial for Long Covid-19
NCT Number: NCT06511063
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Long Covid
Interventions: DRUG: tenofovir disoproxil/emtricitabine|DRUG: Selzentry|DRUG: Placebo
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Yale University|PolyBio Research Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2026-01
Locations: The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE), New York, New York, 10029, United States

Summary:
The trial will test if two repurposed HIV antivirals can reduce symptom burden in adult participants with Long Covid compared to placebo. Viral infection and viral reactivation have been documented in Long Covid.

Participants will be randomly allocated to receive antivirals, Truvada (tenofovir disoproxil/emtricitabine, TDF/FTC, Group 1) or Selzentry (Group 2), or a placebo (pill) (Group 3), taken daily for 90 days.

Primary Outcome Measures: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale, The EQ-5D-5L is a standardized measure of health status that consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with 5 levels of severity, and a visual analogue scale (VAS) where individuals rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health)., at Screening, Day 45, Day 90, and Day 180
Lumbrokinase for Long Covid Clinical Trial
NCT Number: NCT06511050
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Long Covid|Post-treatment Lyme Disease Syndrome|Chronic Fatigue Syndrome|Myalgic Encephalomyelitis
Interventions: DIETARY_SUPPLEMENT: Lumbrokinase
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Columbia University|PolyBio Research Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-02-01
Locations: The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE), New York, New York, 10029, United States

Summary:
This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:

* Long Covid (LC)
* Post-treatment Lyme disease syndrome (PTLDS)
* Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Primary Outcome Measures: EuroQol Visual Analogue Scale Score (EQ-VAS), The EQ VAS is a visual analogue scale that allows individuals to rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health), providing a quantitative measure of health as judged by the patient., Up to 12 weeks
Profiling the Inflammatory Cascade of COVID-19
NCT Number: NCT06511024
Acronym: CASCADE
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COVID-19
Sponsor: University of Edinburgh
Collaborators: NHS Lothian
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 41
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-05-12
Completion Date: 2022-08-10
Locations: Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, United Kingdom

Summary:
COVID-19 is a new and poorly understood virus. It is imperative that the scientific community develops an understanding of the viral mechanisms and human immunological response in order to develop effective therapies and assess their efficacy.

This research study is being initiated in response to the ongoing COVID-19 pandemic and will provide much needed insight into the temporal immune response which can lead to rapid respiratory failure in infected patients.

Primary Outcome Measures: Determine levels of cytokines and chemokines to elucidate the temporal inflammatory cascade in COVID-19, We will determine levels of select cytokines and chemokines in plasma and serum samples from patients and control subjects., Up to 20 days
Secondary Outcome Measures: Identification, quantification and phenotyping of inflammatory cells and biomarkers., Up to 20 days
Older People, New Needs, and Possible Solutions. A Pilot Study on Peer-to-peer Digital Education
NCT Number: NCT06510959
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Well-Being, Psychological|Digital Skills
Interventions: OTHER: Digital course
Sponsor: University of Milano Bicocca
Collaborators: University of Pavia|University of Applied Sciences and Arts of Southern Switzerland|Catholic University, Italy
Sex: ALL
Age: OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-02-08
Completion Date: 2024-07-05
Locations: University of Milan - Bicocca, Milan, 20126, Italy

Summary:
"Older people, new needs, and possible solutions: A pilot study on peer-to-peer digital education" aims to create a digital literacy protocol targeted specifically to older people, providing them with the digital skills needed to age healthily and actively in a changing social context. Specifically, the main goal is to pilot (by designing, implementing, and evaluating) a peer-to-peer digital literacy course, whereby older educators teach less digitally savvy older people how to use smartphone daily utility apps, such as e-Gov, home banking, etc.

To evaluate the effect of the intervention on participants, smartphone usage patterns are measured before, during, and after the course. Then, the impact of the course on participants' perception of well-being is assessed as well.

Primary Outcome Measures: Smartphone usage patterns, To evaluate changes in smartphone usage patterns, the investigators collect smartphone usage data for about four months: (one month) before the start of the course, during the course attendance, and (one month) after the course has ended through the app Stay Free - Screen Time. This app collects the categories of the apps that participants used during the monitoring period, the exact time (day, hour, minutes) the apps started/stopped to be used, and the duration (in seconds) of use of each apps' category. The category of the apps and the duration of use, as well as the day in which they have been used, will be combined to study participants' using habits., Four months (feb 24 - jun 24)|Perception of wellbeing, To evaluate the impact of the peer-to-peer digital education course on participants' wellbeing, the investigators will adopt a quasi-experiment approach, inviting course participants to fill in a short online self-completed questionnaire during the first and last class of the course. The investigators will collect the following five types of measures: current use of and competence on digital device use, attitudes towards technology, life satisfaction, happiness and wellbeing, demographic and socio-economic characteristics, health status., Two measurements: baseline, pre-intervention and immediately after the intervention
MBSR on Nocturnal Hypertension
NCT Number: NCT06510907
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: BEHAVIORAL: mindfulness based stress reduction program
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-12-31
Locations: School of public health and primary care, Hong Kong, Hong Kong

Summary:
Objectives: To examine the feasibility and acceptability of treating nocturnal hypertension by mindfulness-based stress reduction program (MBSR). This will provide data essential for the main trial, which will also examine the definite effectiveness of MBSR to reduce nocturnal blood pressure (BP).

Hypothesis to be tested: MBSR and the current trial are acceptable and safe to patients with nocturnal hypertension; and future main trial is feasible in terms of recruitment, dropout rate and adherence to MBSR/BP measurements.

Design and subjects: This pilot randomized-controlled trial will recruit 76 patients with nocturnal HT (night-time Systolic BP (SBP) during sleep 120 mmHg) and stage I hypertension (awake SBP = 135-159mmHg), as detected by ambulatory blood pressure monitoring (ABPM). Participants will be allocated in 1:1 ratio by stratified block randomization (by age and presence of mood disorder) to receive MBSR (intervention group) or usual care (control group) respectively.

Instruments: ABPM/HBPM/MBSR patients' diary. Interventions: The generic 8-week MBSR will be taught by a certified MBSR teacher. Participants in MBSR arm will be asked to meditate 40 minutes every day during the interventional period.

Main outcome measures: rate of recruitment/dropout/adherence to MBSR/BP measurements Data analysis and expected results: The rate of recruitment/dropout/adherence to MBSR/BP measurements will be presented.

The acceptability of MBSR and the trial will also be assessed by patients' interviews. A high level of rate of recruitment, adherence to both MBSR and BP measurements and acceptability to MBSR are expected.

Primary Outcome Measures: rate of recruitment, number of participants recruited per month during the recruitment period, over 1- year|feasibility of repeated ambulatory blood pressure monitoring, the proportion of patients finishing both ambulatory blood pressure monitoring, baseline, 8 weeks
Secondary Outcome Measures: blood pressure as measured by 24-hour ambulatory blood pressure monitoring, daytime, nighttime and overall 24-hour blood pressure, baseline, 8 weeks
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
NCT Number: NCT06510894
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Sarcoidosis
Interventions: DRUG: Sotagliflozin
Sponsor: University of Pennsylvania
Collaborators: Duke University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-12-31

Summary:
This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.

Participants will be asked to:

* undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications
* take the provided sotagliflozin as instructed for 7 days leading up to the scan
* follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan
* undergo an FDG PET/CT scan, which includes vitals and blood draws

Primary Outcome Measures: Complete myocardial glucose suppression, Rate of complete myocardial glucose suppression after 7-day regimen of sotagliflozin, 7 days
Secondary Outcome Measures: Myocardial glucose utilization, Myocardial glucose utilization in FDG PET/CT measured by SUV in the heart, 7 days
Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate
NCT Number: NCT06510881
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cleft Lip and Palate|Rhinoplasty
Interventions: PROCEDURE: Rhinoplasty with or without cleft alveolus repair
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2027-02-20
Locations: Assiut university, Assiut, Egypt

Summary:
Cleft lip and palate patients are commonly seen among maxillofacial patients. Patients with cleft lip and palate have evident cosmetic nasal deformities. The interrupted insertion of orbicularis oris muscle into the columella on the noncleft side forces the premaxilla, columella and caudal nasal septum towards that side. At the same time, as the orbicularis oris inserts into the alar base on the cleft side, the base is pulled laterally, inferiorly and posteriorly. The malformed lower lateral cartilage on the side of the cleft contributes majorly to the deformity of the nasal tip, causing it to be more blunt. A shorter medial crus and longer lateral crus on the cleft side results in a horizontally wider and displaced nostril on the cleft side. In addition, those patients have alveolar bone defect which results in both cosmetic and dental problems. Repair of the deformed nose along with the reconstruction of the alveolar defect may have an advantage over the staged repair in:- decrease the surgical burden on the patient , correction of the facial asymmetry by redeeming the maxillary bony support , peri-alar augmentation and accordingly obtaining faster and better socio-cosmetic benefit .

Primary Outcome Measures: Evaluation of SCHNOS criteria in both groups for evaluation of both cosmetic and functional improvement . The patients will be assessed on the scale and compared between the obtained pre and post operative results after 6 months of surgery ., 1. Having a blocked or obstructed nose
2. Getting air through my nose during exercise
3. Having a congested nose
4. Breathing through my nose during sleep
5. Decreased mood and self-esteem due to my nose
6. The shape of my nasal tip
7. The straightness of my nose
8. The shape of my nose from the side
9. How well my nose suits my face
10. The overall symmetry of my nose, 6 months after surgery
DurAVR™ THV EU-EFS
NCT Number: NCT06510855
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Symptomatic Aortic Stenosis|Severe Aortic Valve Stenosis|Aortic Valve Calcification|Aortic Valve Failure|Aortic Valve Disease
Interventions: DEVICE: DurAVR™ THV System
Sponsor: Anteris Technologies Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-10
Completion Date: 2030-10

Summary:
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.

Primary Outcome Measures: All-cause mortality or disabling stroke, Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines, 30 Days
Secondary Outcome Measures: All-cause mortality, Mortality would be reported as rate of death/mortality at 30 days., 30 Days|Disabling stroke, Disabling stroke would be reported according to VARC-3 Guidelines, 30 Days|Life-threatening bleeding, Life-threatening bleeding according to VARC-3 Guidelines, 30 Days|Major vascular, access-related, or cardiac structural complication, Major vascular, access-related, or cardiac structural complication according to VARC-3 Guidelines, 30 Days|Acute kidney injury stage 3 or 4, AKI according to VARC-3 Guidelines, 30 Days|Moderate or severe aortic regurgitation, Aortic regurgitation according to VARC-3 Guidelines, 30 Days|New permanent pacemaker due to procedure related conduction abnormalities, Rate of pacemaker interventions in subjects experiencing conduction abnormalities (sAS cohort only), 30 Days|Surgery or intervention related to the device, including aortic valve reintervention, Device related interventions, 30 Days
Lumbar Drainage of Intraventricular Hemorrhage
NCT Number: NCT06510842
Acronym: DRAIN IVH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intraventricular Hemorrhage|Lumbar Drainage|External Ventricular Drainage
Interventions: OTHER: External drainage of intraventricular hemorrhage
Sponsor: University Hospital Heidelberg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 354
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2029-07
Locations: Department of Neurology, University Hospital Heidelberg, Heidelberg, Baden-Württemberg, 69120, Germany|Charite Universitätsmedizin Berlin, Berlin, Germany

Summary:
Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.

Primary Outcome Measures: Rate of mRS, The mRS is frequently employed to assess functional outcome of stroke therapy - its ease of use, simplicity of interpretation for clinicians and families, and agreement with other stroke scales are appealing features. The use of fixed dichotomous analysis of ordered categorical outcomes after stroke (mRS 0-3 favorable vs. 4-6 non-favorable outcome) has proved to be valid and reliable for defining outcome in stroke patients in many previous studies., 180 days (+/- 14 days)
Secondary Outcome Measures: Amount of CSF drained by external ventricular drain, in ml, up to 14 days (duration of hospital stay)|Amount of CSF drained by lumbar drain, in ml, up to 14 days (duration of hospital stay)|Need for VP shunt, operative implantation of VP shunt, up to 14 days (duration of hospital stay)|Need for VP shunt, operative implantation of VP shunt, at 180 days|Clearance of intraventricular blood (via neuroimaging with CT or MRI), Opening of third ventricle (y/n), up to 14 days (duration of hospital stay)|Clearance of intraventricular blood (via neuroimaging with CT or MRI), Opening of fourth ventricle (y/n), up to 14 days (duration of hospital stay)|Bacterial Ventriculitis/Meningitis leading to antibiotic treatment, (y/n), up to 14 days (duration of hospital stay)|Mortality, cerebral cause of death (y/n), up to 14 days (duration of hospital stay) and 6 month
Comparison Between Diode Laser and Bleomycin in Treatment of Hemangioma
NCT Number: NCT06510829
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bleomycin Adverse Reaction
Interventions: DEVICE: Diode laser
Sponsor: Assiut University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-10

Summary:
Assessment of the Effectiveness of Bleomycin Intralesional Injection and Diode Laser on Management of Infantile Hemangioma., with regard to :

* Clinically based on Change in the Size and Color of Hemangioma.
* Ultrasonography considering Vascularity ,Echogenicity , Height , and Morphology .
* Comparison of Complications associated with Bleomycin and Diode Laser.

Primary Outcome Measures: Effect of diode laser on hemangioma, 3 years
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)
NCT Number: NCT06510816
Acronym: ARCHER II
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Geographic Atrophy
Interventions: DRUG: ANX007|OTHER: Sham Administration
Sponsor: Annexon, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 630
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2027-10
Locations: Bay Area Retina Associates Walnut Creek, Walnut Creek, California, 94598, United States|Retina Vitreous Associates of Florida, Saint Petersburg, Florida, 33711, United States|Retina Group of Florida - Sarasota Center, Sarasota, Florida, 34232, United States|Cumberland Valley Retina Consultants PC, Hagerstown, Maryland, 21740, United States|Mid Atlantic Retina Specialists - Hagerstown, Hagerstown, Maryland, 21740, United States|New England Retina Consultants, Springfield, Massachusetts, 01107, United States|Sierra Eye Associates, Reno, Nevada, 89502, United States|Asheville Eye Associates - Retina Division, Asheville, North Carolina, 28803, United States|Verum Research, LLC, Eugene, Oregon, 97401, United States|West Texas Retina, Abilene, Texas, 79606, United States|Retina Consultants of Texas - Bellaire, Bellaire, Texas, 77030, United States|Texas Retina Associates - Fort Worth, Fort Worth, Texas, 76104, United States|Retina Consultants of Texas - (The Woodlands), The Woodlands, Texas, 77384, United States

Summary:
The primary purpose of the study is to determine if IVT injections of ANX007 every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).

Primary Outcome Measures: Proportion of patients experiencing a best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at any two consecutive visits, The primary timepoint is based on accumulation of the target event rate, but no earlier than Month 12 and no later than Month 18
Secondary Outcome Measures: Change From Baseline in the Hazard of ≥15 letter BCVA Loss Through Month 12 and Month 24, Baseline, Months 12 and 24
Sevoflurane Concentrations in Children
NCT Number: NCT06510803
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthetic|Sevoflurane|Age
Interventions: DEVICE: The case intervention is the sevoflurane concentrations with the Drager Apollo workstation
Sponsor: State University of New York at Buffalo
Sex: ALL
Age: CHILD
Enrollment: 28
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-12-15

Summary:
The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia.

Primary Outcome Measures: Sevoflurane concentrations (inspired and expired concentrations) during induction of anesthesia, We will measure the inspired and expired sevoflurane concentrations using an agent monitor during the first 10 minutes of induction, 10 minutes of induction of anesthesia
Secondary Outcome Measures: Other effects, all untoward events including airway responses, unexpected movements will be recorded, First 10 minutes of anesthesia|Maximum sevoflurane concentrations during induction of anesthesia, The maximum sevoflurane concentrations (inspired and expired) during the first 10 minutes of induction of anesthesia, 10 minutes of induction of anesthesia