pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Tributyrin: Time Course & Efficacy to Improve Health & Performance
NCT Number: NCT06501898
Acronym: CoreBiome
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolite Concentration|Gut Permeability|Inflammation|Sleep|Performance
Interventions: DIETARY_SUPPLEMENT: CoreBiome|DIETARY_SUPPLEMENT: Placebo
Sponsor: Florida State University
Collaborators: Compound Solutions Inc.
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-19
Completion Date: 2025-07
Locations: Institute of Sports Sciences & Medicine, Tallahassee, Florida, 32301, United States

Summary:
The purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. Participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.

Primary Outcome Measures: Metabolite Concentration, Fecal butyrate concentration, 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation
Secondary Outcome Measures: Gut permeability, Urine dual sugar absorption, Plasma sCD14, 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)|Inflammation, Whole-body inflammation (IL-6 and IL-10) and gut-specific inflammation (IL-17 and IL-23), 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)|Immune cell composition, Relative proportions of serum immune cells (e.g., macrophages, neutrophils, T cells, B cells, etc.), 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)|Sleep Quality, Number of sleep disturbances, Four weeks prior to day of exercise bout|Sleep quantity, Sleep duration, Four weeks prior to day of exercise bout|Substrate Utilization (mid-exercise), Respiratory exchange ratio assessment via metabolic testing during cycling exercise, During exercise bout|Perceived exertion (mid-exercise), Subjective perceived exertion survey during cycling exercise, During exercise bout|Total completed distance (mid-exercise), Total completed distance during cycling exercise, During exercise bout|Maximum sprint power (mid-exercise), Maximum power quantification during cycling exercise, During exercise bout|Average sprint power (mid-exercise), Average power quantification during cycling exercise, During exercise bout
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pre-Test Phase
NCT Number: NCT06501885
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV
Interventions: BEHAVIORAL: Ethnodrama Intervention
Sponsor: Duke University
Collaborators: National Institutes of Health (NIH)|Fogarty International Center of the National Institute of Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-09
Completion Date: 2025-05-30

Summary:
The investigators will develop and pre-test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using PrEP.

Primary Outcome Measures: Number of participants who find the storylines acceptable, The investigators will gather feedback on the acceptability of the storylines (e.g., perceptions of whether the storylines seem real and identifiable)., Immediately post-intervention|Number of participants who find the interactive components acceptable, The investigators will gather feedback on the acceptability of the audience interactive components (e.g., comfort level)., Immediately post-intervention
Secondary Outcome Measures: Effect of the intervention's storylines on transforming audience members' PrEP-related perceptions as measured by a brief interviewer-administered survey using the Narrative Transportation Scale (NTS), The 12-item scale is divided into two sub-scales: engagement and personal connection. Sample items include: "I wanted to learn what happened to the women after the story ended"; "The stories in the dramas are relevant to my everyday life"; and "The stories in the drama are realistic and believable." The total score ranges from 12 to 84, where a higher score indicates greater narrative transportation., Immediately post-intervention|Effect of the intervention's storylines on transforming young women's perceptions of their ability to use PrEP as measured by a brief interviewer-administered survey using the Narrative Transportation Scale (NTS), The 12-item scale is divided into two sub-scales: engagement and personal connection. The total score ranges from 12 to 84, where a higher score indicates greater narrative transportation., Immediately post-intervention
Rehabilitation With the Shoulder Pacemaker
NCT Number: NCT06501859
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Injuries
Interventions: OTHER: Standard of care physical therapy|DEVICE: Shoulder pacemaker with physical therapy
Sponsor: University of Utah
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-02
Completion Date: 2027-07
Locations: University of Utah Orthopedics, Salt Lake City, Utah, 84108, United States

Summary:
The investigators purpose of the proposed study is to use the FDA approved Shoulder Pacemaker device in patients undergoing reverse shoulder arthroplasty and study the functional outcomes compared to a standard post-operative rehabilitation program. The investigators hypothesize that use of the Shoulder Pacemaker reduce pain and will allow for improved range of motion and function in patients undergoing RSA. The findings of this research may very well improve function in RSA patients through a novel, non-invasive approach.

Primary Outcome Measures: American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., Pre-operatively|American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., 6 weeks after surgery|American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., 3 months after surgery|American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., 6 months after surgery|American Shoulder and Elbow Surgeons score, Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100., 1 year after surgery
Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players
NCT Number: NCT06501833
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Young Soccer Players
Interventions: OTHER: FIFA 11+ KIDS PROGRAM|OTHER: REGULAR TRAINING
Sponsor: Imam Abdulrahman Bin Faisal University
Sex: MALE
Age: CHILD
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2024-12-01

Summary:
Background: Soccer is a prevalent sport worldwide; most soccer players are under 18. Soccer has benefits for your health, but there is also a chance that you could get injuries occasionally. High injury rates have been observed in both adult and young players, which has prompted the development of various preventive measures. FIFA recently introduced the FIFA 11+ Kids program for children under 14 to prevent soccer injuries and enhance kids' performance. To date, no studies have been done to determine whether adding the FIFA 11 + kids program for young players under 14 will enhance soccer-specific skills.

Objective: To investigate the efficacy of FIFA 11+ Kids on soccer-specific skills among young soccer players.

Methods: Thirty six young soccer players (aged 7-13) will be assigned randomly to the following groups: the control group (n =18) and the FIFA 11+ Kids program (n = 18). The experimental group will perform eight weeks of FIFA 11+ kids program (3/week). The control group will be instructed to continue their regular training . Three soccer specific skills tests : the Slalom dribble test, Harre circuit test, and Loughborough soccer passing test, will be done before and after eight weeks of training.

Statistical analysis: IBM SPSS software (version 20) will be used for all statistical analyses. Data will be summarized in terms of mean and SD. Normality is checked with the Shapiro-Wilk test and homogeneity with Levene's tests. If the data are normally distributed, a paired t-test will be used for within-group difference comparison, and an independent t-test will be used for between-group comparison. If the data are not normally distributed, the Wilcoxon-Signed rank and Mann-Whitney U tests will be used.

Primary Outcome Measures: Slalom dribble test, pre and immediately post intervention|Harre circuit test, pre and immediately post intervention|Loughborough soccer passing test, pre and immediately post intervention
Neural Control of Gait & Navigation in ADRD
NCT Number: NCT06501820
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging
Interventions: DEVICE: Transcranial direct current stimulation
Sponsor: University of Florida
Sex: ALL
Age: OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2025-05
Completion Date: 2030-05

Summary:
Brain network segregation, or independent functioning, declines with age and is associated with slower walking speed. Here, the investigators will determine the extent to which brain vestibular network segregation can be altered with bilateral vestibular cortical transcranial direct current stimulation (tDCS) in older adults with subjective cognitive decline. Participants will be randomly assigned to an active or sham stimulation condition. They will receive three, 20-minute sessions of tDCS while they are walking and performing cognitive tasks. MRI of the brain will be acquired before and after these three sessions.

Primary Outcome Measures: Vestibular network segregation score, measured with functional MRI, Independence of brain network functioning, Pre-intervention, within 1 week post-intervention
Secondary Outcome Measures: Gait variability, measured with an inertial measurement unit on the sacrum, Variability of walking, Intervention is applied while participants are walking|Path integration error, measured in degrees, Navigation task performance, Intervention is applied while this task is performed
Pilot Study: Use of the Saccadometer to Detect Characteristic Saccadic Peak Velocity in Myasthenia Gravis Patients
NCT Number: NCT06501794
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myasthenia Gravis
Interventions: DEVICE: Quantitative measurement of eye movements
Sponsor: University of Liverpool
Collaborators: Liverpool University Hospitals NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2016-03
Completion Date: 2018-03

Summary:
Fast eye movements have been shown to demonstrate characteristics that are specific to myasthenia gravis that are not present in other eye movement disorders. It is possible to measure these eye movements and potentially identify these characteristics using new portable eye movement testing equipment. The aim of this pilot study is to discover if these characteristics can be identified using portable eye movement testing equipment in patients with a confirmed diagnosis of myasthenia gravis.

Primary Outcome Measures: Saccadic Peak Velocity, Participants will be recruited, consented and tested at a single visit during their routine clinical visit, up to one year after being recruited. Quantitative assessment of their eye movements using the Saccadometer will be assessed at that point of contact and the outcome measure recorded., Measured at first and only contact point within study i.e. day one and then not tested again
Peer Behavioral Activation Utilization to Address Structural Racism and Discrimination and Improve HIV Outcomes in High-Risk, Substance-Using Populations
NCT Number: NCT06501781
Acronym: PUSH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV Infections|Substance Use
Interventions: BEHAVIORAL: Peer Activate-LAI|DRUG: Cabenuva or Apretude
Sponsor: University of Maryland, Baltimore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 186
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2025-01
Completion Date: 2028-12

Summary:
This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to:

Aim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory)

Aim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.

Aim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives.

This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention.

Primary Outcome Measures: LAI-PrEP/ART Complete Adherence, Defined as receiving all 6 LAI maintenance doses within the +/-7 day window.

Unit of Measure: Binary (Yes/No), 12 months
Major Hepatectomy and Vascular Clamping
NCT Number: NCT06501742
Acronym: HMCV
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Diseases
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-24
Completion Date: 2025-12-31
Locations: Service d'Anesthésie - Réanimation Chirurgicale - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
A major hepatectomy consists of the resection of 3 or more liver segments. Its indications are mainly secondary malignant lesions, then primary malignant lesions, benign lesions and septic resections. Around a hundred major hepatectomies are carried out every year in Strasbourg. This surgery is burdened by 4.5% mortality at day 90 and 20 to 50% morbidity. The main intraoperative risks are hemorrhage and hemodynamic instability. Surgical vascular clamping helps reduce the risk of bleeding but is responsible for sometimes major hemodynamic variations, ischemia-reperfusion syndromes and can lead to acute post-operative liver failure. Recent literature attests to the safety of liver resection without vascular clamping, which is why it is less and less practiced.

Different elements are identified as independent risk factors for morbidity and mortality: the presence of cirrhosis, portal embolization, history of renal or cardiac failure, duration of vascular clamping, resected liver volume, transfusion of products labile blood and associated surgical procedures.

Given the significant risk of intra- and post-operative complications, it seems relevant to analyze pre- and intra-operative data in order to highlight risk factors for vascular clamping. This would allow better anticipation of complications, patient information, adaptation of intraoperative monitoring and postoperative surveillance and perhaps a reduction in complications. This study also makes it possible to take stock of the epidemiology around hepatectomies performed at the STRASBOURG University Hospital.

Primary Outcome Measures: Analyze pre- and intra-operative data from a major hepatectomy in order to identify possible predictive factors for intra-operative vascular clamping., Quantitative variables are described using the usual position and dispersion statistics, namely mean, median, minimum, maximum, standard deviation and quantile. The qualitative variables are described with the numbers (in number) and proportions (in %)of each modality.

The Chi2 test will be used to study the crossover between, Up to 1 year
Kissing as a Protective Factor Against Acidic pH in Saliva
NCT Number: NCT06501729
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries|Tooth Demineralization|Teeth Erosion Limited to the Enamel
Interventions: OTHER: Kiss
Sponsor: Universidad Catolica Santiago de Guayaquil
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-30
Completion Date: 2024-11-30
Locations: School of Dentistry of the Catholic University Santiago de Guayaquil, Guayaquil, Guayas, 17-11-5058, Ecuador

Summary:
The pH of saliva can be acidic or alkaline; When it is acidic, the tooth enamel is demineralized, that is, weakened. Additionally, bacteria in the mouth can increase and cause infections such as cavities. This occurs when we consume sugary or fermented drinks, such as soda or beer.

The intention of the research team is to give some of these drinks to the study participants and verify the decrease in salivary pH. Next, a group of people will be asked to kiss their partner on the mouth, and then the pH will be measured again to see if it increases, that is, if it stops being acidic faster than in the group that did not kiss.

The aim is to demonstrate that kissing on the mouth between two people can protect teeth from cavities by rapidly increasing the pH of saliva after it has decreased to become acidic.

Primary Outcome Measures: salivary pH, It is expected to measure the progressive increase in pH until reaching a neutral point, which occurs physiologically between 30 to 40 minutes, and compare the time spent by the control group with that of the experimental group. Measurements will be taken every 5 minutes from the kiss, which will last 40 seconds. In total, there will be 8 measurements, not counting the initial one for surveying the baseline. The measurement will be carried out with a calibrated pH meter. People will be asked to drool into a test tube, In a period of every 5 minutes, until reaching 40 minutes, which is the time in which physiologically the pH of the saliva is neutralized.
ICG Angiogram as a Predictor of Postoperative Visual Function After EEA Surgery
NCT Number: NCT06501716
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Indocyanine Green|Skull Base Neoplasms
Interventions: PROCEDURE: Indocyanine Green
Sponsor: University of California, San Francisco
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-12
Locations: University of California, San Francisco, San Francisco, California, 94143, United States

Summary:
Endonasal endoscopic approaches are an established treatment for suprasellar lesions compromising the optic nerves (ON). Surgery often involves dissecting tumors from the optic nerves and its blood supply, which can result in nerve damage and visual loss after surgery. To date, there are no reliable methods to monitor the optic nerve function during surgery and thus, post-surgical visual outcomes is unknown until the patients are fully awake after surgery for a visual exam. This delay in diagnosis prevents early therapeutic measures and can result in further harm to the ON. We have recently recognized that when ICG is routinely injected during these cases to check for patency of the big arteries the sub millimetric superior hypophyseal arteries supplying (SHA) the ON are also visible and that lack of visualization of these vessels is associated with worse visual deficits after surgery. Thus, ICG may be a tool to intraoperative predict visual outcomes after endonasal approach for suprasellar lesions and fill the nondiagnostic gap. This study will assess whether endoscopic ICG angiography before and after resection of suprasellar lesions can predict post-operative visual deficits. Successful completion will provide surgeons a novel tool to assess visual function during surgery. The ICG endoscopic angiograms suggested in this study are noninvasive and currently routinely performed at the end of surgery to check for patency of big brain arteries.

Primary Outcome Measures: Percentage of Patients with Post Operative Visual Acuity Impairment and Visual Field Defect, The investigators will evaluate the percentage of participants that present with decreased of visual acuity and any modality of visual field defect after the surgery. Postoperative visual acuity and visual field testing will be performed at 6 weeks postoperative follow up visit to evaluate chiasm function, including cranial nerve examination, bilateral number counting, letter reading, and number identification in 4 quadrants of peripheral vision. Visual evaluations will be performed by the ophthalmology service following our standard postoperative protocol., From the surgery to first post-operative follow up (6 weeks)
The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain
NCT Number: NCT06501703
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain
Interventions: OTHER: Instruments
Sponsor: Sinai University
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-07
Locations: Sinai University, Ismailia, 1141, Egypt

Summary:
this trial will aim to evaluate postoperative pain in terms of incidence and intensity and the frequency rate of analgesic intake in patients with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis after single-visit endodontic treatment of single rooted mandibular premolars using PUI or XPF, Fanta AF max file and dynamic manual agitation in the final irrigation protocol in a randomized clinical trial Postoperative pain will be assessed using a VRS 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment.

Primary Outcome Measures: The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain, Patients will be informed about the possible development of pain. Postoperative pain will be assessed using a VRS 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment. The VRS consisted of a four-step pain scale using a continuous 0-3 point scale; No pain (0): the treated tooth felt normal. Patients did not have any pain or discomfort, mild (1): recognizable, not discomforting), moderate (2): discomforting, but bearable, and severe (3): considerable discomfort, difficult to bear.

Each participant will be given a chart to record the level of postoperative pain and the frequency rate of the analgesic intake., 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment.
Feasibility of a Bedtime Variability Protocol
NCT Number: NCT06501690
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep
Interventions: BEHAVIORAL: Late bedtime|BEHAVIORAL: Variable bedtime
Sponsor: Penn State University
Sex: ALL
Age: CHILD
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-10
Completion Date: 2024-09

Summary:
The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol.

Primary Outcome Measures: Adherence to bedtime protocol, Parents will report on the time their child went to bed, Daily during each of the 3, one-week intervention periods
Secondary Outcome Measures: Parent perception of feasibility of following the protocol (semi-structured interview), Parents will provide qualitative answers to questions about their perceptions of following the protocol, including but not limited to whether the protocol was easy to follow, disruptive to their life, disruptive to their child's life., At the end of 3 week study|Sleep duration, Child sleep duration during each intervention period, measured by actigraphy, Daily during each of the 3, one-week intervention period
Using EMA Data to Inform a Web-intervention for Couples Concerned About Drinking
NCT Number: NCT06501677
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol; Use, Problem
Interventions: BEHAVIORAL: WBI
Sponsor: Stanford University
Collaborators: Portland State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 275
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-08
Locations: Stanford University, Stanford, California, 94305, United States

Summary:
Alcohol misuse is a prevalent and serious problem with significant harms to society, individuals, and their relationships. Romantic partners have a strong influence on their partner's behavior, uniquely positioning them as a motivator and supportive factor in changing their partner's alcohol use, but little evidence exists on the specific ways they can influence their partner. The impact this has on the quality of their relationship, communication, and overall well-being has yet to be explored. Thus, this study utilizes qualitative, quantitative, and ecological momentary assessment (EMA) data from both partners to develop a web-based intervention that applies communication-based personalized feedback to support the concerned partner (CP) in motivating their drinking partner (DP) to reduce drinking and other adverse relationship outcomes.

Primary Outcome Measures: DP Alcohol Use, The frequency of and amount of alcohol use, craving, and consequences experienced by the drinking partner, Baseline, Daily (EMA), 1-month-follow-up|CP Well-Being, The severity of depression and anxiety symptoms, level of anger, and perceived social support in the concerned partner, Baseline, 1-month-follow-up|CP-DP Relationship Quality, The degree of conflict and cohesion, style of communication, satisfaction, frequency of disagreement, and overall quality of the relationship, Baseline, Daily (EMA), 1-month-follow-up
Secondary Outcome Measures: CP Communication and Responsiveness about Drinking, The degree to which the concerned partner employs strategies to reduce the drinking partner's drinking and the level of enablement and responsiveness towards their drinking, Baseline, Daily (EMA), 1-month-follow-up
Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC
NCT Number: NCT06501664
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Esophageal Cancer
Interventions: DRUG: liposomal irinotecan|DRUG: 5-FU|DRUG: LV|DRUG: Irinotecan
Sponsor: Rui-hua Xu, MD, PhD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-11-30

Summary:
The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Primary Outcome Measures: Overall survival, Defined as the time between the date of randomization and death due to various causes, 1 year
Secondary Outcome Measures: Objective Response Rate, Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1, 4 months|Disease Control Rate, Defined as the percentage of patients who achieved CR, PR, and stable disease (SD) according to RECIST v1.1, 4 months|Progress-free survival, Defined as time from the date of randomization to first documented disease progression using RECIST version 1.1 by investigator review or death due to any cause, whichever occurred first., 5 months|Incidence of adverse events, Use NCI-CTCAE version 5.0 for classification and grading, 5 months
AI-based System for Assessing Suspected Viral Pneumonia Related Lung Changes
NCT Number: NCT06501599
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pneumonia, Viral|COVID-19 Pneumonia
Interventions: DIAGNOSTIC_TEST: Medical software (AI-based system)
Sponsor: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Collaborators: Sciberia Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 563
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-03
Completion Date: 2025-12-03
Locations: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department, Moscow, 127051, Russian Federation

Summary:
The AI-based system designed to process chest computed tomography (CT) aims to 1) detect the presence of pathologic patterns associated with interstitial changes in pneumonia; 2) highlight areas on the images with the probable presence of pathologies; 3) provide the physician with the results of image processing, including quantitative indicators of suspected viral pneumonia related lung changes according to visual pulmonary lesion grading system (CT0-4).

The retrospective study aims to demonstrate the clinical validation of the AI-based system. Clinical validation measures (sensitivity, specificity, accuracy, and area under the ROC curve) will be determined to provide evidence about the clinical efficacy of the AI-based system.

The hypothesis is that the measures of clinical validation of the AI-based system differ by no more than 8% from those declared by the manufacturer.

Primary Outcome Measures: Accuracy, The ability of an AI-based system to produce the correct result relative to the total number of trials, Upon completion, up to 1 year|Sensitivity, Effectiveness of the AI-based system to correctly identifies patients with the suspected viral pneumonia related lung changes, Upon completion, up to 1 year|Specificity, Effectiveness of the AI-based system to correctly identifies across a range of available measurements patients that do not have the suspected viral pneumonia related lung changes, Upon completion, up to 1 year|AUC ROC, The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of AI-based system in prediction of suspected viral pneumonia related lung changes, Upon completion, up to 1 year
Secondary Outcome Measures: Approximate volume of affected lung tissue, Approximate volume of affected lung tissue - quantitative characteristics of lung damage volume in percent (%): separately for left lung, right lung and total percentage of damage, Time Frame: Upon completion, up to 1 year
Study of SGB-3908 in Healthy Subjects and Mildly Hypertensive Subjects
NCT Number: NCT06501586
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hypertension,Essential
Interventions: DRUG: SGB-3908|OTHER: SGB-3908-Matching placebo
Sponsor: Suzhou Sanegene Bio Inc.
Collaborators: Innovent Biologics (Suzhou) Co. Ltd.
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-09
Completion Date: 2026-01-20

Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3908 in healthy subjects and mildly hypertensive subjects. The study will be a single ascending dose (SAD) phase.

Primary Outcome Measures: Number of Participants with Adverse Events (AEs), up to approximately 12 months
Secondary Outcome Measures: Change from Baseline in Blood Angiotensinogen (AGT) Level, up to approximately 12 months|Maximum Observed Plasma Concentration (Cmax) of SGB-3908 and of Potential Metabolites, Up to Day 3|Area Under the Concentration-time Curve (AUC) of SGB-3908 and of Potential Metabolites, Up to Day 3|Number of Participants With Anti- SGB-3908 Antibodies, up to approximately 6 months
A Study of SGB-9768 in Adult Healthy Volunteers
NCT Number: NCT06501573
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteer
Interventions: DRUG: SGB-9768|OTHER: Placebo
Sponsor: Suzhou Sanegene Bio Inc.
Sex: ALL
Age: ADULT
Enrollment: 37
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-10-17

Summary:
This study is a randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768 in healthy volunteers. The purpose is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768.

Primary Outcome Measures: Safety and tolerability of SGB-9768, Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs), 169 days
Secondary Outcome Measures: Pharmacokinetics-Cmax, Maximum Observed Plasma Concentration (Cmax), 48 hours|Pharmacokinetics-Tmax, Time at which the maximum plasma concentration (Cmax) occurs, 48 hours|Pharmacokinetics-AUClast, Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration, 48 hours|Pharmacokinetics-AUCinf, Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf), 48 hours|Pharmacokinetics-t1/2, Terminal Elimination Half-Life (t1/2), 48 hours|Pharmacokinetics-CL/F, Total Body Clearance, 48 hours|Pharmacokinetics-Vz/F, Volume of Distribution (Vz/F), 48 hours|Pharmacodynamics-C3, Change From Baseline in Complement 3 (C3), 169 days|Pharmacodynamics-complement acitvity, Change From Baseline in Complement Activity, 169 days
Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.
NCT Number: NCT06501560
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acne Vulgaris
Interventions: GENETIC: GWAS
Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
Collaborators: Indonesian Medical Education and Research Institute
Sex: ALL
Age: CHILD, ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-10-01
Completion Date: 2024-08-17
Locations: Universitas Indonesia, Jakarta Pusat, Jakarta, 10430, Indonesia

Summary:
This study is a series of descriptive-analytic studies on genomic variants in the facial skin of patients with AV at the Dermatology and Venereology Polyclinic by determining the genetic profile by GWAS examination in AVB and analysing the genetic profile in AVB against differences in geographical location. The research design used was a cross-sectional design.

Primary Outcome Measures: Severity of acne vulgaris, Physical examination: identify the number of blackheads, papules, pustules and cysts.

Degree of severity:(1)Mild =Comedo\<20, or inflammatory lesion\<15, or total lesion\<30(2)Moderate = Comedo 20-100, or inflammatory lesion15-50, or total lesion 30-125(3)Severe =cyst\>5, or Comedo\>100, or inflammatory lesion\>50, or total lesion\>125., 1 year|Population structure, Gene testing of blood sample Genetic Inflation Factor (GIF) \>1.1 or \<1.1 Principal Component Analysis (PCA), 3 months|Genomic Profile, Blood sample examination, processed using GWAS Mutations (SNPs)(1)Present(2)Absent, 3 months|Linkage disequilibirium (LD), Gene testing of blood samples Coefficient 0-1, 3 months|Haplotype, Gene testing of blood samples Jumlah gen

1. Satu gen
2. Multipel gen, 3 months|SNP Enrichment, Gene testing of blood samples Mutation position, 3 months|Association analysis and Association analysis of imputation results, Gene testing of blood samples PCA value, 3 months
Association of Leucocyte Telomere Length With DPAS Score in Skin Aging
NCT Number: NCT06501547
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging|Skin Laxity
Interventions: GENETIC: Leucocyte Telomere Length from blood draw
Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
Collaborators: Indonesian Medical Education and Research Institute
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-10-01
Completion Date: 2024-09-01
Locations: Universitas Indonesia, Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Summary:
The goal is to know the profile of photoaging based on clinical examination, Dermoscopic Photoaging Scale and leucocyte telomere length

The main questions of Research are:

* what is the profile of photoaging based on clinical examination results in skin aging
* what is the profile of photoaging based on DPAS Score in skin aging
* what is the profile of leucocyte telomere length in skin aging

Participants are female and male with the age of 29-31 years old and 59-61 years old. They will be examined by dermatovenereologist and will be photographed in 5 positions, they will get dermocopy on forehead, right cheek , left cheek, and chin, and their blood will be drawn about 10 mL in order to get the profile of leucocyte telomere length

Primary Outcome Measures: profile of leucocyte telomere length, profile of leucocyte telomere length in skin aging, 1 year|Profile of skin examination from Glogau scale, Glogau type 1 (mild) is without wrinkles (Age of 28-35 years), type II (moderate) is wrinkles in motion (age of 35-50 years), III (advanced) with wrinkles at rest (age of 50-65 years), type IV (severe) is wrinkles all over the face (age of 60-75), 1 year|profile of skin examination with dermoscopic photoaging scale (DPAS), skin aging is assessed from dermoscopic photoaging scale on dermoscopic images, looking at pigmentary changes, vascular changes, telangiectasis, wrinkles, actinic keratoses, and blackheads. There are four facial regions assessed in the DPAS score calculation, namely the forehead, right cheek, left cheek, and chin. The sum of the scores of the four regions is assessed based on 11 parameters, with a maximum final score of 44.

The greater the score, the higher marks of skin aging, 1 year
Non-invasive Brain Tumor Molecular Diagnostics and Monitoring
NCT Number: NCT06501521
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Tumor
Interventions: DIAGNOSTIC_TEST: Diagnostic test
Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2030-12-31
Locations: Department of Neurosurgery, University Hospital Olomouc, Olomouc, 77900, Czechia

Summary:
This prospective multicenter study aims to enroll GBM patients who will undergo repeated assessments (preoperatively and 3 months post-surgery) to detect circulating tumor cells and analyze the transcriptomic profiles of EVs in their blood. The prognostic and monitoring significance of these biomarkers to disease course (assessing treatment efficacy, resistance incidence, tumor progression) will be evaluated.

Concurrently, proteomic profiles typical of GBM will be analyzed in blood and ocular secretion samples from GBM patients, patients with low-grade gliomas, and patients without brain tumors to identify and validate novel protein biomarkers suitable for disease monitoring. Additionally, this study proposes an innovative approach to monitor GBM patients by investigating the presence of GBM-specific nucleic acid fragments in urine.

Primary Outcome Measures: Proteomic profiles of proximal liquids in brain tumor patients, The protein profiles will be measured in ocular secretion and plasma samples of patients wiht GBM, low-grade glioma and control cohort. Candidate proteins will be correleted with clinical parameters. The number of patients with identified prognostic biomarkers will be reported., 2020-2023|Circulating tumor cells (CTCs) for non-invasive monitoring of GBM patients., The number of CTCs and their molecular characteristics will be measured in peripheral blod of GBM patients. The CTCs counts will be correleted with the clinical parameters. The number of patients with the presence or absence of CTCs will be reported., 2020-2030|Extracellular vesicles (EVs) for non-invasive monitoring of GBM patients., The RNA profiles of EVs will be measured in plasma samples of patients wiht GBM. Candidate RNAs will be correleted with clinical parameters. The number of patients with identified prognostic RNAs will be reported., 2020-2030|Urine as a source of GBM-specific nucleic acids fragments for disease monitoring., The GBM-specific nucleic acids fragments will be measured in urine of GBM patients. Candidate nucleic acids will be correleted with clinical parameters. The number of patients with identified prognostic biomolecules will be reported., 2025-2030
Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery: a Retrospective Observational Study on the Influence of the Suture Used
NCT Number: NCT06501508
Acronym: SUTURA
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgical Wound Dehiscence
Interventions: DEVICE: Stratafix Symmetric
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Ethicon, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1900
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-22
Completion Date: 2024-11-22
Locations: Hospital universitario General de Villalba, Collado-Villalba, Madrid, 28400, Spain|Hospital Universitario Infanta Elena, Valdemoro, Madrid, 28342, Spain|Hospital Universitario Fundación Jiménez Díaz, Madrid, 28040, Spain|Hospital Universitario Rey Juan Carlos, Madrid, 28933, Spain

Summary:
In this retrospective longitudinal observational study we compare the incidence of fascial dehiscence and incisional hernia in patients operated via abdominal wall incision, comparing the barbed suture Stratafix Symmetric to other types of suture during closure of the abdominal wall. In addition, we plan to analize the impact of other risk factors, patient related and patient unrelated, on the incidence of fascial dehiscence.

Primary Outcome Measures: Abdominal Wall Dehiscence, Disruption of all layers of the abdominal wall with exposure of abdominal viscera within 30 days after primary surgery, 30 days
Secondary Outcome Measures: Incisional hernia, Any defect of the abdominal wall in the area of the primary incision, palpable or visible in ultrasound, CT- or MR-Scan, with or without protrusion of intraabdominal content, 1 year|PROMs - Postoperative Pain, One question about pain - 4 answers, 1 year|PROMs - Mental and emotional health, Two questions - 4 answers for each question, 1 year|PROMs - Work an social life performance, Two questions - 4 answers for each question, 1 year|PROMs - Fatigue, Two questions - 4 answers for each question, 1 year|PROMs - Funcionality, One question - 4 answers for each question, 1 year|PROMs - Sexuality, One question - 4 answers for each question, 1 year|PROMs - Body image, One question - 4 answers for each question, 1 year
Links Between Cognitive Deficits During Normal or Pathological Aging and Slow Waves Measured in EEG
NCT Number: NCT06501495
Acronym: MemoAge
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aging|Alzheimer Disease
Interventions: OTHER: video polysomnography|OTHER: Attention task
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2026-09
Locations: Maladies du Sommeil, Paris, 75013, France

Summary:
With age, memory processes (encoding, consolidation and retrieval) as well as daytime vigilance are altered. Sleep is also impaired in older adults, notably slow waves that are known to play a key role in memory consolidation. Interestingly, some slow waves can also be detected in EEG recordings during wakefulness, and have been related to vigilance fluctuations.

The investigators believe that slow waves, during both sleep and wakefulness, could constitute a common biomarker of sleep disturbances and daytime vigilance problems. A dysregulation of slow waves could thus explain the impact of aging on the different memory processes. Since alterations in memory capacity, attention, and sleep quality are further exacerbated in patients with Alzheimer's disease (AD), the investigators propose to study the links between aging (normal and pathological), sleep and daytime vigilance alterations, and their impacts on the different key stages of memory.

The investigators will examine the associations between slow waves and changes in memory and vigilance in normal and pathological aging by studying young adults, seniors without cognitive disorders, and patients with prodromal AD. By replaying sensory cues associated with learning material during sleep, the investigators will also evaluate the effectiveness of auditory stimulation during sleep to enhance memory consolidation in older adults without and without cognitive deficits.

Overall, this study aims to better understand the relationships between slow waves, aging, memory, and vigilance, providing insights into cognitive decline and potential interventions in aging and Alzheimer's disease.

Primary Outcome Measures: slow waves density, quantifying slow waves with their density (during sleep, wakefulness at rest and during tasks), 2 days