pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
PNF Method for Those Working in Special Education
NCT Number: NCT06466239
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caregiver Burden
Interventions: OTHER: PNF Stretching|OTHER: Static Stretching
Sponsor: Istanbul Medipol University Hospital
Collaborators: Istanbul Gedik University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-11-04
Completion Date: 2024-06-06
Locations: Ebrar Atak, Yalova, 77100, Turkey

Summary:
The aim of the study was to examine the acute effect of self-proprioceptive neuromuscular facilitation (PNF) stretching on chest mobility, posterior muscle chain mobility and respiratory functions in caregivers of children with developmental delays. In the study: 1. Does self-PNF stretching have an effect on chest mobility and posterior muscle chain mobility in caregivers of children with developmental delay? 2. Does self-PNF stretching have an effect on respiratory functions in caregivers of children with developmental delays? The questions were answered.

Primary Outcome Measures: Chest Mobility Measurement 1- Axillary region, Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the axillary region with a tape measure and recorded in centimeters., Duration of change in 1 day.|Chest Mobility Measurement 2- Xiphoid region, Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the xiphoid (epigastric) region with a tape measure and recorded in centimeters., Duration of change in 1 day.|Chest Mobility Measurement 3- Subcostal region, Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the subcostal region with a tape measure and recorded in centimeters., Duration of change in 1 day.
Secondary Outcome Measures: Popliteal Angle Measurement, Hamstring muscle flexibility measurement. A digital goniometer was used., Duration of change in 1 day.|Schober Test, Lumbar mobility was evaluated with the Schober Test. A tape measure was used in the testing procedure., Duration of change in 1 day.|Posterior muscle chain mobility measurement, Posterior muscle chain mobility was evaluated with the Finger-Floor Distance Test. A tape measure was used in the testing procedure., Duration of change in 1 day.|FVC Measurement, Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated., Duration of change in 1 day.|FEV1 Measurement, Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated., Duration of change in 1 day.
Acute Effects of Three Different Types Single Leg Exercise in Copd
NCT Number: NCT06466213
Acronym: COPD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise
Interventions: OTHER: single exercise bout about one-leg exercise
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-20
Completion Date: 2025-01-02
Locations: Elif Kocaaga, Ankara, Turkey

Summary:
COPD presents not only respiratory symtoms but also vascular or muscle dysfunction. Exercise training is important for aerobic performance increasing. Generally results show exercise training with both lower limb. Increaed arterial stiffness and muscle oxygenation are observed in COPD. One leg exercise result is not enough to highlight these parameters.

Primary Outcome Measures: six minute walk test, six minute walk test in meter, beginning, day 1
Secondary Outcome Measures: cardiopulmonary exercise test, VO2 max will be recorded as ml/kg/min will be recorded from incremental cycle cpet test, beginning, day 2|single leg extremity test, VO2 max will be recorded as ml/kg/min will be recorded from incremental cycle cpet test, beginning, day 3|lung function, FVC in % , FEV1 in %, FEV1/FVC ratio, PEF in % and FEF 25-75 in %, beginning, day 1|muscle strength (isometric), quadriceps isometric muscle strength will be recorded as kilogram, beginning day 1|muscle strength (10 repeated max), quadriceps 10 repeated max muscle strength will be recorded as kilogram, beginning, day 1|continous exercise acute (single leg), VO2 max will be recorded as ml/kg/min will be performed from incremental cycle exercise at single session, beginning day 4|high intensity interval training acute exercise (single leg), VO2 max will be recorded as ml/kg/min will be performed from incremental cycle exercise at single session, beginning day 5|strength training acute exercise (single leg), VO2 max will be recorded as ml/kg/min will be performed from incremental cycle exercise at single session, beginning day 4,5,6|muscle oxygenation, minumum muscle oxygenation level will be presented as percentage, beginning day 4,5,6|arterial stifness, Aıx@75 in %, beginning day 2,3, 4,5,6
Study of WAL0921 in Patients With Glomerular Kidney Diseases
NCT Number: NCT06466135
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetic Nephropathies|Primary Focal Segmental Glomerulosclerosis|Minimal Change Disease|Primary Immunoglobulin A Nephropathy|Primary Membranous Nephropathy
Interventions: DRUG: WAL0921|DRUG: Placebo
Sponsor: Walden Biosciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2026-03
Locations: Colorado Kidney and Vascular Care, Denver, Colorado, 80012, United States|D & H Tamarac Research Center, Tamarac, Florida, 33321, United States

Summary:
This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.

Primary Outcome Measures: Incidence of treatment emergent adverse events, Baseline to Week 36
Secondary Outcome Measures: Change in albuminuria, Percent change in urine albumin-creatinine ratio (UACR), Baseline up to Week 24|Change in proteinuria, Percent change in urine protein-creatinine ratio (UPCR), Baseline up to Week 24|Change in estimated glomerular filtration rate, Percent change in estimated glomerular filtration rate (eGFR), Baseline up to Week 24|Change in rate of change in eGFR, Slope of eGFR, Baseline up to Week 24
Correlation Analysis of POD and pNCD in Elderly Patients With Gastrointestinal Neoplasms Based on Rs-fMRI
NCT Number: NCT06466096
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Postoperative Delirium|Postoperative Neurocognitive Disorder|Gastrointestinal Surgery
Interventions: OTHER: no intervention
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2026-07-01

Summary:
This is a prospective cohort study to explore the differences of resting-state functional magnetic resonance imaging (fMRI) between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Primary Outcome Measures: the differences of brain functional connectivity (FC) in fMRI between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery, Brain functional connectivity in rs-fMRI can assess the relationship between spontaneous neural activity in different brain regions.In resting-state functional magnetic resonance imaging data, the correlation between the time series of different brain regions is calculated using a formula, and this correlation is represented by the Pearson correlation coefficient. The Pearson correlation coefficient ( r ) is then transformed into Z scores using Fisher's Z transformation. The magnitude of the Z score can be used to quantify the strength of the functional connectivity between different brain regions. Z scores close to 0 indicate weak functional connectivity, while larger absolute Z scores represent stronger functional connectivity., 2024.5.9-2026.7.1
Correlation Analysis of POD and PND in Elderly Spinal Surgery Patients Based on Rs-fMRI
NCT Number: NCT06466083
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Postoperative Delirium|Postoperative Neurocognitive Disorder|Spinal Surgery
Interventions: OTHER: no intervention
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-14
Completion Date: 2026-07-01

Summary:
This study is a prospective cohort study to investigate the differences in resting-state functional magnetic resonance imaging (fMRI) between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Primary Outcome Measures: change in Functional Connectivity between elderly spinal patients with postoperative delirium(POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery, Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity., 2024.5.9-2026.5.1
Metacognitive Therapy for Obsessive-Compulsive Disorder
NCT Number: NCT06466057
Acronym: MCTOCD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obsessive-Compulsive Disorder
Interventions: BEHAVIORAL: Metacognitive Therapy|OTHER: General mental health promotion
Sponsor: Northeast Normal University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-11
Completion Date: 2024-11-01
Locations: Northeast Normal University, Changchun, Jilin, 0431, China

Summary:
The goal of this clinical trial is to learn if metacognitive therapy can be effective in a Chinese sample of obsessive compulsive disorder (OCD) . The main questions it aims to answer are:

Can metacognitive therapy significantly reduce participants' levels of obsessive-compulsive symptoms? Can metacognitive therapy significantly improve participants' metacognitive adaptations?

The researchers will compare metacognitive therapy to a control condition without psychotherapy to see if metacognitive therapy is effective in treating OCD.

Participants will:

Receive the metacognitive therapy intervention or under control conditions for 8 to 15 weeks.

Be assessed for symptoms and metacognitive beliefs at pre-intervention, post-intervention and 12 weeks post-intervention

Primary Outcome Measures: Severity of participants' obsessive-compulsive symptoms, Assessed using the Yale Brown Obsessive-Compulsive Scale (Y-BOCS) , with higher scores indicating more severe symptoms., Pre-intervention to 12 weeks post-intervention
Secondary Outcome Measures: Levels of Participants' Dysfunctional Metacognitive Beliefs, Assessed using the Metacognition Questionnaire (MCQ-30), with higher scores being associated with more dysfunctional metacognition., Pre-intervention to 12 weeks post-intervention
Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort
NCT Number: NCT06466018
Acronym: BIOCOR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ocular Rosacea|Pachychoroid Disease
Interventions: DIAGNOSTIC_TEST: Schirmer test paper
Sponsor: Clinact
Collaborators: Association CRO - Tous unis pour la vision
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-19
Completion Date: 2026-10-01
Locations: Departement of Ophthalmology, COCHIN Hospital, Paris Cedex 14, 75679, France

Summary:
BIOCOR is an interventional clinical trial whose main objectives are Objectif are identify molecular biomarker(s) of ocular rosacea and pachychoroid. Endpoints are : Correlation between pachychoroidosis (defined by choroidal phenotype parameters in OCT and autofluorescence) or the stage of ocular rosacea (ROSCO(29) definition) and biological markers selected on the basis of preclinical work (animal model) and by unbiased methods (proteomics, metabolomics, meibum lipidomics). The study of circulating, ocular and functional biomarkers would enable us to confirm our hypothesis and identify patients who could benefit from treatments that regulate the ANS and/or mineralocorticoid pathways.

Primary Outcome Measures: Clinical phenotype of ocular rosacea, * OSDI score
* QoL score VF24 questionnaire
* Stage and type of Rosacea
* Blepharitis stage
* Oxford score
* Schirmer score
* OSI Index
* Meibomian meibography score
* Quantification of corneal opacity and neovascularization by standardized score
* Limbal insufficiency score
* Clinical evolution under therapeutic effect, Screening visit, visits A1, A2, and end-of-study visit|Pachychoroid clinical phenotype, * Measurement of total choroidal thickness
* Measurement of choroidal vascular caliber
* Measurement of foveolar avascular area
* Calculation of fundus autofluorescence areas
* Calculation of retinal non-perfusion areas
* Cone counting, From inclusion to end of study (Inclusion, year 1, year 2, year 3)
Secondary Outcome Measures: Evolvolution of clinical profile of each phenotype in the cohort, Progression of limbic insufficiency (Deng grades) of ocular rosacea;

* Ocular dryness (Oxford score, OSDI questionnaire);
* Quantification of corneal nerves (density),
* tear film (OSI score, Schirmer score, BUT score, OXFORD score),
* meibomian glands (meibographic score);
* variation in the thickness of the subfoveal choroid, a vascular index of the choroid quantified on analysis of the foveolar section in EDI;
* Quantification of the surface area of epithelial atrophy on blue autofluorescence blue ;, From inclusion to end of study (Inclusion, year 1, year 2, year 3)|Heart rate, * Measurement of static and dynamic heart rate variability (HRV) in patients and control group
* Correlation of HRV with phenotypic stages and biological markers of interest, At inclusion and end of study (Inclusion, year 3)
UnityPhilly Response App for Overdose Reversal
NCT Number: NCT06466005
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Opioid Overdose
Interventions: OTHER: UnityPhilly app
Sponsor: Drexel University
Collaborators: University of Michigan|Bar Ilan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2028-07

Summary:
The goal of this clinical trial is to discover if an overdose prevention app (UnityPhilly) can encourage citizen responders to respond and prevent opioid overdoses using the UnityPhilly app. The main hypotheses to answer are:

Hypothesis 1: UnityPhilly signal rates relative to EMS calls will increase over time. The primary outcome will be assessed as the total number of overdoses signaled by participants relative to all overdose-related EMS calls, per year.

Hypothesis 2: The number of cases where a nearby UnityPhilly participant successfully reverses an overdose with naloxone will increase over time. The primary outcome will be assessed as the number of successful reversals relative to the total number of responder arrivals, per year.

Participants will be supplied with the UnityPhilly app, training on how to use the app and respond to an opioid overdose using naloxone, and respond to follow up surveys about their experiences.

Primary Outcome Measures: Rate of Overdoses Signaled, # events signaled by participants vs. # all overdose-related EMS calls, per year, 2 year period|Rate of Overdoses Reversed, # successful opioid reversals vs. # all arrivals, per year, 2 year period
Liposomal Bupivacaine With Dexamethasone for Foot Surgery
NCT Number: NCT06465992
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Foot Surgery|Ankle Surgery|Post Operative Pain|Popliteal Nerve Block
Interventions: DRUG: Exparel 266 MG Per 20 ML Injection|DRUG: Bupivacaine Hcl 0.75% Inj|DRUG: Dexamethasone
Sponsor: Rothman Institute Orthopaedics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2025-06-30
Locations: Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, 19107, United States

Summary:
This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.

Primary Outcome Measures: Amount of pain medication used after surgery, Collected as tablets taken since all participants will be prescribed oxycodone, 14 days|Pain level after surgery, Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale, 14 days
Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
NCT Number: NCT06465940
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hip Arthropathy
Interventions: DEVICE: Total hip arthroplasty
Sponsor: Societe dEtude, de Recherche et de Fabrication
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-03
Completion Date: 2020-07-07
Locations: Centre Hospitalier de la Côte Basque, Bayonne, 64109, France

Summary:
This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).

Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.

Primary Outcome Measures: Functional score, The information will be collected through questionnaires to compare preoperatively situation to last follow-up situation, per operative period to at least 2 year
Secondary Outcome Measures: Patient satisfaction, The information will be collected from patient through questionnaires to compare preoperatively situation to last follow-up situation, per operative period to at least 2 year|Safety adverse event, Type and occurence of adverse events, per operative period to at least 2 year|Survival rate, Kaplan-Meier survival rates of cups and liners, per operative period to at least 2 year
Clinical Significance of Appendicoliths in Elderly Patients Over 80 Years Old Undergoing Emergency Appendectomy
NCT Number: NCT06465927
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Appendicoliths in Elderly Patients
Interventions: OTHER: Clinical data collection
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-31

Summary:
Acute appendicitis with an appendicolith is one of the most common abdominal emergencies in elderly patients and is more likely to progress to gangrene and perforation. This study aimed to analyze the clinical data of patients over 80 years old who underwent emergency appendectomy for acute appendicitis, to explore the clinical significance of appendicoliths, and to improve treatment strategies.

Primary Outcome Measures: Morbidity of elderly patients undergoing emergency appendectomy, Morbidity of elderly acute appendicitis patients with an appendicolith who underwent emergency appendectomy, January 01, 2024 to December 31, 2024.|Mortality of elderly patients undergoing emergency appendectomy, Mortality of elderly acute appendicitis patients with an appendicolith who underwent emergency appendectomy, January 01, 2024 to December 31, 2024.
A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI
NCT Number: NCT06465901
Acronym: MARLIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Site Infection
Interventions: OTHER: Chlorhexidine Gluconate 2.0% to 4.0% (e.g. Hibiscrub) preoperative shower|OTHER: Intraoperative wound wash (e.g. Granudacyn)|OTHER: DACC surgical wound dressing (e.g. Leukomed Sorbact)
Sponsor: University of Birmingham
Collaborators: Kigali University Teaching Hospital|Université d'Abomey-Calavi
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10092
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2026-09-30
Locations: University of Abomey-Calavi, Abomey-Calavi, Benin|Tamale Teaching Hospital, Tamale, Ghana|Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008, India|Hospital Espanola Veracruz, Veracruz, 91700, Mexico|Lagos University Teaching Hospital (Hub), Lagos, Nigeria|University Teaching Hospital of Kigali (Hub), Kigali, Rwanda|University of the Witwatersrand, Johannesburg, South Africa

Summary:
MARLIN is a stratified, multi-arm, multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection (SSI).

Primary Outcome Measures: Surgical site infection, The primary outcome is surgical site infection (SSI) within 30 days post-surgery, defined according to Centre for Disease Control criteria collected using an adapted, validated Wound Healing questionnaire (TALON)., Within 30 days of surgery
Secondary Outcome Measures: Surgical site infection, SSI at or prior to discharge from hospital, At or prior to discharge from hospital, usually within approximately 7 days of surgery|Mortality, Mortality (and likely cause), Within 30-days post-surgery|Length of hospital stay, Length of hospital stay for index admission, Within 30 days of surgery|Return to normal activities, Return to normal activities (e.g. work, school, or family duties), Within 30 days of surgery|Unplanned wound opening, Unplanned wound opening (i.e. not relating to necessary re-intervention), Within 30 days of surgery|Re-operation for SSI, Re-operation for SSI, Within 30 days of surgery
Influence of Eggs on Cognitive Performance
NCT Number: NCT06465888
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Function
Interventions: OTHER: egg whites|OTHER: whole eggs|OTHER: Omega-3 eggs|OTHER: egg yolk
Sponsor: Texas A&M University
Collaborators: Egg Nutrition Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 106
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2017-08-22
Completion Date: 2020-03-19
Locations: Gilchrist Building, College Station, Texas, 77843, United States

Summary:
This clinical trial aims to evaluate the nutrients in eggs in healthy adult's cognitive performance. The main questions it aims to answer are:

* How do the nutrients in eggs impact visual cognitive performance (VCP) in generally healthy older individuals?
* Will omega-3 fatty acids in eggs improve VCP in generally healthy older individuals?

Participants will be randomly placed in one of five dietary treatment groups, including four egg whites, two whole regular eggs, two whole omega-3 fortified eggs, four egg yolks, and a no-egg control. Blood will be drawn at baseline. During the first two weeks, participants will eat assigned eggs, consume their usual diet other than the eggs, and keep five food logs. Cognitive performance testing will start on day 15 and be measured over a 10-day period using the Neurotracker (NT) 3-D program. Data on ancillary factors influencing outcomes will be collected, and food will be logged on each NT training day. Blood will be drawn at the end of the study and compared with baseline levels.

Primary Outcome Measures: Cognitive performance, Neurotracker 3-Dimensional software used to measure cognitive performance, 15 cognitive sessions within 10 days over 2 week period|Nutrient Intake (Lutein and Zeaxanthin), Serum will be drawn and analyzed for lutein and zeaxanthin content, Through study completion which may take up to 2 years.
Secondary Outcome Measures: Serum Lipid Levels, Serum will be drawn and analyzed for lipoprotein subfractions, Through study completion which may take up to 2 years.
The Effect of Book Reading on Comfort, Hope, Anxiety and Vital Signs of Intensive Care Unit Patients
NCT Number: NCT06465875
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hope|Comfort|Anxiety|Vital Signs
Interventions: OTHER: Reading a book
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2024-12-31

Summary:
This study was planned to investigate the effect of reading aloud books on comfort, hope, anxiety and vital signs in patients hospitalized in intensive care unit. This study was designed as a randomized controlled clinical trial. Data will be collected by using the Descriptive Characteristics Questionnaire, General Comfort Scale, Dispositional Hope Scale, State-Trait Anxiety Inventory, and the Vital Signs Monitoring Form.

Primary Outcome Measures: Comfort level to be evaluated with the General Comfort Scale, It was developed to assess the comfort level of patients. The scale consists of three levels: relief, relaxation and superiority and four dimensions: physical, psychospiritual, sociocultural and environmental., After reading the book of the 3rd day|Level of hope to be assessed with the Dispositional Hope Scale, It was conducted to evaluate individuals' hope levels. It is an eight-point Likert type scale consisting of 12 items. Scores from the scale vary between 8 and 64., After reading the book of the 3rd day|Anxiety level to be assessed with State-Trait Anxiety Inventory, The inventory was developed to determine the state and trait anxiety levels of individuals. The scale consists of 40 items in total. While the first 20 items measure the state anxiety level, the items from 21 to 40 measure the trait anxiety level of the individual. The total score value obtained from both parts varies between 20 and 80., After reading the book of the 3rd day
Secondary Outcome Measures: Blood pressure to be assessed with monitor, The patient's blood pressure will be measured from the brachial artery with a bedside monitor and the result will be recorded in mmHg., After reading the book of the 3rd day|Pulse to be assessed with monitor, Heart rate will be measured with a bedside monitor that can be measured from a finger and recorded as beats/min., After reading the book of the 3rd day|Oxygen saturation to be assessed with Pulse Oximeter, Oxygen saturation from the finger will be measured and recorded with a Pulse Oximeter., After reading the book of the 3rd day|Pain to be assessed with Numeric Rating Scale, The number "0" on the scale means that they do not feel any pain and the number "10" refers to the worst pain., After reading the book of the 3rd day
Development of a Silica Microparticle Taggant System to Measure ART Adherence
NCT Number: NCT06465862
Acronym: TruTag
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hiv|Medication Adherence|Compliance, Medication
Interventions: DEVICE: TruTag System|DRUG: Biktarvy Pill
Sponsor: Brigham and Women's Hospital
Collaborators: Trutag Technologies|Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-15
Completion Date: 2025-04-15

Summary:
Developing technologies to help measure and provide tools to support medication-taking behaviors (medication adherence) is an important step to ending the human immunodeficiency virus (HIV) epidemic. TruTag Technologies has pioneered the use of a microparticle system that can be incorporated into the coating of medications may help users both identify the medication they are taking and record adherence events. By using a standard smartphone camera, shining light on TruTag-coated medications automatically identifies them to an onboard smartphone app which then indirectly records the adherence event. This study evaluates the real-world usability and feasibility of operating this system among people living with HIV (PLWH).

Primary Outcome Measures: Feasibility of TruTag to Measure Antiretroviral (ART) Adherence, Successful operation of the TruTag system will be measured over the 90-day study period. Total ingestions recorded by the TruTag system will be compared against total expected ingestions., 30, 60, 90 days|Acceptability of TruTag, via System Usability Scale, Acceptability will be measured via the System Usability Scale (SUS). The SUS is a 10-item measure of perceived usability of a technological system, scored on a 5-point Likert scale (1: strongly disagree, 5: strongly agree), with higher scores indicating greater perceived usability. A mean score of \>68 will be used to indicate that the technology is acceptable., 90 days|Acceptability of TruTag, via Qualitative Interviews, Acceptability will be evaluated via qualitative interviews exploring participants' lived experiences operating the TruTag system and suggested improvements., 90 days
Secondary Outcome Measures: Correlation of TruTag-Measured Adherence with Dried Blood Spot Concentrations, Preliminary accuracy of the TruTag system will be measured by correlating TruTag-detected ART adherence with tenofovir alafenamide concentrations in dried blood spots (DBS) collected at the 90-day visit., 90 days
Simplified Conservative Measures in Managing Morbidly Adherent Placenta in Beni-Suef University
NCT Number: NCT06465836
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Placenta Accreta
Interventions: PROCEDURE: O, lreay suture|PROCEDURE: modified O, lreay suture
Sponsor: Nesreen Abdel Fattah Abdullah Shehata
Sex: FEMALE
Age: ADULT
Enrollment: 172
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2025-06-30
Locations: Beni-Suef University, Cairo, Egypt

Summary:
To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.

Primary Outcome Measures: Amount of blood loss, The primary outcome for the study is the total volume of blood loss in the intra and postoperative period., 6 hours postoperatively
Secondary Outcome Measures: Maternal morbidity, Coagulopathy, need for massive blood transfusion (\> 4 units), length of hospital stay, and visceral injuries ICU admission and post-operative pain., 24 hours post operatively|Maternal mortality, Maternal death, 24 hours postoperatively
Other Outcome Measures: Gynecological conditions, Gynecological complications as amenorrhea, intrauterine adhesions and niche formation., 6 months
Observational Bronchoscopy Video Data Collection Study With Adult Patients
NCT Number: NCT06465797
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Lung Diseases|Lung Neoplasms|Lung Cancer|Lung Transplantation|Lung Diseases, Obstructive
Interventions: DIAGNOSTIC_TEST: Bronchoscopy
Sponsor: Ambu A/S
Collaborators: Odense University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 115
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-08
Completion Date: 2024-02-09
Locations: Odense University Hospital, Odense, 5000, Denmark

Summary:
The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

Primary Outcome Measures: Number of bronchial segments accessed during bronchoscopy, Accurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities, 1 year
Laser Lithotripsy for Ureteral Stones
NCT Number: NCT06465784
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Ureteric Stone
Interventions: PROCEDURE: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy
Sponsor: Mahmoud Helmy El saeed Hussein
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-01
Completion Date: 2023-12-31
Locations: Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt., Damietta, 34517, Egypt

Summary:
Objectives: To present the outcomes of retrograde and antegrade ureteroscopic laser lithotripsy in the treatment of proximal ureteral stones ranging in size from 10 to 20 millimeters in diameter.

Patients and methods: From March 2023 to December 2023, 70 patients were included in this prospective randomized double-arm interventional study. Patients were divided into two groups: Group 1: (35 patients) had semi-rigid retrograde ureteroscopic laser lithotripsy and group 2: (35 patients) had semi-rigid antegrade ureteroscopic laser lithotripsy.

Primary Outcome Measures: Stone free rate, number of patients reported complete clearance of stones after intervention, Direct after intervention
Feasibility of a Youth-led NCD Risk Reduction Initiative in Selected Schools of Slums in Karachi, Pakistan: a Mixed-methods, pre-and Post-intervention Study
NCT Number: NCT06465771
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus|Cardiovascular Diseases|Cancer|Lung Diseases
Interventions: BEHAVIORAL: Youth-led NCD risk reduction intervention
Sponsor: Aga Khan University
Collaborators: Royal Society of Tropical Medicine and Hygiene (RSTMH) funded by NIHR
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-08-31

Summary:
The study will occur in ten selected schools within Azam Basti and Mehmoodabad, organized into five sequential phases. Phase I involves identifying NCD modifiable risk factors among younger peers (Classes 5 and 6 students) using structured diaries. Phase II includes qualitative interviews with youth (Classes 9 and 10 students), parents, and stakeholders to discuss intervention material and delivery. Phase III comprises a one-day workshop to co-create an intervention. Phase IV involves three-day training for youth to understand and deliver the intervention to their peers. Finally, Phase V assesses the intervention's feasibility using a pre-and post-test design approach.

Primary Outcome Measures: The compliance of delivering the intervention in schools using a fidelity checklist, Once the intervention will be finalized, a fidelity checklist will be developed and used to assess adherence to the intervention delivery. It will be reported as if the intervention is delivered completely, partially, or incomplete based on each component of the intervention, Three months|The recruitment and attrition rates for schools and children, The recruitment and attrition rates will be assessed by reporting the frequencies and percentages of schools and children (youth and younger peer) enrolled and retained in the study., Ten months|The rate for completing the structured diaries for diet, physical activity, and tobacco use at pre-and post-intervention assessments, The frequencies and percentages of children completing the structured diaries for diet, physical activity, and tobacco use at pre-and post-intervention assessments will be reported., Ten months|The change in the frequency and percentages of risk factors, including unhealthy diet, physical inactivity, and tobacco use at post-intervention compared to the baseline using a structured diary, The change in the frequency and percentages of risk factors, including unhealthy diet, physical inactivity, and tobacco use at post-intervention compared to the baseline will be reported. The information will be collected through structured diaries at baseline and after the intervention is delivered. The students will complete the diary for four days before and after the intervention., Ten months
AltaValve Pivotal Trial
NCT Number: NCT06465745
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mitral Regurgitation|Mitral Insufficiency|Mitral Valve Incompetence|Mitral Valve Regurgitation|Mitral Incompetence
Interventions: DEVICE: AltaValve System.
Sponsor: 4C Medical Technologies, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2031-09

Summary:
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.

Primary Outcome Measures: Composite of all-cause mortality or heart failure hospitalization., 12 months.
Secondary Outcome Measures: All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention., Composite., 30 Days or hospital discharge (whichever is longer).|Technical success., Technical success will be considered achieve when all of the following are present:

* Successful application of the delivery system as intended.
* Successful device placement.
* Reduction in mitral regurgitation grade to ≤ 2+., Day 0.|Mitral valve re-intervention., Mitral valve re-intervention after index procedure, At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.|Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ)., Quality of life improvement., 6 months and 1 year.|Changes in Six-minute walk test (6MWT)., Quality of life improvement., 6 months and 1 year.|New pacemaker rate., 1 month, 6 months and 1 year.
Tract-based Artificial Intelligence (AI) Robot Guiding System in Basal Ganglion Hemorrhage Evacuation
NCT Number: NCT06465719
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Basal Ganglia Hemorrhage
Interventions: PROCEDURE: Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System|DRUG: "Hemocoagulase Bothrops Atrox for Injection"；"Nicardipine"
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Huashan Hospital|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|China-Japan Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 380
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-12-31
Locations: the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China

Summary:
A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with small-volume basal ganglion hemorrhage.

Primary Outcome Measures: Prognosis improvement rate (proportion of mRS≤3 patients), Prognosis improvement rate at 6 months of follow-up (proportion of mRS≤3 patients), 6 months of follow-up
Secondary Outcome Measures: Mortality, Mortality at 6 months of follow-up, 6 months of follow-up|Activity of daily living (ADL) score prognostic improvement rate (Proportion of patients with ADL≤3), Activity of daily living (ADL) score prognostic improvement rate (Proportion of patients with ADL≤3) at 6 months of follow-up, 6 months of follow-up|Hematoma clearance rate, Hematoma clearance rate at 1 day and 1 month after treatment, 1 day and 1 month after treatment|Duration of hospitalization, Duration of hospitalization, 6 month after treatment|Total medical expenses during hospitalization, Total medical expenses during hospitalization, 6 month after treatment
Assessing the Safety and Efficacy of the LAmbre™ Plus Device
NCT Number: NCT06465706
Acronym: REDUCE-AF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation
Interventions: DEVICE: LAmbre investigational device
Sponsor: Kansas City Heart Rhythm Research Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1826
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2030-01-31

Summary:
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.

Primary Outcome Measures: Major procedure related complications - cardiac perforation, Cardiac perforation can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE., up to 7 days following implant procedure|Major procedure related complications - pericardial effusion with tamponade or requiring drainage, Common complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE., up to 7 days following implant procedure|Major procedure related complications - device embolization, Procedure complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE., up to 7 days following implant procedure|Major adverse event - Death, Death is observed by lack of oxygen, lack of pulse, succession of neurological activity., up to 7 days following implant procedure|Major adverse event - all strokes, Stroke is identified by neurologic imaging and transient or permanent motor or sensory deficient., up to 7 days following implant procedure|Major adverse event - systemic embolization, Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging., up to 7 days following implant procedure|Major adverse event - major bleeding, Visual bleeding or a drop in hemoglobin of 2 units and requiring transfusion., up to 7 days following implant procedure
Secondary Outcome Measures: Major adverse event, composite of cardiovascular death, overs CNS injury and major bleeding, 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years|mortality, cardiovascular or non-cardiovascular and reported cumulatively and individually, 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years|myocardial infarction, Defined as ST or nonST ECG changes with positive cardiac bio markers., 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years|periprocedural stroke, Motor and sensory deficits observed and imaging confirmed., 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years|bleeding complications, Visual bleeding or a drop in hemoglobin, 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years|major procedure-related complications, vascular or cardiac complications occurring due to the procedure., 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years|vascular complications, vascular complications are hematomas, aneurysms, and ischemic limb., 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
NCT Number: NCT06465693
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: DEVICE: Unblinded CGM plus nutrition therapy|BEHAVIORAL: Nutrition therapy only
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-01
Completion Date: 2026-07-01
Locations: University of Minnesota, Minneapolis, Minnesota, 55455, United States

Summary:
Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.

Primary Outcome Measures: HgbA1c, week 12
Secondary Outcome Measures: Glucose variability/coefficient of variation, using CGM data, week 12|mean glucose, using CGM data, week 12|time in range (glucose 70-180 mg/dl), using CGM data, week 12|time above range (glucose 70-180 mg/dl), using CGM data, week 12|Weight, week 12|Fasting plasma glucose, week 12|Fasting serum insulin, week 12|Serum lipid panel, week 12|Intervention Acceptability Questionnaire, week 12|Diabetes Treatment Satisfaction Questionnaire (DTSQ), week 12|Diet Satisfaction Questionnaire (DSat-28), week 12|Diabetes Management Self-Efficacy Scale (DMSES), week 12|Medication Effect Score, week 12