pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Videolaryngoscopy vs Direct Laryngoscopy for Double Lumen Tube Lumen Tube Placement - A Multicentre Randomized-controlled Trial (VOLCANO Study)
NCT Number: NCT06466759
Acronym: VOLCANO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: One Lung Ventilation|Intubation Complication
Interventions: DEVICE: Mc Grath Videolaryngoscope
Sponsor: Luca Brazzi
Collaborators: A.O.U. Città della Salute e della Scienza - Molinette Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 750
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-07-02
Completion Date: 2026-12-31

Summary:
The general aim of the study is to observe whether the use of the Mc Grath™ videolaryngoscope instead of direct laryngoscopy can represent, as in the case of the single-lumen tube, an added value in the placement of the double-lumen tube for surgical procedures involving one-lung ventilation, making intubation on the first attempt more likely and quicker. Secondary objectives include evaluating the presence of an advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for the correct placement of the double-lumen tube, the need for additional maneuvers during the intubation procedure, and the presence of intra- and post-procedural complications.

Primary Outcome Measures: Number of partecipant with first pass intubation success, first pass intubation success of the Mc Grath™ videolaryngoscope over direct laryngoscopy for double-lumen tube intubation., up to 1 hour
Secondary Outcome Measures: Intubation-related complications, Evaluation of the advantage of the Mc Grath™ videolaryngoscope over direct laryngoscopy for intra- and post-procedural complications, need for additional maneuvers, and correct placement of the double-lumen tube., 24 hours
Pathways to Care-Understanding the Impact of an Indigenous Elder Co-lead in Perinatal Dialectical Behaviour Therapy
NCT Number: NCT06466694
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dialectical Behaviour Therapy
Interventions: BEHAVIORAL: Modified Dialectical Behavioural Therapy
Sponsor: University of Manitoba
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-20
Completion Date: 2025-03-30
Locations: College of Nursing, University of Manitoba, Winnipeg, Manitoba, R3T 2N2, Canada

Summary:
To integrate traditional Indigenous Knowledge with gold-standard therapy to enrich the patient experience from an anti-oppressive, culturally safe perspective for marginalized individuals with psychosocially complex pregnancies. The Knowledge Carrier does not have a prescribed way of integrating Indigenous knowledge but will respond to each patient on an individual basis depending on the needs in the current session, supporting the patients with story-telling and validation of Indigenous beliefs regarding well-being in pregnancy.

Specific Aim 1: To evaluate through a patient lens content of the Dialectical Behavior Therapy (DBT) through the lens of an Indigenous Knowledge Carrier (Elder) to make content more rich and accessible to marginalized persons.

Specific Aim 2: To provide a culturally safe space and anti-oppressive care environment for both Indigenous and non-Indigenous patients in keeping with the Truth and Reconciliation Call to Action #22

Primary Outcome Measures: Outcomes of Modified Dialectical Therapy on marginalized pregnant patients., Outcomes of Modified Dialectical Therapy with patient interviews pre and post therapy using thematic analysis., 1 year
De Oorzaak: Citizen Science Project on the Impact of Environmental Noise
NCT Number: NCT06466668
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Noise Exposure|Sleep|Hyperacusis
Interventions: DIAGNOSTIC_TEST: Sleep study|DIAGNOSTIC_TEST: stress-related biomarkers and microbiome composition will be assessed using saliva samples|DIAGNOSTIC_TEST: Audiological tests
Sponsor: University Hospital, Antwerp
Collaborators: Universiteit Antwerpen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-29
Completion Date: 2025-10-31
Locations: Antwerp University Hospital (UZA), Edegem, 2650, Belgium

Summary:
"De Oorzaak" is a large-scale citizen science project aiming to assess the impact of environmental sounds on the quality of life. This particular study is a part of a broader citizen science research project "De Oorzaak", which focuses on mapping the effects of ambient noise with high resolution and on a large scale across Flanders. The specific goal of the underlying sub study is to expand our current knowledge of how ambient noise affects sleep quality and stress.

Primary Outcome Measures: Sound-induced sleep disturbances, Polysomnographic analysis of the sleep to incedence of (micro)arousals. Using a class I sound sensor it will be assessed whether and which sounds are present at the time of these arousals., Single time point (before December 31 2025)
Secondary Outcome Measures: Differences in the levels of stress-related biomarkers in saliva, Quantification of hormones (e.g., cortisol) and cytokines (e.g., IL-8) by ELISA, Single time point before sleep analysis|Differences in salivary microbiome composition, Amplicon sequencing with the Illumina MiSeq, Single time point before sleep analysis
Daily Stress and Vascular Function in Midlife as a Risk Factor for Cognitive Decline
NCT Number: NCT06466655
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Middle-aged Adults
Interventions: OTHER: MitoTempol
Sponsor: University of Delaware
Collaborators: National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-30
Completion Date: 2025-06-30
Locations: University of Delaware, Newark, Delaware, 19713, United States

Summary:
The goal of this clinical trial is to better understand how day-to-day stress affects cardiovascular health and brain function in middle-aged adults. The main question is aims to answer is whether the link between daily stress and vascular dysfunction is a potential mechanism of increased risk for future cognitive decline. Participants will complete two 15-day "testing cycles" separated by \~6 months. During each cycle, participants will complete two daily assessments of stress and brain health using an online survey tool for 14-consecutive days. On the last day of each cycle, vascular function will be assessed during a laboratory visit.

Primary Outcome Measures: nitric oxide (NO)-mediated endothelium-dependent dilation (EDD), NO-mediated EDD will be calculated as the percent change (%) from the local heating-induced plateau to the post-L-NAME plateau., following a standard local heating protocol, an average of 4 hours
Secondary Outcome Measures: local heating-induced endothelium-dependent dilation (EDD), Local heating-induced EDD will be calculated as the percent change (%) from baseline to the local heating-induced plateau., following a standard local heating protocol, an average of 4 hours
The Optimal Timing of Vaccination in Pregnancy
NCT Number: NCT06466629
Acronym: MATIMMUNE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pertussis/Whooping Cough
Interventions: BIOLOGICAL: Triaxis, Sanofi Pasteur
Sponsor: Elke Leuridan, MD, PhD
Collaborators: Université Libre de Bruxelles
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-07-01
Completion Date: 2025-04-30
Locations: Vaccinopolis, Edegem, Antwerp, 2650, Belgium

Summary:
The central aim of this study is to investigate the optimal timing of vaccination in pregnant women. Therefore, pregnant women will be vaccinated against pertussis at different timepoints and blood and breast milk samples will be taken at several timepoints. The main objectives are to assess the impact of timing on humoral and cellular immune responses in pregnant women, on antibody characteristics transferred across the placenta and on transplacental transport efficiency. The impact of maternal pertussis vaccination and timing of maternal pertussis vaccination on breastmilk antibody composition will also be investigated, as well as the impact of vaccination during pregnancy on the mucosal uptake of breastmilk IgA antibodies by the infant respiratory and gastrointestinal tract.

Primary Outcome Measures: Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy., Before Tdap vaccination|Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy., One month after Tdap vaccination|Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy., At delivery|Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy., 6 months postpartum
Secondary Outcome Measures: Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy., Before Tdap vaccination|Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy., One month after Tdap vaccination|Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy., At delivery|Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy., 6 months postpartum|Measurement of antibody levels in cord blood at delivery after Tdap vaccination at different timings in pregnancy to calculate the transport of antibodies across the placenta, At delivery|Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk after Tdap vaccination at different timings in pregnancy., 6 months postpartum
Shock Waves Therapy Combined With Leg Stretching in Patients With Plantar Fasciitis
NCT Number: NCT06466616
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plantar Fascitis
Interventions: OTHER: Real stretching|OTHER: Placebo stretching
Sponsor: University of Alcala
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-06
Completion Date: 2025-07-01
Locations: University of Alcalá, Faculty of Nursing and Physiotherapy, Alcalá De Henares, Comunidad De Madrid, 28805, Spain

Summary:
The aim of this study is to evaluate the efficacy of a combination treatment consisting of ESWT and stretching of different muscles in the lower body compared to ESWT treatment alone in patients with plantar fasciitis.

Primary Outcome Measures: Pain intenisty VAS, To evaluate the difference in pain after the intervention. We are going to use the Visual Analogue Scale, being 0 the better result and 10 the worst possible., Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention|Pain intensity PSFP, We are also to use the Pain Scale for Plantar Fasciitis in their section for pain measure. The minimum score is 0 (better) and the maximum 100 (worst)., Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
Secondary Outcome Measures: Disability, To evaluate the difference in disability after the intervention. The Foot Function Index is going to be used to evaluate the disability, in its section intended for this. This scale gives a result in percent, the highest the percent is the worst., Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
Other Outcome Measures: Activity limitation FFI, To evaluate the difference in activity limitation after the intervention. The Foot Function Index is going to be used in order to evaluate the activity limitation, in its section intended for this. This scale gives a result in percent, the highest the percent is, the worst., Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention|Activity limitation FAAM, The Foot and Ankle Ability Measures is going to be used to evaluate activity limitation. It's section destinated to evaluate this item fives a number that goes from 0 to 84. This number must be divided by 100 to get de final percent. The highest the percent is, the better., Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
Probiotics for Anxiety Study
NCT Number: NCT06466603
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anxiety
Interventions: DIETARY_SUPPLEMENT: GABA Probiotic Dose 1|DIETARY_SUPPLEMENT: GABA Probiotic Dose 2|DIETARY_SUPPLEMENT: Placebo Group
Sponsor: Verb Biotics LLC
Collaborators: People Science, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 122
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-04
Completion Date: 2025-02-11
Locations: People Science, Inc., Los Angeles, California, 90034, United States

Summary:
The purpose of this study is to observe the effect of a consumer-grade probiotic capsule called GABA (gamma-aminobutyric acid ) Probiotic ("Study Product"), a probiotic capsule containing Lactiplantibacillus plantarum 815, on anxiety. The purpose of this study is to evaluate the effects of 2 different doses of this probiotic study product on anxiety in comparison to placebo. Additionally, the study aims to observe the effects of the probiotic study product on mood, cognitive function, quality of life and sleep. After the 6-week study product use period, all participants will be given the option to continue using GABA Probiotic for an additional 4 weeks.

Participants in this study will complete surveys and questionnaires about their experience before, during and after taking the study product. Additionally, this study will incorporate the use of a wrist-worn electronic device to measure sleep.

Primary Outcome Measures: To observe the effect of the 2 different doses of the study product on anxiety, Change in Generalized Anxiety Disorder-7 (GAD-7) score by 4 points between placebo and study product groups. Baseline period will be compared as well GAD-7 scores between the 2 doses., 7 Weeks
Secondary Outcome Measures: To assess the effect of 2 different doses of the study product symptoms of sleep disturbance, Change in the Insomnia Sleep Index (ISI) score by 4.5 points between placebo and study product groups. Baseline period will be compared as well ISI scores between the 2 doses., 7 Weeks|To assess the effect of 2 different doses of the study product on sleep quality, Change in average sleep quality score by 1 point as measured by daily 10-point visual analogue rating scale (VAS) between placebo and study product groups. Baseline period will be compared as well as average scores between the 2 doses., 7 Weeks|To assess the effect of 2 different doses of the study product on quality of life, Change in average mood score by 1 point between placebo and study product groups as measured by a daily 10-point VAS scale. Baseline period will be compared as well the scores between the 2 doses., 7 Weeks|To assess the effect of 2 different doses of the study product on cognitive ability, Change in average score between placebo and study product groups on the Cognitive Assessment: Raven's Progressive Matrices collected weekly. Baseline period will be compared as well the scores between the 2 doses., 7 Weeks
Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire
NCT Number: NCT06466590
Acronym: VRSQ-F
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Virtual Reality Cyber Sickness
Interventions: DIAGNOSTIC_TEST: Use of Measurement Instrument
Sponsor: Pôle Saint Hélier
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06
Completion Date: 2025-03
Locations: Centre de Rééducation Fonctionnelle Neurologique PROPARA, Montpellier, 34090, France|Pôle Saint-Hélier, Rennes, France|Fondation Ildys, Roscoff, 29684, France

Summary:
This is a multicenter, controlled, non-randomized interventional clinical study, with minimal risks and constraints, aimed at verifying the reliability of the French version of the VRSQ questionnaire (VRSQ-F) and the validity of the VRSQ-F score by comparing it with the SSQ score.

Primary Outcome Measures: Check the reliability of the French version of the VRSQ questionnaire (VRSQ-F), Reliability of VRSQ-F using the intraclass correlation coefficient between measurements immediately after VR exercises and 15 min after and Cronbach's coefficient of the VRSQ-F questionnaire, Immediately after exercises|Check the validity of the VRSQ-F score by comparing it with the SSQ score, Criteria validity between SSQ and VRSQ-F. SSQ questionnaire with 16 questions scoring from 0 to 48 VRSQ-F questionnaire with 9 questions from 0 to 27, Immediately after exercises
Secondary Outcome Measures: Calculate the minimum detectable change in the questionnaire, Clinimetric quality: Calculation of the standard error of measurement SEM and the minimum detectable change MDC, Immediately after exercises
Clinical Study of CT 5400 RT for System Validation
NCT Number: NCT06466577
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Performance and Safety
Interventions: DIAGNOSTIC_TEST: CT 5400 RT System
Sponsor: Philips Healthcare (Suzhou) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-28
Completion Date: 2024-09-28

Summary:
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.

Primary Outcome Measures: Clinical image quality, Image quality will be assessed by Likert score (1-5), 14 days (anticipated)
Secondary Outcome Measures: General function assessment, A three-scale assessment will be used for Image exposure level, couch movement, speaker\& microphone voice quality, image post processing capability, data storage.

A three-scale criteria- Very satisfied, Satisfied, Dissatisfied

Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements., 14 days (anticipated)|Convenience assessment, A three-scale assessment will be used for laser positioning, panel control, user-friendly interface of post-processing software, operation of post-processing software.

A three-scale criteria- Very satisfied, Satisfied, Dissatisfied

Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements., 14 days (anticipated)|Workflow and stability assessment, A three-scale assessment will be used for workflow, Image display and transmission, system inactivation, unexpected system shutdown, unexpected termination during scanning, fail to expose during scanning

A three-scale criteria- Very satisfied, Satisfied, Dissatisfied

Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements., 14 days (anticipated)|Incidence of CT Scan-Emergent Adverse Events, Monitor adverse events and serious adverse events(safety and tolerance) during the study, 30 days (anticipated)
Bioabsorbable/Nufairy Coil Application Trial in China
NCT Number: NCT06466564
Acronym: NuCATCH
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intracranial Aneurysm
Interventions: DEVICE: Nufairy® Coil embolization system for intracranial aneurysm
Sponsor: MicroPort NeuroTech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 258
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-24
Completion Date: 2026-06-01
Locations: Shanghai Changhai Hospital, Shanghai, China

Summary:
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.

Primary Outcome Measures: Successful occlusion rate of aneurysm at 12-month post-procedure., It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization)., 12 month
Secondary Outcome Measures: Complete occlusion rate of aneurysm at 12-month post-procedure., The "complete occlusion rate of aneurysm" was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I (i.e., 100% aneurysm embolization)., 12 month|Recurrence rate of aneurysm at 12-month post-procedure., The "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure., 12 month|Retreatment rate of aneurysm at 12-month post-procedure., The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period, 12 month|Device-related serious adverse events at 1, 6, and 12 months after surgery;, 12 month|The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 12 months., 12 month|The incidence of ipsilateral ischemic stroke of the target aneurysm within 12 months., 12 month
Other Outcome Measures: Successful occlusion rate of aneurysm at 18-month post-procedure., It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization)., 18 month|Recurrence rate of aneurysm at 18-month post-procedure., The "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure., 18 month|Retreatment rate of aneurysm at 18-month post-procedure., The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period, 18 month|The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 18 months., 18 month|Device-related serious adverse events at 18 months after surgery, 18 month
The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children
NCT Number: NCT06466551
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Procedural|Anxiety|Pain Management
Interventions: OTHER: intravenous catheterization
Sponsor: Toros University
Sex: ALL
Age: CHILD
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-15
Completion Date: 2025-03
Locations: Toros Üniversty, Mersin, Turkey

Summary:
Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Considering the developmental period characteristics, virtual reality glasses and stress ball squeezing may be effective in the 6-12 age group during painful intervention. However, no study has been found in the literature on which technique is more effective (9-23). Therefore, investigating the effects of virtual reality goggles and stress ball squeezing on pain and fear in children aged 6-12 years as a distraction method during intravenous catheterization may enable nurses to determine the technique with high clinical usefulness in pain management.

Primary Outcome Measures: Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale, Pain scores will be measured using the Wong-Baker FACES Pain Rating Scale. Scores will be recorded before, during, and after intravenous catheterization. Pain will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure)., Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)|Change in Fear Scores Assessed by the Children's Fear Scale, Fear levels will be assessed using the Children's Fear Scale. Scores will be recorded before, during, and after intravenous catheterization. Fear will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure)., Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
Investigate"Clinically" the Effectiveness of Boswellia Based Intracanal Medication Compared to Calcium Hydroxide Ca(OH)2 and Ledermix on the Levels of Bacteria and Inflammatory Cytokines in Root Canals and Periradicular Tissues of Teeth With Apical Periodontitis
NCT Number: NCT06466538
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Microbial Colonization
Interventions: DRUG: Calcium hydroxide|DRUG: Leddermix|DRUG: Boswellia
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-01
Completion Date: 2024-07-20
Locations: May Abuzoor, Mansoura, Egypt

Summary:
The objective of this study is to investigate "clinically" the effectiveness of Boswellia based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Primary Outcome Measures: Microbiological culture (manual counting to bacterial cells), Bacterial counting after culturing of bacteria, up to 8 months
Secondary Outcome Measures: ELISA test to measure levels of Inflammatory cytokines (tumor necrotizing factor, prostaglandin E2, Interleukin 1B), ELISA test to measure levels of Inflammatory cytokines (tumor necrotizing factor, prostaglandin E2, Interleukin 1B), 30 weeks
A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.
NCT Number: NCT06466525
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Parkinson Disease
Interventions: DRUG: LBT-3627|DRUG: Placebo
Sponsor: Longevity Biotech Australia Pty Ltd (subsidiary)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-03
Locations: Alfred Hospital, Melbourne, Victoria, Australia|Nucleus Networks, Melbourne, Victoria, Australia

Summary:
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.

Primary Outcome Measures: Incidence, nature, and severity of adverse events [Safety and Tolerability], Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Secondary Outcome Measures: Maximum Plasma Concentration [Cmax], The peak plasma concentration of a drug after administration., Day of treatment to end of follow-up period (1, 2 or 4 weeks)|Elimination half life [T1/2], The time required for the concentration of the drug to reach half of its original value., Day of treatment to end of follow-up period (1, 2 or 4 weeks)|Time to reach Cmax [Tmax], Time required to reach Cmax., Day of treatment to end of follow-up period (1, 2 or 4 weeks)|Volume of Distribution [Vd], The apparent volume in which a drug is distributed (i.e., the parameter relating drug concentration in plasma to drug amount in the body)., Day of treatment to end of follow-up period (1, 2 or 4 weeks)|Concentration [C], Amount of drug in a given volume of plasma, Day of treatment to end of follow-up period (1, 2 or 4 weeks)|Area under the curve [AUC], The integral of the concentration-time curve (after a single dose or in steady state)., Day of treatment to end of follow-up period (1, 2 or 4 weeks)|Clearance [CL], The volume of plasma cleared of the drug per unit time., Day of treatment to end of follow-up period (1, 2 or 4 weeks)|Bioavailability [f], The systemically available fraction of a drug., Day of treatment to end of follow-up period (1, 2 or 4 weeks)
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults
NCT Number: NCT06466473
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Phenytoin (Ascoli)|DRUG: Phenytoin (Vega Baja)
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-03
Completion Date: 2024-11-08
Locations: Pfizer Clinical Research Unit - New Haven, New Haven, Connecticut, 06511, United States

Summary:
The purpose of this study is to understand how the different formulation of phenytoin is taken up into the blood in Healthy Adults.

This study is seeking healthy adult participants. All the study participants will receive Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site.

We will measure how the phenytoin will be taken up into the blood in Healthy Adults following oral dosing of Phenytoin.

This will help us determine if the Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site are similar or not.

Primary Outcome Measures: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast), 72 hours|Maximum Observed Plasma Concentration (Cmax) of Phenytoin, 72 hours
Secondary Outcome Measures: Number of Participants With Adverse Events (AEs) According to Seriousness, Baseline, up to 35 days post last dose.
Child and Adolescent OCD Outcomes From Exposure and Response Prevention Video Teletherapy Treatment
NCT Number: NCT06466447
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Obsessive-Compulsive Disorder
Interventions: BEHAVIORAL: Exposure and response prevention therapy
Sponsor: NOCD
Sex: ALL
Age: CHILD
Enrollment: 2173
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-23
Completion Date: 2024-05-03
Locations: NOCD, Inc., Chicago, Illinois, 60601, United States

Summary:
This is a naturalistic, observational study of children and adolescents with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy.

Primary Outcome Measures: Dimensional Obsessive-Compulsive Scale, self-rated psychometric instrument to measure symptom severity of multiple OCD subtypes (score range: 0-80), change from pre-treatment to post-treatment (after 11 weeks)
Secondary Outcome Measures: Depression Anxiety and Stress Scale (DASS-21), self-rated psychometric instrument to measure depression, anxiety, and stress (score range: 0-63), pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
NCT Number: NCT06466434
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Unresectable Melanoma
Interventions: OTHER: Prebiotic Food-Enriched Diet
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12-31
Completion Date: 2029-06-30
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.

Primary Outcome Measures: Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline., Up to 2 years
Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
NCT Number: NCT06466421
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Uremic Pruritus|Chronic Kidney Disease-associated Pruritus|Hemodialysis|End-stage Renal Disease|Renal Replacement Therapy|ESRD
Interventions: DRUG: Fexofenadine|DRUG: Gabapentin
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-12-20
Locations: Tanta University, Tanta, Elgharbia, 31527, Egypt

Summary:
Several studies investigated the effectiveness of Gabapentin in Uremic Pruritus (UP). No previous studies investigated the use of fexofenadine in UP. The aim of this trial is to assess the safety and possible efficacy of fexofenadine in patients with UP.

Primary Outcome Measures: The Visual Analogue Scale (VAS), The change in mean score of Visual Analogue Scale (VAS) from baseline., 3 months|Skindex score, The change in mean Skindex score from baseline., 3 months|Kidney Disease Quality of Life Short Form (KDQOL-SF™), The change in mean KDQOL-SF score from baseline., 3 months
Secondary Outcome Measures: Interleukin-6 (IL-6), The change in mean serum level of Interleukin-6 (IL-6) from baseline., 3 months|Substance P, The change in mean serum level of Substance P from baseline., 3 months
Effect of Vegetable and Fruit Enzyme Supplementation on Muscle Activation, Aerobic Capacity, and Blood Biochemical Parameters After High-Intensity Interval Exercise: Feasibility Study of Exercise Design With Exergaming
NCT Number: NCT06466408
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overtraining Syndrome
Interventions: DIETARY_SUPPLEMENT: Supplementation Protocol|DIAGNOSTIC_TEST: Blood Lactate Test|DIAGNOSTIC_TEST: Training Impulse|DIAGNOSTIC_TEST: Exergaming HIIE Test
Sponsor: Shu-Cheng Lin
Sex: FEMALE
Age: OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-25
Completion Date: 2024-07-30
Locations: Tainan University of Technology, Tainan City, 710302, Taiwan

Summary:
This study explores the effectiveness of fruit and vegetable enzyme supplementation in reducing fatigue and enhancing aerobic capacity in elderly individuals after engaging in high-intensity interval exercise (HIIE) through exergaming. Sixteen elderly female participants were divided into two groups based on pre-test lactate levels: an enzyme group and a placebo group, to ensure comparability. They performed HIIE using Nintendo Switch Ring Fit Adventure, completing eight sets of 20-second high-effort exercises with 30-second rest intervals, totaling 370 seconds of activity. The primary metrics evaluated were blood lactate levels, heart rate (HR), rating of perceived exertion (RPE), and training impulse (TRIMP). Participants in the enzyme group received a fruit and vegetable enzyme supplement in a 30 c.c. dose twice daily for 14 days. The study aimed to determine if enzyme supplementation could effectively mitigate the physiological stress of HIIE and improve exercise outcomes in the elderly.

Primary Outcome Measures: Lactate, Measure lactate level with fingertip blood test in Exergaming HIIE, pre and after-intervention: measurements taken before the test, during the 2 and 4 minute of the test, and 5 and 10 minutes after the test.|Heart rate (bpm), Use a heart rate monitor to record heart rate in Exergaming HIIE, Collect the heart rate at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test|Borg 0-10 score rating of perceived exertion (RPE), Use Borg 0-10 score RPE to record RPE in Exergaming HIIE, Collect the RPE at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Secondary Outcome Measures: Training Impulse, Calculate the subjective and objective training Impulse (arbitrary unit, AU) based on the heart rate and RPE., During Exergaming HIIE
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
NCT Number: NCT06466395
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Refractory Acute Leukemia|Relapsed Acute Leukemia|Undifferentiated Leukemia|Bi-Phenotypic Leukemia
Interventions: DRUG: Venetoclax|DRUG: Hyper-CVAD
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 22
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2031-12-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia
NCT Number: NCT06466369
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: BPH With Other Lower Urinary Tract Symptoms
Interventions: DRUG: Tadalafil
Sponsor: Al-Azhar University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 306
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2024-08-01
Locations: outpatient clinic of the urology department at AlZahraa University Hospital, Al-Azhar University, Faculty of Medicine for Girls., Cairo, Egypt

Summary:
The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients.

Primary Outcome Measures: Evaluation of International prostate symptom score (IPSS)/quality of life (QoL)., 3 months compared to baseline|Evaluation of International index of erectile function (IIEF)., 3 months compared to baseline
Immunohistopathologic Findings of Cesarean Scar Niche
NCT Number: NCT06466343
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cesarean Scar Niche
Interventions: PROCEDURE: hysteroscopic resection of lower edge of cesarean scar niche
Sponsor: Sohag University
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-01
Completion Date: 2025-12-30
Locations: Sohag University Hospitals, Sohag, Egypt

Summary:
Niche is iatrogenic pouch like defect, present on the uterine isthmus' anterior wall where a previous caesarean section scar was made. Still, a niche has generally been defined as the myometrium's depression of at least 2 mm (Lumbanraja et al., 2024).

The literature is lacking in information about the accurate histopathologic characteristics of cesarean scar niche ridges that have been removed by hysteroscopy, as well as what critical findings to highlight and what gynaecologists can anticipate from pathology reports of cesarean scar niche specimens (AbdullGaffar \& Almulla ,2022).

In this study the aim of the work is to study the histopathologic findings in cesarean scar niche specimens repaired by hysteroscopy in our institution, identify the causes of local thinning of the uterine scar after c-section to direct gynecologists regarding the efficacy of their hysteroscopic corrective repair of cesarean scar niche concerning the amelioration of symptoms, restoration of fertility, and patient follow-up.

Primary Outcome Measures: the incidence and type of different pathological variations within examined CS niche specimens., measure the incidence and type of different pathological variations within examined CS niche specimens., three weeks
Secondary Outcome Measures: correlation of predominant pathological variation with symptoms of patient and radiological findings., estimate correlation of predominant pathological variation with symptoms of patient and radiological findings., 2 weeks
Is There Effect of Adding Honey Intake to Free Walking in Metabolic Syndrome Children
NCT Number: NCT06466317
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome
Interventions: BEHAVIORAL: Honey intake with walking exercise|BEHAVIORAL: Walking exercise
Sponsor: Ahram Canadian University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2024-10-01
Locations: Ahram canadian university, Giza, Egypt

Summary:
Metabolic Syndrome is common in Children and complementary therapies are important in its treatment such exercise and functional food intake including honey.

Primary Outcome Measures: high density lipoprotein, it is a component of lipid profile, it will be assessed after 12 weeks
Secondary Outcome Measures: triglycrides, it is a component of lipid profile, it will be assessed after 12 weeks|body mass index, it will be measured in morning with empty stomach and badder, it will be assessed after 12 weeks|waist circumference, it will be measured by a tape at the level of umblicus, it will be assessed after 12 weeks|systolic blood pressure, it will be measured by manual sphygomamnaometer, it will be assessed after 12 weeks|diastolic blood pressure, it will be measured by manual sphygomamnaometer, it will be assessed after 12 weeks|fasting blood glucose, it will be measured at morning, it will be assessed after 12 weeks
Inspiratory Muscle Training in Children With Beta Thalasemia
NCT Number: NCT06466304
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Beta Thalassemia Major
Interventions: BEHAVIORAL: inspiratory muscle training
Sponsor: Ahram Canadian University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2024-10-01
Locations: Ahram canadian university, Giza, Egypt

Summary:
respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important

Primary Outcome Measures: forced expiratory volume t the first second of expiration, it will measure pulmonary function, it will be assessed after 12 weeks
Secondary Outcome Measures: forced vital capcity, it will measure pulmonary function, it will be assessed after 12 weeks|FEV1/FVC, it will measure pulmonary function, it will be assessed after 12 weeks|maximal inspiratory pressure, it will measure strength of inspiratory muscles, it will be assessed after 12 weeks|six minute walk testing, it will measure aerobic capacity, it will be assessed after 12 weeks|Pediatrics' Quality of Life Inventory (children proxy), it will assess quality of life and filled by children, it will be assessed after 12 weeks|Pediatrics' Quality of Life Inventory (parent proxy), it will assess quality of life and filled by parents of children, it will be assessed after 12 weeks
Spanish Wilson Disease Registry
NCT Number: NCT06466291
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Wilson Disease
Sponsor: Asociación Española para el Estudio del Hígado
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-12-02
Completion Date: 2030-12
Locations: Hospital Clinic, Barcelona, 08036, Spain

Summary:
The main objective and purpose of the Registry is to know the current status of Wilson Disease in Spain.

As secondary objectives, the prevalence and incidence of the disease will be analysed.

Likewise, the analysis aims to define future areas of interest in its pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment.

Improving knowledge at a national level can help to design screening strategies and improve diagnostic circuits.

Primary Outcome Measures: To know the current status of Wilson Disease in Spain, 2025
Secondary Outcome Measures: To analyse the prevalence of Wilson Disease in Spain, 2025|To analyse the incidence of Wilson Disease in Spain, 2025
Other Outcome Measures: To define future areas of interest in Wilson Disease, To define future areas of interest in the disease pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment, 2025
IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion
NCT Number: NCT06466278
Acronym: SALVAGE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Aortic Valve Stenosis
Interventions: DRUG: Icosapent ethyl|DRUG: Placebo
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2026-12-01
Locations: Academic Medical Center, Amsterdam, 1105AZ, Netherlands

Summary:
This study invastigates the effect of icosapent ethyl in patients with aortic valve stenosis.

Primary Outcome Measures: Change in aortic valve calcium (AVC) score, 2 years
Development and Psychometric Testing of HPV Knowledge Scale
NCT Number: NCT06466252
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Parents|Parent-Child Relations
Interventions: BEHAVIORAL: Psychometric Group
Sponsor: Kaohsiung Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 673
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2023-05-01
Locations: Elementary school, Ngawi, East Java, 63271, Indonesia

Summary:
The aim of this study is to develop and conduct psychometric testing of a new scale, the Human Papillomavirus Knowledge Scale (HPV-KS), particularly designed to assess HPV knowledge among parents of school-age children in Indonesia.

Primary Outcome Measures: Human papillomavirus knowledge scale, it consists of 3 subscales assessed awareness and understanding about human papillomavirus that encompass transmission, related to diseases, prevention, vaccine domestic policy context. it has a binary response format with a true /false response. the items contain favourable and unfavourable statement. A 1-point reflects that the answer is correct and 0-point is incorrect answer. The total scores indicated the knowledge level. The higher score means a better knowledge level, one time collected. participants took 15 minutes to complete all items in form.