pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effect of Whey Powder Bread on Blood Glucose
NCT Number: NCT06565676
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diet, Healthy
Interventions: DIETARY_SUPPLEMENT: Bread with whey protein powder added
Sponsor: TC Erciyes University
Collaborators: Tübitak
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-20
Completion Date: 2025-03-01
Locations: Erciyes University, Kayseri, 38039, Turkey

Summary:
The aim of the study was to add whey powder, which is lost as waste in cheese production and has many health benefits, to bread, which is consumed very much daily in Turkey, to enrich bread in terms of nutrients and to examine the effect of whey powder added bread on postprandial blood glucose. In the study, all volunteer participants will be randomly assigned to a breakfast meal containing all types of bread (white flour bread, white flour bread with whey powder added, whole wheat flour bread and whole wheat flour bread with whey powder added) for four consecutive days and their blood glucose levels will be measured at certain minutes. There are no studies in the literature investigating the effect of whey powder added to bread on blood glucose.

Primary Outcome Measures: Postprandial glucose response, Postprandial glucose response was quantified as incremental area under the curve (iAUC), which was calculated according to the trapezoidal rule by using serum glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes. Higher values represent a worse outcome., Two hours postprandial period (from fasting to 120 minutes after the test breakfast)
A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.
NCT Number: NCT06565650
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Dry Eye
Interventions: DRUG: Miebo|DRUG: Saline
Sponsor: Bausch & Lomb Incorporated
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2026-02
Locations: Site 101, Glendale, California, 91204, United States|Site 112, Murrieta, California, 92562, United States|Site 102, Newport Beach, California, 92663, United States|Site 109, Rancho Cordova, California, 95670, United States|Site 111, Santa Ana, California, 92705, United States|Site 106, Torrance, California, 90505, United States|Site 113, Delray Beach, Florida, 33484, United States|Site 107, Morrow, Georgia, 30260, United States|Site 105, Carmel, Indiana, 46290, United States|Site 110, Kansas City, Missouri, 64111, United States|Site 104, Saint Louis, Missouri, 63131, United States|Site 108, Asheville, North Carolina, 28803, United States|Site 103, Memphis, Tennessee, 38119, United States

Summary:
A Randomized, Multicenter, Double-Masked, Saline-Controlled Trial to Evaluate Corneal Endothelial Cell Density in Subjects With Dry Eye Disease Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months

Primary Outcome Measures: Mean change from baseline in ECD, Mean change from baseline in ECD in the study eye at the Month 3 and Month 12 Visits, Assessed at Month 3 and Month 12 Visits
Targeting Minority Stressors to Improve Eating Disorder Symptoms in Sexual Minority Individuals With Eating Disorders
NCT Number: NCT06565637
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Eating Disorders|Sexual Minorities
Interventions: BEHAVIORAL: Promoting Resilience to Improve Disordered Eating
Sponsor: Auburn University
Collaborators: San Diego State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2026-07-01
Locations: Auburn University, Auburn, Alabama, 36849-9027, United States|San Diego State University, San Diego, California, 92182, United States

Summary:
The goal of this clinical trial is to learn if a new intervention (Promoting Resilience to Improve Disordered Eating; PRIDE) can decrease internalized stigma and increase the ability to cope effectively with stressors in sexual minority populations diagnosed with eating disorders. The main question it aims to answer is:

Will an eating disorders treatment focused on decreasing internalized stigma and increasing sexual minority stress coping self efficacy in sexual minority populations? Participants Will

* Complete a telephone screen with study staff to determine preliminary eligibility for the study
* Undergo a behavioral eligibility screening that includes structured clinical interviewing in order to determine proper diagnosis of an eating disorder along with ensuring absence of non-eating disorder diagnoses
* Complete self-report measures to determine study eligibility
* Attend up to 14 weekly therapy sessions as part of the PRIDE intervention, where participants will work with qualified clinicians to address eating pathology and disordered body image along with developing effective strategies for coping with sexual minority stressors
* Complete surveys upon completion of the intervention 3 and 6 months post follow-up

Primary Outcome Measures: Internalized Homophobia Scale (IHP), Assesses internalized stigma (9 items, 5-point scale, higher scores indicate greater internalized stigma)., Change from Baseline through 3- and 6-month follow-up|Sexual Orientation Implicit Association Test, Assesses internalized stigma via computerized behavioral task involving categorizing positive/negative words with sexual minority and heterosexual people., Change from Baseline through 3- and 6-month follow-up|Coping Self Efficacy Scale (CSES), Assesses sexual minority(SM)-stress coping self efficacy, as adapted for address SM stress in prior research (13 items, 11-point scale, higher scores indicate greater SM-stress coping self-efficacy)., Change from Baseline through 3- and 6-month follow-up
Evaluation of Reflex Tear Production
NCT Number: NCT06565624
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Eye Disease
Interventions: PROCEDURE: Cotton Swab Nasal Stimulation
Sponsor: Alcon Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10
Completion Date: 2025-03

Summary:
The purpose of this study is to evaluate reflex tear production following cotton swab nasal stimulation in subjects with dry eye disease (DED).

Primary Outcome Measures: Change from baseline in TMH immediately following stimulation, TMH (the distance between the line of reflection along the top of the tear prism to the edges of the eyelids) will be measured in millimeters using OCT, a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. TMH will be assessed prior to nasal stimulation and upon completion of nasal stimulation. Only one eye will be assessed by OCT., Day 1 pre-stimulation (Baseline); Day 1 immediately post-stimulation
Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy
NCT Number: NCT06565598
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nonfunctional Kidney|Renal Cancer
Interventions: PROCEDURE: Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy
Sponsor: The First People's Hospital of Xiushui
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2025-12-01
Locations: First People 's Hospital of Xiushui, Jiujiang, China

Summary:
To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization

Primary Outcome Measures: intraoperative blood loss, Blood loss during operation, 24 months|postoperative time of getting out of bed, Time to get out of bed after surgery, 24 months|postoperative hospital stay, Length of hospital stay after surgery, 2-5 Days|Whether to convert to laparotomy or not, According to the surgical records in the medical records, whether the operation was converted to laparotomy was checked, and the data were recorded when collecting the data., 24 months|Operation time, Complete operative time, 1-3 Hours|whether the tumor was completely removed, Observe whether the tumor is complete according to the naked eye after surgery，Record and record to the surgical record, record when collecting the receipt., 24 months
Secondary Outcome Measures: Clavien-Dindo grading, Grade I : long-term pain, fever, continuous bleeding and exudate, transient intestinal obstruction ; grade II : need blood transfusion, pneumonia ; grade III : hematuria requiring cystoscopy ; level IV : renal insufficiency requiring hemodialysis, respiratory insufficiency requiring ICU treatment, and cardiac insufficiency requiring ICU care., 24 months
Prediction of Local Recurrence and Its Impact on Long-term Outcomes After Low-risk Glans-sparing Surgery for Penile Squamous Cell Carcinoma
NCT Number: NCT06565585
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Penile Cancer, Recurrent
Interventions: PROCEDURE: Glans-sparing surgery
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-03
Completion Date: 2025-06
Locations: University hospitals Leuven, Leuven, 3000, Belgium

Summary:
The treatment paradigm for primary penile squamous cell carcinoma (PSCC) has increasingly favored maximal organ preservation without compromising oncological outcomes. However, the literature has often included heterogeneous patient cohorts and varied surgical approaches, making it challenging to draw definitive conclusions about the impact of local recurrence (LR) on survival.

Since the investigators recently published the results from a large, multicentric international study on a homogeneous cohort of high-risk PSCC patients who were treated with upfront complete glansectomy, the investigators have been demonstrating that local recurrence after upfront glansectomy was strongly correlated with worse overall survival and cancer-specific survival in this more homogeneous cohort, therefore challenging the dogma that LR following organ-sparing surgery for PSCC does not affect survival outcomes (Roussel et al., BJU Int 2021; DOI: 10.1111/bju.15297).

The investigators hypothesized that these findings were caused by an enrichment of higher risk tumors in this cohort since solely glansectomy patients with a complete removal of all the glandulopreputhial epithelium were included. Consequently, the hypothesis has arisen that LR might not be a predictor of poorer survival outcomes in lower-risk tumors who underwent glans-sparing surgery defined as circumcision, wide local excision, laser ablation, glans resurfacing and partial glansectomy, and that previous findings influencing the guidelines may be heavily influenced by the inclusion of large proportions of low-risk tumors in rather heterogenous cohorts in terms of technical approach.

Therefore, this study aims to explore whether LR similarly affects survival in lower-risk tumors treated with glans-sparing techniques such as circumcision, wide local excision, glans resurfacing, laser ablation, and partial glansectomy.

Primary Outcome Measures: long-term oncologic outcomes (OS, CSS), impact of local recurrence after glans-sparing surgery on long-term oncologic outcomes (OS, CSS), 1/01/2000 - 1/06/2023
Secondary Outcome Measures: Predictive histopathological factors for local recurrence, Identify histopathological factors that might predict the occurrence of local recurrence, 1/01/2000 - 1/06/2023
Antisense Oligonucleotide Treatment for PCARP Disease Due to Mutation in FLVCR1
NCT Number: NCT06565572
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Posterior Column Ataxia With Retinitis Pigmentosa
Interventions: DRUG: nL-FLVC-001
Sponsor: University of Colorado, Denver
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-23
Completion Date: 2028-12-31
Locations: Childrens Hospital Colorado, Aurora, Colorado, 80045, United States

Summary:
The goal of this clinical trial is to evaluate a specific antisense oligonucleotide medication in one patient with posterior column ataxia with retinitis pigmentosa. The main question it aims to answer is: what is the safety and tolerability of this medication in a single participant.

Primary Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Over 12 months|We will measure visual acuity, retinal thickness, examine changes in fundus photos and biomicroscopic exam post nL-FLVC-001 administration in a participant with FLVCR1 gene mutation, Over 12 months
Secondary Outcome Measures: Measure any changes in the Cardiff Visual Ability Questionnaire for Children (CVAQC-25) in one patient with PCARP after nL-FLVC-001 intravitreal injection., Over 12 months
CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs
NCT Number: NCT06565546
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventral Hernia
Interventions: OTHER: Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin|OTHER: Acetaminophen and Gabapentin: standard postoperative pain medications
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2025-12

Summary:
Pilot pragmatic trial using an implementation science approach to determine the feasibility of a CYP2D6-guided opioid prescribing for patients undergoing elective VHRs compared to usual care. Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.

Primary Outcome Measures: Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care., Percentage of potential participants approached will enroll and complete study., 6 months
Secondary Outcome Measures: Assess the efficacy of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs., Participants may report improved post-operative pain control and quality of life., 6 months
Exploring the Synergistic Effects of Virtual Reality and Retrogressive Imagery on Basketball Free Throw Performance and Self-efficacy Among University Students: A Randomized Controlled Trial
NCT Number: NCT06565533
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: RETI|VR|FTSE
Interventions: BEHAVIORAL: Retrogressive imagery (RETI)|BEHAVIORAL: Virtual Reality (VR)
Sponsor: Wu Jiarun
Sex: ALL
Age: CHILD, ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-05
Completion Date: 2024-06-10
Locations: Universiti Sains Malaysia, Kota Bharu, Kelantan, 16150, Malaysia

Summary:
This research contributes to the growing body of evidence supporting the use of mental training techniques in sports. By demonstrating the effectiveness of RETI and VR in improving FT performance and FTSE, this study provides valuable insights for coaches, athletes, and sports psychologists.

Primary Outcome Measures: Free Throw (FT) Shooting Performance, Free throw (FT) are a closed skill technique used for scoring points under practice, field study, or game conditions. Testing was conducted before, during, and after the intervention. FTs are typically awarded to players who are fouled while shooting, and the player takes the shot from behind the FT line, which is 15 feet away from the basket. Each successful FT is worth one point. In this study, to measure shooting accuracy more precisely, we employed the following scoring system: a shot that goes through the basket without touching the rim scores 3 points; a shot that goes in after hitting the rim scores 2 points; a shot that hits the rim but does not go in scores 1 point; and a complete miss scores 0 points. Each testing session comprised two sets of 10 FT shots, with a 15-minute rest period between the sets. The total score for each testing session was calculated by summing the scores from the two sets of 10 shots, resulting in a possible range of 0 to 60., week 8|Free throw shooting self-efficacy (FTSE), We utilized the Free-Throw Self-Efficacy (FTSE) scale developed by Fazel (2015) to measure participants' self-efficacy in basketball free-throw shooting, following the microanalytic technique guidelines proposed by Bandura (2006). Participants were asked to imagine taking 10 consecutive free throw and to rate their confidence in successfully making each of these shots. Specifically, they were asked to indicate how certain they were that they could successfully make 1 out of 10, 2 out of 10, and so on, up to 10 out of 10 free throw. Participants rated their confidence on a scale from 0 (completely uncertain) to 10 (very certain)., week 8
Modulating Cortical Excitability to Improve Functional Movements in Individuals With Patellofemoral Pain
NCT Number: NCT06565520
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patellofemoral Pain Syndrome
Interventions: DEVICE: transcranial direct current stimulator
Sponsor: University of Nevada, Las Vegas
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-24
Completion Date: 2025-04-21
Locations: University of Nevada, Las Vegas, Las Vegas, Nevada, 89154, United States

Summary:
This study sought to investigate whether modulation of cortical excitability of the gluteal musculature, via tDCS paired with exercise, will reduce the amount the knee caves in during functional tasks in individuals with PFP. The objective is the explore if having tDCS target the area of the brain controlling hip muscles, when paired with exercise, will be more effective in reducing the amount the knee caves in for individuals with PFP versus those who receive exercise alone as their treatment. The aim is to contribute our findings to the growing knowledge in this area in order to help establish the possibility, and feasibility, of its use in clinical settings to strengthen traditional treatments for this patient population.

Primary Outcome Measures: trunk lean angle, Baseline and Immediately after intervention|knee frontal plane projection angle, Baseline and Immediately after intervention|hip frontal plane projection angle, Baseline and Immediately after intervention|dynamic valgus index, Baseline and Immediately after intervention
MDMA-Assisted Therapy for Pathological Narcissism
NCT Number: NCT06565494
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Narcissism
Interventions: DRUG: midomafetamine (MDMA)-Assisted Therapy
Sponsor: University of Washington
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-27
Completion Date: 2027-01-31
Locations: University of Washington, Seattle, Washington, 98195, United States

Summary:
This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine (MDMA) - assisted therapy (AT) for participants diagnosed with pathological narcissism. As all participants will be allocated to a single group assignment, there will be no blinding, randomization, or comparator treatment. Participants will have a screening visit, a preparation period of 3 visits, a treatment period receiving MDMA-AT at 3 monthly visits, a 6 month follow up period coming in at one week, one month, three months and six months after last treatment visit.

Primary Outcome Measures: Pathological Narcissism Inventory (PNI)--Participant version, Assess changes in diagnostic features of pathological narcissism per self-report. This measure has 52 items each rated on a 6-point Likert scale with higher scores indicating higher severity., Baseline, After each MDMA session (approx every month for 3 months); After MDMA sessions end, 1 month, 3 months, 6 months
Other Outcome Measures: Reported adverse events, Assess incidence of adverse events that may be indicative of an acute medical complication of MDMA, for example, chest pain, shortness of breath, or neurological symptoms or any other signs or symptoms that prompt additional vital sign measurements. Assess incidence of AEs by severity and by severity categorized as leading to discontinuation of MDMA, resulting in death or hospitalization, or continuing at Study Termination. Assess incidence of Treatment Emergent AEs (TEAEs) to determine relationship to the MDMA based on relative incidence. Assess incidence of TEAEs by severity reported during an Experimental Session, 1 day, and 2 days after each Experimental Session., Baseline, After each MDMA session (approx every month for 3 months); After MDMA sessions end, 1 month, 3 months, 6 months|Columbia Suicide Severity Rating Scale (C-SSRS), Assess incidence of positive or serious ideation and suicidal behavior. The screening version of this measure produces a 'low', 'moderate', or 'high' risk of suicide., Baseline, After each MDMA session (approx every month for 3 months); After MDMA sessions end, 1 month, 3 months, 6 months
La CASA (Comunidad, Alimentación, Seguridad y Amén) Healthy Eating Intervention
NCT Number: NCT06565455
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Obesity|Health Behavior, Risky
Interventions: BEHAVIORAL: La CASA (Comunidad, Alimentación, Seguridad y Amén) Program: Healthy Eating Intervention
Sponsor: University of Arkansas
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-03
Completion Date: 2026-05-31
Locations: University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States

Summary:
Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called CASA (Comunidad, Alimentacion, Seguridad y Amen).

Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (the CASA) in collaboration with Hispanic churches and their congregants.

SA2. To conduct the CASA intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention.

SA3. To assess the impact of the CASA intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child).

The investigators will compare between the intervention group (16 mother-child dyads) versus the control/attention group (16 mother-child dyad) to see if the intervention is effective in improving diet quality and changing cooking behaviors.

Participants will:

1. Participate in cooking workshops and one to one learning activities
2. Report on diet and physical activity
3. Will measure fruit and vegetable intake

Primary Outcome Measures: Changes in dietary behavior, Evaluated via eating habits as reported through the Food Frequency Questionnaire, Baseline (T0), Week 22 (T1)|Change in diet quality, Evaluated based on eating habits reported through the Food Frequency Questionnaire, Baseline (T0), Week 22 (T1)|Change in diet quality, Evaluated based on eating habits reported through the Healthy Cooking Questionnaire-2, Baseline (T0), Week 22 (T1)
Secondary Outcome Measures: Consumption of fruits and vegetables, Evaluated through the Veggie Meter measures, Baseline (T0), Week 22 (T1)|Consumption of sugary drinks, Evaluated through the FFQ, Baseline (T0), Week 22 (T1)|Physical activity, Evaluated through the PA Screener, Baseline (T0), Week 22 (T1)
Feasibility of Using NeuraSignal Transcranial Doppler Robot
NCT Number: NCT06565442
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Autoregulation
Interventions: DEVICE: NeuraSignal transcranial doppler robot
Sponsor: University of Alabama at Birmingham
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-12-15

Summary:
The purpose of this study is to determine the feasibility of using the NeuraSignal transcranial doppler robot in a neuro ICU setting to measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves

Primary Outcome Measures: Primary outcome, Cerebral autoregulatory curve generation using the NeuraSignal transcranial doppler robot correlated with arterial blood pressure measurements in neuro ICU patients admitted for blood pressure management after spinal surgery, one year
Secondary Outcome Measures: Secondary outcome, left or right shifting of the autoregulatory curve as a result of vasopressor use, one year
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
NCT Number: NCT06565416
Acronym: OPTIC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder|Opioid Misuse|Chronic Pain
Interventions: BEHAVIORAL: Implementation Strategies
Sponsor: University of New Mexico
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 225
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2028-07
Locations: Clinic Site A (blinded pending tribal approval), Arcata, California, 95521, United States|Clinic Site C (blinded pending tribal approval), Minneapolis, Minnesota, 55404, United States|Clinic Site B (blinded pending tribal approval), Toppenish, Washington, 98948, United States

Summary:
The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder.

Primary Outcome Measures: Number of clients screened for chronic pain and opioid misuse/opioid use disorder, Derived from electronic medical records, 6 months (or duration of implementation phase)|Number of clients screened for chronic pain and opioid misuse/opioid use disorder, Derived from electronic medical records, 6 months (or duration of sustainment phase)
Hyperlactatemia in Critically Ill Patients With Acute Kidney Injury
NCT Number: NCT06565403
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury
Sponsor: University Medical Centre Maribor
Collaborators: University of Maribor, Faculty of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-15
Completion Date: 2024-08-19
Locations: Robert Ekart, Maribor, 2000, Slovenia

Summary:
The aim of the research is to determine the prevalence of patients with acute kidney injury in the intensive care unit, the role of dialysis treatment in the treatment of these patients.

Primary Outcome Measures: Hyperlactatemia in critically ill patients with acute kidney injury treated with renal replacement therapy in the intensive care unit, survival, 90 days
Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization
NCT Number: NCT06565390
Acronym: ROMPER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emergencies
Interventions: DEVICE: Babies in the Owlet monitor group
Sponsor: University of Alabama at Birmingham
Collaborators: Owlet Baby Care, Inc.
Sex: ALL
Age: CHILD
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2030-12-31

Summary:
This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge.

Primary Outcome Measures: Emergency room visits and high-acuity rehospitalizations., Number of emergency room visits and high-acuity rehospitalizations., 6 months
Secondary Outcome Measures: Number of participants with serious outcome events, The number of participants with serious adverse event composite outcome: includes death, medical provider delivered cardiac pulmonary resuscitation (CPR), receipt of positive airway pressure, or intubation during study period., 6 months|High-acuity rehospitalizations, The number of high-acuity rehospitalizations., 6 months|All-cause mortality., The rate of all-cause mortality., 6 months|Other rehospitalizations, The number of other rehospitalizations., 6 months|Emergency room visits, The number of emergency room visits., 6 months|Sick visits, The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping., 6 months|Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE), Number of episodes of ALTE/BRUE, 6 months|Healthcare utilization, Healthcare utilization in cost effectiveness analysis, 6 months|Safe-sleep practice adherence, Number of participant caregivers reporting adherence to safe-sleep practices on questionnaire., 6 months|Caregiver sleep disturbance., Caregiver sleep disturbance using the sleep quality scale., 6 months|Caregiver anxiety score., Caregiver anxiety score assessed using State Trait Anxiety Inventory., 6 months
Immunogenicity and Thrombotic Potential of Circulating Protamine-heparin Complexes in Cardiac Surgery Patients
NCT Number: NCT06565364
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Thrombocytopenia|Antibodies Drug Specific
Interventions: DIAGNOSTIC_TEST: "ZYMUTEST™ HIA" immunoglobulin g ELISA (enzyme-linked immunosorbent assay )
Sponsor: Medical University of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-07
Completion Date: 2023-03-31
Locations: Medical University of Vienna, Vienna, 1090, Austria

Summary:
The primary aim of this study was to describe the prevalence and time course of the occurrence of protamine/heparin antibodies in patients undergoing cardiac surgery on cardiopulmonary bypass.

The second aim was to identify triggers of immunization.

The third aim of this study was to evaluate a potential clinical impact of protamine/heparin antibodies and their platelet-activating properties leading to thromboembolism and other adverse outcomes.

Primary Outcome Measures: prevalence of protamine/heparin antibodies, preoperatively until postoperative day 10
Secondary Outcome Measures: Potential triggers, The presence of the following conditions was evaluated preoperatively:

* repeated surgery on cardiopulmonary bypass (CPB)
* bleeding disorders
* age in years
* height in meters
* weight in kilograms
* weight and height will be combined to report the body-mass-index in kg/m\^2
* previous thromboembolic event
* diabetes mellitus with/without insulin treatment
* cardiac function and valve diseases
* preoperative presence of peripheral artery disease
* preoperative presence of renal diseases
* fish allergy
* men after vasectomy, preoperatively|Clinical impact, Information about the following events were collected until day 10 or discharge of the patients:

* cardiovascular events: thrombosis, tachycardic atrial fibrillation, cardiopulmonary resuscitation
* delay in platelet count recovery
* difference in severity of thrombocytopenia (platelet count in 10\^9/l)
* cerebrovascular events: stroke, seizure
* kidney function: creatinine in mg/dl, urea in mg/dl, need for renal replacement therapy
* inflammation parameters: white blood count in 10\^9/l, C-reactive protein in mg/dl, until postoperative day 10
Other Outcome Measures: Thrombin generation, measurement of thrombin generation in a reduced number of participants, preoperatively until postoperative day 6
S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries
NCT Number: NCT06565351
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Spinal Cord Injuries|Renal Failure
Interventions: OTHER: eGFR estimated from creatinine and cystatin C
Sponsor: Rigshospitalet, Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 248
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-06-01
Completion Date: 2022-01-01
Locations: Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet; Glostrup, Glostrup, DK-2600, Denmark

Summary:
* In individuals with spinal cord injury (SCI) kidney function defined as Glomerular Filtration Rate (GFR) is monitored by injection of e.g.99mDTPA and subsequent blood sampling (DTPA-clearance)
* GFR calculated from plasma samples of the endogenous substance s-Cystatin C (eGFR cystatin C) was compared to DTPA-clearance in 248 individuals with SCI.
* It is concluded that eGFR based on plasma s-cystatin C can replace the more tedious 99mDTPA-clearance procedures in individuals with SCI

Primary Outcome Measures: Estimated clearance of Cystatin C (eGFR cystatin C), The estimated clearance of cystatin (eGFR) C is calculated from s-cystatin C and the age and height and weight of the individual. It is corrected for Body Surface area. In this study it is compared to the Gold Standard examination DTPA-clearance, through study period (2 years)
Secondary Outcome Measures: Test/ retest variability of eGFR cystatin C, Blood samples for determination of Cystatin C is taken twice within maximally three months, to determine the repeatability of eGFR cystatin C, Up to three months|Long term repeatability of eGFR cystatin C, Blood samples for determination of cystatin C is taken twice with an interval of two-three years to determine long term repeatability. This is compared to simultaneously acquired measurements of DTPA-clearance, Up to three years
Comparison Between Effect of Vitamin D Versus Dexmedetomidine in Patients With Head Trauma Using Interleukin 6
NCT Number: NCT06565338
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Traumatic Brain Injury
Interventions: DRUG: Dexmedetomidine|DRUG: Vitamin D3
Sponsor: Minia University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-04-25
Completion Date: 2024-02-05
Locations: Asmaa, Minya, Egypt

Summary:
in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker

Primary Outcome Measures: The primary endpoint aims to measure the inflammatory markers level (interleukin 6'CRP'ESR)., * IL-6 in the unit of (pg/mL)
* ESR in the unit of in the unit of(mm/hr)
* CRP in the unit of (mg/L), 5 days
Secondary Outcome Measures: The secondary endpoints aim to compare ICU stay, disability ,morbidity and mortality in both groups, * ICU stay in the unit of days
* Glascow outcome scale ( units on scale from 1 to 5 with better scale towards 5 and worse towards 1), 3 months
The Immediate Effect of Combined Terminal Knee Extension Exercise With Audible Cues
NCT Number: NCT06565325
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Muscle Weakness
Interventions: BEHAVIORAL: Exercise + Audible Cues|BEHAVIORAL: Exercise
Sponsor: Mahidol University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-02-10
Completion Date: 2025-02-07
Locations: Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Salaya, 73170, Thailand

Summary:
Typically, patients perform TKE by themselves after exercise prescription. The investigators thought that a lack of attention and preferred speed of patients might not provide the best outcome. Therefore, an increased effectiveness of TKE is interesting for physical therapy implication. Besides, adding sensory input which is audible cues or rhythm during exercise may enhance the efficacy of the exercise by increasing neuromuscular control and function.

Therefore, the study aimed to investigate the immediate effects of combined TKE with audible cues on motor unit behavior. The researchers expect that adding rhythm from the metronome will enhance neuromuscular control which may change motor unit behavior of VM muscle. The findings of the study may have helped explain the mechanism behind the acute effects of combined TKE with audible cues on VM function and their potential application in the field of physical therapy.

This study aims to investigate the immediate effect of combined TKE with audible cues on motor unit behavior in healthy participants and to investigate reliability of decomposition electromyography procedure during single leg squat.

Primary Outcome Measures: Motor unit firing rate, one parameter to explain the motor unit behavior of vastus medialis muscle, At the end of Cycle 1 (each cycle is 1 day)|Peak motor action potential, one parameter to explain the motor unit behavior of vastus medialis muscle, At the end of Cycle 1 (each cycle is 1 day)
A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.
NCT Number: NCT06565312
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginal Health|Vaginal pH
Interventions: DIETARY_SUPPLEMENT: Flora Power Probiotic Vaginal Suppository
Sponsor: Love Wellness
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-10
Completion Date: 2024-07-10
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.

Primary Outcome Measures: Effect on Vaginal pH and Health, Measure the change in vaginal pH levels with a test strip from baseline to 24 hours after the 5-day intervention period., Baseline, Day 6 (24 hours after the last suppository insertion)|Effect on Vaginal pH and Health, Measure the change in overall vaginal health from baseline to 24 hours after the 5-day intervention period with a questionnaire., Baseline, Day 6 (24 hours after the last suppository insertion)
Secondary Outcome Measures: Participant Perception of Vaginal Freshness and Odor, Evaluate participants' perceptions of the vaginal suppository's impact on vaginal freshness and odor, as well as the support of a calm, soothed, and balanced vaginal environment. This outcome measure is assessed with questionnaires., Baseline, Day 2, Day 5
Cognitive and Speech Disorders in Children With Congenital Heart Defects
NCT Number: NCT06565299
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cognition Disorder
Interventions: PROCEDURE: Cardiovascular surgery with cardiopulmonary bypass
Sponsor: Kemerovo State Medical University
Sex: ALL
Age: CHILD
Enrollment: 217
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-03-01
Completion Date: 2024-08-01
Locations: Aleksandra Aeksandrovna Rumiantseva, Kemerovo, Kuzbass, 650066, Russian Federation

Summary:
The study is aimed to found out expressive speech disorders as a sign of neurocognitive development delay in children with congenital heart defects before and after surgery

Primary Outcome Measures: Neurocognitive status, Monitoring before the cardiovascular operation and in postoperative period (in 1 and 2 years).

Assessment of speech disorders, short-term and long-term memory impairments., 2 years
Graft Versus Flap in Management of Proximal Penile Hypospadias
NCT Number: NCT06565286
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Proximal Penile Hypospadias
Interventions: PROCEDURE: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias
Sponsor: Sohag University
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-18
Completion Date: 2026-08
Locations: Sohag Faculty of Medicine, Sohag, Egypt

Summary:
Proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. However, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the Holy Grail for hypospadias specialists.

Primary Outcome Measures: measure complications after staged repair of proximal penile hypospadias using different techniques., urinary fistulas, urethral strictures, diverticula and failed repair., 6 month after end of treatment
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
NCT Number: NCT06565247
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Prostate Cancer
Interventions: DRUG: [18F]PSMA-PET|DEVICE: MRI sequences optimized for prostate cancer examinations
Sponsor: Region Västerbotten
Collaborators: Umeå University|Region Skane|Lund University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2031-12

Summary:
In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.

Primary Outcome Measures: Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions, Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology., Pre-surgical imaging vs. post-surgery histopathology
Microvascular Blood Flow During Passive Heating
NCT Number: NCT06565221
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Flow
Interventions: DEVICE: Heat and negative pressure
Sponsor: San Diego State University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-12

Summary:
Determine whether passive heating intervention effects microvascular blood flow as measured with near-infrared spectroscopy

Primary Outcome Measures: Microvascular blood flow volume, Measured using NIRS, Baseline and during intervention
First in Human SAD/MAD Safety and PK Study With Adult DMD Safety and PK Cohort
NCT Number: NCT06565208
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Duchenne Muscular Dystrophy
Interventions: DRUG: SAT-3247|DRUG: matched placebo
Sponsor: Satellos Bioscience, Inc.
Sex: MALE
Age: ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2025-03
Locations: CMAX, Adelaide, South Australia, 5000, Australia|Veritus, Bayswater, Victoria, 3153, Australia

Summary:
This is a first-in-human (FIH), Phase 1 study of orally administered SAT-3247 in healthy adult volunteers (HVs) and adult participants with DMD to determine safety, tolerability, pharmacokinetics and pharmacodynamics.

Primary Outcome Measures: Incidence and severity of treatment emergent adverse events, Safety and tolerability of SAT-3247 as compared to placebo, Part A: Day 1-3; Part B: Day 1-8; Part C: Day 1-3; Part D: Day 1-28
Secondary Outcome Measures: Serum plasma Pharmacokinetics of SAT-3247, Plasma PK parameters including Cmax, Tmax, AUC, terminal half-life, CL/F, Vz/F, and ratios of Cmax and AUC, Part A: Day 1-3; Part B: Day 1-8; Part C: Day 1-3; Part D: Day 1-28
A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind, Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681
NCT Number: NCT06565195
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Parkinson's Disease
Interventions: DRUG: LY3962681|OTHER: Placebo
Sponsor: Prevail Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2029-05-05
Locations: Austin Clinic PPD, Austin, Texas, 78744-1625, United States|P-One Clinic, Keikokai Medical Corporation, Hachioji City, Tokyo, 192-0071, Japan

Summary:
The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease.

The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo administered into the spinal fluid.

* The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart.
* The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.

Primary Outcome Measures: Incidence of Serious Adverse Events (SAEs), Up to 76 weeks|Incidence of Treatment Emergent Adverse Events (TEAEs), Up to 76 weeks|Number of discontinuations due to Adverse Events (AEs), Up to 76 weeks
Secondary Outcome Measures: LY3962681 Maximum Observed Concentration (Cmax), Up to 76 weeks|LY3962681 area under the concentration versus time curve, Up to 76 weeks|Change from baseline in CSF total alpha-synuclein, Up to 76 weeks