pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures
NCT Number: NCT06582550
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carpal Tunnel Syndrome|Hand Cyst Ganglion|Trigger Finger
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-19
Completion Date: 2026-01-02

Summary:
The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience.

Primary Outcome Measures: patient satisfaction with the operative experience, Questionnaire to assess patient satisfaction with the operative experience will be distributed within a week in post operative visit, within 1 week|patient instruction recall, Questionnaire to assess patient instruction recall will be distributed within a week in post operative visit. It consists of 9 questions, the maximum score is 9 and indicates excellent recall., within 1 week|patient satisfaction with the information given, Questionnaire to assess patient satisfaction with the information givenwill be distributed within a week in post operative visit

Overall, are you satisfied with the provided post-operative instructions for your hand surgery? Likert-scale 1-10 (with smile face) Overall, were the provided post-operative instructions for your hand surgery easy to understand? Likert-scale 1-10 (with smile face) Overall, did the provided post-operative instructions for your hand surgery had the appropriate amount of information? Likert-scale 1-10 (with smile face), within 1 week|patient compliance, Questionnaire to assess patient instruction compliance will be distributed within a week in post operative visit. It consists of 13 questions, each with a score, with 13 being thre maximum patient compliance., within 1 week
Secondary Outcome Measures: Nursing staff patient experience, Nursing staff will be asked to present which patients reached out to clinic number/email with questions and if the instrutions decreased the incidence of such

Assessed as binomial outcome

Have you called your surgeon's office post-operatively regarding any unexpected post-operative course? Yes No Unsure, within 3 months|Dash Scores, Questionnaire to assess patient outcome will be distributed within a week in post operative visit

Quick dash score

QuickDASH DISABILITY/SYMPTOM SCORE= (sum of n responses) - 1 x 25, wherenis equal to the number of completed responses., within 1 week
LAMA2 Genetic Correction
NCT Number: NCT06582537
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: MDC1A
Sponsor: Maastricht University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-01
Completion Date: 2024-07-18

Summary:
Merosin-deficient congenital muscle dystrophy type 1a (MDC1a), or LAMA2 muscular dystrophy (LAMA2-MD) is a severe autosomal recessive form of muscular dystrophy that is caused by homozygous or compound heterozygous mutations in the laminin alpha 2 (LAMA-2) gene. Many different LAMA-2 mutations have been reported. In most cases, MDC1a is diagnosed within the first year of life, and is characterized by hypotonia, delayed motor development and white matter abnormalities. Currently, no efficient treatment is available for this patient group. Generally, MDC1a patients with mutations causing a premature stop codon are most severely affected (early onset LAMA2-MD) and patients with missense mutations are generally affected more mild affected and more late-onset (late onset LAMA2-MD). However, large variation in disease severity and clinical course is observed, even between individuals with the same mutation, e.g. the LAMA2 c.5562+5G\>C mutation, which is frequently observed in Dutch MDC1a patients. This study aims to isolate and culture fibroblasts and myogenic stem cells called mesoangioblasts from the skin and muscle biopsies of adult LAMA2 mutation carriers to explore if genetic correction of LAMA2 mutations using CRISPR-Cas9 can be achieved and subsequently assess the effect in vitro, as a first step towards therapy development.

Primary Outcome Measures: Compare RNA transcription of corrected and not corrected DNA, qPCR, 1 day|Assess effect LAMA2 mutations on muscle protein quantity (amount of LAMA2), LAMA2 immunostaining, 1 day|Assess effect LAMA2 mutations on muscle protein quality (localization of LAMA2), LAMA2 immunostaining, 1 day|Assess effect LAMA2 mutations on muscle protein quantity (LAMA2 overall levels), LAMA2 western blot, 1 day|Assess effect LAMA2 mutations on muscle protein quality (fibrosis), LAMA2 HE staining, 1 day
Secondary Outcome Measures: Verification of the LAMA2 mutations or exclusion of LAMA2 mutations in controls, DNA analysis, 1 day|Blood markers to assess level of muscle inflammation, damage and regeneration in MDC1a patients: CK, ELISA assay, 1 day|Blood markers to assess level of muscle inflammation, damage and regeneration in MDC1a patients: TNFa, ELISA assay, 1 day|Blood markers to assess level of muscle inflammation, damage and regeneration in MDC1a patients: IL-6, ELISA assay, 1 day|Blood markers to assess level of muscle inflammation, damage and regeneration in MDC1a patients: SDF1, ELISA assay, 1 day
Pegzilarginase in Subjects &lt;24 Months Old With Arginase 1 Deficiency
NCT Number: NCT06582524
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Arginase 1 Deficiency
Interventions: DRUG: Pegzilarginase
Sponsor: Immedica Pharma AB
Sex: ALL
Age: CHILD
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-12-31
Locations: Univ. Klinik für Kinder- und Jugendheilkunde Medizinische Universität, Graz, A-8036, Austria|Unidade de Doenças Metabólicas Pediatria, Hospital Santa Maria, Lisboa, Portugal|Bradford Royal Infirmary Duckworth Lane, Bradford, BD9 6RJ, United Kingdom

Summary:
This is an open-label, multicentre study to evaluate the safety, PK, and activity (PD) of weekly subcutaneous (SC) administration of pegzilarginase in subjects with ARG1-D who are \< 24 months of age. The study consists of a screening period of up to 4 weeks, a subsequent 12-week treatment period, and a safety follow-up period of 8 weeks.

Primary Outcome Measures: To evaluate the effect of pegzilarginase, To evaluate the effect of pegzilarginase on plasma arginine concentrations in subjects \<24 months of age with arginase 1 deficiency (ARG1-D), From baseline up to 12 weeks
Secondary Outcome Measures: To evaluate the safety of pegzilarginase, Safety assessments will include: adverse events (AEs), including hypersensitivity reactions (HSRs), injection site reactions (ISRs), safety labs and hyperammonaemic events, From baseline up to 12 weeks|To characterize the pharmacokinetic (PK) profile of pegzilarginase, PK parameters with evaluation of half-life (T½), From baseline up to 12 weeks|To characterize the pharmacokinetic (PK) profile of pegzilarginase, PK parameters with evaluation on time to maximum observed concentration (Tmax), From baseline up to 12 weeks|To characterize the pharmacokinetic (PK) profile of pegzilarginase, PK parameters with evaluation of maximum observed concentration (Cmax), From baseline up to 12 weeks|To characterize the pharmacokinetic (PK) profile of pegzilarginase, PK parameters with evaluation on area under the plasma drug concentration-time curve, From baseline up to 12 weeks|To evaluate the pharmacodynamic (PD) response of pegzilarginase, PD response evaluation including anti-drug antibodies (ADAs), levels of plasma arginine and ornithine, From baseline up to 12 weeks|To describe changes in physical function, Changes in physical function after 12 weeks of pegzilarginase treatment as measured by Gross Motor Function Measure (GMFM)-66 Parts A through E, as age appropriate and feasible, From baseline up to 12 weeks|To evaluate the safety of pegzilarginase, Safety assessments will include electrocardiograms (ECGs) to evalute P Wave, QRS Complex, QT Interval, From baseline up to 12 weeks
Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associated Acute Respiratory Failure
NCT Number: NCT06582459
Acronym: HFCNV-PAH
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Arterial Hypertension|Acute Respiratory Failure|High-flow Nasal Cannula|Noninvasive Ventilation
Sponsor: The First People's Hospital of Neijiang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2025-01-01

Summary:
This is a single center, retrospective, propensity score matching cohort study that explores the efficacy and safety of high flow nasal cannula and non-invasive ventilation in the treatment of acute respiratory failure associated with pulmonary arterial hypertension, stratified by the severity of right ventricular dysfunction.

The study will compare two groups: high flow nasal cannula (HFNC) and non-invasive ventilation (NIV).

Main objective: heart function parameters (e.g. TAPSE and RVSP) Secondary objectives: respiratory support success rate (defined as the avoidance of endotracheal introduction or death duration hospitalization), respiratory support duration, length of intensive care unit (ICU) stay, length of hospital stay, and in-hospital mortality.

This study addresses whether NIV or HFNC should be prioritized for the treatment of acute respiratory failure associated with pulmonary arterial hypertension in patients with severe right ventricular dysfunction who require high flow nasal cannula and non-invasive ventilation.

This study is of great significance as it is based on a patient stratification method of right ventricular dysfunction severity to evaluate the effectiveness of HFNC treatment and NIV in PH related ARF patients.

Primary Outcome Measures: heart function parameters, (e.g., TAPSE and RVSP) from baseline to 24 h after respiratory support initiation., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Secondary Outcome Measures: respiratory support success rate, defined as the avoidance of endotracheal intubation or death during hospitalization, From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Solution-focused Counseling for Menopausal Symptoms
NCT Number: NCT06582433
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menopause|Menopause Related Conditions|Menopausal Depression
Interventions: OTHER: Intervention
Sponsor: Karabuk University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-03-02
Locations: Karabuk, Karabuk, 78050, Turkey

Summary:
This research will be conducted in a prospective pre-test post-test measurement randomized controlled experimental design. The population of the study consists of women who have entered menopause and live in Karabük. The research sample size was calculated considering the literature information that in experimental studies each group should consist of at least 30 individuals, taking into account the power of the test with G\*Power 3.1 Program. It was calculated that at least 32 observations are needed in both the experimental and control groups to reach a power level of 90% at a significance level of 5% with an effect size of 0.75, and the sample size of the study was calculated as 64 women. The data of the study will be collected using the "Personal Information Form", "Psychological Well-being Scale", "Menopausal Symptoms Evaluation Scale" and "Menopause Attitude Evaluation Scale".

WORKFLOW

Pre-procedure:

* Women who meet the inclusion criteria for the study will be divided into experimental and control groups using simple randomization method.
* Before the procedure, women in both groups will fill out the PIF, PWBS, MSES, and MAES (1st Measurement).

During the procedure:

At this stage, Solution-Focused Counseling (SFC) will be used on women in the experimental group by the researcher. SFC sessions for patients will be held individually, once a week, with a total of 6 sessions that may have deviations of 2-3 days before or after the previous session. Each session is planned to last 60 minutes. Counseling for patients will be conducted in a comfortable environment. At this stage, women in the control group will be given information on typical menopausal symptoms.

Post-procedure:

One week after the completion of SFC sessions, the PIF, PWBS, MSES, and MAES will be filled out by the experimental and control groups (2nd Measurement).

Follow-up evaluation after 2 months:

Two months after the completion of SFC sessions, the PIF, PWBS, MSES, and MAES will be applied to the experimental and control groups (Follow-up Measurement) to determine whether the results of the applied SFC are continuing.After monitoring measurements are taken on the control group, counseling will be provided to women according to their needs (addressing issues, answering questions, informing them according to their needs).

Primary Outcome Measures: prevention, Menopausal complaints, One session per week, each session is 90 minutes, a total of 6 sessions.
Machine Learning Models for Predicting Unforeseen Hospital Admissions or Discharges After Anesthesia
NCT Number: NCT06582407
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Anesthesia Complication|Surgery-Complications|Pain, Postoperative
Sponsor: HUmani
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 68683
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2024-07-30

Summary:
Unexpected hospital admissions after ambulatory surgery not only bring discomfort to patients but also causes a decrease in the efficiency of the healthcare system. In addition, unanticipated patient's orientation carry the risk of unsuitable post operative orders. The hypothesis of this project is that artificial intelligence models will outperform traditional models in predicting which patients will require hospital admission after ambulatory surgery or unforeseen hospital discharge after surgery.

Primary Outcome Measures: Rate of patient reorientation, Rate of unforeseen hospital admission after an ambulatory surgery and rate of discharge after an hospitalised surgery, On the day of the operation
Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors
NCT Number: NCT06582394
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: COMBINATION_PRODUCT: Exp Group|OTHER: Control group
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-10-30
Locations: Depalpur, Lahore, Punjab, Pakistan

Summary:
In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way.

Primary Outcome Measures: Barthel index, The Barthel Index is a scale used to measure a person's ability to perform basic activities of daily living (ADL) independently. It assesses 10 areas of functioning, with a focus on mobility and self-care. Scores range from 0 to 100, with higher scores indicating greater independence. Stroke-Specific Quality of Life Scale (SS-QOL) It assesses the impact of stroke on the quality of life across various domains, including physical, emotional, social, and cognitive aspects. It uses 12 domains with items scored on a 5-point Likert scale, 12 Months
Evaluation of Biomarkers for Predicting Macronutrient Intake
NCT Number: NCT06582381
Acronym: Microdialysis
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glucose Metabolism|Amino Acid Metabolism
Interventions: OTHER: Meal set A|OTHER: Meal set B|OTHER: Meal set C|OTHER: Meal set D
Sponsor: Texas A&M University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2023-12-06
Completion Date: 2026-12
Locations: Center for Translational Research in Aging &amp; Longevity, College Station, Texas, 77843, United States

Summary:
The goal of this clinical trial is to establish the relationship between macronutrient food intake and the resulting blood and intersticial fluid (ISF )levels of small molecule markers, as well as, validate wearable optical readers and data fusion algorithms to accurately predict individual-specific macronutrient availability in real time.

The study involves 1 screening visit of approximately 2 hours and up to 4 study days of approximately 14 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening visit, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed.

Primary Outcome Measures: Glucose metabolism, Prediction models of postprandial plasma glucose in relation to the macronutrient content of predefined meals as assessed by plasma and/or ISF concentrations of amino acids, glucose, and/or triglycerides, Up to 14 hours per study visit, up to 4 visits
Secondary Outcome Measures: Amino acid metabolism, Prediction models of postprandial plasma amino acid patterns in relation to the macronutrient content of predefined meals as assessed by plasma and/or ISF concentrations of amino acids and/or glucose, Up to 14 hours per study visit, up to 4 visits
Determinants of Portal Vein Pulsatility Index
NCT Number: NCT06582368
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Fluid Overload|Congestion
Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2024-08-01
Locations: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases, Bucharest, 022328, Romania

Summary:
The pulsatile pattern of the portal vein is considered a marker of right ventricular dysfunction, but volemia may also contribute to this phenomenon. The separate influence of each factor remains debated, as the interplay between right ventricular dysfunction and volume status is complex. Additionally, right ventricular dysfunction can originate from either diastolic or systolic dysfunction, further complicating the understanding of their distinct impacts on portal vein pulsatility.

Primary Outcome Measures: Fluid Intolerance, A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin., Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
Secondary Outcome Measures: Volemia, Volemia will be assessed using the mean systemic filling pressure analogue (MSFPa), which estimates the overall volume status and preload of the circulatory system. This measurement provides an indirect evaluation of volemia, reflecting the balance between blood volume and vascular capacity. Higher or lower values can indicate fluid overload or deficit, respectively., Within the first six hours of admission to the intensive care unit (simultaneously with other measures).|Right Ventricular Dysfunction, Right ventricular dysfunction will be assessed using three ancillary measures: Tricuspid Annular Plane Systolic Excursion (TAPSE), Right Ventricular Fractional Area Change (RVFAC), and the Right Ventricular End-Diastolic Area to Left Ventricular End-Diastolic Area ratio (RVEDA/LVEDA). TAPSE measures longitudinal shortening of the right ventricle, RVFAC assesses overall systolic function by evaluating the change in the right ventricular area during the cardiac cycle, and RVEDA/LVEDA compares the size of the right ventricle to the left, indicating potential dilation or pressure overload., Within the first six hours of admission to the intensive care unit (simultaneously with other measures).
Investigating the Clinical Utility of the Oxford Virtual Autism Assessment Tool (OVAAT)
NCT Number: NCT06582290
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder|Healthy|Neurotypical
Interventions: DIAGNOSTIC_TEST: Oxford Virtual Autism Assessment Tool (OVAAT)
Sponsor: Oxford Health NHS Foundation Trust
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-09-22
Completion Date: 2025-05
Locations: Oxford Health NHS Foundation Trust, Oxford, OX3 7JH, United Kingdom

Summary:
The goal of the study is to evaluate a new Autism Spectrum Disorder (ASD) diagnostic tool (Oxford Virtual Autism Assessment Tool (OVAAT)) to see whether it can:

* Be able to identify autistic traits
* Be able to distinguish between autistic and non-autistic young people
* Is the tool better, similar or worse than another evidence-based observational tool (ADOS-2) in identifying features of autism?

Primary Outcome Measures: Oxford Virtual Autism Assessment Tool (OVAAT), The OVAAT is an online ASD diagnostic tool that has been designed to identify both the external/observable features of autism but also the internal/experiential features of autism., Up to 3 weeks after recruitment
Secondary Outcome Measures: Revised Children's Anxiety and Depression Scale (and Subscales) (RCADS), Used in the screening for group 2 47 item questionnaire scored on a scale of 0-3, with 0 being "never" and 3 being "always"). Participants in group 2 will score statements based on how often the things (statements) happen to them e.g., "I worry about things"., Day 0|Autism Spectrum Quotient (AQ-10), Used in group 2 screening process. 10 item measure that looks at whether a person should be be referred for further autism assessment. Participants are asked to indicate their level of agreement on 10 statements (on a scale of 1-4, 1 being "definitely agree" to 4 "definitely disagree")., Day 0|Adult ADHD Self-Report Scale (ASRS), Used in the group 2 screening process 18-item questionnaire spilt into 2 parts (part a. and part b.). Participants are asked to score rate themselves based on how they have felt and conducted themselves over the past six months (using "never", "rarely", "sometimes", "often" or "very often")., Day 0|Prodromal Questionnaire (PQ-16), Used in group 2 screening process. 16-item questionnaire that asks participants to either indicate "true" or "false" for 16 items that look at the risk of potential psychosis. For any statements that participants indicate as "true" they are asked to rate their level of distress (on a scale of 0-3, with 0 being "none" and 3 being "severe")., Day 0|Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), This used before the OVAAT and is used in the diagnostic assessment in group 1. The ADOS-2 is an observation-based tool used to assess and diagnose ASD. It uses a combination of questions and activities to assess and evaluate a person's communication skills, social interaction and imaginative se of materials., Within 2 to 3 months of consent form being signed
Immunogenicity and Safety of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836
NCT Number: NCT06582277
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Vaccine-Preventable Diseases|Influenza
Interventions: BIOLOGICAL: OVX836 shot
Sponsor: Osivax
Collaborators: Harmony Clinical Research|Clinfidence|Inferential|University Hospital, Ghent|KCAS Bio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 214
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2025-08
Locations: Centre for Vaccinology (CEVAC) Ghent University Hospital, Ghent, Belgium

Summary:
This phase 2a is designed to evaluate the anamnestic response of a booster dose (either 180 µg or 480 µg) of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to five years ago in OVX836-002 or OVX836-003 studies. Participants who had received a placebo or Influvac Tetra® in previous studies would serve as controls and would receive one of these two doses of OVX836 vaccine (either 180 µg or 480 µg) as a primary vaccination.

Primary Outcome Measures: Cell-mediated immune response to OVX836 (180μg and 480μg) in term of NPspecific IFNγ spot forming cells frequencies in peripheral blood (ELISPOT), at Days 1, 8 and 29|Geometric mean titers (GMTs) of anti-NP Immunoglobulin G (IgG) (ELISA, serum), at Days 1, 8 and 29|Number and percentage of subjects with an increase (two-fold and four-fold) in anti-NP IgG (ELISA, serum), at Days 1, 8 and 29
Secondary Outcome Measures: Cross-reactivity of the NP influenza-specific responses by IFNγ ELISPOT against selected circulating and emerging strains of influenza, at Days 1, 8 and 29|Frequencies of NP-specific CD4+ and CD8+T-cells expressing IL-2, TNFα and/or IFNγ, measured by flow cytometry, following in vitro stimulation of PBMC, at Days 1, 8 and 29|GMTs of anti-OVX313 tag (Oligodom®) IgG level (ELISA, serum), at Days 1, 8 and 29|Anti-C4bp (C4b-binding protein) oligomerization domain IgG titers (ELISA, serum) in subjects with positive result for anti-OVX313 (anti-OVX313 titer >12.5)., at Days 1, 8 and 29|8. Safety evaluation of OVX836 (180µg and 480µg), Proportion of subjects reporting:

* solicited local and systemic symptoms within 7 days after vaccine administration
* unsolicited AEs within 29 days after vaccine administration
* SAEs during the entire study duration
* ILIs and RT-PCR confirmed influenza A or B (overall and occurring more than 14 days post-vaccination, i.e., vaccine failure), RSV and/or SARS-CoV-2, From enrollment to the end of trial at 180 days.
A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
NCT Number: NCT06582264
Acronym: COMPOSER-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Ulcerative Colitis
Interventions: BIOLOGICAL: MB310|OTHER: Placebo|DRUG: Vancomycin
Sponsor: Microbiotica Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

Summary:
A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis.

Primary Outcome Measures: Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs, From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)|Incidence of treatment-emergent clinically significant changes in laboratory parameters, based on haematology, clinical chemistry, and urinalysis test results, From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)|Incidence of treatment-emergent clinically significant changes in 12-lead ECG parameters, vital signs, and physical examination, From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)
Secondary Outcome Measures: Percentage of patients achieving clinical remission at Day 91, Clinical remission defined as a Modified Mayo Score (MMS) 0 to 2 with endoscopic subscore of 0 or 1, Day 91|Percentage of patients achieving steroid-free remission at Day 91, No steroid exposure at Day 91 with a MMS score of 0 to 2 with endoscopic subscore of 0 or 1, Day 91|Percentage of patients achieving persistent steroid-free remission at Day 91, No steroid exposure between Day 64 and Day 91 with a MMS score of 0 to 2 with endoscopic subscore of 0 or 1, Day 64 to Day 91|Percentage of patients achieving clinical response at Day 91, Clinical response defined as a decrease in MMS by 2 or more points and at least a 30% reduction from baseline, and a decrease in the rectal bleeding subscore of 1 or more or an absolute rectal bleeding subscore of 0 or 1, Day 91|Percentage of patients achieving endoscopic improvement at Day 91, Endoscopic improvement is defined as a decrease in MMS endoscopic subscore by 1 or more point from baseline, Day 91|Percentage of patients who achieve clinical improvement at Day 64 (Visit 10) and Day 91 (Visit 11), Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline, Day 91|Time to clinical improvement, Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline, End of Follow-Up (12 weeks after the last dose of study treatment)|Engraftment of MB310 bacteria into patients' intestinal microbial community, Measurement of MB310 strain colonisation in stool samples using a qPCR-based approach., Up to End of Follow-Up (12 weeks after the last dose of study treatment)
The Effects of High-Intensity Functional Training in Tactical Populations
NCT Number: NCT06582251
Acronym: HIFT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: BEHAVIORAL: High-intensity functional training|BEHAVIORAL: Traditional resistance training|BEHAVIORAL: Concurrent training
Sponsor: University of South Carolina
Collaborators: National Strength and Conditioning Association
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-26
Completion Date: 2026-01-01
Locations: University of South Carolina Sport Science Lab, Columbia, South Carolina, 29208, United States

Summary:
The purpose of this study is to investigate the effects of high-intensity functional training (HIFT) as compared to traditional resistance training (RT) and concurrent training consisting of RT and high-intensity interval training (HIIT) on physical performance metrics, body composition, and mental and physical readiness of tactical personnel.

Primary Outcome Measures: Changes in body composition body fat percentage., Body fat percentage via air-displacement, Baseline and Week 10|Changes in body composition fat-free mass., Fat-free mass via air-displacement plethysmography., Baseline and Week 10|Changes in body composition dry fat-free mass., Dry fat-free mass via air-displacement plethysmography and bio-electrical impedance., Baseline and Week 10|Changes in upper body strength., Upper body strength assessed by 1 repetition maximum bench press., Baseline and week 10|Changes in lower body strength., Lower body strength assessed by isometric mid-thigh pulls on bilateral force plates., Baseline and week 10|Changes in maximal oxygen consumption., Changes in VO2max measured by maximal graded exercise test with indirect calorimetry., Baseline and week 10|Changes in ventilatory threshold., Changes in ventilatory threshold measured by maximal graded exercise test with indirect calorimetry., Baseline and week 10|Changes in velocity at VO2 max., Assessed by maximal graded exercise test with indirect calorimetry., Baseline and week 10
Secondary Outcome Measures: Internal training load between groups., Assessed by heart rate chest strap using Edwards training impulse calculation., Every training session over the 8-week intervention period will be included in this calculation.|Changes in training distress, Overall training distress and subscales including depressed moods, vigor, physical signs and symptoms, sleep disturbances, perceived stress, and general fatigue using the multicomponent training distress scale, scaled 0 - 110 with higher scores indicating more distress., Baseline, once per week for the 8 training weeks.|Changes in anaerobic power., Measured by countermovement jump through bilateral force plates., Baseline, once per week for the 8 training weeks.
Dentine Hypersensitivity Management KAP Study
NCT Number: NCT06582238
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Dentin Sensitivity
Interventions: OTHER: Dentists in Clinical Practice
Sponsor: Muhammad Modu
Collaborators: Cairo University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-21
Completion Date: 2025-04-11
Locations: Faculty of Dentistry, Cairo University, Cairo, 12613, Egypt

Summary:
The study aims to assess and compare the knowledge, attitudes, and practices of Egyptian and Nigerian dentists on etiology, diagnosis, and management of DH. Also to identify if level of education, culture and environment have influence in the diagnosis and management of DH.

Primary Outcome Measures: Knowledge, % of Dentists with adequate knowledge of appropriate etiology diagnosis and management of DH among practicing dentists in Egypt and Nigeria using a validated questionnaire with options of various etiologies, diagnosis and management options. the subject chooses yes, no or i don't know., 6 months
Secondary Outcome Measures: Comparison, Comparison of Knowledge and management practices of dentists in Egypt and Nigeria in the management of dentine sensitivity, 6 months
Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm
NCT Number: NCT06582186
Acronym: VORIPRECI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Aspergillosis Invasive|Fungal Infection|Hematologic Malignancy
Sponsor: University Hospital, Grenoble
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-10

Summary:
The goal of this interventional single-arm study is to evaluate the interest of a multiparametric algorithm for individualization of first voriconazole maintenance doses for improvement of initial voriconazole exposure in adult patients with haematological malignancies. The main objective it aims is to determine the percentage of patients with initial voriconazole trough concentrations in the therapeutic range after individualization of first maintenance doses.

Participants will benefited from individualization of first voriconazole maintenance doses through a previously developed and validated multiparametric algorithm (publication in progress) taking into account CYP2C19 genotype, C reactive protein level and age.

Primary Outcome Measures: Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range, Day 5 +/-2
Secondary Outcome Measures: Frequency of initial plasma voriconazole trough concentrations above the therapeutic range, Day 5 +/-2|Frequency of initial plasma voriconazole trough concentrations below the therapeutic range, Day 5 +/-2|Voriconazole area under the curve (AUC0-12h) after the first maintenance dose individualized, Day 2|Time to get the therapeutic range, through study completion, an average of 3 months|Treatment outcome in patients curatively treated, At month 3 +/- 15 days|Frequency of side effects, through study completion, an average of 3 months|Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range, comparison with an historic cohort, Day 5 +/-2
Mapping the Healthcare Pathway to Multidisciplinary Assessment of 12-25 Year Olds with Somatic Symptom Disorder
NCT Number: NCT06582173
Acronym: PSOMA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Somatic Symptoms|Medically Unexplained Symptoms|Somatoform Disorders
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-10

Summary:
This study aims to describe the course of successive care events that follow individuals with somatic symptom disorder until they are assessed by a specialized multidisciplinary team. Data is collected during interviews with subjects aged 12 to 25 years old accompanied by their parents. A biographical grid is used to retrospectively identify all care events that occurred from first symptoms until multidisciplinary assessment. Life events and symptoms are collected as well to explore how history of healthcare consumption is linked to other trajectories. A qualitative analysis of the recorded interviews aims to describe the subjective experience of this healthcare pathway.

Primary Outcome Measures: Occurrence of healthcare events, Successive healthcare events of individuals with somatic symptom disorder, from first symptoms to specialised multidisciplinary assessment, Day of inclusion
Secondary Outcome Measures: Raise of healthcare events occurrence, Raise of healthcare events occurrence following the occurrence of somatic symptoms.

From first symptoms to specialised multidisciplinary assessment, Day of inclusion|Raise of life events occurrence, From first symptoms to specialised multidisciplinary assessment, Day of inclusion|Decrease of healthcare events occurrence, Decrease of healthcare events occurrence following the occurrence of somatic symptoms.

From first symptoms to specialised multidisciplinary assessment, Day of inclusion|Decrease of life events occurrence, From first symptoms to specialised multidisciplinary assessment, Day of inclusion|Modification of somatic symptoms occurrence, From first symptoms to specialised multidisciplinary assessment, Day of inclusion|Modification of life events occurrence, Modification of life events occurrence following healthcare. From first symptoms to specialised multidisciplinary assessment, Day of inclusion|Qualitative analysis of the transcribed interviews, Identification of themes emerging from the qualitative analysis of the transcribed interviews, Up to 24 months
Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinson's Disease
NCT Number: NCT06582121
Acronym: SOMPARK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|REM Sleep Behavior Disorder (iRBD)
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 457
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-11

Summary:
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\&#39;s disease (SOMPARK)

Primary Outcome Measures: Polysomnography to compare sleep efficiency, Using polysomnography to compare sleep efficiency in the 3 study populations during the first night, 25 months
Digital Health Integration With Pulmonary Rehabilitation on Patients With Chronic Obstructive Lung Disease
NCT Number: NCT06582082
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Lung Disease
Interventions: OTHER: pulmonary rehabilitation|OTHER: pursed lip breathing
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-10
Completion Date: 2026-12-30
Locations: Faculty of Physical Therapy, Cairo, Egypt

Summary:
It is an interventional study in which 60 COPD patients estimated to enrol according to random allocation and divided into two groups. The study group will receive pulmonary rehabilitation while the control group will stick to pursed lip breathing only.

Pulmonary function (FEV1, FVC, FEV1/FVC), cognitive function by mini mental state examination, physical function by physical tests also, physical activity and sleep by google fit app and vital signs by using different mobile apps. measurements will be evaluated before initiation of the interventions and 12 weeks thereafter.

Primary Outcome Measures: pulmonary function, Pulmonary function test will be carried out by SPIROVIT SP-1 spirometer to determine FVC, FEV1, FEV1/FVC. Subjects will remain in the straight sitting or standing position throughout the test, and a nose clip will be tightly attached to the nostrils, allowing no air to escape during the test. A mouthpiece will be placed at least two centimeters into the subject's mouth, with lips closed around it., 12 weeks
Secondary Outcome Measures: cognitive function, A Mini-Mental State Examination (MMSE) is a set of 11 questions. It's used by to check for cognitive impairment. The test takes about 5 to 10 minutes. The top score for the MMSE is 30 - a score of 25 or higher is said to be normal., 12 weeks|physical activity, The Google Fit® is an open platform developed by Google Inc., which allows the users to control their fitness data. It is also available as a free application for smartphones, which works with versions above 4.0 in Android systems. The Google Fit® consists of a set of high level sensors, such as an accelerometer, a gyroscope, and a GPS system which can detect changes in position (for example, moving from sitting to standing), various types of movement (walking, cycling, and others), several kinds of data (number of steps, walked distance, heart rate, and others), and different bouts of activity (time of each bout) ( Google Developers, 2016

)., 12 weeks
Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel
NCT Number: NCT06582069
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Discoloration, Tooth
Interventions: DEVICE: Bleaching
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-01-01

Summary:
ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth whitening, And based on the above, in this study kiwi extract and ozone gas will be used individually and combined to evaluate the resultant effects on bleaching, enamel microhardness and micromorphology.

Primary Outcome Measures: Color change assessment, all participants will be requested to return after 24 hours to permit rehydration of tooth surfaces before shade assessment Tooth Shades will then record using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb), 24 Hours|Color change assessment, all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at one month, one month|Color change assessment, all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at three months, three month|Color change assessment, all participants will be requested to return after one month for tooth shades recording using colorimeter. The color change (ΔE) will be calculated using the formula: ΔE= {(ΔL) 2+ (Δa) 2+ (Δb) at six months, six months
Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
NCT Number: NCT06582056
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Disease
Interventions: PROCEDURE: Investigational Procedure
Sponsor: Sanofi Pasteur, a Sanofi Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-20
Completion Date: 2024-12-12

Summary:
The purpose of this study is to learn about the interactions of markers of type 2 diabetes (T2DM) and periodontitis (PD). Study VPE00001 is a multi-center cross-sectional study. Participants will be categorized based on point-of-care hemoglobin A1c (HbA1c) and periodontal disease (PD) staging into 9 subgroups. The key objectives of the study are:

* To evaluate immune signatures in well-characterized populations with or without PD and/or T2DM
* To evaluate baseline clinical biomarkers of T2DM and PD in well-characterized populations
* To evaluate the influence of clinical, immunological, and microbiological biomarkers on the bidirectional relationship between T2DM and PD

Primary Outcome Measures: Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab), Day 01|Serum protease activity inhibition (PAI) titers, Day 01|Serum hemagglutination inhibition (HAI) titers, Day 01|Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva), Day 01|DNA-based detection of Pg (sub-gingival plaque), Day 01|Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay), Day 01
Secondary Outcome Measures: Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay, Day 01|Levels of inflammatory mediators in saliva (including MMP-8), Day 01|Salivary titers of total anti-Pg Ab, Day 01|Measurement of high sensitivity C-reactive protein (hsCRP) in serum, Day 01|Measurement of serum levels of pro-insulin, Day 01|Measurement of serum levels of c-peptide, Day 01|Measurement of serum levels of prostaglandin E2 (PGE2), Day 01