pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
NCT Number: NCT06506916
Acronym: BE UNIQUE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis|Psoriatic Arthritis
Interventions: DRUG: bimekizumab
Sponsor: UCB Biopharma SRL
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2027-01-18

Summary:
The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR).

Primary Outcome Measures: Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48, Composite gene expression score using RT-PCR in lesional skin at Baseline and Week 48 using preselected genes based on bimekizumab mechanism of action and PSO disease biology pathways., Week 48, compared to Baseline
Secondary Outcome Measures: Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU), An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs are defined as those AEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy)., From Baseline to End of SFU (up to Week 100)|Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU, A serious adverse event (SAE) must meet 1 or more of the following criteria:

* Results in death
* Is life-threatening
* Requires inpatient hospitalization or prolongation of existing hospitalization
* Results in persistent disability/incapacity
* Is a congenital anomaly/birth defect
* Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious.

TESAEs are defined as those SAEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy)., From Baseline to End of SFU (up to Week 100)|TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU, This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason., From Baseline to End of SFU (up to Week 100)
Study to Determine the Difference in Reduction of Bioaerosols in a Long-term Care Facility
NCT Number: NCT06506890
Acronym: C-PolarLTC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Air Pollution
Interventions: OTHER: Use of C-Polar coated HVAC Filter versus conventional HVAC Filter
Sponsor: C-Polar Innovations
Collaborators: Kelowna General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-05
Completion Date: 2025-08-31
Locations: Kelowna General Hospital, Kelowna, British Columbia, V1Y 1T2, Canada

Summary:
This is a CONTROLLED PROSPECTIVE COHORT study of a long-term care facility. At the start of the study a dedicated section A of the facility ventilation system will have routine HVAC filters of the same dimensions installed, while section B of the same facility ventilation system will have C-POLAR (cationic polymeric coated) HVAC filters installed. There will be continuous Indoor Air Quality monitors (PM 2.5, CO2, VOC, Radon, Temp, and RH) installed at different vent locations throughout the long-term care facility for the duration of the study. Air samples with an Airport MD8 BAMS machine will be taken once a week at various vent locations at the long-term care facility.

Primary Outcome Measures: The primary endpoint is comparing the difference in reduction of bioaerosols between MERV 13 HVAC filters., The aim of this study is to determine the difference in reduction of bioaerosols in a long-term care facility with MERV 13 C-POLAR (cationic polymeric coated) HVAC filters compared to conventional MERV 13 HVAC filters., Nine Months
A Cognitive Risk Calculator and Screening Tool for Primary Care Settings
NCT Number: NCT06506877
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Risk Assessment
Interventions: BEHAVIORAL: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)
Sponsor: The Cleveland Clinic
Collaborators: National Institute on Aging (NIA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-04-03
Completion Date: 2025-08-31
Locations: Cleveland Clinic, Cleveland, Ohio, 44195, United States

Summary:
This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).

Primary Outcome Measures: Adoption of RC and BACH: Frequency of Cognitive Screening, Number of cognitive screening events per month, stratified by screening tool (BACH vs other) and Risk Calculator category (high vs low risk)., Monthly assessment over the study duration (up to 1 year)|Adoption of RC and BACH: Frequency of BACH Orders, Number of BACH orders or pre-visit order sets executed per month, stratified by Risk Calculator category (high vs low risk)., Monthly assessment over the study duration (up to 1 year)|Effectiveness of RC and BACH: Frequency of MCI/ADRD, Sleep Disorders, and Depression Diagnoses, Incidence of new diagnoses for cognitive impairment (including MCI and ADRD), sleep disorders, and depression per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk)., Monthly assessment over the study duration (up to 1 year)|Effectiveness of RC and BACH: Frequency of Referrals to Neuropsychology, Geriatrics/Neurology, Psychiatry/Psychology, and Sleep Medicine, Number of orders and consults placed to specialty services per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk)., Monthly assessment over the study duration (up to 1 year)|Effectiveness of RC and BACH: Prescription Rates for Related Medications, Number of new medication orders relevant to cognition, sleep, and mood per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk)., Monthly assessment over the study duration (up to 1 year)
Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®)
NCT Number: NCT06506851
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Equipment and Supplies|Augmented Reality|Nurse's Role
Interventions: OTHER: AR-based Training with Microsoft HoloLens 2®|OTHER: Traditional Guideline-based Self-Learning
Sponsor: Samsung Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-07-17
Completion Date: 2023-09-05
Locations: Samsung Medical Center, Seoul, 06351, Korea, Republic of

Summary:
The goal of this clinical trial is to compare the effectiveness of AR-based training with traditional guideline-based self-learning in practical nurses without prior Level-1® experience. The main questions it aims to answer are:

Does AR-based training using Microsoft HoloLens 2® improve clinical performance compared to traditional guideline-based self-learning? Does AR-based training affect self-efficacy and educational satisfaction compared to traditional methods?

Participants will:

Receive AR-based training using Microsoft HoloLens 2® (experimental group) Follow traditional guideline-based self-learning (control group) Researchers will compare the AR-based training group to the traditional self-learning group to see if AR-based training leads to better clinical performance, higher self-efficacy, and greater educational satisfaction.

Primary Outcome Measures: Clinical Competency, This measurement assesses nurses' clinical competency in rapid infusion procedures. It includes evaluation of learning time, performance time, accuracy, and assistance requests., before training, immediately after training
Secondary Outcome Measures: Self-efficacy, This assessment measures nurses' self-efficacy in rapid infusion procedures using a modified self-efficacy scale. It evaluates confidence levels in performing tasks related to rapid infusion., efore training, immediately after training
Other Outcome Measures: Educational Satisfaction Evaluation, This evaluation assesses nurses' satisfaction with the educational program. It includes measures of confidence, relevance, and willingness to recommend the training to others using a structured questionnaire., Educational satisfaction will be assessed immediately after the completion of the training program.
Anlotinib Combined With Doxorubicin and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma
NCT Number: NCT06506838
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Soft Tissue Sarcoma|Doxorubicin|Radiotherapy
Interventions: DRUG: Anlotinib
Sponsor: Guangdong Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2028-07-20
Locations: Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China|Guangdong provincial people's hospital, Guangzhou, Guangdong, 516008, China

Summary:
Exploring the Efficacy and Safety of Anlotinib Combined with Doxorubicin Monotherapy and Radiotherapy as Neoadjuvant Treatment for Soft Tissue Sarcoma

Primary Outcome Measures: Major Pathological Response rate, Typically defined as residual tumor cells ≤10% in the surgical specimen after treatment, 3 months|Pathologic Complete Response rate, Absence of any residual tumor cells in the surgical specimen following treatment., 3 months
Secondary Outcome Measures: Objective Response Rate, The proportion of patients in a clinical trial whose tumor size decreases (partial response) or disappears (complete response) after treatment., 3 months|Disease-Free Survival, The length of time during and after treatment that a patient lives with the disease without it progressing, 2 years
Construction and Application of Database of Hebei Provincial Gastric Cancer Collaborative Network Driven by Artificial Intelligence Technology
NCT Number: NCT06506825
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: The Study Focuses on Gastric Cancer
Interventions: DIAGNOSTIC_TEST: Gastric Cancer AI-driven Data Integration Genomic Analysis Biomarker
Sponsor: Qun Zhao
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2030-12-31
Locations: Department of General Surgery, Shijiazhuang, Hebei, 050011, China

Summary:
This clinical trial aims to construct and apply a collaborative network database for gastric cancer in Hebei Province, driven by artificial intelligence (AI) technology. The project seeks to integrate clinical data, genomic information, and treatment outcomes from multiple hospitals and research centers within the region. By leveraging advanced AI algorithms, the database will facilitate comprehensive data analysis to identify novel biomarkers, optimize therapeutic strategies, and improve patient outcomes. This initiative will also support real-time data sharing and collaboration among healthcare providers, researchers, and policymakers, ultimately enhancing the overall management and treatment of gastric cancer in Hebei Province.

Primary Outcome Measures: 5-year overall survival, 5-year overall survival, 2025-12-31
Secondary Outcome Measures: 5-year recurrence-free survival, 5-year recurrence-free survival, 2025-12-31
Effect of Training on the Use of Physical Restraints
NCT Number: NCT06506799
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fixation Device; Complications|Nursing Caries
Interventions: OTHER: Training Given to Intensive Care Nurses on the Use of Physical Fixation
Sponsor: Fenerbahce University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-28
Completion Date: 2024-10-25

Summary:
Patients in the intensive care unit may harm themselves by pulling medical equipment such as endotracheal tube, monitoring, arterial and peripheral catheters. Physical detection is also one of the common practices used in this case. Physical restraint is a practice performed by using patient aids to protect the individual or other patients around him, to ensure his safety and to control his behavior. Although physical detection seems to be a useful and simple method, it brings with it various physical, psychological, ethical, legal and moral problems. Nurses should use alternative strategies to prevent and reduce the use of restraint, and to avoid the negative consequences that may be caused by restraint by performing restraint appropriately and effectively, and thus ensure the safety of the patient. Evaluating nurses' knowledge on this subject, identifying deficiencies and providing training is important in terms of improving the quality of care and ensuring patient safety.

Primary Outcome Measures: outcome 1, Training on the Use of Physical Restraint Given to Intensive Care Nurses Will Increase the Score of the Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale., 2 week
Garden-fresh Foods and Gut Microbiomes
NCT Number: NCT06506786
Acronym: GFF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gut Microbiome
Interventions: OTHER: Garden-fresh Produce|OTHER: Supermarket Produce
Sponsor: University of Oregon
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-07-01
Completion Date: 2024-12-31
Locations: Institute for Health in the Built Environment, University of Oregon, Eugene, Oregon, 97403, United States

Summary:
The purpose of this research is to explore what types of microbes are present on garden-fresh versus store-bought fruits and vegetables, as well as how they might affect the human gut microbiome.

Primary Outcome Measures: Difference in fecal bacterial abundance, as characterized by qPCR with "universal" bacterial primers, ANOVA statistical test of bacterial gene copies (a proxy for absolute abundance) used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal bacterial abundance., Baseline, 1 week, 3 weeks|Difference in fecal microbial diversity, as characterized by shotgun metagenomics., ANOVA statistical test of Shannon index used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial diversity., Baseline, 1 week, 3 weeks|Difference in fecal microbial composition, as characterized by shotgun metagenomics., PERMANOVA statistical test used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial composition., Baseline, 1 week, 3 weeks|Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics., Negative binomial GLM statistical test used to identify microbial taxa associated with either Garden-Fresh Produce or Supermarket Produce intervention., Baseline, 1 week, 3 weeks
Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)
NCT Number: NCT06506773
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-09
Completion Date: 2026-08
Locations: St. Luke's Cystic Fibrosis Center of Idaho, Boise, Idaho, 83702, United States|Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, 46202, United States|ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center, Toledo, Ohio, 43606, United States|Prisma Health Clinical Research Unit - Midlands, Columbia, South Carolina, 29203, United States

Summary:
The purpose of the study is to evaluate the natural history of exocrine pancreatic function by assessing Fecal elastase-1 (FE-1) in infants with CF during their first year of life.

Primary Outcome Measures: Proportion of Participants with FE-1 greater than or equal to (≥) 200 microgram per gram (µg/g) Over Time, From Enrollment up to the Infant turning 12 Months of Age
Secondary Outcome Measures: FE-1 level Over Time, From Enrollment up to the Infant turning 12 Months of Age
Navigated Photogrammetry Compared to Standard Stereophotogrammetry
NCT Number: NCT06506747
Acronym: FSTMP
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Doctor Efficiency|Dental Prosthesis Fit
Interventions: DEVICE: Navigated Photogrammetry|DEVICE: Standard Photogrammetry
Sponsor: X-Nav Technologies, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2025-06-25
Locations: Capital Center For Oral and Maxillofacial Surgery and For Cosmetic Surgery, Washington, District of Columbia, 20037, United States

Summary:
The purpose of this study is to compare the clinical outcome of Navigated Photogrammetry to standard stereophotogrammetry techniques in digital dentistry for the following two parameters:

* The amount of time needed to prepare the provisional digital files for use in the lab, measured in direct doctor interaction time.
* Suitability of delivered provisional occlusion.

Participants will receive either a provisional manufactured by the output of Navigated Photogrammetry, or a provisional manufactured by the output of standard stereophotogrammetry.

Primary Outcome Measures: Provisional prosthesis fit, The passive fit of the provisional prosthesis onto the implants as well as occlusal fit with the opposing jaw., at provisional placement completion, approximately 2 weeks|Clinician interaction time, The amount of time needed to prepare each type of provisional digital files for use in the lab, measured in direct doctor interaction time., at provisional placement completion, approximately 2 weeks
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
NCT Number: NCT06506734
Acronym: SMILE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dental Diseases
Interventions: OTHER: Questionnaires
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-02
Locations: University Hospital Bordeaux, Bordeaux, France|University Hosptial Caen, Caen, France|University Hospital Lille, Lille, France|Hospices Civils de Lyon, Lyon, France|University Hospital Marseille, Marseille, France|Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov, Paris, France|Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris, Paris, France|Assistance Publique-Hôpitaux de Paris, Hôpital Necker, Paris, France|University Hospital Rennes, Rennes, France

Summary:
The main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years. The study will also examine risk factors associated with this condition, such as the duration and severity of hyperbilirubinemia, underlying diseases, and treatments received.

The researchers hypothesize that the quality of life of individuals with dental dyschromia is lower than that of individuals without dyschromia. The results of this study will be used to discuss coverage for dental care with health insurance for children affected by this condition.

Primary Outcome Measures: Prevalence of dental dyschromia, presence of dyschromia or not evaluated by 2 investigators, from birth to study completion, a maximum of 19 years
Secondary Outcome Measures: Presence or absence of dental dyschromia, Presence or absence of dental dyschromia based on various variables such as bilirubin levels or the duration of hyperbilirubinemia., through study completion, an average of 18 months
Other Outcome Measures: Quality of life score by patient group, Assess the quality of life score based on the patient's group classification, through study completion, an average of 18 months
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
NCT Number: NCT06506721
Acronym: DiBal
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Delivery, Obstetric|Cesarean Section|Obstetric Delivery
Interventions: DEVICE: Double ballon device, Cook|DEVICE: Hygroscopic cervix dilators, Dilapan-S
Sponsor: Insel Gruppe AG, University Hospital Bern
Sex: FEMALE
Age: ADULT
Enrollment: 137
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-12-29
Completion Date: 2026-12-28
Locations: University Hospital of Obstetrics and Gynäkologie, Inselspital, Bern, 3010, Switzerland

Summary:
The objective of the study ist to compare the Dilapan-S and the Cook Ballon device for the mechanical induction of labour in women with a previous C-section. There is currently lack of data regarding this comparison of the two methods for mechanical labour induction in this patient collective. Any method used for labour induction is therefore off-label. The primary outcome is the time between placement of the device and delivery. Ad secondary outcomes are among others the cesarean delivery rate and patient satisfaction with the induction method.

Primary Outcome Measures: Induction-to-delivery interval (IDI) after induction of labour (COOK catheter or Dilapan) in women with previous CS., The time between placement of the device and delivery, 72 hours
Secondary Outcome Measures: Cesarean delivery rate, How many women will get at the end a C-section after inducing the labour, 72 hours|Neonatal outcomes, The cord arterial pH (\< 7.10), 2 hours|Neonatal outcomes, 5 minutes APGAR-Score (\< 7), 2 hours|Neonatal outcomes, Transfer to the ICU, 2 hours|Maternal infection rate, To asses the maternal infection status the investigators use the temperature (fever \>38.0°), Leucocytosis (\> 16.000 G/l), CRP (\> 50), 96 hours|Patient satisfaction, All participant will receive a questionnaire after birth regarding the time from induction initiation until active phase of labour, covering questions such as convenience of the induction method (multiplicity of vaginal manipulation, comfort and pain experience), 96 hours
Comparing CIMT With Virtual Reality to CIMT
NCT Number: NCT06506682
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: BEHAVIORAL: Constraint Induced Movement Therapy|BEHAVIORAL: CIMT + VR
Sponsor: Texas Scottish Rite Hospital for Children
Collaborators: Texas Woman's University
Sex: ALL
Age: CHILD
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-05-17
Completion Date: 2024-05-01
Locations: Scottish Rite for Children, Dallas, Texas, 75219, United States

Summary:
This study is being done to compare constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) and its impact on how the children with unilateral cerebral palsy use their arm. CIMT is an intensive upper limb therapy for children with one sided (unilateral) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Both groups will work on using both arms together to complete activities (bimanual training) as a way to transfer newly learned skills with one hand into two handed tasks. Assessments before and after the intervention will include clinical assessments (where a research team member observes the child doing tasks and ask questions), motion capture (where the child's movement is recorded using multiple cameras), and wearable sensors on the wrists (like a watch).

Primary Outcome Measures: Assisting Hand Assessment (AHA), assessment of bimanual hand skills in children with cerebral palsy well the involved hand performs during two handed activities,, Baseline, pre-intervention and immediate post-intervention
Secondary Outcome Measures: Melbourne Unilateral Upper Limb Assessment (MUUL), how well the involved hand works and active range of motion, Baseline, pre-intervention and immediate post-intervention|ICF Brief Core Set for Cerebral Palsy, Interview based on ICR Core Set, Baseline, pre-intervention|Hypertonia Assessment Tool Assessment Tool (HAT), tone assessment, Baseline, pre-intervention and immediate post-intervention|Canadian Occupational Performance Measure Occupational Performance Measure (COPM), Goal setting, Baseline, pre-intervention and immediate post-intervention|sensory assessment, assess sensory of hand stereognosis, two point discrimination, proprioception,, Baseline, pre-intervention and immediate post-intervention|motion capture with electromyography (EMG), while completing the AHA, Baseline, pre-intervention and immediate post-intervention|option wearing of ActiGraphs on upper limbs, real time tracking of use of upper extremities, Baseline, pre-intervention and immediate post-intervention
Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors (NausiCAA)
NCT Number: NCT06506578
Acronym: NausiCAA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Benign Brain Tumor
Interventions: RADIATION: Radiation
Sponsor: University Hospital, Bordeaux
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-20
Completion Date: 2026-06
Locations: CHU de Bordeaux, Service de Radiothérapie, Bordeaux, France|Hospices Civils de Lyon, Service d'Oncologie Radiothérapie - Hôpital Neurologique, Lyon, France|Institut de cancérologie Strasbourg Europe (ICANS), Service d'Oncologie Radiothérapie, Strasbourg, France

Summary:
Patients irradiated to the brain frequently experience nausea. The dorsal vagal complex (DVC) area is a specific brainstem zone and has been identified as likely responsible for nausea. Existing clinical studies show correlation between dose to the DVC and nausea, but they concern tumors of the airways and upper digestive tract, where there are many confounding factors.

The aim of this study is to establish a ling between radiation dose to the DVC and nausea. Defining a dose threshold to the DVC will allow radiation oncologists to optimize radiation dose distribution and reduce nausea in patients.

Primary Outcome Measures: Functional Living Index-Emesis (FLIE score), Validated score with 9 items of Likert scale concerning nausea, At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Secondary Outcome Measures: Nausea grading, Common Terminology Criteria for Adverse Events (CTCAE) V5.0, At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy|Brief Fatigue Inventory (BFI), Validated score with 9 items of Likert scale concerning fatigue, At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy|Dosimetric parameters of the Dorsal Vagal Complex, Mean Dose to the Dorsal Vagal Complex, One day after completion of radiotherapy|Dosimetric parameters of the Braintem, Mean Dose to the Braintem, One day after completion of radiotherapy
Low-Dose Ketamine Infusion During Burn Wound Care
NCT Number: NCT06506565
Acronym: IMPROVE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Burn|Pain|Dissociation|Opioid
Interventions: DRUG: Ketamine|DRUG: 0.9% NaCl
Sponsor: University of Tennessee
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-08
Completion Date: 2025-12
Locations: Regional One Health, Memphis, Tennessee, 38103, United States

Summary:
The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.

Primary Outcome Measures: Analgesia, Numeric Pain Rating Scale, up to 7 days from enrollment
Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
NCT Number: NCT06506526
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulpal Necrosis
Interventions: PROCEDURE: Sodium hypochlorite irrigating solution|PROCEDURE: one minute NaOCL+Chitosan|PROCEDURE: Three minute NaOCL+Chitosan
Sponsor: Suez Canal University
Sex: ALL
Age: CHILD
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-14
Completion Date: 2023-12-20
Locations: Mostafa youssef, Ismailia, Egypt

Summary:
45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):

Group1(control group):

The teeth will be irrigated by 2 ml 1% NaOCl after each file.

Group2:

The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.

Group 3:

The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes.

Evaluation

Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold.

Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively.

The decrease of radiolucency and the presence of internal or external root resorption will be evaluated.

Bacteriology :

The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University.

PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.

Primary Outcome Measures: Spontanous Pain, Visual analog scale "A scale from 1 to 10 where 1 is mild pain and 10 Worst pain", after one month, 3 months, six months and 12 months|Radiographical evaluation, The change of radiolucency, immediately after restoration, 3 months, six months and 12 months|Radiographic examination " internal or external root resorption", Presence (1) or absence (0), immediately after restoration, 3 months, six months and 12 months|Bacteriology, PCR will be used for detection of Enterococcus faecalis.

- Microbiological investigation will be used for counting the number of Enterococcus faecalis, During procedure
Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease
NCT Number: NCT06506513
Acronym: MYO-MASLD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Interventions: OTHER: High-intensity interval training|OTHER: Moderate intensity exercise training|OTHER: Low intensity exercise training
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators: Concerted Research Action|Fonds National de la Recherche Scientifique
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-09
Locations: Cliniques universitaires Saint-Luc, Brussels, 1200, Belgium|Centre d'investigation clinique en nutrition, Louvain-La-Neuve, 1348, Belgium

Summary:
Muscle changes including myosteatosis are reported as highly prevalent in metabolic dysfunction-associated steatotic liver disease (MASLD). Recent studies highlighted a link between muscle fat content and liver disease severity. Conversely, MASLD histological remission though diet or metabolic surgeries is also linked to a decrease in muscle fat content. Therefore, skeletal muscle appears as a potential target to treat MASLD.

Primary Outcome Measures: the impact of physical activity on muscle and liver phenotypes, the investigators will assess at baseline and every four weeks till study completion the impact of intervention on liver phenotype assessed by transient elastography and muscle phenotype assessed by MRI, every four weeks from baseline till study completion
Unilateral Biportal Endoscopy Lumbar Interbody Fusion (ULIF) Versus Posterior Lumbar Interbody Fusion (PLIF) in Management of Single Level Lumbar Degenerative Disease: A Retrospective Study
NCT Number: NCT06506500
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Lumbar Degenerative Disease
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-01
Completion Date: 2024-05-01
Locations: Sun Yat-sen Memorial Hospital, Sun Yat-sen University,, Guangzhou, Guangdong, 512000, China

Summary:
The study aimed to compare the clinical efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion (ULIF) with posterior lumbar interbody fusion (PLIF) in the treatment of single-level lumbar degenerative diseases.

Primary Outcome Measures: ODI, Oswestry Disability Index, before surgery，1-week，1-month，3-month，6-month and 1-year postoperative
Effectiveness of Doll Therapy in People With Dementia
NCT Number: NCT06506487
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dementia
Interventions: BEHAVIORAL: Doll Therapy
Sponsor: University of Malaya
Sex: ALL
Age: OLDER_ADULT
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-31
Completion Date: 2024-12-31

Summary:
This study aims to evaluate the effectiveness of doll therapy in reducing the daily dose of medications (DDM), behavioral and psychological symptoms of dementia (BPSD), and improving the activities of daily living (ADL) in people living with dementia (PLwD) in residential care facilities in China. The study employs a cluster randomized controlled trial design, involving 142 participants from six nursing homes, divided into an intervention group receiving doll therapy plus routine nursing care and a control group receiving routine nursing care alone. Additionally, the study will explore the experiences and perceptions of staff and family caregivers through qualitative research methods to provide a comprehensive understanding of the intervention's impact.

Primary Outcome Measures: Change in Daily Dose of Medication (DDM), This primary outcome measure will assess the effectiveness of doll therapy in altering the daily dose of medications (DDM) required by participants. The daily dose of medications includes antipsychotics, antidepressants, anxiolytics, and cognitive enhancers, converted to standardized doses (e.g., chlorpromazine equivalents for antipsychotics, diazepam equivalents for anxiolytics, donepezil equivalents for cognitive enhancers, and defined daily dose (DDD) for antidepressants). The change in medication dosage will be measured and compared between the intervention group (doll therapy plus routine care) and the control group (routine care alone)., 12 weeks
Secondary Outcome Measures: Change in Behavioral and Psychological Symptoms of Dementia (BPSD), This secondary outcome measure will evaluate the change in behavioral and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI-12). This inventory includes 12 domains such as delusions, hallucinations, agitation/aggression, depression, anxiety, and others. The scores will be measured and compared between the intervention and control groups. The NPI-12 scores range from 0 to 144, with higher scores indicating more severe symptoms., 12 weeks|Change in Activities of Daily Living (ADL), This secondary outcome measure will assess the change in activities of daily living (ADL) using the Chinese version of the Barthel Index of ADL. This index measures the functional independence of participants in performing daily activities such as feeding, bathing, dressing, toileting, transferring, and walking. The scores will be measured and compared between the intervention and control groups. The Barthel Index scores range from 0 to 100, with higher scores indicating better functional independence., 12 weeks
Empagliflozin Reversal of Arterial StiffnEss in Aging
NCT Number: NCT06506422
Acronym: ERASE-Aging
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Aging|Arterial Stiffness
Interventions: DRUG: Empagliflozin 10 MG|DRUG: Placebo
Sponsor: University of Missouri-Columbia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-18
Completion Date: 2029-02-28

Summary:
Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.

Primary Outcome Measures: Carotid Femoral Pulse Wave Velocity (cfPWV), cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points.

Report, Baseline (day 0), Week 4, Week 8, Final (week 12)
Coronary Artery Disease Mortality in Turkiye
NCT Number: NCT06506383
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease (CAD) Mortality
Interventions: OTHER: No Intervention as this is an ecological study
Sponsor: Medipol University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 81
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2023-06-30
Locations: Istanbul Medipol University, Beykoz, Istanbul, 34810, Turkey

Summary:
This study aims to analyze the geographical variations and identify key environmental and behavioral predictors of coronary artery disease (CAD) mortality in Turkiye.

Primary Outcome Measures: CAD Mortality, coronary artery disease (CAD) mortality per 100,000 population, 2010-2019
Nonsurgical Periodontal Care for Diabetes Patients: A Case-Control Study
NCT Number: NCT06506370
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Periodontitis|Diabetes
Interventions: OTHER: nonsurgical periodontal treatment
Sponsor: Universidad de Murcia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-03-04
Completion Date: 2013-12
Locations: Clínica Odontológica Universitaria, Murcia, 30008, Spain

Summary:
Diabetes mellitus (DM) and periodontitis are two chronic diseases that are interconnected. The coexistence of these conditions leads to increased severity of periodontitis and challenges in controlling blood glucose levels in diabetic patients. The aim of the present study was to evaluate both the influence of periodontal disease and its treatment in patients with DM in terms of a reduction in glycosylated haemoglobin levels at 3 and 6 months after treatment.

Primary Outcome Measures: Level of glycosylated haemoglobin (HbA1c), The HbA1c test is expressed as a percentage, with a normal range being below 5.7%, prediabetes between 5.7% and 6.4%, and diabetes 6.5% or higher., All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.
Secondary Outcome Measures: Plaque index, The plaque index is a clinical measure used to assess the amount of dental plaque on teeth. It evaluates the thickness and extent of plaque accumulation on the tooth surfaces. Typically, a scoring system is used, ranging from 0 (no plaque) to 3 (abundant plaque), All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.|Bleeding on probing, Bleeding on probing (BOP) is a clinical sign used in dentistry to assess gum health. It occurs when gentle probing of the gums around the teeth causes bleeding, indicating inflammation or infection, such as gingivitis or periodontitis., All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.|Periodontal probing depth, Periodontal probing depth is the measurement of the space between the gum and the tooth, from the top of the gumline to the bottom of the pocket. This is done using a periodontal probe and is used to assess the health of the gums and diagnose periodontal disease. Healthy gums typically have probing depths of 1-3 mm., All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.|Clinical attachment level, Clinical attachment level (CAL) is the measurement from the cementoenamel junction (CEJ) to the base of the periodontal pocket. It indicates the extent of periodontal support loss around a tooth, combining probing depth and gum recession. CAL is crucial for diagnosing and monitoring periodontal disease., All the samples were reviewed at 3 and 6 months after treatment, and all the periodontal and endocrine-metabolic variables mentioned above were noted.
A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.
NCT Number: NCT06506357
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginal Health|Women's Health
Interventions: DIETARY_SUPPLEMENT: Good Girl Probiotics
Sponsor: Love Wellness
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-24
Completion Date: 2024-06-24
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.

Primary Outcome Measures: Vaginal and Urinary Tract Health and Balance, Assessment of vaginal and urinary tract health and balance through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8., Baseline, Week 2, Week 4, Week 6, Week 8
Secondary Outcome Measures: Vaginal Environment and Odor, Assessment of the vaginal environment and odor through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8., Baseline, Week 2, Week 4, Week 6, Week 8
Syncing Screening and Services for Suicide Prevention Across Health and Justice Systems
NCT Number: NCT06506344
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Suicide Prevention
Interventions: BEHAVIORAL: 5S Trial
Sponsor: Henry Ford Health System
Collaborators: National Institute of Mental Health (NIMH)|Michigan State University|HealthPartners Institute|Brown University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-24
Completion Date: 2027-06-30
Locations: Henry Ford Health, Detroit, Michigan, 48202, United States|HealthPartners Institute, Bloomington, Minnesota, 55425, United States

Summary:
This study aims to harmonize jail release record data with electronic health record data in order to connect patients to an evidence-based suicide prevention and clinical care pathway upon jail release.

Primary Outcome Measures: Composite measures of suicide attempt and death, Nonfatal medically treated suicide attempts will be identified using diagnosis and encounter codes from all inpatient, outpatient, and emergency department encounters recorded in the EHR (for services delivered by participating systems) or claims (for outside services). All suicide deaths will be identified via linkage to regularly updated state mortality data and the National Death Index (NDI). Suicide deaths will be identified using ICD-10 codes indicating definite or possible self-inflicted injury, or deaths identified as suicides in official state government mortality data (updated monthly in each site)., 6-months from jail release date