pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)
NCT Number: NCT06555419
Acronym: PIERRE-PK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Muscular Atrophy, Spinal
Interventions: DRUG: Nusinersen|DEVICE: ThecaFlex DRx System
Sponsor: Biogen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-16
Completion Date: 2025-12-12

Summary:
In this PIERRE-PK study, researchers will learn how the body processes nusinersen when it is given through the ThecaFlex DRx™ System, compared to when nusinersen is given by lumbar puncture (LP). The ThecaFlex DRx system is an investigational implantable medical device developed by Alcyone Therapeutics, Inc. It consists of a catheter, which is a flexible tube, connected to a port which is placed under the skin. Alcyone Therapeutics, Inc. has an ongoing study called PIERRE to test the ThecaFlex DRx system. Participants with spinal muscular atrophy (SMA) in the PIERRE study may be enrolled in the PIERRE-PK study.

The main objective of the PIERRE-PK study is to learn how the body processes nusinersen when given by the ThecaFlex DRx system compared to a lumbar puncture. The main questions researchers want to answer are:

* What is the highest amount of nusinersen found in the blood after dosing?
* How much nusinersen is found in the blood over the first 24 hours after dosing?

The PIERRE-PK study will be done as follows:

* Participants will be screened to check if they can join the study. The screening period will be up to 30 days for this study and may overlap with the PIERRE study.
* Participants will receive a dose of nusinersen by lumbar puncture.
* The ThecaFlex DRx system will be implanted after the lumbar puncture, as part of the PIERRE study.
* Participants will receive a dose of nusinersen by the ThecaFlex DRx system, as part of the PIERRE study.
* Researchers will take blood samples before and after each dose. The last blood sample will be taken 24 hours after the dose.
* The total study duration for each participant in the PIERRE-PK study will be up to 5 months. This period will overlap with the participant's first 5 months in the PIERRE study.

Primary Outcome Measures: Maximum Observed Concentration (Cmax) of Nusinersen Delivered via Standard LP and via ThecaFlex DRx System, Pre-dose and at multiple time points post-dose up to 4 months|Area Under the Plasma Concentration-Time Curve From Zero Time to 24 Hours After Intrathecal Administration (AUC0-24h) of Nusinersen Delivered via Standard LP and via ThecaFlex DRx System, Pre-dose and at multiple time points post-dose up to 4 months
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
NCT Number: NCT06555393
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: High Blood Sugar|High Blood Pressure|Overweight and Obesity
Interventions: DIETARY_SUPPLEMENT: Egg White Powder
Sponsor: University of Alberta
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-10
Locations: University of Alberta, Edmonton, Alberta, T6G 2P5, Canada

Summary:
Bioactive peptides derived from food proteins show potential for improving human health. One of such promising peptides is namely IRW made from egg white hydrolysate and composed of three peptides. This is a feasibility study to assess the acute effect of IRW in egg white hydrolysate for the management of high sugar and blood pressure.

Participants at high risk of type 2 diabetes (T2D) or having T2D will undergo 4 consecutive treatments of 1 day each (randomly), during which they will consume a standardized breakfast with a smoothie containing different protein powders. Each treatment will be separated by a minimum of 1-week.

Participants in the healthy control group will undergo 1 treatment only (one day).

Primary Outcome Measures: Plasma Peptide concentration (IRW) overtime, iAUC for the plasma peptide concentration (IRW) after the test treatments compared to negative control smoothie, 5, 10, 20, 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Secondary Outcome Measures: Plasma glucose over time, iAUC for plasma glucose (up to T= 180 minutes), 30, 60, 90, 120, and 180 minutes after consumption of the smoothie|Plasma Insulin over time, iAUC for plasma insulin (up to T=180 minutes), 30, 60, 90, 120, and 180 minutes after consumption of the smoothie|Blood pressure over time, Acute effect on blood pressure during the intervention, 60, 120, and 180 minutes after consumption of the smoothie
Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
NCT Number: NCT06555367
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ocular Surface Disease
Interventions: DEVICE: scleral lenses
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-08
Completion Date: 2026-08-31
Locations: Second Affiliated Hospital of Zhejiang University Hospital, Hangzhou, Zhejiang, China

Summary:
To evaluate the therapeutic efficacy of scleral lenses in patients with irregular corneal astigmatism stemming from ocular surface diseases (OSD), focusing on visual acuity improvement, comfort, and overall satisfaction. This prospective clinical study enrolled patients diagnosed with OSD-related irregular corneal astigmatism. Participants underwent comprehensive ophthalmic evaluation, including corneal topography, visual acuity assessment, and tear film analysis. Qualified subjects were fitted with scleral lenses and followed up at intervals of one week, one month, and three months post-fitting. The primary outcomes measured were uncorrected and corrected visual acuity, comfort levels assessed via a standardized questionnaire, and fitting success rates. Data were analyzed using appropriate statistical methods to compare pre- and post-intervention values.

Primary Outcome Measures: Scleral lens fitting assessment, The fitting assessment is conducted using a slit lamp microscope to observe the central positioning of the lens, the tear film space under the lens, and the vascular compression on the peripheral conjunctival surface. OCT is applied to measure the tear film space between the central and peripheral non-contact areas of the lens and the anterior corneal surface, as well as the landing zone of the lens in all peripheral directions., 4 hours later
Secondary Outcome Measures: Subjective comfort assessment, Level 1: Very uncomfortable; Level 2: Uncomfortable; Level 3: Moderate comfort; Level 4: Comfortable; Level 5: Very comfortable., 4 hours later
MicroRNAs and Prognosis in Breast Cancer
NCT Number: NCT06555354
Acronym: BREMIR
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female|Metastases Breast
Interventions: DIAGNOSTIC_TEST: miRNA targeted analysis on breast cancer tissues|DIAGNOSTIC_TEST: miRNA targeted analysis on plasma samples|DIAGNOSTIC_TEST: miRNA profiling of breast cancer tissues
Sponsor: Casa Sollievo della Sofferenza IRCCS
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1432
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-10-28
Completion Date: 2019-11-28
Locations: Casa sollievo della Sofferenza IRCCS, San Giovanni Rotondo, FG, 71013, Italy

Summary:
Mono-centric, observational retrospective and prospective study, designed for breast cancer patients to identify novel miRNA based biomarker able to predict metastases development in breast cancer patients.

Primary Outcome Measures: Risk of metastases development, Identification of miRNAs associated with the risk to develop distant metastases., evaluation 5 and 10 years after diagnosis
Secondary Outcome Measures: Overall Survival, Identification of miRNAs associated with the risk of cancer specific death, evaluation 5 and 10 years after diagnosis
Insulin Administration Skills of Nursing Students
NCT Number: NCT06555341
Acronym: Skills
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus
Interventions: BEHAVIORAL: Experimental: Six Thinking Hats Group|BEHAVIORAL: Other: Video Group
Sponsor: Kahramanmaras Sutcu Imam University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-02-15
Completion Date: 2024-06-15
Locations: 1Kahramanmaraş Sütçü İmam University, Kahramanmaras, Kahramanmaraş, 46040, Turkey

Summary:
Aim: The effects of training delivered to nursing students through the traditional method, the Six Thinking Hats method, and the video method were examined on insulin application skill.

Method: This study, using mixed methods was conducted between 15 February and 15 May 2024, with a total sample of 90 nursing students. The control group (n=30) received traditional training only. The Six Thinking Hats group (n=30) received traditional training and Six Thinking Hats training. The video group (n=30) received traditional training and video training. Three skill measurements were taken at the same times from all the groups. The video and Six Thinkng Hats groups were asked open-ended questions and the responses were recorded. Quantitative data were analyzed using IBM SPSS vn.23 software and qualitative data with MAXQDA 2024.

Primary Outcome Measures: Insulin skill 1nd measurement, insulin skill 1nd measurement, One mounth
Secondary Outcome Measures: Insulin skill 2nd measurement, insulin skill 2nd measurement, Three mounth
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
NCT Number: NCT06555328
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Urticaria, Idiopathic|Hidradenitis|Hidradenitis Suppurativa
Interventions: DRUG: CSU lower dose treatment|DRUG: CSU high dose treatment|DRUG: CSU non responders IgE - high dose treatment|DRUG: HS low dose treatment|DRUG: HS medium dose treatment|DRUG: HS high dose treatment
Sponsor: InflaRx GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2025-12

Summary:
The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.

Primary Outcome Measures: Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)., Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) using MedDRA classification., Through study completion, an average of 10 weeks
Secondary Outcome Measures: Maximum Plasma Concentration [Cmax], Plasma PK parameters of INF904, Through study completion, an average of 10 weeks|Minimum Plasma Concentration [Cmin], Plasma PK parameters of INF904, Through study completion, an average of 10 weeks|Time of occurrence of maximum plasma concentration [tmax], Plasma PK parameters of INF904, Through study completion, an average of 10 weeks|Systemic exposure, defined as the Area Under the Curve [AUC0-24], Plasma PK parameters of INF904, Through study completion, an average of 10 weeks|Systemic exposure, defined as the Area Under the Curve [AUClast], Plasma PK parameters of INF904, Through study completion, an average of 10 weeks
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
NCT Number: NCT06555315
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Very Low Birth Weight Infant|Premature Infants|Anemia of Prematurity|Iron Deficiency, Anaemia in Children|Extremely Low Birth Weight
Interventions: DIETARY_SUPPLEMENT: 6 mg/kg of oral iron as ferrous sulfate administered every other day.|DIETARY_SUPPLEMENT: 6 mg/kg of oral iron as ferrous sulfate administered every day.
Sponsor: CHRISTUS Health
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2026-03-28
Locations: CHRISTUS Children's, San Antonio, Texas, 78207, United States

Summary:
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates

Primary Outcome Measures: Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA., The iron replete status will be measured by reticulocyte hemoglobin (Ret-Hb) between EOD and daily iron supplementation., 1 Week-36 Weeks
Secondary Outcome Measures: Characterize Ret-Hb levels in preterm infants., Laboratory data obtained from a query of the medical records will be used to characterize reticulocyte-hemoglobin (Ret-Hb) levels. The units used for Ret-Hb is "pg" or picograms., 12-24 Months|Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups., Blood bank data obtained from a query of the medical records will be used to identify the number of blood transfusions received by each study participant., 12-24 Months|Determine prevalence of bronchopulmonary dysplasia between two groups., A chart review of medical records will be used to identify which participants developed a diagnosis of bronchopulmonary dysplasia (BPD), clinically defined as the study participant requiring supplemental oxygen and/or respiratory support either at 28 days postnatal age or 36 weeks' postmenstrual age. The severity of BPD will be defined as that outlined by the 2019 Jensen guidelines., 12-24 Months|Identify the number of subjects with sepsis between two groups., Microbiology data obtained from a query of medical records will be used to identify which participants developed blood, urine, or cerebrospinal fluid culture positive sepsis., 12-24 Months|Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups., A chart review of medical records will be used to identify which participants developed necrotizing enterocolitis and/or gastrointestinal perforations., 12-24 Months|Characterize growth between two groups., A query of medical records will be conducted to identify weight (grams), height (centimeters), and head circumference (centimeters) percentiles and velocity for the infants at birth up until 36 weeks' postmenstrual age., 12-24 Months
Outcomes of Clareon PanOptix in Patients With Prior Myopic Refractive Surgery
NCT Number: NCT06555289
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cataract
Interventions: DEVICE: Clareon PanOptix IOL
Sponsor: Juliette Eye Institute Research Center
Collaborators: Sengi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Juliette Eye Institute Research Center, Albuquerque, New Mexico, 87113, United States

Summary:
This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.

Primary Outcome Measures: Binocular corrected distance visual acuity (logMAR), 3 months postoperative
Secondary Outcome Measures: Binocular distance corrected visual acuity at intermediate (logMAR), 3 months postoperative|Binocular distance corrected visual acuity at near (logMAR), 3 months postoperative|Binocular unccorrected visual acuity at distance (logMAR), 3 months postoperative|Binocular unccorrected visual acuity at intermediate (logMAR), 3 months postoperative|Binocular unccorrected visual acuity at near (logMAR), 3 months postoperative
Other Outcome Measures: Visual Disturbance Questionnaire, Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances., 3 months postoperative|Satisfaction Questionnaire, The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction., 3 months postoperative
Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
NCT Number: NCT06555276
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Disease
Interventions: DEVICE: Disposable endoscope linear cutting stapler and components
Sponsor: Suzhou Kerui Medical Technology Co., Ltd
Collaborators: Jiangsu Channel Medical Device Co., Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 195
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2024-12-31
Locations: The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Summary:
This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.

Primary Outcome Measures: anastomosis success rate, According to surgical records and hospitalization records, the condition of no reoperation in situ was defined as successful anastomosis. Anastomosis success rate=cases of successful anastomosis/total cases of surgery ×100%, within six months after surgery
Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer
NCT Number: NCT06555263
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Cancer|Lung Cancer Metastatic|Lung Cancer, Nonsmall Cell|Lung Cancer Non-Small Cell Stage IIIB|Lung Cancer Non-small Cell Stage IV|Lung Cancer, Non-small Cell
Interventions: DRUG: Luveltamab tazevibulin
Sponsor: Sutro Biopharma, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2026-10
Locations: Florida Cancer Specialists, Lake Mary, Florida, 32746, United States|Mary Crowley Cancer Research, Dallas, Texas, 75230, United States

Summary:
A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1

Primary Outcome Measures: Objective Response Rate (ORR), Best response of complete response (CR) or partial response (PR) per RECIST 1.1, up to 24 months
Secondary Outcome Measures: Duration of Response (DOR) per Investigator's assessment., Confirmed CR or PR from the first documented response to the date of documented disease progression or death., up to 24 months|Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment., Time between the date of first dose and the first date of documented progression or death, up to 24 months|Incidence and severity of adverse events and clinical laboratory abnormalities, Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities., up to 24 months|ADC concentration, To evaluate the PK of luveltamab tazevibulin, up to 24 months|Total antibody concentration, To evaluate the PK of luveltamab tazevibulin, up to 24 months|Cytotoxic warhead concentration, To evaluate the PK of luveltamab tazevibulin, up to 24 months
Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis
NCT Number: NCT06555250
Acronym: PSR
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Rhizarthrosis|Prosthesis Failure
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-15
Completion Date: 2023-10-31
Locations: CHU de Brest, Brest, 29609, France

Summary:
Rhizarthosis can be treated by prothesis of the carpo-metacarpal (CM) joint of the thumb. But, if the scaphotrapeziotrapezoid (STT) joint is also affected by arthrosis, treating the CM joint exclusively may result in partial pain relief. Thus, bone scintigraphy could identify early arthrosis of the STT joint when its appearance seems to be normal on planar radiography, suggesting another surgical procedure.

Primary Outcome Measures: Search for a statistically significant association between scintigraphic STT hyperfixation and residual pain after TM prosthesis for patients with no radiographically obvious STT involvement., STT scintigraphic hyperfixation and pain before surgery and 4 months after TM arthroplasty, before surgery and 4 month after surgery
Secondary Outcome Measures: Search for an association between scintigraphic STT hyperfixation in quantitative analysis and residual pain after TM prosthesis for patients without advanced STT involvement on radiography., SUVmax STT and pain before surgery and 4 months after TM arthroplasty, before surgery|Assessing the involvement of other carpal joint compartments, Scintigraphic hyperfixation of other carpal joint compartments and pain before surgery and 4 months after TM arthroplasty, before surgery
MEK Inhibitors for the Treatment of Hypertrophic Cardiomyopathy in Patients With RASopathies
NCT Number: NCT06555237
Acronym: MEKinRAS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cardiomegaly|Noonan Syndrome
Interventions: DRUG: Trametinib tablet|DRUG: Standard therapy
Sponsor: Medical University of Warsaw
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-01
Locations: Department of Paediatrics, The Medical University of Warsaw, Poland, Warsaw, 02-091, Poland

Summary:
The goal of this study is to evaluate the effectiveness of trametinib treatment in patients with Hyperthropic cardiomyopathy and a genetic mutation in the RAS/MAPK pathway.

Primary Outcome Measures: Effectiveness of the trametynib treatment on cardiac hyperthropy, Reduction of cardiac hypertrophy and/or LVOTO at 6 and 12 months of treatment and at 3 months of follow-up after treatment discontinuation using echocardiographic examination., 1 year|Effectiveness of the trametynib treatment on laboratory enzymes levels, Decrease in cardiac enzyme levels (NT-pro-BNP and high-sensitivity troponin I) determined in the 6th and 12th month of treatment and in the 3rd month of observation after its discontinuation., 1 year
Secondary Outcome Measures: MEK kinase activity, Assessment of MEK kinase activity before treatment and after 6 months of its duration, in the patients' blood samples, 6 months|Effectivness of the trametynib treatment assessed in the cardia magnetic resonance, reduction of cardiac hypertrophy in magnetic resonance imaging in the age group of 7-18 years not requiring general anesthesia (comparison of results before inclusion in the study, after 12 months of trametinib treatment and after the end of follow-up after its discontinuation), 1 year
Cardio and Renovascular Effects of Isometric Exercise in the Healthy Human Measured by PET/CT and MRI
NCT Number: NCT06555211
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidneys
Interventions: PROCEDURE: MRI|PROCEDURE: PET/CT
Sponsor: Bispebjerg Hospital
Sex: MALE
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-07
Completion Date: 2024-12
Locations: Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine, Copenhagen, Capital Region, 2400, Denmark

Summary:
This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PET/CT, using 15-oxygen labeled water as tracer, against the validated multiparametric MRI technique.

The study will determine:

* Total renal blood flow and regional renal perfusion at baseline (rest) and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
* The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
* Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI.
* The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI.

Primary Outcome Measures: Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET/CT with 15-Oxygen labeled water and MRI, No metric unit, Each participant's study day during the span of the study (approximately 5 months)|Total blood flow at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI, Volume of blood pr unit time, ml/min, Each participant's study day during the span of the study (approximately 5 months)|Regional renal perfusion at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI, Volume of blood pr unit time pr unit tissue mass, ml/min/g, Each participant's study day during the span of the study (approximately 5 months)|Regional renal oxygenation at rest and during isometric muscle exercise using MRI, Percentage, fraction, Each participant's study day during the span of the study (approximately 5 months)|Regional renal extraction of oxygen at rest and during isometric muscle exercise using MRI, Percentage, fraction, Each participant's study day during the span of the study (approximately 5 months)|Coefficient of variation on regional renal oxygenation and extraction of oxygen measurements at rest and isometric muscle exercise using MRI, No metric unit, Each participant's study day during the span of the study (approximately 5 months)
Promotion of Nurses' Lower Extremity Health by Foot(at)Work Intervention
NCT Number: NCT06555198
Acronym: Foot(at)Work
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lower Extremity Problem|Foot Deformities
Interventions: BEHAVIORAL: Foot(at)Work intervention
Sponsor: University of Turku
Collaborators: The Hospital District of Satakunta|Finnish Work Environment Fund
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-12

Summary:
The quasiexperimental study aims to analyse the effecs of Foot(at)Work intervention on nurses' lower extremity health. The Foot(at)Work intervention is in electronic format consisting of 5 themes. The idea is that the participants familiarizes with the foot health -related content. The primary outcome is knowledge about lower extremity self-care. Secondary outcomes are work well-being, lower extremity health and musculoskeletal health. The outcomes are measured before the intervention (M0), after the intervention (M1), one month after the intervention (M2), six months after the intervention (M3) and 12 months after the intervention (M4).

The purpose of the Foot(at)Work intervention is to support nurses ability to self-care their lower extremities. The intervention consists of text, videos, and pictures that educate nurses to self-care their lower extremities and to select proper footwear.

Primary Outcome Measures: Knowledge of lower extremity self-care, Knowledge will be measured with self-administered questionnaira that contains 20 items (response options yes-no) about self-care for lower extremity problems., before intervenion, right after the intervention, one, six and 12 months after the intervention
Secondary Outcome Measures: Self-assessed foot health, Self-Administered Foot Health Assessment Instrument (S-FHAI) will measure subjective self-assessment measure of current foot health with 22 items. Four subcategories were included: skin health (12 items), nail health (4 items), foot structure (5 items), and foot pain (1 item)., before intervenion, right after the intervention, one, six and 12 months after the intervention|Musculoskeletal health, Nordic Musculoskeletal Questionnaire will be used as self-report measure to assess the impact of a musculoskeletal condition on an individual's functioning and on the impact of the condition on daily activities., before intervenion, right after the intervention, one, six and 12 months after the intervention|Self-perceived work ability, Work ability index: one question where respondent indicates the level of perceived current work ability. Range 1-10 where 1 indicates not capable of working - 10 best possible work ability., before intervenion, right after the intervention, one, six and 12 months after the intervention
Acute Responses to a Potentiation Warm-up Protocol in Female Football Players.
NCT Number: NCT06555185
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Athletic Performance
Interventions: OTHER: Potentiation warm-up protocol|OTHER: Usual warm-up protocol
Sponsor: University of Tromso
Collaborators: Universidade do Porto
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 17
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-09-01
Completion Date: 2023-04-30
Locations: Futebol Clube de Famalicão, Famalicao, Portugal

Summary:
This study aims to determine if the performance of female football players is affected after exposure to a potentiation protocol. It is hypothesized that performance in the selected physical tests will improve significantly and meaningfully after performing the chosen potentiation protocol compared to the control group's warm-up.

Primary Outcome Measures: Agility T-test, Used to determine speed with directional changes such as forward sprinting, left and right side shuffling., First moment: beginning of the first training session; Second moment: at the end of the third week, after the fourth protocol session had been completed.|40-m sprint test, After a 5 s countdown, the participants ran forward following the route marked by cones, one at 0m indicating the start place and the other at 40m indicating the finish place. Participants started the test from a standing start position with the front foot approximately 2 cm behind the first cone., First moment: beginning of the first training session; Second moment: at the end of the third week, after the fourth protocol session had been completed.
Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy
NCT Number: NCT06555146
Acronym: Sema-RMA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2|Kidney Disease, Chronic
Interventions: DRUG: Semaglutide, 0.5 mg/mL|DRUG: Placebo, Saline
Sponsor: Bispebjerg Hospital
Sex: MALE
Age: ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2025-03
Locations: Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine, Copenhagen, Capital Region, 2400, Denmark

Summary:
The goal of this double-blinded, placebo-controlled, randomized, crossover study is to examine the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), on renal hemodynamics and function in patients with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD).

The study will determine the effects of semaglutide on:

* Renal arterial blood flow, regional renal perfusion, and oxygenation
* Activity of the renin-angiotensin-aldosterone system (RAAS)
* The glomerular filtration rate (GFR)
* Sodium excretion in urine
* Blood pressure and heart rate

Primary Outcome Measures: Total blood flow, Volume of blood per unit time, ml/min, Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year).|Regional renal perfusion, volume of blood per unit time per unit tissue mass, ml/min/g, Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)
Secondary Outcome Measures: Glomerular filtration rate, Volume per unit time, ml/min, Measured with Tec99-DTPA clearance. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)|Sodium excretion in urine, Concentration, mmol/l, One measurement will be done on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)|Activation of the renin angiotensin aldosterone system, Concentration, mmol/l, Blood samples will be taken 3 times on each intervention day, a total of 6 measurements for each participant, over the span of the study (approximately 1 year)|Blood pressure, mmhg, Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)|Heart Rate, Beats pr. minute, Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)
Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
NCT Number: NCT06555133
Acronym: METEORITE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Colorectal Carcinoma Metastatic in the Liver
Interventions: COMBINATION_PRODUCT: yttrium-90 radioembolization
Sponsor: Brown University
Collaborators: Sirtex Medical|Genentech, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2029-09-01

Summary:
BrUOG-430 is a prospective, single-arm, phase 2 trial evaluating yttrium-90 radioembolization in combination with capecitabine and atezolizumab for the treatment of unresectable colorectal cancer liver metastases in individuals who have been treated with two or more lines of systemic therapy.

Primary Outcome Measures: To assess the preliminary efficacy with the combination of yttrium-90, capecitabine, and atezolizumab based on the intrahepatic disease control rate (iDCR) at 12 weeks, Disease control rate is defined as the proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) within the liver at first post-Y-90 follow-up imaging by NCI's response evaluation criteria in solid tumors (RECIST 1.1), which is a standard way to measure if the tumor is responding to treatment by measuring tumor lesions (cm)., 12 weeks
Secondary Outcome Measures: To evaluate the preliminary safety of the combination of yttrium-90, capecitabine, and atezolizumab, Adverse events will be collected (side effects) per the National Cancer Institute's Common Terminology Criteria for Adverse Events CTCAE v5 (adverse events (side effects) are graded from 1-5)., Approximately 18 months|To determine the extrahepatic disease control rate (eDCR) with the combination of yttrium-90, capecitabine, and atezolizumab, assessment of extrahepatic disease control rate (eDCR), measurements from up to three of the target lesions identified outside the liver will be utilized to categorize non-liver response according to NCI's response evaluation criteria in solid tumors (RECIST 1.1), which is a standard way to measure if the tumor is responding to treatment by measuring lesions (cm)., Approximately 18 months|To estimate the median overall response rate (ORR), progression free survival (PFS), and overall survival (OS) with the combination of yttrium-90, capecitabine, and atezolizumab, CT imaging will be performed beginning on Day 90 (+7 days) or Day 132 (+7 days) depending on if the participant received one or two doses of Y-90, respectively. Subsequently, imaging is to be performed every 90 days (+14 days) until disease progression according to NCI's response evaluation criteria in solid tumors (RECIST) 1.1, which is a standard way to measure if the tumor is responding to treatment by measuring lesions (cm)., Approximately 18 months
Screening for Familial Hypercholesterolemia in Children
NCT Number: NCT06555120
Acronym: HYPERCHOF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypercholesterolemia, Familial
Interventions: BIOLOGICAL: blood sample
Sponsor: Centre Hospitalier Universitaire, Amiens
Sex: ALL
Age: CHILD, ADULT
Enrollment: 300
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08
Completion Date: 2026-02
Locations: CHU Amiens Picardie, Amiens, Picardie, 80054, France

Summary:
Familial hypercholesterolemia is the most common treatable genetic disorder for which a simple, effective treatment is available, with few side effects.

It leads to a significant increase in LDL levels, generally in excess of 1.9g/l, including in children. It is much higher than the values usually found in secondary or polygenic hypercholesterolemia. This condition multiplies the cardiovascular risk in adulthood by a factor of 13, and is responsible for 6,500 early cardiovascular events per year. In the absence of treatment, the state of the arteries of patients with familial hypercholesterolemia, at the age of 40, would be equivalent to that of 80-year-olds.

Currently, the prevalence is estimated at 1 in 300 people in France. However, this prevalence is largely underestimated, as targeted screening is rarely carried out, and it is estimated that only 10% of sufferers are diagnosed in France, and only 5% of affected children are known and treated.

Today, according to the French health authority, the indications for screening children are: a history of an early vascular event in one of the two parents, or familial hypercholesterolemia in a first-degree relative.

However, the World Health Organization and numerous studies recommend extending screening to the general population. Screening all children and teenagers could make it possible to introduce healthy dietary habits at an early stage, to better adapt the choice of contraception in young women, to treat before the first symptoms appear and thus reduce mortality in adulthood by up to 48%, and to screen relatives who have not yet had a cardiovascular event.

In Slovenia, 90% of children have had a lipid panel since 1994, significantly reducing mortality. In the United Kingdom, the lipid check-up, offered as part of a compulsory visit at the age of two, is being rolled out: 90% of families naturally take it up on the recommendation of their doctors.

The treatment of hypercholesterolemia is simple, and relies first and foremost on hygienic dietary rules and treatments such as statins and Liptruzet (a combination of atorvastatin and ezetimibe), treatments that are easily accessible, effective, with few side effects and low cost.

Primary Outcome Measures: prevalence of hypercholesterolemia in children in the general population, at 16 months
Acute Preoperative Pain and Chronic Post-surgical Pain in Emergency Surgery
NCT Number: NCT06555107
Acronym: POCSE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Postsurgical Pain|Acute Pain|Emergency Surgery|Opioid|Postoperative Pain|Risk Factors
Interventions: OTHER: questionnaire|OTHER: phone call
Sponsor: Centre Hospitalier Universitaire, Amiens
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 693
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2026-04
Locations: CHU Amiens-Picardie, Amiens, 80054, France

Summary:
Studies evaluating postoperative pain as a risk factor for CPSP are almost exclusively carried out in the context of scheduled surgery. As a result, the preoperative pain studied as a risk factor for chronicity is essentially a state of pain that has persisted for several weeks or even several months.

In emergency surgeries, patients are subject to acute preoperative pain of varying intensity and the duration of which may vary by a few days. A few studies have highlighted the intensity of acute preoperative pain as a factor favouring moderate to severe postoperative pain. At this point, no study has addressed the long-term consequences of this intense preoperative pain the emergency context.

An evaluation in the field of emergency surgery, where the preoperative pain is often intense and limited in time, would enable us to identify more precisely the impact of acute pain on the incidence of CPSP.

The investigators are hypothesising that the occurrence of CPSP at 3 months in patients undergoing emergency orthopaedic or abdominal surgery is associated with acute preoperative pain.

Primary Outcome Measures: Frequency of CPSP, at 3 months
Randomized Clinical Trial of Supplementing Brief Psychotherapy With a Mobile App
NCT Number: NCT06555094
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicidal Ideation|Suicide|Suicide Attempt
Interventions: BEHAVIORAL: Ecological momentary assessment (EMA)|BEHAVIORAL: Treatment as usual (TAU)|BEHAVIORAL: Brief skills sessions plus EMI skills practice prompts
Sponsor: Rutgers, The State University of New Jersey
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-14
Completion Date: 2025-01
Locations: Rutgers University Behavioral Healthcare, Piscataway, New Jersey, 08854, United States

Summary:
The aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.

Primary Outcome Measures: Within-person changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment) from pre- to post-EMI, Overall changes in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) from pre- to post-EMI use, among those in the experimental condition only, Through study completion (up to 28 days after inpatient hospital discharge)|Between-condition differences in momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale via ecological momentary assessment), Means and slopes of momentary self-reported intensity of suicidal urges (measured on a 11-point rating scale up to 4x/day via ecological momentary assessment) will be compared between the experimental and control conditions, Through study completion (up to 28 days after inpatient hospital discharge)
A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants
NCT Number: NCT06555081
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: Ruxolitinib IR|DRUG: Ruxolitinib XR
Sponsor: Incyte Corporation
Sex: ALL
Age: ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-25
Completion Date: 2024-11-22

Summary:
This study is conducted to determine the Bioequivalence of Ruxolitinib XR 55 mg Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants

Primary Outcome Measures: INCB018424 pharmacokinetic (PK) in Plasma, INCB018424 concentration in plasma., Up to Day 16
Secondary Outcome Measures: Number of participants with Treatment Emergent Adverse Events (TEAEs), Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug., Up to Day 33|Additional INCB018424 pharmacokinetic (PK) in Plasma, Additional INCB018424 concentration in plasma., Up to Day 16
Trochlear Thickness and Its Effect on the Outcomes of Total Knee Arthroplasty
NCT Number: NCT06555055
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Knee Osteoarthritis
Interventions: OTHER: CT trochlear thickness change
Sponsor: Ibrahim barsoum
Collaborators: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 87
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-30
Completion Date: 2024-07-01
Locations: Ain Sahms University, Cairo, Abbasia, 11517, Egypt

Summary:
Total knee arthroplasty (TKA ) is the gold standard treatment for advanced knee osteoarthritis. only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications.

Numerous biomechanical studies suggest that patellofemoral tracking is not always restored to physiological values, because the prosthetic trochlea may differ from the native trochlea. no study has been con-ducted to investigate the thickness of the trochlear groove and its effect on the outcome of Total knee replacement (TKR), So many people has different measurements of trochlear thickness which may affect Patellofemoral joint (PFJ) so knowing of native trochlear thickness in patients with KNEE Osteoarthritis (OA) can affect the outcomes of total knee arthroplasty.

Primary Outcome Measures: Functional outcome, knee society score (KSS)., preoperative and six months postoperatively|Functional Outcome, Patellofemoral score (Barlett patellofemoral score)., preoperative and six months postoperatively|Functional Outcome, ROM, preoperative and six months postoperatively