pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Hyperbaric Oxygen Treatment for Veterans with Traumatic Brain Injury
NCT Number: NCT06581003
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Traumatic Brain Injury|Military Operations
Sponsor: University of South Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 420
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2029-08-15

Summary:
The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are:

* Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms?
* How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms?
* Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms?

Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen.

Participants will:

1. Complete baseline assessments to determine eligibility.
2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks.
3. Complete questionnaires and interviews throughout the course of the study.
4. Complete a 2-week post treatment visit

Primary Outcome Measures: Change from Baseline in the Neurobehavioral Symptoms at 2 weeks Post Intervention, Measured by the Neurobehavioral Symptom Inventory (NSI). The severity of each symptom on the NSI is measured using a 5-item scale (0-none to 4-very severe) that asks patients to indicate the extent to which each symptom has disturbed them in the previous 2 weeks. The NSI total score is the sum of severity ratings of the 22 symptoms. Cluster scores (domains: physical, cognitive, affective, and sensory) were derived., at 2 weeks post treatment
Secondary Outcome Measures: Change from Baseline in post traumatic stress disorder symptoms at 2 weeks post intervention, measured by the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-5); PTSD Checklist-5 (PCL-5). The PTSD Checklist for DSM-5 (PCL-5) is a self-report measure used to assess the presence and severity of PTSD symptoms based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). A score between 0-80 Higher Scores: Indicate a worse outcome, as they suggest a greater severity of PTSD symptoms.

Lower Scores: Indicate a better outcome, as they suggest fewer or less severe PTSD symptom, at 2 weeks post treatment
Heat and Exercise in Aging as Therapy (HEAT)
NCT Number: NCT06580964
Acronym: HEAT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prediabetic State
Interventions: BEHAVIORAL: Heat therapy|BEHAVIORAL: High-intensity interval training
Sponsor: Hui Ying Luk
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2025-02
Completion Date: 2029-07
Locations: Texas Tech University, Lubbock, Texas, 79409, United States

Summary:
The main goal of this two-phase clinical trial is to learn whether local heat therapy, using heat pads applied to the legs, can enhance skeletal muscle health, physical function, and blood sugar control in a manner comparable to exercise, specifically High-Intensity Interval Training (HIIT), in older individuals with prediabetes. The study aims to answer the following questions:

1. Does local heat therapy improve muscle architecture (e.g., muscle cross-sectional area, capillary density, mitochondrial content), glucose tolerance, and frailty indicators similarly to HIIT in older individuals with prediabetes?
2. Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes?

Primary Outcome Measures: Glycemic control, Oral glucose tolerance test (OGTT), Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)|Skeletal muscle architecture 1, Immunohistochemical assessment of muscle fiber cross-sectional area and capillary density, Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)|Skeletal muscle architecture 2, Assessment of skeletal muscle mitochondrial content, Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)|Frailty status, Fried's Phenotypic Frailty assessment, Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)|Exercise capacity, VO2peak testing, Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Secondary Outcome Measures: Anthropometrics 1, Body mass and height to calculate body mass index (BMI), Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks|Anthropometrics 2, Waist-to-hip ratio, Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks|Body composition, Lean versus fat mass assessed by dual-energy x-ray absorptiometry (DEXA), Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)|Sleep quality, 7-point likert scale, Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Intra-Articular Catheter Total Knee Arthroplasty
NCT Number: NCT06580899
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Continuous Local Infiltration Analgesia|Intra-articular Catheter|Total Knee Arthroplasty
Interventions: DEVICE: Intra-articular catheter|OTHER: Routine Standard of Care Treatment
Sponsor: OrthoCarolina Research Institute, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: OrthoCarolina Research Institute, Inc., Charlotte, North Carolina, 28207, United States

Summary:
This is a prospective, randomized clinical trial evaluating three groups. The groups are:

Group 1 (Control): Subjects that receive only the existing standard-of-care multimodal pain management protocol and do not receive post-operative intra-articular catheter.

Group 2 (Investigational Treatment/Intervention): Subjects that receive the brand 1 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.

Group 3 (Investigational Treatment/Intervention): Subjects that receive the newer brand 2 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.

Primary Outcome Measures: Numeric Pain Rating Scale, Numeric Pain Rating Scale (0-10 scale where 10 is worse), 2 days postoperative, 2 weeks postoperative
Secondary Outcome Measures: Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.), KOOS Jr. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health, 6 weeks postoperative
Other Outcome Measures: Anesthesia Type, type of anesthesia used during procedure, at time of surgery|tourniquet times, how long was a tourniquet used during procedure, at time of surgery|range of motion, knee range of motion, preoperative, 2 weeks postoperative, 6 weeks postoperative
Psychiatric Multi-omics and Neuroimaging Project
NCT Number: NCT06580860
Acronym: PMNP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental Disorders|Healthy Control
Sponsor: mingjun Zhong
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1899
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01
Completion Date: 2025-12

Summary:
This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.

Primary Outcome Measures: cortical morphology, Data were obtained using magnetic resonance scans, 40 minutes|target gene charaacteristics, 10ml peripheral blood was extracted for gene analysis, 1 day|scale scores, The score of each dimension and the total score were calculated according to the scale.The scale includes three dimensions: negative symptom, positive symptom and general psychopathology, and the score range of each dimension is different. The total score ranges from 30 to 210, with higher scores indicating worse results., 90 minutes.
Efficacy of the Modified Free Gingival Graft Technique
NCT Number: NCT06580821
Acronym: FGG
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Modified Free Gingival Graft , Connective Tissue Graft
Sponsor: Universidad de Especialidades Espiritu Santo
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-12-15

Summary:
Gingival recessions can be defined as the exposure of the root surface after an apical migration of the gingival margin in relation to the cemento-enamel junction. Gingival recessions affect both younger and older populations. Various surveys revealed that 88% of people ≥65 years of age and 50% of people between 18 and 64 years of age have ≥1 site with gingival recession. Gingival recessions can occur due to anatomical, pathological factors or trauma and will result in a loss of attachment.

Primary Outcome Measures: To evaluate the long-term efficacy of the modified free gingival graft technique on root coverage., This technique is a modified version of the Free gingival graft, which is a surgery that attempts to improve the height of the keratinized tissue, as well as augment the thickness of the gingival phenotype. This modified version is based on a connective pedicle flap is flipped from its apical origin to cover the exposed root surface prior to the positioning of the Free gingival Graft. The rationale behind the approach is to improve the revascularization of the graft., From enrollment to the end of treatment at 12 months, evaluating at 7 days, 14 days, at the first month and after that every 3 months.
Effects of an Immersive Virtual Reality Program
NCT Number: NCT06580769
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physical Activity|Virtual Reality|Physical Fitness
Interventions: OTHER: Physical activity
Sponsor: Universidad Autónoma de Chile
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2024-12-31

Summary:
A tool that could be useful to eliminate the barriers of not practicing physical activity can be immersive virtual reality, which is characterized by being a technique where a person, through the use of a screen mounted on the head, receives images, sounds and tactile sensations of a simulated world.

In the area of physical exercise, evidence places immersive virtual reality as a tool that encourages healthy behaviors and the practice of physical activity, increasing adherence to exercise in the long term. In addition to the fact that performing physical activity by this means generates a high level of enjoyment in the participants, so if the use of this technology generates enjoyment in those who use it and contributes to complying with the recommendations of physical activity, it is logical to think that a physical exercise program executed through immersive virtual reality could contribute to improving parameters related to people's health. Therefore, the objective of this randomized controlled trial is to evaluate the effect of a physical exercise program carried out through immersive virtual reality on health-related variables.

Primary Outcome Measures: Physical fitness, Cardiorespiratory fitness will be measured through the 20-meter shuttle run test, and maximum oxygen consumption will be estimated. Lower body muscle strength will be measured through the long jump test. Upper body muscle strength will be measured through manual grip strength (Takei 5401). Speed/agility will be assessed through the 4x10 test., From registration to the end of the physical activity intervention, it will be a period of 16 weeks.|Body Composition, Weight will be evaluated through a scale (Seca 222), with the participant barefoot and with the least possible clothing. Size will be obtained with a height gauge (Seca 222), with the participant barefoot, in an upright position, at the end of a normal inspiration. Both measures will be taken in duplicate, using the mean for statistical analyses.

Body mass index will be determined by dividing weight by height squared. Waist circumference will be determined at the midpoint between the last rib and the iliac crest. The average of two measurements will be used.

The percentage of adipose and muscle tissue will be calculated by means of tetrapolar electrical bioimpedance (Tanita MC 780U). It will be complemented by the measurement of body perimeters, bone diameters and skin folds, according to the protocol described by the International Society for the Advancement of Kineanthropometry., From registration to the end of the physical activity intervention, it will be a period of 16 weeks.
Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients
NCT Number: NCT06580704
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lumbosacral|Erector Spinae Plane Block|Psoas Muscle Compartment Block|Sciatic Nerve Block|Anesthesia|Unilateral|Lower Limb|Critically Ill Patients
Interventions: DRUG: Lumbosacral Erector Spinae Plane Block|DRUG: Psoas Muscle Compartment With Sciatic Nerve Block
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2025-03-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients.

Primary Outcome Measures: Incidence of failure, Incidence of failure will be recorded. After 30minutes, the pinprick test will be performed. If pain persists, the patient will be excluded., Intraoperatively
Secondary Outcome Measures: Hear rate, Hear rate will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery., Every 15 minutes till the end of surgery (up to 2 hours)|Mean arterial pressure, Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 minutes till the end of surgery., Every 15 minutes till the end of surgery (up to 2 hours)|Duration of analgesia, Duration of analgesia (time from the injection of anesthetic solution to the first request of rescue analgesic drug) will be assessed., Till the first request of rescue analgesic drug (up to 24 hours after surgery)|Degree of pain, Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at PACU, 2, 4, 6, 8, 12, and 24 h postoperatively., 24 hours postoperatively|Degree of patient satisfaction, The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)., 24 hours postoperatively|Incidence of adverse events, Incidence of adverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, postoperative nausea and vomiting (PONV), hematoma, or any other complication will be recorded., 24 hours postoperatively
Autologous Plasma Gel Injection Versus Polydioxanone Cog Threads Insertion for the Treatment of Atrophic Post-acne Scars: a Split-face
NCT Number: NCT06580691
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acne Vulgaris|Atrophic Acne Scar
Interventions: PROCEDURE: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads
Sponsor: Sameh Sarsik
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2023-12-05
Locations: Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Gharbia, 31527, Egypt

Summary:
Both male and female patients, with atrophic acne scars

All patients underwent one session of subcision before receiving:

A: cog PDO threads on one side of the face (one session). B: plasma gel on the other side (one session). Primary outcomes: clinical improvements reported by physicians. Secondary out come: satisfaction levels of patients.

Primary Outcome Measures: Clinical improvement, The improvement was assessed using the Goodman and Baron scale., after 3 month of the procedure|Clinical improvement, The improvement was assessed using the ECCA grading scale., after 3 month of the procedure|Clinical improvement, The improvement was assessed using the physician global assessment., after 3 month of the procedure|Clinical improvement, The improvement was assessed using the FASQoL questionnaire to assess the effect on patients quality of life., after 3 month of the procedure
Secondary Outcome Measures: Patients satisfaction., participant satisfaction score, improvement in scar texture., 3 months from the procedure|Side effects of the procedures., patients reporting of adverse events., During 3 months from the procedure
A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of Erupted Wisdom Tooth With Dentin Caries
NCT Number: NCT06580678
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Dentin Caries
Interventions: DRUG: KH001|DRUG: Placebo
Sponsor: Byoung-Moo Seo
Collaborators: HysensBio Co., Ltd
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-13
Completion Date: 2025-03-31
Locations: Seoul National University Dental Hospital, Seoul, 03080, Korea, Republic of

Summary:
The purpose of this study is to evaluate physiologic dentin regeneration and safety of KH001 in the administration of erupted wisdom tooth with dentin caries

Primary Outcome Measures: Evaluation of physiological dentin formation, Histological analysis after wisdom tooth extraction by histological analysis, Week 5
Secondary Outcome Measures: Adverse Events, The adverse event name, onset date, resolution date, and other relevant details will be recorded until end of visit., Up to 9 weeks|Oral soft/hard tissue examination, Evaluation of oral condition by referring to maximum probing depth., Up to 9 weeks
Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer
NCT Number: NCT06580665
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-small Cell Lung Cancer
Sponsor: Shanghai Chest Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 134
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2030-08-11

Summary:
Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery. It has been reported that cryoablation may enhance immune response and synergize with immunotherapy.

This study is a multicenter, randomized, controlled, exploratory trial, and is expected to enroll a total of 134 patients. The enrolled patients were stage Ia, Ib, or IIa lung cancer with negative driver gene mutations, who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation. Eligible patients will be randomly assigned in a 1:1 ratio to receive either cryoablation alone (CA group) or cryoablation combined with immunotherapy (I-CA group). The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and the incidence of adverse events between the two groups.

Primary Outcome Measures: 3-year progression-free survival (PFS), This refers to the length of time between the participant's first onset of disease progression or death from any cause after treatment., 3 years
Secondary Outcome Measures: 1-year, 2-year, and 3-year Objective Response Rate (ORR), The percentage of patients that achieve complete response (CR) and partial response (PR) after treatment., 3 years|Overall Survival (OS), The time from the start of treatment to the patient's death or the last follow-up, with a maximum observation period of 5 years from randomization., 5 years|Incidence of Adverse Events, Adverse events include those related to the cryoablation procedure occurring during or after the procedure, as well as drug-related adverse events caused by immunotherapy., 1 year|Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines), This refers to the changes from baseline in the immunological responses following the cryoablation (with or without Serplulimab) and comparison between the two groups, including the percentage and function of lymphocyte phenotypes, the expression of PD-L1, the concentration of IFN-γ levels, etc., 1 year
The Role of a Mycobacterium Growth Inhibition Assay to Quantify Host Immune Control of M. Tuberculosis
NCT Number: NCT06580639
Acronym: MGIA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tuberculosis|Immunologic Activity Alteration
Interventions: OTHER: No intervention.
Sponsor: Linkoeping University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 280
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-08-01
Completion Date: 2025-12-01
Locations: Kalmar County Hospital, Kalmar, 391 85, Sweden|Dept of Infectious Diseases, Linköping, 581 85, Sweden

Summary:
The goal of this observational study is to learn about how the blood leucocytes from patients with and without exposure or disease from tuberculosis (TB) are able to kill live mycobacteria (M. tuberculosis). The main question it aims to answer is:

Is intracellular growth suppression of M. tuberculosis in peripheral blood mononuclear cells variable among healthy blood donors and higher than in patients with latent TB compared to active TB?

Primary Outcome Measures: Mycobacterial inhibition of host macrophages, Mycobacterial inhibition of host macrophages, Up to 10 days incubation|Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs), Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs), Up to 10 days incubation
Secondary Outcome Measures: Cytokine expression of host peripheral blood mononuclear cells (PBMCs), Proteome analysis following exposure of PBMCs to gamma-irradiated M. tuberculosis, 24 hours
Various Techniques of Horizontal Ridge Augmentation
NCT Number: NCT06580626
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Horizontal Ridge Deficiency
Interventions: PROCEDURE: decompression technique|PROCEDURE: guided bone regenaration using Ethoss|PROCEDURE: ridge splitting technqiue
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2024-08-01
Locations: Heba Elsheikh, Mansoura, Egypt

Summary:
42 patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth or multiple teeth in posterior mandible by dental implant in horizontally atrophic ridge.

Primary Outcome Measures: Alveolar ridge width., Overall width of the ridge was evaluated preoperatively, after implant placement immediately, after 6, and 12 months postoperative, 1 year
Effect of Esterogen Receptor Modulator on Gene in Bipolar Diseas
NCT Number: NCT06580535
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bipolar Disorder
Interventions: OTHER: blood sample
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-05
Completion Date: 2025-12

Summary:
1. Identify randomized controlled trials of tamoxifen (Estrogen Receptor modulator) in in addition to traditional treatment of bipolar disorder and synthesize the results using meta-analysis.
2. Systematically estimate the effects of Phospholipase C epsilon 1 gene (PLCE1) rs2274223and gene polymorphism on the susceptibility to treatment.
3. Study the pathway involved in the action of tamoxifen by incorporating TMX into nanoparticles and evaluating tyrosine kinase in responders WBCS culture and evaluate nanoparticle as a hope for future treatment of CNS disorders.

Primary Outcome Measures: change in Young Mania Rating Scale(YMRS) Score, Mean change in YMRS score from baseline to the end of treatment (range:0-60;higher score indicate sever mania), e.g.4 weeks
Secondary Outcome Measures: Percentage of Participants with Treatment Response, Percentage of participants with a ≥50% reduction in attack rating scores from baseline to end of treatment., e.g.,4 weeks
The Effect of the Position Given to the Child After Weaning from Noninvasive Mechanical Ventilation on Physiological Symptoms
NCT Number: NCT06580522
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prone Position|Supine Position|Child
Sponsor: Acibadem University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-03-01
Completion Date: 2024-07-26

Summary:
The aim of this clinical trial was to investigate the effect of the position given to children after weaning from noninvasive mechanical ventilation on the physiological symptoms (heart rate, oxygen saturation, respiratory rate and blood pressure) of children aged six months to six years in the Pediatric Intensive Care Unit.

Primary Outcome Measures: Pulse changes in children after weaning from noninvasive mechanical ventilation, Changes in the pulse rate of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to the children after weaning from noninvasive mechanical ventilation. The changes in the pulse rate values of the children between the age groups in the study in terms of minutes/pulse rate and the difference values between them according to minutes will be examined., 120 minutes after weaning from noninvasive mechanical ventilation
Other Outcome Measures: Oxygen saturation changes in children after weaning from noninvasive mechanical ventilation, Changes in oxygen saturation values of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to children after weaning from noninvasive mechanical ventilation. The changes in % of oxygen saturation values of children between the age groups in the study and the difference values between them according to minutes will be analyzed., 120 minutes after weaning from noninvasive mechanical ventilation|Respiratory rate changes in children after weaning from noninvasive mechanical ventilation, Changes in respiratory rate values of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to children after weaning from noninvasive mechanical ventilation. The changes in the respiratory rate values of the children between the age groups in the study in minutes/respiratory rate and the difference values between them according to minutes will be examined., 120 minutes after weaning from noninvasive mechanical ventilation|Blood pressure changes in children after weaning from noninvasive mechanical ventilation, Changes in blood pressure values of children will be measured and recorded at 20 minute intervals for 120 minutes after the position given to children after weaning from noninvasive mechanical ventilation. The changes in the blood pressure values of the children in mm/Hg between the age groups in the study and the difference values between them according to minutes will be examined., 120 minutes after weaning from noninvasive mechanical ventilation
Assessment of Two Filling Materials for Teeth-tissue Supported Overdenture
NCT Number: NCT06580483
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Jaw, Edentulous, Partially
Sponsor: Delta University for Science and Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-20
Completion Date: 2024-06-15

Summary:
Methods: 28 patients with bilateral remaining first premolar in the maxillary or mandibular arch were enrolled in the study. Dome shaped preparations of the abutments were performed. The amalgam and composite restorations were randomly assigned to either the right or left remaining premolar; then conventional steps of overdenture fabrication and insertion were accomplished. Patients were followed up for 3 years.

Primary Outcome Measures: Wear depth, For each patient, a scan of the abutments was performed using intra-oral scanner in the day of overdenture insertion and another scan was performed after 36m follow up periods and then both scans are compared, 36 months|Survival of the restoration, Restoration survival was assessed according to the criteria approved by the FDI World Dental Federation (FDI) Scientific Committee in 2007 and the General Assembly in 2008 as criteria specifically developed for use in clinical trials., 36 months
Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease
NCT Number: NCT06580431
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis|Smoking|Inflammatory Response
Interventions: OTHER: Saliva and serum sampling
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-12-21
Completion Date: 2024-06-25
Locations: Istanbul Medipol University, School of Dentistry, Istanbul, Fatih, 34083, Turkey

Summary:
Salivary and serum levels of TMAO and TNF-A can distinguish between individuals with periodontitis and periodontally healthy persons, including smoking and nonsmoking patients.

Primary Outcome Measures: Pocket probing depth, Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe, 3 months|Clinical attachment level, Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ.

To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth.

In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract), 4 months|Bleeding on probing, Bleeding on probing referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth, 4 months
Secondary Outcome Measures: serum and saliva analyses for TMAO levels, TMAO levels were determined in saliva and serum samples using liquid chromatography-mass spectrometry (LC-MS/MS). TNF-α levels were measured by ELISA method., 1 month
Evaluation of an Anti-TREM-1 Treatment on an ex Vivo Human Intestinal Model
NCT Number: NCT06580418
Acronym: TIME
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Bowel Diseases
Interventions: OTHER: Additional biopsies and blood samples
Sponsor: Inotrem
Collaborators: IRCCS San Raffaele
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-31
Completion Date: 2025-03-31
Locations: IRCCS San Raffaele, Milano, MI, 20132, Italy

Summary:
TIME is an observational study performed on UC and CD patients under endoscopic surveillance for monitoring the clinical activity of their disease.

The main objective of the study is to confirm the therapeutic potential of TREM-1 in inflammatory bowel disease.

Primary Outcome Measures: Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist, Derivation of RNA and proteins from biopsy specimens upon in vitro exposure to the TREM-1 antagonist, 20 months
Secondary Outcome Measures: Evaluation of TREM-1 antagonist compound efficacy in terms of pro-inflammatory markers expression, Starting from the isolated samples, as well as blood samples collected:

* measurement of pro-inflammatory cytokine levels
* evaluation of genes involved in biological processes directly related to the treatment with the TREM-1 antagonist, 26 months
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
NCT Number: NCT06580392
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: The Primary Endpoint is Change in QMS From Baseline(Pre-CCM) to 6 Month Follow up (Post-CCM) of the Optimizer Device Implant
Sponsor: Impulse Dynamics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2027-12

Summary:
The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.

Primary Outcome Measures: Change in Quad Medication Score, Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant, 6 month
Secondary Outcome Measures: Change in loop diuretic dose, Change in loop diuretic dose from baseline to 6-month follow-up., 6-month|Change in eGFR, Change in eGFR from baseline to 6-month follow-up, 6-month|Change in SBP, Change in SBP from baseline to 6-month follow-up., 6-month|Adverse events (AEs) associated with CCM therapy., 12-month|Percentage of patients achieving maximal/optimal GDMT following CCM therapy, Percentage of patients achieving maximal/optimal GDMT following CCM therapy, 12-month|GDMT adherence as measured by change in QMS score, GDMT adherence as measured by change in QMS score from 6 months (post-CCM) to 12 months (post-CCM)., 12-month
Spine Surgery Video Observation Study. The Creation of a Benchmark Video (RGB-Depth) Dataset to Investigate the Feasibility of Developing a Markerless Tracking System for Spine Surgery.
NCT Number: NCT06580379
Acronym: SPIVOS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spine Fusion|Spine Injury|Spine Degeneration|Navigation, Spatial
Interventions: PROCEDURE: Spine surgery
Sponsor: Imperial College London
Collaborators: Imperial College Healthcare NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-10

Summary:
The primary study objective is to build a video dataset, consisting of both colour and depth information, of spine surgery that includes both 'open' and 'minimally invasive' (MIS) surgeries. Using accompanying preoperative CT scans of the patient's spine, we aim to develop a markerless tracking system for spine surgery, which the collected dataset will be used to both train, and then benchmark against.

Primary Outcome Measures: Number of Data Collection completed, Success in recording 25 RGB-D videos of spine surgeries along with corresponding CT scans, 3 years (initial recording duration)|Number of Data points collected containing a variety of exposed spine anatomy, Collected samples should contain a wide variety of exposed vertebrae, including cervical, thoracic and lumbar vertebrae, 3 years (initial recording duration)|Patient diversity in Ethnicity, Patients undergoing surgery should be diverse in terms of ethnicity, diversity being the % of patients who are not 'white british', 3 years (initial recording duration)|Patient diversity in Age, Patients undergoing surgery should be diverse in terms of age, diversity being captured by range and standard deviation measures, 3 years (initial recording duration)
Secondary Outcome Measures: Usefulness for training navigation system, Outcome is to leverage the recordings to train a markerless tracking system that will intraoperatively track the pose and location of the spine within the surgical site. The trained system will be benchmarked against a test subset of the collected videos. The success of the trained system will be determined by its accuracy in automatically tracking the pose of vertebrae features within the test subset videos, against the labelled pose indicated in the video by the operating surgeon., 4 years (initial recording duration + 1)
Comparing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation
NCT Number: NCT06580366
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Bowel Preparation
Interventions: DRUG: Sennosid A+B|DRUG: Sodium Picosulfate/Magnesium Oxide/Citric Acid
Sponsor: Hitit University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SCREENING
Start Date: 2024-08-22
Completion Date: 2025-03-22
Locations: Hitit University Erol Olcok Training and Research Hospital, Çorum, 19030, Turkey

Summary:
Colonoscopy Preparation: Comparing Sennoside A+B and PM/Ca

Colonoscopy is a test used to examine the inside of the bowel. Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure.

What is Sennoside A+B? Sennoside A+B is a type of laxative made from the senna plant. It works by stimulating the bowel to move and reducing the absorption of water, making it easier to pass stools. Research has shown that high doses of sennoside A+B can be effective for bowel preparation.

Sennoside A+B vs. PEG:

Some studies have found that sennoside A+B is more effective than PEG, another laxative, but can cause more abdominal pain. Other studies have found no significant difference in effectiveness between the two.

What is Picosulfate/Magnesium Oxide/Citric Acid (PM/Ca)? PM/Ca is a combination of sodium picosulfate, magnesium oxide, and citric acid. Sodium picosulfate stimulates bowel movements, while magnesium oxide and citric acid help increase water in the bowel, making it easier to pass stools.

PM/Ca vs. PEG:

Research has shown that PM/Ca is as effective as PEG for bowel preparation. Patients using PM/Ca generally tolerate the preparation process better than those using PEG.

Conclusion:

While PEG is the preferred option according to guidelines, its high cost can make it less accessible in some places. In this study, we aim to compare the effectiveness and patient tolerance of Sennoside A+B and PM/Ca since no direct comparison between these two preparations has been made before.

Primary Outcome Measures: Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study, Effectiveness of bowel preparation using the Boston Bowel Preparation Scale (BBPS).

The BBPS is a standardized 9-point assessment scale for the colon. The structure of the colon is divided into its three segments: right colon, transverse colon, and left colon. Each segment is classified from 0 to 3 depending on the degree of soiling. The sum total of the three segments represents the degree of soiling, so that a total ≤ 5 points shows poor bowel preparation, while 6-7 shows good bowel preparation, and ≥ 8 very good bowel preparation. The investigators will consider patients with a score of 6 or higher as successful., 4 months
Viscoelastic Properties of Respiratory and Peripheral Muscles of COPD Patients
NCT Number: NCT06580353
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COPD|Muscle Tone Abnormalities
Sponsor: Gaziantep Islam Science and Technology University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-05-01
Locations: Gaziantep İslamic Science and Technology University, Gaziantep, Şahinbey, 27000, Turkey

Summary:
The aim of this study was to compare the viscoelastic properties of auxiliary respiratory muscles and peripheral muscles of chronic obstructive pulmonary disease patients with healthy subjects. Myotonometry was used to evaluate the viscoelastic properties of the muscles. The viscoelastic properties of the sternoclaidus mastoid, pectoralis major, upper trapezius, deltoid, biceps brachii, rectus femoris, gastrocinemius, and tibialis anterior muscles were evaluated.

Primary Outcome Measures: Respiratory functions (PEF), Peak expiratory flow (PEF) were measured was evaluated with spirometry. It will be recorded as liters and expected percentage, 1 Day|The Medical Research Council Scale, Patients simply indicate on the scale the level of activity that causes dyspnoea in them according to the activities between 0-4., 1 Day|The COPD Assessment Test, This statement describes a scale consisting of eight items, each with response values ranging from 0 to 5. The total score is calculated by summing the responses to all the items, resulting in a range from 0 to 40. A higher total score indicates a greater negative impact of the disease on the individual's quality of life and daily activities., 1 Day|Viscoelastic properties of muscles, The viscoelastic properties of the muscles (muscle tone (Hz), and elasticity (Relative), stiffness (N/m)) were measured using a hand-held myotonometer., 1 Day|Respiratory functions (FEV1), In pulmonary function test was evaluated with spirometry. forced expiratory volume in the first second (FEV1);will be recorded as liters and expected percentage, 1 Day|Respiratory functions (FVC), In pulmonary function test was evaluated with spirometry. forced expiratory volume in the first second (FEV1);will be recorded as liters and expected percentage, 1 Day|Respiratory functions (FEV1/FVC), ratio of forced expiratory volume in the first second to vital capacity (FEV1/FVC) was evaluated with spirometry., 1 Day
Effect of Finerenone in IgA Nephropathy
NCT Number: NCT06580288
Acronym: FIGHT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: IgA Nephropathy
Interventions: DRUG: Finerenone|DRUG: Placebo
Sponsor: Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-08
Completion Date: 2026-10-08

Summary:
The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.

The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.

Primary Outcome Measures: change in uACR between the two groups, at 12months
Secondary Outcome Measures: eGFR slop, at 12months|change in uPCR between the two groups, at 12months|renal failure (eGFR decline of 40% or progression to ESKD, defined as initiation of dialysis, kidney transplantation, or eGFR ≤ 15 ml/min/1.73 m²);, at 12months|cardiovascular event endpoints: cardiovascular death or non-fatal myocardial infarction or non-fatal stroke; hospitalization due to heart failure; major cardiovascular events; all-cause mortality., at 12months
The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure
NCT Number: NCT06580275
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Stroke Prevention
Interventions: DEVICE: CLAAS
Sponsor: Conformal Medical, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-30
Completion Date: 2025-12

Summary:
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.

Primary Outcome Measures: Successful LAA closure (Evaluated at 45 Days Post-procedure), Complete closure is defined as absence of a significant leak (\>5 mm) as assessed based upon core lab evaluation of 45 Day Imaging assessment without device or procedure related SAEs., 45 Days|Successful LAA closure without procedural complication within 7 days post-procedure, The absences of any of the following complications: Cardiac perforation, pericardial effusion requiring drainage, ischemic stroke, device embolization, and major vascular complications., 7 Days
Secondary Outcome Measures: Stroke: Ischemic, Hemorrhagic, Disabling, Non-Disabling, 12 Months|Bleeding (BARC 3-5), Procedural and Non-Procedural, 14 Days|Device Leak, \>5 mm, 3-5 mm, 1-3 mm leak is based on core lab imaging assessment at 45 days, 45 Days|Pericardial Effusion requiring drainage, 12 Months|Procedural and Device related AEs and SAEs, 1 Day|Device Success, CLAAS implantation in correct position without complications till discharge, 1 Day|Conversion to TEE, 1 Day|Conversion to general anesthesia (GA) with endotracheal intubation, 1 Day
Study of the Drug B11-FC (Botulism Treatment)
NCT Number: NCT06580236
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Botulism
Interventions: DRUG: B11-FC|DRUG: Botulinum neurotoxin type A|OTHER: Placebo
Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03-30

Summary:
Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults

Primary Outcome Measures: heart rate, heart rate measurement, through study completion, an average of 1 year|respiratory rate, respiratory rate measurement, through study completion, an average of 1 year|blood pressure (both systolic and diastolic), blood pressure measurement, through study completion, an average of 1 year|ECG Cardiac rate (beats per minute), ECG Cardiac rate (beats per minute) measurement, through study completion, an average of 1 year|ECG RR Interval (ms), ECG RR Interval (ms) measurement, through study completion, an average of 1 year|ECG PQ interval (ms), ECG PQ interval (ms) measurement, through study completion, an average of 1 year|ECG QRS interval (ms), ECG QRS interval (ms) measurement, through study completion, an average of 1 year|ECG QT interval (ms), ECG QT interval (ms) measurement, through study completion, an average of 1 year