pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Photobiomodulation Before or After In-office Tooth Whitening for Sensitivity Reduction: a Blinded, Randomized, Controlled Study
NCT Number: NCT06518629
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Sensitivity|Tooth Bleaching|Laser Therapy
Interventions: OTHER: Photobiomodulation with low power laser
Sponsor: Universidade Federal do Para
Sex: ALL
Age: ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-12

Summary:
The objective is to evaluate the effect of photobiomodulation (PBM) applied before or after in-office tooth whitening in reducing tooth sensitivity (TS) and color change. Sixty-six patients aged between 18 and 28 years old, of both sexes, with good oral and general health will be selected for the study. A randomization process will be carried out to allocate participants into the three different groups: FBM-Before, FBM-After and Placebo. All groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whitness HP, FGM, Joinville, SC, Brazil). Three whitening sessions will be carried out, considering a seven-day interval between sessions. TS will be measured using a visual analogue scale (VAS) and a five-point numerical rating scale (NRS), while shade change will be assessed using a spectrophotometer: before the bleaching treatment (T0), after the first (T1), second (T2). ) and third (T3) weeks of treatment and 30 days (T4) after the end of the bleaching treatment.

Primary Outcome Measures: Tooth sensitivity, To assess pain sensitivity, patients will be instructed to fill out a form to record tooth sensitivity, based on individual pain perception. This form will be delivered at each whitening session, and will be returned to the researcher at the next appointment, that is, always one week after each whitening session., 21 days
Secondary Outcome Measures: Color change, To measure shade, the VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used, where the area of tooth correspondence to be evaluated will be the middle third of the buccal surface of the upper right canine. To standardize color readings, silicone guides will be made (Cub Kit Profle, Vigodent)., 51 days
Meditation to Reduce Firefighter Distress
NCT Number: NCT06518616
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Psychological Distress
Interventions: BEHAVIORAL: 10-day meditation intervention|BEHAVIORAL: 10-day health education intervention
Sponsor: University of Arizona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2025-08-31

Summary:
The more than one million firefighters in the United States provide critical emergency medical services in communities they serve and are on the front lines of healthcare delivery, including in the post-pandemic world. As a result of exposure to occupational stressors, a high proportion of firefighters experience considerable stress-related burden including psychological distress (i.e., increased features of anxiety and depression). To address this need, this project will test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) among career firefighters to decrease psychological distress (i.e., anxiety and depression).

Primary Outcome Measures: anxiety features, PROMIS (Patient Reported Outcomes Measurement Information System) Short Form Emotional Distress - Anxiety - 8a, before, immediately after, 30 days after, and 3 months after the 10-day interventions
Secondary Outcome Measures: depression features, PROMIS Short Form Emotional Distress - Depression - 8a, before, immediately after, 30 days after, and 3 months after the 10-day interventions
Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia
NCT Number: NCT06518603
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Premature Infant Disease|Apnea of Prematurity|Development, Infant
Interventions: DRUG: Caffeine citrate 20mg/kg/day|DRUG: Placebo-Sterile water 1ml/kg/day
Sponsor: University of Alabama at Birmingham
Collaborators: University Teaching Hospital, Lusaka, Zambia|Centre for Infectious Disease Research in Zambia
Sex: ALL
Age: CHILD
Enrollment: 340
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2026-09-30
Locations: University Teaching Hospital, Lusaka, Lusaka Province, 10100, Zambia

Summary:
The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.

Our research questions are:

1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?
2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?

Researchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.

Parents of participants will:

1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge
2. Keep a diary of symptoms and any apneic events
3. Check in with researchers via telephone call once a week
4. Return to clinic for infant physical examination at 28 days
5. Return to the clinic for infant physical examination at 2 months

5. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age

Primary Outcome Measures: Number of apneic events, Documentation or report of apnea of prematurity \[AoP\], a condition exhibited by cessation of breathing for ≥20 or \<20 seconds accompanied by bradycardia and/or cyanosis, 28 days after discharge|Number of visits to healthcare professionals related to apneic events, Documentation or report of sick visit, 28 days after discharge
Secondary Outcome Measures: Number of all-cause sick visits, Documentation or report of sick visit, 2 months after discharge|Percentage of neonatal mortality within 2 months after discharge, Documentation of neonatal death, 2 months after discharge|Infant/Child Developmental Assessment, Score on "Ages and Stages Questionnaire" obtained at clinic visit, 12 months
Effect of Single-versus Double-limb Cycling Exercise on Blood Flow in Patients With Peripheral Artery Disease
NCT Number: NCT06518590
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Peripheral Arterial Disease
Interventions: DEVICE: Cycle
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-12

Summary:
This study will be conducted to investigate the effect of single limb cycling exercise and the effect of double limb cycling exercise on blood flow in patients with peripheral artery disease and compare between both effects.

Primary Outcome Measures: Blood flow velocity by Doppler, Blood flow (velocity) and circulation: which will be measured by the doppler ultrasonogrophy at the begining and at the end of the study.

- Doppler ultrasonogrophy of the lower extremity arteries, from common femoral to pedal arteries peak systolic velocity (PSV) recorded in meters per second (Ugwu.,et al .,2021 ) .The normal peak systolic velocity (PSV ) in peripheral lower limb arteries varies from 45-180 cm/s .

Severe arterial disease manifests as a PSV in excess of 200 cm/s , monophasic waveform and spectral broading of the doppler wave form ., baseline
Secondary Outcome Measures: Functional capacity test (6 Min walk test ), Functional capacity which will be : measured by a Six min walk test before and after the program of exercising according to the American Thoracic Society 113, TECHNICAL ASPECTS OF THE 6MWT (at the beginning and at the end of the study)., baseline|The ankle -brachial index test, which will be measured by Duplex at the beginning and at the end of the program of exercising, baseline|Walking impairment questionnaire, Walking impairment questionnaire: An effective tool to assess the effect of treatment in patients with intermittent claudication.

WIQ is a valid tool to detect improvement or deterioration in the daily walking ability of patients with intermittent claudication., baseline
Evaluate Efficacy of Devimistat in Combination With mFFX in 2nd Line Patients With Metastatic Pancreatic Cancer
NCT Number: NCT06518538
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Cancer Stage IV
Interventions: DRUG: CPI-613, modified Folfirinox
Sponsor: Cornerstone Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-11
Locations: Hirschfeld Oncology, Brooklyn, New York, 11206, United States

Summary:
Open label, randomized phase II study to evaluate efficacy and safety of CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

Primary Outcome Measures: Overall Response Rate (ORR) [Time Frame: At least 2 months (minimum of 4 cycles)] Defined as the rate of Complete Response (CR) plus Partial Response (PR), 12 months
Secondary Outcome Measures: Overall Survival (OS) Defined as the duration from the date of randomization to the date of death from any cause, 24 months|Progression Free Survival (PFS) Defined as the duration from the date of randomization to the date of progressive defined as the duration from the date of randomization to the date of progressive disease or death from any cause., 12 months
Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet AMD Patients
NCT Number: NCT06518512
Acronym: AVIGA2
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Age-Related Macular Degeneration|Wet Age-related Macular Degeneration
Interventions: DEVICE: Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) system
Sponsor: Tan Tock Seng Hospital
Collaborators: Occutrack Medical Solutions Pte Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-18
Completion Date: 2024-12
Locations: Tan Tock Seng Hospital, Singapore, 308433, Singapore

Summary:
The study aims to evaluate the Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) system in the ability to detect and assess central vision dysfunction in a personalized, adaptive, objective, and automated way through eye gaze tracking in age-related macular degeneration (AMD). We also aim to develop a novel algorithm / scoring methodology for disease activity monitoring over time (delta-change). AVIGA visual risk prediction cut-off scores will be presented together with probabilities of occurrence of prespecified adverse clinical outcome.

Primary Outcome Measures: Main Aim, Identify and develop a correlation scoring between the three clinical measures of central visual function. Specifically, to determine the correlation of the eye gaze as tracked by AVIGA to standard clinical tools for evaluating central visual function, including the optical coherence tomography (OCT), visual acuity and fundoscopy imaging. Through this, we aim to determine if AVIGA is suitable for identification of AMD disease activity in patients with macula degeneration., 1 year
Secondary Outcome Measures: Aim, We also aim to develop a novel algorithm / scoring methodology for disease activity monitoring over time (delta-change)., 1 year
Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
NCT Number: NCT06518499
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pilonidal Sinus
Interventions: PROCEDURE: Pilonidal sinus surgery
Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 145
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-08-20
Locations: Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital, İstanbul, Other, Turkey

Summary:
Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. This study will compare the Karydakis procedure, a flap method, and the Bascom's pit-pick procedure, a minimally invasive procedure, in terms of recurrence, complications and aesthetics, especially in female patients with three or fewer pits.

Primary Outcome Measures: Recurrence Rate, This measure evaluates the rate of pilonidal sinus disease recurrence in female patients undergoing Karydakis flap or Bascom's pit-pick surgical procedures over a 12-month period. Recurrence is defined as the reappearance of disease symptoms after the wound has completely healed., 12 months post-surgery
Secondary Outcome Measures: Complication Rate, This measure records the incidence of postoperative complications such as infections (superficial or deep), seromas, hematomas, wound dehiscence (partial or complete), and anesthesia-related complications within the first 30 days post-surgery., 30 days post-surgery|Aesthetic Outcome (Visual Analog Score for pain), Assessment of aesthetic outcomes using the Visual Analog Scale (VAS) for pain. The VAS is a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes., Up to 1 year post-surgery|Healing Time, This measure records the time required for complete wound healing post-surgery, defined as the integrity along the incision line without any complications., Up to 12 weeks post-surgery|Functional Recovery, This measure assesses the time taken for patients to resume daily activities comfortably., Up to 24 weeks post-surgery
Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients
NCT Number: NCT06518473
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: DIAGNOSTIC_TEST: Skin prick test
Sponsor: Mansoura University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-14
Completion Date: 2025-01-15
Locations: Mohamed AbdElmoniem, Mansoura, 35516, Egypt

Summary:
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.

The presence of non-fully reversible airflow obstruction (FEV1/FVC \< 0.7 post-bronchodilation) measured by spirometry confirms the diagnosis of COPD

Primary Outcome Measures: Atopy in chronic obstructive pulmonary disease patients, Total IgE (mg/dl) and ) will be assessed in chronic obstructive pulmonary disease patients, 6 months|Chronic obstructive pulmonary disease patients, Blood eosinophil count (%) will be assessed in chronic obstructive pulmonary disease patients, 2 months
Functional Efficiency of Self-sufficiency Test
NCT Number: NCT06518460
Acronym: FEST
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke/Brain Attack
Interventions: DIAGNOSTIC_TEST: Functional Efficiency of Self-sufficiency Test
Sponsor: Palacky University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-08-01
Locations: Palacky University, Olomouc, Czech, 77515, Czechia

Summary:
The aim of this study is to design and validate new tool for evaluation of self-sufficiency in post-acute stroke patients. And further identify the factors influencing changes in the Functional Efficiency of Self-sufficiency Test (FEST) in post-acute rehabilitation care.

Primary Outcome Measures: Psychometric characteristics validation, The following tests will be performed on the FEST test: internal consistency, correlation between variables, convergent validity, and factor analysis. The psychometric properties of the FEST will be compared with those of the Barthel Index and the Action Research Arm Test., 1.8.2024-31.8.2025
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
NCT Number: NCT06518434
Acronym: CanHep
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma|Cannabis
Interventions: DRUG: Medical Cannabis
Sponsor: University Medical Center Groningen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-04-15
Completion Date: 2027-04-15
Locations: University Medical Center Groningen, Groningen, 9713 GZ, Netherlands

Summary:
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria

Primary Outcome Measures: Tumor size, Tumor size based on RECIST and mRECIST criteria, 9 months
Secondary Outcome Measures: Tumor size, Tumor size based on RECIST and mRECIST criteria, 3 months|Tumor size, Tumor size based on RECIST and mRECIST criteria, 6 months|Tumor markers, Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT), 3 months|Tumor markers, Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT), 6 months|Tumor markers, Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT), 9 months|Quality of Life questionnaires, EORTC-QLQ30 and -HCC18, 3 months|Quality of Life questionnaires, EORTC-QLQ30 and -HCC18, 6 months|Quality of Life questionnaires, EORTC-QLQ30 and -HCC18, 9 months
The Degree of Knowledge and Attitude of Egyptian Nurses Regarding Emergency Management of Traumatic Dental Injuries.
NCT Number: NCT06518395
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Traumatic Dental Injuries
Interventions: OTHER: Questionnaire for The degree of knowledge and attitude.
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 371
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-10
Locations: Cairo University, Cairo, Manial, Egypt

Summary:
This study intends to evaluate medical and dental nurses' fundamental knowledge and attitude regarding the management of Traumatic Dental Injuries in Egypt.

Primary Outcome Measures: the degree of knowledge and attitude of Egyptian medical and dental Nurses about Emergency Management of Traumatic Dental Injuries., the degree of knowledge and attitude of Egyptian medical and dental Nurses about Emergency Management of Traumatic Dental Injuries using Questionnaire as Measurement Method including Binary question (yes/no) and Multiple choice question.

., 3 months
Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients
NCT Number: NCT06518382
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HER2-positive Breast Cancer
Sponsor: Giampaolo Bianchini
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-08
Locations: IRCCS San Raffaele Hospital, Milano, Lombardy, 20132, Italy

Summary:
This retrospective observational study aims at the comparison of the tumour-microenvironment tissue architecture before and after neo-adjuvant therapy in samples from HER2-positive (HER2+) breast cancer (BrCa) patients that display residual invasive disease in the breast/lymph node at surgery after standard-of-care combined chemotherapy and trastuzumab treatment.

The working hypothesis of the investigators is that:

Therapy imposes a selective pressure on tumour-microenvironment features promoting resistance to treatment.

Participant that have already undergone neo-adjuvant treatment as part of their regular medical care for HER2-positive breast cancer will provide access to formalin-fixed paraffin-embedded (FFPE) samples taken before and after therapy.

Tumoral, peri-tumoral and stromal regions of each specimen will be analyzed with the ultimate goal to identify new biomarkers (and putative targets) of resistance to therapy.

Primary Outcome Measures: number of different cells per each phenotype, Cell types will be classified based on the expression of specific lineage/phenotype markers., before and within 3 months from neo-adjuvant therapy (at surgery)|density of each phenotype, Cell phenotype densities will be calculated by dividing the number of total cells counted by the total area of the tissue acquired., before and within 3 months from neo-adjuvant therapy (at surgery)|fraction of proliferative/active cells of each phenotype, The proportion of cells positive for the proliferation marker Ki67 will be assessed per cell phenotype. To assess the proportion of active immune cells, we will quantify the expression level of activation markers., before and within 3 months from neo-adjuvant therapy (at surgery)|frequency of interactions, Cells will be defined as partaking in an interaction if their whole-cell profiles are in direct contact (contiguous pixels). Cell phenotypes will be mapped to cell-cell interaction masks, and for each specimen proximity events (cell-cell interactions) will be classified as homotypic or heterotypic proximity events, before and within 3 months from neo-adjuvant therapy (at surgery)|frequency of functional crosstalk events, Cells will be defined as participating in a functional crosstalk event if the proximal (contiguous pixels) cells express functional pairs (receptor/ligand) of markers (e.g. PD1/PDL1).

The frequency of functional crosstalk events will be computed as the number of interactions between cells expressing functional pairs divided by the total number of cells expressing one of the markers (receptor, e.g. PD1) in the specimen., before and within 3 months from neo-adjuvant therapy (at surgery)
Preoperative Prehabilitation Program For Geriatric Patients in a Rural Healthcare Setting
NCT Number: NCT06518369
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgery
Interventions: OTHER: Prehabilitation
Sponsor: The Guthrie Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-18
Completion Date: 2025-06
Locations: Robert Packer Hospital, Sayre, Pennsylvania, 18840, United States

Summary:
The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.

Primary Outcome Measures: Postoperative hospital length of stay, Number of days in hospital from date of surgery to date of discharge, From date of hospitalization until date of hospital discharge, up to 30 days|Discharge disposition, Binary measure of either home or rehabilitation facility, From date of hospitalization until date of hospital discharge, up to 30 days
Secondary Outcome Measures: Adverse outcomes after surgery, Assess adverse outcomes postoperatively, 30 days after surgery|Hospital readmission rates, Number of times patients are readmitted to the hospital within 30 day of surgery, 30 days after surgery
Mastoid taVNS-fMRI
NCT Number: NCT06518356
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Auricular Stimulation
Interventions: DEVICE: Transcutaneous Auricular Neurostimulation (tAN)
Sponsor: Medical University of South Carolina
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-07-02
Locations: Medical University of South Carolina Institute of Psychiatry, Charleston, South Carolina, 29425, United States

Summary:
The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. Investigators will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.

Primary Outcome Measures: Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation, taVNS will be administered to participants within the bore of the MRI scanner while the investigators acquire high-resolution functional neuroimaging. Both a general linear model and SNM approach will be used to examine BOLD signal changes during stimulation relative to rest blocks, comparing each of the 3 stimulation targets within- and between- subjects to identify any differences in brain activity during stimulation of the mastoid site compared to the cymba site and sham site., 30 minutes
Psychosis Associated With Methylphenidate in Children and Adolescents
NCT Number: NCT06518330
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Psychosis
Interventions: DRUG: Intake of Methylphenidate
Sponsor: University Hospital, Caen
Sex: ALL
Age: CHILD
Enrollment: 46233
Study Design: Observational Model: |Time Perspective: p
Start Date: 1967-01-01
Completion Date: 2024-02-16
Locations: Caen University Hospital, Department of Pharmacology, Caen, France

Summary:
perform a study in VigiBase® to assess if methylphenidate was associated with an over-reporting of psychosis including hallucinations in children and adolescents and to characterize those psychosis.

Primary Outcome Measures: Correlation between methylphenidate and psychosis in children and adolescents using a disproportionality analysis in Individual Case Reports involving at least one liable drug with an indication in ADHD., from the 01/01/1967 to the 16/02/2024
Short Versus Long Antiplatelet Therapy After TAVI
NCT Number: NCT06518317
Acronym: SOLOTAVI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Transcatheter Aortic Valve Replacement
Interventions: DRUG: Aspirin
Sponsor: University Hospital, Caen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-09

Summary:
The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime treatment by aspirin (standard treatment regimen).

The main questions it aims to answer are:

Does the reduction of the duration of aspirin reduces rates of bleeding without increasing the risk of cardiovascular events.

Researchers will compare a short treatment by aspirin (3 months) to a long treatment by aspirin (12 months) after percutaneous replacement of the aortic valve.

Participants will:

Take aspirin for 3 months in one group or 12 months in another group Be contacted by phone or visit the clinic at 3, 4, 6, 8, 10 and 12 months after hospital discharge Keep a diary of any bleeding or cardiovascular events occurring during the study period

Primary Outcome Measures: Net clinical benefit, The composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system injury and non-procedure-related major or disabling bleeding VARC 3 types 2 or 3, 12 months after randomisation
Secondary Outcome Measures: Non-procedure-related bleeding, VARC 3 classification 1 to 4 bleeding, 12 months|Major or disabling or life threatening bleeding, VARC 3 classification 2 or 3 bleeding, 12 months|Major cardiovascular events, The composite of all cause death, type 1 myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury, 12 months
Other Outcome Measures: Minor bleeding, Type 1 VARC 3 classification bleeding, 12 months|Major bleeding, Type 2 VARC 3 classification bleeding, 12 months|Disabling or life threatening bleeding, Type 3 VARC 3 classification bleeding, 12 months|Fatal bleeding, Type 4 VARC 3 classification bleeding, 12 months|Death, Death of any cause, 12 months|Cardiovascular death, Death of cardiovascular cause, 12 months|Myocardial infarction, Type 1 myocardial infarction based on the universal definition, 12 months|Ischemic Stroke, NeuroARC types 1a, or 1d ischemic CNS injury, 12 months|Intracranial bleeding, NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury, 12 months|Transient cerebral ischemic attack, NeuroARC type 3a, 12 months|Hospitalization, Hospitalization for any cause, 12 months|Cardiovascular hospitalization, Hospitalization for cardiovascular causes as defined by VARC 3, 12 months|clinically significant prosthetic valve thrombosis, VARC 3 classification -defined, 12 months|Death at 2 years, Death assessed using the national mortality database, 24 months
Effectiveness of GentleWave System in Endodontic Treatment
NCT Number: NCT06518304
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Postoperative|Root Canal Infection|Endodontically Treated Teeth
Interventions: OTHER: GentleWave|OTHER: Conventional Protocol
Sponsor: University of Salamanca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-09-20
Locations: City Endodontics, Manhattan, New York, 10016, United States

Summary:
This study aims to evaluate the efficacy of the GentleWave® System compared to conventional methods in reducing postoperative pain in patients with necrotic pulp or requiring endodontic retreatment.

Primary Outcome Measures: To evaluate whether using the Gentlewave system demonstrates a significant reduction in the level of postoperative pain after endodontic treatment measured by the VAS (Visual Analog Scale)., Pain measurements were made using a VAS (Visual Analog Scale of 0-10. Where the value of 0 represented absence of pain and value 10 represented the greatest intensity of pain., 24 hours
COMPARISON OF NITROFURANTOIN WITH FOSFOMYCIN in TREATING CYSTITIS IN WOMEN
NCT Number: NCT06518291
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Urinary Tract Infections
Interventions: DRUG: Nitrofurantoin 100 MG|DRUG: Fosfomycin
Sponsor: Shalamar Institute of Health Sciences
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 392
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2025-06

Summary:
Fosfomycin and nitrofurantoin are increasingly being prescribed in outpatients for the oral treatment of urinary tract infection (UTI). The newest guidelines for empirical treatment of women with uncomplicated urinary tract infections (UTIs) advise clinicians to choose among three venerable antibiotics: trimethoprim-sulfamethoxazole, nitrofurantoin, and fosfomycin. Although both nitrofurantoin and fosfomycin have shown efficacy against most urinary pathogens, no recent head-to-head comparisons have been reported. So, this study will be conducted to compare effectiveness of both drugs.

Primary Outcome Measures: clinical response following completion of therapy by history, 7 days
Secondary Outcome Measures: bacteriologic response after therapy completion by urine culture test result, 14 days
Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails: What Results for Which Patients?
NCT Number: NCT06518265
Acronym: OFCCF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ankle Fractures:Osteosynthesis of High-Risk Ankle Fractures Using Locked Fibula Nails
Sponsor: University Hospital, Grenoble
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-07
Locations: Grenoble Alpes university Hospital,La tronche, La Tronche, 38700, France

Summary:
Ankle fractures are among the most common injuries in orthopedic and trauma surgery, accounting for 9% of all fractures. They can be classified into isolated malleolar fractures (internal and/or external), pilon fractures, and distal tibia fractures, which affect the entire distal part of the tibia, depending on whether they are intra-articular or extra-articular.

The aging of the population and the increase in survival of multiple trauma patients lead to an increase in ankle fractures with high skin risk, whether due to an open fracture, soft tissue injury (crush, dermabrasion, etc.). ) or a major risk of scarring (chronic venous insufficiency, lymphedema, unbalanced diabetes.

The fibula nail is a recent, minimally invasive osteosynthesis method whose results seem at least equivalent to those of screwed plate osteosynthesis in numerous series in the literature. The most commonly used and most studied fibula nail in the literature is the Acumed fibula nail. In recent literature, the use of the fibula nail in the fixation of tibial pilon fractures and/or fractures of the distal quarter of the leg is associated with satisfactory results.

The elements collected as part of this study could make it possible to validate the use of the fibula nail in the management strategy for these fractures and thus better codify and standardize practices in this restricted and complex area of traumatology.

Primary Outcome Measures: Evaluate the clinical and radiological results of patients treated for fixation of an unstable ankle fracture with high cutaneous risk including a fibula nail without access to the fibular fracture site., obtaining bone consolidation (healing) without cutaneous complications., 1 year
Secondary Outcome Measures: Evaluation of the quality of the radiological reduction., Radiological criteria of McLenann, 1 year|Evaluation of clinical results, Clinical scores of EFAS, 1 year|Evaluation of clinical results, Clinical scores of Olerud and Molander, 1 year|Evaluation of clinical results, Clinical scores of Kitaoka hindfoot, 1 year|Assessment of complications, Complications: re-intervention(s), 1 year|Assessment of complications, Complications: infection, 1 year|Assessment of complications, Complications: healing disorders, 1 year|Assessment of complications, Complications: secondary displacement, 1 year|Assessment of complications, Complications: discomfort of osteosynthesis equipment, 1 year
Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position
NCT Number: NCT06518239
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: DEVICE: Peep Belt
Sponsor: Tinashe Maduke
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2024-08

Summary:
The purpose of this study is to determine whether the Enlight 2100 electrical impedance tomography (EIT) belt can optimize positive end-expiratory pressure (PEEP) during surgery better than standard anesthesia machines.

Primary Outcome Measures: Optimal PEEP, Optimal positive end-expiratory pressure (PEEP) measured using the electrical impedance tomography (EIT) belt during surgery., From the time of consent to the end of surgery, assessed up to 24 hours.
Secondary Outcome Measures: Difference between EIT and standard of care measured PEEP, Measured difference between optimal positive end-expiratory pressure from the study device and the standard of care anesthesia machines., From the time of consent to the end of surgery, assessed up to 24 hours.|Delays in extubation, Number of delays in extubating the patient due to breathing complications during surgery., From the day of surgery to discharge, up to 1 week|Incidence of extubation complications, Number of reintubations needed and/or failed extubations after surgery., From the day of surgery to discharge, up to 1 week
Efficacy and Safety of First-line ART With BIC/FTC/TAF Introduced at the First Clinical Visit
NCT Number: NCT06518213
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: HIV Infections
Sponsor: University Hospital for Infectious Diseases, Croatia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 112
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-05-01
Completion Date: 2024-03-31
Locations: University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic'', Zagreb, City Of Zagreb, 10000, Croatia

Summary:
Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral regimen. Croatia has a centralized care for people living with HIV (PLWH) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. This retrospective cohort study evaluated antiretroviral therapy (ART) naïve PLWH who initiated BIC/FTC/TAF, in a same-day model. The goal of the study is to assess safety and efficacy of this model by collecting information from the electronic database of the Croatian HIV Reference Centre.

Primary Outcome Measures: Virological suppression (HIV-1 RNA below 50 copies/mL plasma), Virological suppression (HIV-1 RNA below 50 copies/mL plasma) after 12±3 months of antiretroviral treatment with first-line ART (BIC/FTC/TAF) initiated at first clinical contact, 12±3 months of ART (BIC/FTC/TAF)
Secondary Outcome Measures: HIV-1 RNA 50-200 copies/mL, HIV-1 RNA 50-200 copies/mL of plasma after 6 and 12 months of treatment, 6 and 12 months of treatment|HIV-1 RNA above 200 copies/mL, HIV-1 RNA above 200 copies/mL of plasma after 6 and 12 months of treatment, 6 and 12 months of treatment|Virological failure, Virological failure (HIV-1 RNA above 50 copies/mL) after 6 and 12 months of treatment with BIC/FTC/TAF, 6 and 12 months of treatment|Number of CD4+ T-lymphocytes, Change in the number of CD4+ T-lymphocytes per microL of blood compared to the initial value after 6 and 12 months of treatment, 6 and 12 months of treatment|Change in CD4+/CD8+ T-lymphocytes ratio, Change in ratio of CD4+ and CD8+ T-lymphocytes measured after 6 and 12 months of treatment, 6 and 12 months of treatment|Side effect to the drug BIC/FTC/TAF, Side effect to the administered medication which required discontinuation of treatment, through study completion, an average of 1 year|Change in weight, Change in patient's weight in kilograms measured after 6 and 12 months of treatment, 6 and 12 months of treatment|Change in eGFR, Change in estimated glomerular filtration rate (mL/min/1.73 m2) measured after 6 and 12 months of treatment, 6 and 12 months of treatment|Change in liver enzymes, Change in liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) concentration (U/L) measured after 6 and 12 months of treatment, 6 and 12 months of treatment|Lipids concentration, Change in lipids (total cholesterol, LDL, HDL and triglycerides) concentration (mmol/L) measured after 6 and 12 months of treatment, 6 and 12 months of treatment
Investigating the Influence of Catheter Advancement Techniques on Needle Tip Movement During Intravenous Insertion
NCT Number: NCT06518187
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Health Care Utilization
Interventions: OTHER: Assessing the impact of three different catheter advancement techniques on needle tip movement during intravenous insertion
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-07-31

Summary:
This proposed study aims to fill this gap by investigating whether needle tip movement during catheter advancement is affected by whether the individual performing the insertion pushes the catheter off the needle themselves or if it is done by another person.

Primary Outcome Measures: Needle tip movement (displacement) in mm during initial advancement of a 16ga IV catheter off of its needle during simulated intravenous catheter insertion with three different catheter advancement techniques.., If there is a significant difference in needle tip movement during catheter advancement related to technique of advancement (one handed, two handed, two person) a preferred technique(s) can be identified, 15 minutes
A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury
NCT Number: NCT06518174
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Injury
Interventions: DIAGNOSTIC_TEST: MRI, SWE, and US evaluation
Sponsor: University of Colorado, Denver
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 22
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-01
Completion Date: 2025-03
Locations: University of Colorado, Aurora, Colorado, 80045, United States|University of Colorado, Aurora, Colorado, 80045, United States

Summary:
The goal of this pilot study is to assess the ability of a new imaging modality, shear-wave-elastography (SWE) and magnetic resonance imaging (MRI) to identify radiation-induced uterine injury (RIUI). The investigator will recruit female patients treated for colorectal or anal cancer at 15 to 39 years with ≥ 50 Gy pelvic radiation (PRT) at least 12 months prior to study initiation.

Primary Outcome Measures: SWE feasibility, SWE will be considered feasible if at least 85% (e.g., ≥15/17) of all patients achieve the diagnosability criteria, defined as having at least 1 of 6 locations with IQR/M ≤ 30%. The IQR/M and the number of patients who achieved diagnosability will be descriptively characterized., Up to six months|Compare the degree of fibrosis according to SWE and MRI parameters across treatment groups, Since fibrosis thresholds have not been thoroughly established for SWE tissue stiffness nor MRI parameters, continuous SWE tissue stiffness (kPA) will be compared separately to each MRI parameter: uterus size, junctional anatomy, endometrial thickness, cervical length, myometrial thickness, T2 signal, and enhanced features., Up to six months|Evaluate the correlation between MRI images collected at pretreatment and after recruitment, using repeated measures correlation., Descriptive statistics and previously described figures will be similarly used to characterize the change in each MRI parameter between the pre-treatment and post-treatment timepoints. Additionally, linear mixed effects regression models will be performed separately with each MRI parameter. The predictors will include pre- and post- treatment time points and treatment group. If appropriate, radiation dose will be included in the model as well, where the radiation dose will be assigned as 0 for the control patients. Contrast statements will be used to assess the change in each outcome comparing treatment groups and the radiation doses effect., Up to six months
Secondary Outcome Measures: Characterize uterine parameters after PRT, On-study uterine volume and arterial resistance will then be assessed with SWE. Previously described descriptive statistics and plots will be used to depict differences in each measurement across cases and controls. Sample size permitting, t-tests will be considered to secondarily quantify the differences across groups. Transabdominal and transvaginal SWE measurements will also be compared as an exploratory endpoint, Up to six months
Development of an Atlas of Respiratory Host-microbiome Interactions in Healthy Volunteers
NCT Number: NCT06518161
Acronym: HEALTHY LUNG
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Patients
Interventions: OTHER: Voluntary
Sponsor: Nantes University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2027-04-01

Summary:
The role of the pulmonary microbiome in the pathophysiology of lung disease is becoming increasingly well understood. Studies on murine models have highlighted the immunomodulatory and antibacterial activity of certain commensal bacteria, such as S. mitis, and have led to an understanding of their potential therapeutic impact. The investigators will therefore couple their analyses of the respiratory microbiome with an in-depth analysis of mucosal immunity. In particular, they will characterize immune cell types and frequencies using high-dimensional (spectral) flow cytometry and single cell RNA-sequencing. Finally, they will study the mediators exchanged between the microbiome and the host using proteomic and metabolomic analyses of respiratory fluids.

Primary Outcome Measures: Atlas of host-microbiome interactions, Healthy respiratory metacluster, 1 day
Causes of Visual Impairment Among Patients Applying for the Visually Disability Certification
NCT Number: NCT06518148
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Visual Impairment
Interventions: DIAGNOSTIC_TEST: 1- uncorrected and best corrected visual acuity (UCVA and BCVA) by Snellen's-chart.2-slit lamp bio microscopy (Haag-Streit, USA).3-IOP measurements (Goldmann Applanation tonometer)
Sponsor: New Valley University
Collaborators: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-20
Completion Date: 2024-12-20
Locations: Assiut University, Assiut, 33033, Egypt

Summary:
Causes of Visual Impairment Among Patients Applying for the Visually Disability Certification in Upper Egypt: A Retrospective Study

Primary Outcome Measures: The relative frequencies or prevalence of different eye diseases/conditions causing visual disability, 10 month|2-Ranking of the leading cause(s) of visual impairment, 10 month