pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Using Virtual Reality Goggles on Fear and Pain Level During Vaccination in Children
NCT Number: NCT06560320
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fear of Pain|Fear|Virtual Reality|Pain|Vaccination|Children
Interventions: BEHAVIORAL: Virtual Reality Glasses
Sponsor: Burdur Mehmet Akif Ersoy University
Sex: ALL
Age: CHILD
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-04-01
Completion Date: 2024-12-31
Locations: Burdur Bucak, Burdur, Bucak, 15030, Turkey

Summary:
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses reducing fear and pain during routine vaccination in children.

Primary Outcome Measures: Children's Fear Scale, CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety)., Through painful procedure completion, an average of 10 minutes|Wong-Baker FACES Pain Rating Scale, In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels., Through painful procedure completion, an average of 10 minutes
Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome
NCT Number: NCT06560294
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glue Embolization|Pelvic Congestion Syndrome
Interventions: DRUG: Micronized purified flavonoid fraction (Daflon ®)|OTHER: Glue embolization
Sponsor: Tanta University
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-17
Completion Date: 2024-12-01
Locations: Tanta University, Tanta, ElGharbia, 31527, Egypt

Summary:
The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.

Primary Outcome Measures: Degree of pain, Degree of pain will be assessed using a Visual Analog Scale (VAS). The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 10 cm long. An introductory question asks the patient to mark a point on the line that best refers to his or her pain. Patients will be encouraged to assess the intensity of subjective manifestation of each symptom by scoring from 0 (no symptom) to 10 (the most extreme manifestation possible)., Post intervention for 3 months
Secondary Outcome Measures: Incidence of recurrence of pain, Incidence of recurrence of pain will be recorded., Post intervention for 3 months|Pelvic Venous Clinical Severity Score (PVCSS), Assessment of treatment outcomes will be standardized using the disease-specific Pelvic Venous Clinical Severity Score (PVCSS) for female patients with pelvic congestion syndrome. The PVCSS takes into account 10 major symptoms and signs of the disease, each of which is scored from 0 (no symptom) to 3 (maximum severity) for a maximum score of 30, which indicates an extremely severe degree of disease., Post intervention for 3 months
Improving Hand Movements in Kids With One-Sided Arm Stiffness Cerebral Palsy Through Motion Minder Therapy (MoMT)
NCT Number: NCT06560281
Acronym: MoMT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy Spastic Hemiplegic
Interventions: OTHER: Motion Minder Therapy (MoMT)
Sponsor: Saveetha University
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-22
Completion Date: 2024-10-25
Locations: Saveetha Medical College and Hospital, Chennai, Tamil Nadu, 602117, India|Aadhuraa Special School, Kānchipuram, Tamil Nadu, 631501, India

Summary:
Motion Minder Therapy is a targeted intervention for fine motor skill challenges in spastic hemiplegic cerebral palsy children, emphasizing affordability, particularly in middle-income countries like India. Diverging from previous models requiring extensive daily supervision of 5 to 6 hours, Motion Minder Therapy optimizes resources by utilizing smartwatches for a focused 1-hour intervention. The study employs a Pilot phase with 5 children. Materials range from smart watch to sensory tools, offering a comprehensive approach. Statistical analysis, incorporating repeated measure ANOVA, aims to underscore Motion Minder Therapy's effectiveness in addressing the complex challenges of fine motor skill enhancement in spastic hemiplegic cerebral palsy.

Primary Outcome Measures: Shriners Hospital Upper Extremity Evaluation (SHUEE), The Shriners Hospital Upper Extremity Evaluation is a video-based tool for the assessment of upper extremity function. The outcome is the total score of the spontaneous functional analysis, dynamic positional analysis, and grasp/release analysis. Total scores of 45 for spontaneous functional analysis, 72 for dynamic positional analysis and 6 for grasp/release. Higher scores mean a better outcome., Baseline, 4th week, 8th week, 12th week|Nine Hole Peg Test, Nine Hole Peg Test is used to measure the dexterity. Scores on nine-hole peg test are measured in seconds, indicating time taken to complete task. Higher scores indicate worse outcome, as they show slower completion times and reduced dexterity., Baseline, 4th week, 8th week, 12th week
Secondary Outcome Measures: Strengths and difficulties questionnaire, The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The Strengths and Difficulties Questionnaire is scored on a 3-point Likert-type scale, with total scores (excluding the prosocial scale) ranging from 0 to 40. Higher scores reflect greater behavioral and emotional difficulties., Baseline, 4th week, 8th week, 12th week
Low Flow Anesthesia in Children Undergoing Strabismus Surgery
NCT Number: NCT06560268
Acronym: LFA in child
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Low Flow Anesthesia|Sevoflurane|Strabismus|Emergence Delirium
Interventions: DRUG: Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.
Sponsor: Cukurova University
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-11-04
Completion Date: 2025-07-04

Summary:
Emergence agitation (EA) involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. Sevoflurane and desflurane have increased the incidence of EA in children. A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function, due to differences in clearance of inhalational anesthetics from the central nervous system; whereas audition and locomotion recover first, cognitive function recovers later, resulting in EA. Low-flow anaesthesia (LFA) occurs when the fresh gas flow (FGF) is significantly lower than the patient's minute volume. In a low-flow system, the recirculated fraction should amount to at least 50% after carbon dioxide (CO2) absorption.In LFA using minimal FGF (250-500 mL/min), if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed, the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more. In a study conducted on infants undergoing cleft lip-palate surgery, it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 0.5 L/min FGF.

Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA (40-86%). The incidence of EA after strabismus surgery is high, especially due to visual disturbances; however, the pathogenesis of this condition remains unclear. In our study, the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.

Primary Outcome Measures: Emergence agitation, Comparison of emergence agitation rates between groups., At postoperative 5th, 10th, 15th, 30th, 45th min and 2 hour
Secondary Outcome Measures: Sevoflurane consumption, Effects of different fresh gas flows on sevoflurane consumption, İntraoperative period
Giving Resources to lOw-income Children to Enhance RecoverY
NCT Number: NCT06560229
Acronym: GROCERY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Discharged Pediatric Patients and Their Families
Interventions: OTHER: Grocery gift card
Sponsor: Children's Hospital Medical Center, Cincinnati
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-19
Completion Date: 2026-07-31
Locations: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States

Summary:
The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of a Medicaid Accountable Care Organization will provide benefits. The main question it aims to answer:

Does this monthly food support intervention reduce food insecurity and healthcare utilization in these patients.

Participants will complete surveys in the hospital, 14-days after discharge, and then quarterly for up to 18 months. Families randomized to the intervention group will receive monthly grocery gift cards for one year.

Primary Outcome Measures: Reutilization, Validated measure of reutilization which includes unplanned readmission, return to the emergency department, or a visit to urgent care, 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months|UDSA 6-question food insecurity survey, Adapted version of the UDSA 6-question food insecurity survey, 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Secondary Outcome Measures: Primary Care Healthcare Utilization, Planned and unplanned visits to primary care provider, 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months|Vaccine uptake at primary care clinic, Immunization percentage as part of the Medicaid accountability measure, 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months|Recovery and return to normal routine, Family-designed measure of recovery and return to normal routine, 14-days after discharge|Post-Discharge Difficulty Coping Scale, Post-Discharge Coping Difficulty Scale uses an 11 point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty., 14-days after discharge|Ability to pay for medications, Family-designed measure of difficulty obtaining medications after discharge, 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months|Perceived Stress Scale, Perceived Stress Scale (PSS) uses a 5 point scaling format (0-4) with total scores ranging from 0 to 40. Higher scores represent higher perceived stress., 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Cryopreservation Medium With Apigenin on Post-thaw Human Sperm
NCT Number: NCT06560216
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Apigenin
Sponsor: Chulalongkorn University
Sex: MALE
Age: ADULT
Enrollment: 57
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-06
Locations: Chulalongkorn University, Bangkok, 10330, Thailand

Summary:
The goal of this clinical trial is to compare the effect of apigenin supplementation in freezing medium with no apigenin supplementation in freezing medium on post-thaw human sperm motility. It will also evaluate the sperm viability, total antioxidant capacity, and oxidative stress markers. The main questions it aims to answer are:

* Does apigenin supplementation in freezing medium improve the post-thaw sperm motility?
* Does apigenin supplementation in freezing medium improve the post-thaw sperm viability, total antioxidant capacity, and oxidative stress?

Primary Outcome Measures: Percentage of sperm motility, Sperm motility (total motility, progressive motility, non-progressive motility, immotile spermatozoa) will be reported in percentage.

Compare results among freezing medium with apigenin group, control group, and baseline pre-freeze sperm suspension., At least 1 week of freezing
Secondary Outcome Measures: Percentage of sperm viability comparison between intervention and control group, Viability test will be assessed by eosin-nigrosin staining technique, At least 1 week of freezing
Other Outcome Measures: Total antioxidant capacity comparison between intervention and control group, Total antioxidant capacity will be assessed by ABTS assay, At least 1 week of freezing|Reactive oxygen species comparison between intervention and control group, Reactive oxygen species will be assessed by DCFH-DA assay and Chemiluminescence assay, At least 1 week of freezing
WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users
NCT Number: NCT06560125
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Wound
Interventions: OTHER: Standard care
Sponsor: Woundchek Laboratories BV
Collaborators: Salem VA Heath Care System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-01-31
Locations: Salem VA Medical Centre, Salem, Virginia, 24153, United States

Summary:
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) with untrained users in diverse CLIA waived locations and trained users and compare the results to those obtained in the study used for De Novo approval (DEN180014). Untrained and trained users are as defined in the FDA guidance document entitled 'Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices' (Feb 2020). The test result will be blinded to the clinician treating the wound. The healing outcome at 12 weeks following the test will be compared for wounds positive vs negative for bacterial protease activity (BPA). Study success criteria will be that the positive likelihood ratio (PLR) of a BPA positive wound being non-healing at 12 weeks for both trained and untrained users will be statistically comparable to the PLR obtained in the study submitted for DEN180014.

Primary Outcome Measures: Wound healing, Complete wound closure, 12 weeks
Secondary Outcome Measures: Wound size reduction, Percent change in wound size, 12 weeks
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
NCT Number: NCT06560112
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Recurrent Ovarian Cancer
Interventions: DRUG: AK104|DRUG: AK112|DRUG: Chemotherapy
Sponsor: Akeso
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 172
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-05-01

Summary:
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer

Primary Outcome Measures: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator, Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria, Up to 2 years
Secondary Outcome Measures: progression-free survival (PFS) assessed by investigator per RECIST v1.1, PFS is defined as the time from the date of first dosing till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first., Up to 2 years|duration of Response (DOR) assessed by investigator per RECIST v1.1, DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria., Up to 2 years|Time to Response (TTR) assessed by investigator per RECIST v1.1, TTR refers to Time to Response., Up to 2 years|Overall Survival(OS), OS is defined as the time from randomization or first dosing to death due to any cause., Up to 2 years|Number of participants with adverse event (AE), The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment., Up to 2 years
Standard Oxytocin Versus High Dose Oxytocin to Control Postpartum Hemorrhage in High Risk Pregnancy During Elective Cesarean Section
NCT Number: NCT06560099
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Partum Hemorrhage
Interventions: DRUG: Oxytocin
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-25
Completion Date: 2025-04-25

Summary:
Controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional use of uterotonics in the first 24 hours after cesarean section for high risk pregnancy.

Primary Outcome Measures: blood loss, measure blood in suction, towels and pads, at the end of the operation
Secondary Outcome Measures: haemoglobin, by laboratory asessment, immediate preoperative|haemoglobin, by laboratory asessment, 6 hours postoperative
Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2
NCT Number: NCT06560086
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cryptorchidism
Interventions: DRUG: Ketoconazole|DRUG: Luteinizing Hormone
Sponsor: Affiliated Hospital of Nantong University
Sex: MALE
Age: CHILD
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-02-03
Completion Date: 2024-12-31
Locations: Affiliated hospital of nantong university, Nantong, Jiangsu, 226001, China

Summary:
Reduced hormone insulin-like 3, exclusively secreted by Leydig cells, has been identified as the recognized mechanism for cryptorchidism. Testicular macrophages residing in the testicular interstitium were thought to play a vital role in maintaining hormone secretion of Leydig cells. However, the contribution of macrophages to cryptorchidism remained poorly understood. Here, after 14 days of ketoconazole treatment, levels of both Trem2 and insulin-like 3 significantly decrease in human embryonic testes compared to the untreated control group. Conversely, 14 days of luteinizing hormone stimulation lead to elevated levels of Trem2 and insulin-like 3 in the testes compared to the untreated control group. Additionally, researchers find a positive correlation between Trem2 and insulin-like 3 expression in a human ex vivo tissue culture model. In summary, the study will propose Trem2 as a novel target for maintaining normal testicular descent by regulating the testicular immune microenvironment.

Primary Outcome Measures: Relative expression of Trem2 and insulin-like 3 protein, Ketoconazole promotes a decrease in Trem2 and a decrease in insulin-like 3, and they are strongly correlated., The date of 14 days cultured
Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries
NCT Number: NCT06560073
Acronym: TXA-DMTRD
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Diabetic Retinopathy|Macular Traction Retinal Detachment
Sponsor: Ahalia Foundation Eye Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-01-15
Completion Date: 2022-10-31
Locations: Ahaliafoundation Eye Hospital, Palakkad, Kerala, 678557, India

Summary:
The goal of this observational study is to learn about safety and results of peroperative and intraoperative intravenous Tranexamic acid for diabetic macular tractional detachment eye surgeries . The main question it aims to answer is:

Adverse events and their frequency? immediate postoperative bleeding incidence? effective vitrectomy time?

Primary Outcome Measures: Number of systemic adverse events, Safety of intravenous tranexamic acid, intraoperatively and postoperatively 24 hours
Secondary Outcome Measures: Number of systemic adverse events in patients having Chronic kidney disease, Safety of intravenous tranexamic acid in Patients also having Chronic Kidney Disease, intraoperatively and postoperatively 24 hours|Surgical time for vitrectomy, Surgical time for vitrectomy that is less view blurring because of intraoperative bleed, intraoperatively|Any relation between intraoperative use of Tranexamic acid and labetalol, labetalol dose needed, intraoperatively|Number of vitrectomies converted intraoperatively to bimanual technique, Highly complex surgeries, intraoperatively|Number of surgeries in which retinectomy required, Instances where it bleeds profusely and surgery could yet be completed successfully, intraoperatively|Number of surgeries in which Perfluorocarbon liquid had to be used, PFCL acts as third hand- denotes complexity of surgery, intraoperatively|Number of surgeries in which Internal Limiting Membrane peeling done, ilm peeling done after staining retina with Brilliant blue, intraoperatively|Number of eyes having preretinal bleed at the end of surgery, to find efficacy of Tranexamic acid in decreasing immediate post operative bleed, immediate postoperatively|Visual acuity change after surgery, improvement in visual acuity, 6 months postoperatively
Do People With Complications of Type 1 Diabetes Mellitus Have a Different Microbiome (MARVEL)
NCT Number: NCT06560060
Acronym: MARVEL
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 1 Diabetes
Interventions: OTHER: No intervention
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Diabeter Nederland BV
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2043-10

Summary:
This study looks at whether people with type 1 diabetes have different gut bacteria. We also want to see if this is linked to keeping insulin production up and preventing complications like heart disease and nerve damage. The aim is to find ways to keep more of the functions working, avoid low blood sugar and reduce diabetes complications.

Primary Outcome Measures: Residual β-cell insulin secretion capacity:, assessed by non-invasive 2-hour post meal c-peptide release (residual β-cell function) in urine, composed of a urinary c-peptide to creatinine ratio (UCPCR)., At 0,3,6 and 10 years follow-up.
Secondary Outcome Measures: Presence and incidence of diabetes complications, cardiovascular disease, nephropathy, neuropathy, retinopathy and liver stiffness collected through medical history, yearly check-ups, bioimpadance measurement and questionnaires, At 0, 3, 6 and 10 years follow up|Glycemic control:, changes in plasma biochemistry (glucose, HbA1c), glucose time in range (Freestyle Libre), urine (microalbuminuria) and subsequent exogenous insulin dose., At 0,3,6 and 10 years follow-up.|Intestinal microbiota composition, changes in gut microbiota composition as measured with shotgun sequencing in feces. Bristol stool chart for fecal composition., At 0,3,6 and 10 years follow-up.
Other Outcome Measures: Circulating microbiota-derived metabolites, Changes in untargeted plasma metabolites., At 0,3,6 and 10 years follow-up.|Autoimmunity markers, HLA and immunotyping will be performed., At 0,3,6 and 10 years follow-up.
VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements
NCT Number: NCT06560034
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Diseases|Blood Pressure|Hypertension
Interventions: DEVICE: VicorderCS
Sponsor: 80 Beats Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-08-01
Locations: Manos Health Study Site, Breckenridge, Colorado, 80424, United States

Summary:
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. It is faster, easier to use, and more portable than its predecessor, with enhanced connectivity options for extended marker collection and analysis. These markers enable early diagnosis of cardiovascular disease, ensuring positive patient outcomes. With a strong foundation in numerous published clinical studies, the VicorderCS enhances data collection and analysis capabilities, empowering the research community in developing new drugs and therapeutics. This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system, which is Non-invasive Blood Pressure (NIBP) via the common oscillometric cuff-based method.

Primary Outcome Measures: Blood Pressure Reading, Collect blood pressure readings using the VicorderCS device, One visit (1hour)
Secondary Outcome Measures: Waveform Data, Collect raw waveform data on the opposite arm, and both ankles in order to optimize analysis capabilities in the future., One visit (1hour)
Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
NCT Number: NCT06560021
Acronym: URBI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Bowel Diseases|Crohn Disease|Ulcerative Colitis
Interventions: OTHER: Biopsy strategy
Sponsor: University of Pennsylvania
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1642
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-12-01
Completion Date: 2029-06-30

Summary:
The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.

Primary Outcome Measures: number of dysplastic or SSA lesions detected per colonoscopy, The rationale for this as the primary outcome is that it is important to detect and remove all precancerous lesions. For this outcome, the investigators will include low grade dysplasia (LGD), high grade dysplasia (HGD), SSA or CRC but not indefinite for dysplasia (IFD). Dysplasia will include both conventional and nonconventional forms of dysplasia. Although SSAs do not typically have histologic changes of dysplasia, they are considered precancerous lesions and are more difficult to detect than sporadic adenomatous polyps. The number of dysplastic or SSA lesions will be defined as the number of pathology jars containing a specimen with low-grade or high-grade dysplasia (including CRC) or serrated changes consistent with a sessile serrated adenoma-like change. Even if there are more than one biopsy sample in a jar with dysplasia or SSA, it will be counted as one location with dysplasia or SSA., At index colonoscopy
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
NCT Number: NCT06559995
Acronym: KSAW
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Alcohol Use Disorder|Alcohol Withdrawal|Ketosis
Interventions: DIETARY_SUPPLEMENT: ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,|DIAGNOSTIC_TEST: magnetic resonance imaging session|DIETARY_SUPPLEMENT: Placebo beverage
Sponsor: University of Pennsylvania
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-12
Completion Date: 2027-12
Locations: Center for Studies of Addiction, Philadelphia, Pennsylvania, 19104, United States

Summary:
The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center.

Primary Outcome Measures: Group changes in the total milligrams of benzodiazepines given to subjects during alcohol withdrawal management after receiving either ketone supplement or placebo beverage after 4 days of study intervention., Patients in alcohol withdrawal management receive benzodiazepines measured in milligrams to treat their alcohol withdrawal symptoms. The primary outcome of this study is to compare the group differences in the amounts of benzodiazepines given to subjects after receiving either a ketone supplement or placebo beverage after 4 days, while undergoing in-patient acute withdrawal management., 4 days
Secondary Outcome Measures: To measure the group differences of BHB levels in millimoles, in subjects receiving ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention., Subjects will undergo a high-field strength, 7 Tesla 1H-MRS scan to measure brain BHB levels in millimoles after the 4 days of the study intervention., 4 days|To measure the group differences of Gamma-Aminobutyric Acid levels in millimoles in subjects receiving a ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention., Subjects will undergo a high-field strength, 7 Tesla 1H-MRS scan to measure brain Gamma-Aminobutyric Acid levels in millimoles after the 4 days of the study intervention., 4 days
IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia
NCT Number: NCT06559969
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Laparotomy
Interventions: DRUG: Intravenous administered opioid|DRUG: Epidural administered opioid
Sponsor: Yair Rubin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-29
Completion Date: 2024-11-30
Locations: University of Iowa Health Care, Iowa City, Iowa, 52242, United States

Summary:
The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain

Primary Outcome Measures: With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous, Quality of Recovery (QoR) 15 score from 0-150 with the higher the score the better, Once daily until one day after the epidural in discontinued which would mean a maximum of 8 days post-operatively
Secondary Outcome Measures: With a local anesthetic epidural, are there any differences in the incidence of opioid side effects between intravenous and epidural administered opioids, will assess patient for symptoms suggestive of opioid side effects and look in the patient's chart to see if they require any medication treatments that could be linked to opioid side effects, Assessed daily until the epidural is removed, which is maximum of 7 days post-operatively|Does the route of epidural opioid administration, intravenous vs epidural, affect the return of bowel function, Will assess patient and chart looking for signs of bowel function return and look how patient is able to progress with diet, daily assessment until epidural removed, which is a maximum of 7 days post-operatively|Does the route of epidural opioid administration, intravenous vs epidural, impact patient ability to be discharged, Will look in chart to see when surgery documents that they feel patient has recovered enough to be discharged home, Will follow until patient discharged or maximum 10 days post-operatively
The Effect of Kinesio Taping Applications on Pain, Neck Awareness and Functionality in Neck Pain
NCT Number: NCT06559943
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physiotherapy|Kinesiotape|Chronic Neck Pain
Interventions: OTHER: Traditional Physiotherapy + Placebo Kinesio Tape|OTHER: Traditional Physiotherapy + Kinesio Tape Treatment with Inhibition Method
Sponsor: University of Beykent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2024-09-10

Summary:
It is important to clarify neck awareness, functional status and pain severity in people with chronic neck pain. Since neck pain, which has become a big problem among the public, cannot be treated definitively, it was aimed to examine the effect of kinesio taping technique on individuals with neck pain. The purpose of the research; To examine the positive and negative effects of kinesio taping applied in addition to traditional treatment on pain, functional status and neck awareness in patients with neck pain. The aim of this study by the researchers is to gain a new perspective on the treatments applied to individuals with neck pain.

Primary Outcome Measures: Visual Analog Scale, Participants will be asked to mark the pain they feel on a 10-centimeter horizontal line. Between 0 and 10, 0 (zero) indicates no pain, while 10 indicates unbearable pain., 3 weeks|Fremantle Neck Awareness Questionnaire, Likert type assessing individual-specific altered perception (0 = I never feel like this, 1 = I rarely feel like this, 2 = I feel like this sometimes or some of the time, 3 = I feel like this often, 4 = I feel like this all the time or most of the time) It is a simple survey. The survey asks individuals 9 questions, such as how they perceive their neck in relation to their body and how they perceive their body position. The total score is 0-36 and a high score indicates a poor prognosis., 3 weeks
Effectiveness on Family Cohesion and Happiness of Using Social Media to Enhance Happiness Accounts for Late-Stage Cancer Patients and Their Families
NCT Number: NCT06559917
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: OTHER: life review
Sponsor: YANG WEN-CHI
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
The study period is from September 1, 2024, to December 31, 2025. The subjects are cancer patients from the medical center of this hospital. A block randomization will be used to assign 100 patients to the experimental group and 100 patients to the control group, totaling 200 patients. During the study process, questionnaires and medical records of the subjects will be collected. The experimental group will receive the social media "Happiness Ledger" intervention, while the control group will receive routine treatment. Questionnaires will be collected from both groups before and after the intervention.

Primary Outcome Measures: Family Cohesion, This study uses the Family Adaptability and Cohesion Evaluation Scale (FACES II) developed by Olson et al. (1979), which consists of 30 items to measure the family cohesion of patients and their families ., Baseline (pre-intervention) and 1 week after intervention
Secondary Outcome Measures: Happiness, This study uses the Subjective Happiness Scale (SHS) created by Lyubomirsky \& Lepper (1999), which consists of 4 items to measure the happiness of patients and their families.", Baseline and 1 week
The Effect of the Mediterranean Diet on Fatty Acids in Biological Fluids of Women Undergoing Infertility Treatment
NCT Number: NCT06559904
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Women Diagnosed With Infertility
Interventions: OTHER: Mediterranean diet
Sponsor: Trakya University
Collaborators: Gazi University
Sex: FEMALE
Age: ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2020-02-01
Completion Date: 2023-11-02
Locations: Gazi University, Ankara, Turkey

Summary:
The aim of this study was to examine the effect of the Mediterranean diet, which is accepted as one of the adequate and balanced nutrition models today, as well as serum and follicular fluid fatty acid profile and implantation success in women with an age range of 19-40 (years) before infertility treatment. The study was conducted as a prospective and case-control study with a total of 32 volunteer women, 16 in the intervention group and 16 in the control group, who applied to Gazi University Hospital between February 2021 and February 2022.

Primary Outcome Measures: first meeting, using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days, through study completion, an average of 1 year|second meeting, An explanation of the individual Mediterranean diet, through study completion, an average of 1 year|third and forth meeting, recording three-day food intake evaluate adherence to the Mediterranean diet using anthropometric measurements, through study completion, an average of 1 year|fifth meeting, using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days, collecting follicular fluid samples, through study completion, an average of 1 year
Secondary Outcome Measures: analysis of blood and follicular fluid samples, Fatty acid analyses of the collected samples were performed by gas chromatography-flame ionization detector (GC-FID) at Gazi University Faculty of Pharmacy., through study completion, an average of 1 year
Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans
NCT Number: NCT06559878
Acronym: ALPHA
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-alcoholic Fatty Liver Disease NAFLD
Interventions: DIAGNOSTIC_TEST: 13C-α-Ketoisocaproic Acid Breath Test|DIETARY_SUPPLEMENT: Ethanol|DIETARY_SUPPLEMENT: Lipid Emulsion|OTHER: Normal Saline
Sponsor: Helsinki University Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2027-01-31
Locations: Helsinki Central University Hospital, Helsinki, Uusimaa, 00290, Finland

Summary:
The goal of this clinical trial is to investigate in healthy volunteers the mechanisms by which ethanol and lipids, the two key risk factors of steatotic liver disease (SLD), affect liver mitochondrial metabolism.

The main question it aims to answer is:

• Does acute administration of ethanol and lipids increase hepatic mitochondrial reductive stress as determined by orally ingested stable isotope tracer 13C-alpha-ketoisocaproate and by plasma beta-hydroxybutyrate to acetoacetate ratio (b-OHB/AcAc) in humans?

Primary Outcome Measures: Change in arterialized plasma b-OHB to AcAc ratio, Arterialized plasma b-OHB and AcAc concentrations, From baseline to the end of treatment at 240 minutes|Breath 13CO2 enrichment after ingesting 13C-alpha-ketoisocaproate, Measured as area under the curve, From baseline to the end of treatment at 330 minutes.
Other Outcome Measures: Plasma metabolomics, Arterialized plasma analyzed by nuclear magnetic resonance and mass spectrometry, From baseline until the end of treatment at 240 minutes.
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion
NCT Number: NCT06559865
Acronym: Breathe
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Concussion, Mild
Interventions: BEHAVIORAL: Breathing exercises
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-12-15
Locations: McGill University Health Center, Montréal, Quebec, H4A 3S5, Canada

Summary:
The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention.

Participants will:

will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from a concussion follow-up program.

A weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments.

All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.

Primary Outcome Measures: Feasibility-days of practice, number of days children in the experimental group will engage in performing their breathing exercises, 4 weeks|Feasibility-daily duration of practice, number of minutes children in the experimental group will engage in performing their breathing exercises, 4 weeks
Secondary Outcome Measures: Autonomic nervous system function-Heart rate, heart rate during autonomous nervous system testing, initial and 4 week evaluation|Autonomic nervous system function-Heart rate variability, heart rate variability during autonomous nervous system testing, initial and 4 week evaluation
The Impact of Yoga on Endometriosis-Related Pain
NCT Number: NCT06559852
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis
Interventions: BEHAVIORAL: Yoga
Sponsor: Milton S. Hershey Medical Center
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-09-15

Summary:
The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.

Primary Outcome Measures: Change in Endometriosis Health Profile-30 Pain Score, Identify the impact of yoga on endometriosis related pain based on the Endometriosis Health Profile-30, with specific focus on the domain of pain. The EHP-30 questionnaire consists of five scales which includes pain, control and powerlessness, emotional well-being, social support, and self-image and a total of 30 questions. Each scale is translated into a score ranging from 0, or the best health status, to 100, the worst health status., Baseline to completion at 12-weeks
Secondary Outcome Measures: Change in Visual Analog Scale scores, Comparison of visual analog scale scores from start to the end of the study. The visual analog scale is a validated scale for measuring acute and chronic pain. Scores are recorded on a scale between 0 or "no pain" and 10, the "worst pain"., Baseline to completion at 12-weeks
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
NCT Number: NCT06559826
Acronym: KAP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Major Depressive Disorder
Interventions: DRUG: Ketamine|BEHAVIORAL: Psychotherapy
Sponsor: Icahn School of Medicine at Mount Sinai
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-08
Locations: Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States

Summary:
The proposed study is a single-site, randomized, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study participants will be adults with major depressive disorder (MDD). Adults with MDD will be randomized to KAP or KET in a 1:1 allocation. Each treatment group will receive KAP or KET over a period of four weeks. Measurement of depression severity, wellness, neurocognitive functioning and other parameters will occur at baseline prior to treatment, immediately following the end of the acute treatment period, and over an 8-week (two month) treatment follow-up period.

Primary Outcome Measures: Montgomery-Asberg Depression Rating Scale (MADRS), MADRS: The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points, with higher scores indicating more severe depressive symptoms., 9 weeks from baseline assessment