pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Patients With Coronary Artery Disease or at High Cardiovascular Risk: Measuring Compliance With Treatment for Obstructive Sleep Apnea Syndrome
NCT Number: NCT06568159
Acronym: PACOAM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea|Coronary Disease|Cardiovascular Diseases
Sponsor: University Hospital, Montpellier
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-09-15

Summary:
Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases.

Continuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI\>30) OSA.

Primary Outcome Measures: Compliance with MAD and CPAP at 6 months (wearing time)., MAD compliance at 6 months (wearing time): a sleep diary will be given to the patient at the inclusion visit.

CPAP compliance at 6 months: data transmitted by the CPAP device (sleep diary)., 6 months post-inclusion
Secondary Outcome Measures: Assessment of oral status, plaque index, the day of inclusion|Assessment of oral status, mobility index, the day of inclusion|Assessment of oral status, bleeding index, the day of inclusion|Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear), survey, 6 months post-inclusion|Clinical parameters of OSA (subjective), survey, 6 months post-inclusion|Clinical parameters of OSA (objective), ventilatory polygraphy or polysomnography, 6 months post-inclusion|Assessment of quality of life, survey WHOQOL Bref, 6 months post-inclusion
A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.
NCT Number: NCT06568146
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health and Wellbeing
Interventions: DIETARY_SUPPLEMENT: Multivitamin Supplement
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: HEALTH_SERVICES_RESEARCH
Start Date: 2024-05-23
Completion Date: 2024-08-23
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This is a hybrid single-group clinical trial that will last 12 weeks. Participants will take 2 capsules daily with the first meal of the day in the morning. Participants will undertake blood tests at Baseline and Week 12. Study-specific questionnaires will be completed at Baseline, Week 4, Week 8, and Week 12. Cognitive Battery Testing will take place at Baseline, Week 4, Week 8, and Week 12.

Primary Outcome Measures: Changes in Blood Levels of Vitamin B12, This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin B12., Baseline and Week 12|Changes in Blood Levels of Insulin, This outcome measure will assess the effect of the multivitamin supplement on serum levels of Insulin., Baseline and Week 12|Changes in Blood Levels of Vitamin D, This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin D., Baseline and Week 12|Changes in Blood Levels of Iron, This outcome measure will assess the effect of the multivitamin supplement on serum levels of Iron., Baseline and Week 12
Secondary Outcome Measures: Participants' Perceptions of Health and Wellbeing, Evaluation of participants' perceptions via a questionnaire exploring the convenience and efficacy of the multivitamin supplement in supporting overall health and wellbeing., Baseline, Week 4, Week 8, and Week 12
Drug-drug Interaction Study Between UIC201603, and UIC201604
NCT Number: NCT06568133
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: UIC201603 and co-administration of UIC201603 and UIC201604|DRUG: UIC201604 and co-administration of UIC201603 and UIC201604
Sponsor: Korea United Pharm. Inc.
Sex: ALL
Age: ADULT
Enrollment: 57
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2017-03-15
Completion Date: 2018-02-07
Locations: Chungnam National University Hospital, Daejeon, Korea, Republic of

Summary:
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201603 and UIC201604 in healthy volunteers

Primary Outcome Measures: Plasma pharmacokinetics(AUCss,τ) of Cilostazol and Active metabolites(OPC-13015, OPC-13213), Area under the serum drug concentration-time curve within a dosing interval at steady state, Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h|Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213), Maximum concentration of drug in serum at steady state, Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h|Plasma pharmacokinetics(AUCss,τ) of Rosuvastatin, Area under the serum drug concentration-time curve within a dosing interval at steady state, Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h|Plasma pharmacokinetics(Css,max) of Rosuvastatin, Maximum concentration of drug in serum at steady state, Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h
Effect of Using a Dragon Design Nebulizer Mask on Treatment Duration, Compliance and Fear in Children
NCT Number: NCT06568120
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fear
Interventions: DEVICE: dragon themed nebulizer masks
Sponsor: Koç University
Sex: ALL
Age: CHILD
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2025-10
Locations: Koc University, Istanbul, Turkey

Summary:
Incorporating playful elements into medical devices has been shown to enhance the overall experience for pediatric patients. Children want a healthcare setting that is spacious, creative, imaginative, and contemporary. Additionally, a current retrospective study of 127,368 pediatric patients indicates that 71.26% of the visits involved children under five years old, and 23.64% of the cases were due to respiratory infections. This information highlights the prevalence of inhaler therapy in emergency departments, particularly among young children with respiratory issues. This study aims to evaluate the impact of using dragon/turtle-themed nebulizer masks on treatment application time, treatment adherence, and fear levels in children who present to emergency rooms. By addressing these environmental and procedural challenges, the study seeks to improve the overall experience and outcomes for pediatric patients undergoing inhaler therapy.

Primary Outcome Measures: Fear - Child Fear Scale, Thurillet et al. (2022) is used to learn about children's fears based on the autobiographical stories of children aged 4-12. The Turkish adaptation was made by Tavşan et al. in 2023. The scale consists of six facial expressions. The scale is graded with a score between 0 and 10 (graded gradually by two) along with fear and pain rating rates. It is seen that the first facial expression does not indicate fear, fear increases from right to left, and fear is most common in people's facial expressions., Immediately before (baseline) treatment (approximately 5 minutes before), each child's fear level will be assessed by the child and the nurse. Similarly, fear levels will be measured again during the intervention.
Secondary Outcome Measures: Duration of Treatment and Compliance, The start and end times of the inhaler treatment of the children in the experimental and control groups, as well as whether the children have complied with the treatment, will be evaluated with a form. The children in the experimental and control groups will be observed by nurses throughout the treatment period. The treatment durations of the children and their behaviors towards the treatment will be recorded as follows., During the intervention, children will be given nebulizer treatment appropriate to their age, and the duration of treatment and compliance will be recorded by the nurse. This takes an average of 15-20 minutes.
A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
NCT Number: NCT06568094
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: HRS-5041 tablets|DRUG: Abiraterone Acetate tablets（II）|DRUG: Prednisone Acetate tablets|DRUG: Docetaxel Injection|DRUG: HRS-1167 tablets|DRUG: SHR2554 tablets
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: The Second Affiliated Hospital of Harbin Medical University, Ha'erbin, Heilongjiang, 150000, China|Shanghai Jiao Tong University School of Medicine, Renji Hospital, Shanghai, Shanghai, 200433, China

Summary:
The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.

Primary Outcome Measures: Recommended phase II dose (Phase Ib), 21 or 28 days|Incidence and severity of adverse events (AE) (Phase Ib), 2 years|PSA response rate (Phase II), 1 year
Secondary Outcome Measures: Objective response rate (ORR), 1 year|Disease control rate (DCR), 1 year|Duration of response (DoR), 1 year|PSA response rate, 1 year|Time to PSA progression, 1 year|Radiographic progression-free survival (rPFS), 1 year|Overall survival (OS), 2 years|Blood concentrations of HRS-5041, 16 weeks|Blood concentrations of HRS-1167, 16 weeks|Blood concentrations of SHR2554, 16 weeks
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
NCT Number: NCT06568042
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neuropathic Pain|Distal Sensory Polyneuropathy
Interventions: DRUG: LY3848575|DRUG: Placebo
Sponsor: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-09
Locations: Northwest Clinical Research Center, Bellevue, Washington, 98007, United States

Summary:
The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee.

Participation may last up to 30 weeks including screening.

Primary Outcome Measures: Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS), Baseline, Week 12
Secondary Outcome Measures: Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS), Baseline, Week 12|Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1, Baseline, Week 12|Mean Change from Baseline in Pain Interference with Sleep, Baseline, Week 12|Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a), Baseline, Week 12|Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b), Baseline, Week 12|Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2), Baseline, Week 12|Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity, Baseline, Week 12|Mean Overall Improvement as Measured by Patient's Global Impression of Change, Week 12|Use of Rescue Medication, Baseline up to Week 12|Pharmacokinetic (PK): Plasma Concentration of LY3848575, Baseline up to Week 12
Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
NCT Number: NCT06567990
Acronym: DIATONIC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Dysfunction-Associated Liver Disease
Interventions: DIAGNOSTIC_TEST: Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D.
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-15
Completion Date: 2026-11-15
Locations: Service d'Endocrinologie, Diabète et nutrition, Pierre-Bénite, 69495, France

Summary:
Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Thus, patients with T2DM are recognized as a priority target for the screening of MASLD-related advanced fibrosis and a systematic screening for AF is currently recommended in T2DM patients using FIB-4 and liver stiffness measurement (LSM).The main objective of the project is to investigate the ability of baseline non-invasive biomarkers to discriminate patients with a progression of MASLD from patients without progression of MASLD among patients with T2DM and to investigate the association between clinical outcomes related to the natural evolution of MASLD and T2DM and baseline biomarkers.

Primary Outcome Measures: Progression of MASLD for T2D and MASLD patients without AF at baseline (cohort A) or progression to confirmed diagnosis of cirrhosis for T2D and MASLD patients with presence of AF at baseline and without cirrhosis (cohort B)., COHORT A = Composite outcome defined by either histological stage of fibrosis ≥ F3 if a liver biopsy is performed in clinical care or concordant patented Fibrotest≥ F3 and LSM≥ 8 kPa according to EASL guidelines or overt imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI COHORT B = Histological stage of fibrosis 4 or imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI, One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
Secondary Outcome Measures: Assessment of clinical events associated with the natural history of MASLD and T2D for both cohorts, Occurrence of T2D COMPLICATIONS (retinopathy, neuropathy, nephropathy, diabetes foot ulcer ), CARDIOVASCULAR EVENTS (coronary artery disease, myocardial infarction, coronary revascularization, stroke, arteriopathy of the lower limbs), LIVER RELATED EVENTS (ascites, esophageal variceal bleeding or needed prophylactic treatment, liver transplantation, hepatocellular carcinoma), KIDNEY RELATED EVENTS (occurence or progression of diabetic nephropathy), DEATHS (all causes)., One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients
NCT Number: NCT06567977
Acronym: Trimaximize PL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Asthma
Interventions: OTHER: Trimbow
Sponsor: Chiesi Poland Sp. z o.o.
Collaborators: Gesellschaft für Therapieforschung mbH
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-08-01
Locations: Indywidualna Specjalistyczna Praktyka Lekarska, Tarnowskie Gory, 42-609, Poland

Summary:
TriMaximize: A multicentre, prospective, non-interventional trial monitoring therapy pathways of asthma patients treated with an extra-fine ICS/LABA/LAMA single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related outcomes.

Primary Outcome Measures: The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice., Primary outcome measures include:

Descriptive analisys of patients demografic

Descriptive analisys of patient demographic, 12 months
Secondary Outcome Measures: Assess asthma control (ACT), - Assess asthma control (ACT) - Change from baseline in ACT scores, 12 months|Assess quality of life To measure the functional impairments, - Assess quality of life - Change from baseline in Mini-AQLQ scores, 12 months|Treatment adherence, - Assess treatment adherence - Change from baseline in TAI scores, 12 months|Lung function, - Analyse parameters of lung function using spirometry - Change from baseline in FEV1, 12 months|Small airways parameters, - Analyse parameters of small airways disease - Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system, 12 months|Airway inflammation, - Analyse parameters of asthma-related airway inflammation - Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb, 12 months|Persistent airflow limitation, - Analyse parameters of persistent airflow limitation - Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 \<80% predicted and post-BD FEV1/FVC Ratio \< 0.7, 12 months|Asthma exacerbations, - Analyse the incidence of asthma exacerbations - Number of exacerbations 12 months prior to baseline and during study, 12 months|Rescue medication use, - Analyse use of rescue medication - Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit, 12 months|Systemic corticosteroids use, - Analyse use of systemic corticosteroids - Use of any systemic corticosteroids 12 months prior to baseline and during study, 12 months|Adverse events occurence, - Assess adverse events associated with use of Trimbow - Assessment of the number and type of adverse events, 12 months|Retention rate with Trimbow, - Assess retention rate with Trimbow - Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12, 12 months
Ultrasound-guided ESP Block vs. Wound Infiltration in Lumbar Surgery: A Comparative Analysis (ESP:Erector Spinae Plane)
NCT Number: NCT06567964
Acronym: ESP
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lumbar Spinal Stenosis|Lumbar Spine Instability|Lumbar Spine Degeneration
Interventions: PROCEDURE: Erector Spinae Plane Block(ESPB)|PROCEDURE: Wound infiltration
Sponsor: Saglik Bilimleri Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-05-01
Completion Date: 2023-06-30
Locations: Saglik Bilimleri Universitesi, Istanbul, Turkey

Summary:
This study aimed to compare the efficacy of ultrasound-guided erector spinae plane block (ESPB) with that of wound infiltration (WI) for postoperative analgesia in lumbar spinal surgeries involving instrumentation.

Primary Outcome Measures: Postoperative pain intensity, The pain intensity was assessed via the visual analog scale (VAS).The VAS is a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain)., 1., 6., 12., 24., and 48. hours postoperatively
Secondary Outcome Measures: Total Opioid Consumption, Recorded as morphine equivalents, In the first 48 hours postoperatively|Time to first request for rescue analgesia, Noted in hours postoperatively, Noted in hours in the first 48 hours postoperatively|Incidence of Side Effects, Including nausea, vomiting, pruritus, and urinary retention,, Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively|Patient Satisfaction with Pain Management, Patient satisfaction was assessed via a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied), At 48 hours postoperatively
The Development of the Simulation Curriculum and AI-incorporated Assessment Tool for Transesophageal Echocardiography
NCT Number: NCT06567912
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Out-Of-Hospital Cardiac Arrest
Interventions: BEHAVIORAL: TEE simulation curriculum
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2025-12-31
Locations: Lien, Taipei, Taiwan

Summary:
This study aims to establish a novel transesophageal echocardiography (TEE) simulation curriculum based on previous research results and suggestions from the American College of Emergency Physicians. To better evaluate the efficacy of the curriculum, an evaluation model utilizing artificial intelligence (AI) would be introduced. The study population is at least 60 junior physicians in the emergency department or other departments interested in TEE. After the curriculum, junior physicians could utilize TEE on cardiac arrest patients and improve diagnostic accuracy and patient outcomes.

Primary Outcome Measures: learning outcomes:immediate assessment, image acquisition and image quality using 5-point Likert scales. The range from 1 (the worst) to 5 (the best)., 4 hours|learning outcomes: 3-month evaluation, image acquisition and image quality using 5-point Likert scales. The range from 1 (the worst) to 5 (the best)., 3 months|the efficiency of AI model, the AI model to recognize the TEE views, including sensitivity, specificity, PPV, NPV, 6 months
Mechanistic Underpinnings of Preeclampsia
NCT Number: NCT06567899
Acronym: MUP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Preeclampsia
Sponsor: University of Arizona
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2028-12-31

Summary:
Preeclampsia is a dreadful disease with significant morbidity and mortality. Despite decades of research, we still need a proper diagnostic test or therapeutic option to treat this disorder. The proposed study will determine the diagnostic value of PBMC-secreted sFlt1 and determine the molecular mechanisms involved in its secretion. The molecular mechanisms can be novel therapeutic targets to treat this disorder.

Primary Outcome Measures: sFLT1 levels, sFLT1 levels in preeclampsia should be higher than normal pregnancy., Outcome will be measured at 12 weeks, 24 weeks and 36 weeks of pregnancy.
Fibromyalgia Sleep A to ZZZ Study
NCT Number: NCT06567886
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: DEVICE: Light Therapy|BEHAVIORAL: Sleep Stabilization
Sponsor: University of Michigan
Collaborators: National Institute of Nursing Research (NINR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 390
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2029-02
Locations: University of Michigan, Ann Arbor, Michigan, 48105, United States

Summary:
This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

Primary Outcome Measures: Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score, The FIQR is 21 questions. Each question has 11 boxes similar to a visual analog scale. Questions include the difficulty associated with various physical activities and the severity of symptoms. The score for the questions is on a scale from 0 - 100, where lower scores represented better functional status., baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Secondary Outcome Measures: Change in Brief Pain Inventory (BPI) score, The BPI consists of 11 questions and assesses for the presence of pain, pain intensity (i.e., worst, least, average, current) and functional interference from pain. A higher score indicates more pain., baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).
Gastric Ultrasound Assessment for Patients Taking Cannabis
NCT Number: NCT06567873
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Ultrasound|Point of Care Ultrasound|Cannabis Use
Interventions: OTHER: Gastric Ultrasound Exam
Sponsor: Hospital for Special Surgery, New York
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-03

Summary:
The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who report cannabis use.

Primary Outcome Measures: Incidence of delayed gastric emptying, A full stomach on gastric ultrasound is defined by the presence of either solid food, thick liquids, or a specific volume (\>1.5 ml/kg) of clear liquids on gastric ultrasound., This will be measured pre-operatively in the holding room area.
Secondary Outcome Measures: Nothing by mouth (NPO) intervals, Measure the NPO interval after last solid food and liquid consumption, This will be measured pre-operatively in the holding room area.|Presence of gastric peristalsis, Gastric peristalsis will be graded as absent, slow, or normal on gastric ultrasound, This will be measured pre-operatively in the holding room area.|Time interval since last cannabis use, Measure the time from last cannabis consumption to the time the gastric ultrasound was performed, This will be measured pre-operatively in the holding room area.
Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations
NCT Number: NCT06567860
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Influenza A
Interventions: BIOLOGICAL: Influenza Fluzone vaccine
Sponsor: Tal Einav
Sex: ALL
Age: ADULT
Enrollment: 23
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-21
Completion Date: 2025-02-01
Locations: La Jolla Institute for Immunology, La Jolla, California, 92037, United States

Summary:
Every 1-2 years, the seasonal influenza vaccine composition changes to include updated viruses, yet the precise effects of updating the vaccine remain understudied. Since the vaccine formulation for each season (with a season defined as starting in July and ending the following June) expires on June 30, vaccine formulations cannot be compared head-to-head. Thus, the 2023 and 2024 vaccines have only been compared by analyzing people given the former vaccine in the fall of 2023 and people given the latter vaccine in the fall of 2024, and baseline repertoires may have greatly changed over the course of that year. To that end, the investigators will vaccinate a cohort with the 2023 influenza vaccine between May-June 2024, in order to compare responses between individuals receiving the 2023 vaccine last fall, the 2023 vaccine late in the season (this cohort), and the 2024 vaccine next fall. The investigators will further assess whether the late-season 2023 vaccine primed this cohort to respond better to the standard 2024 vaccine with standard timing (vaccine administered around September-October).

Primary Outcome Measures: Magnitude of antibody response post-vaccination, The antibody response will be measured by hemagglutination inhibition (HAI) in adults between 18 and 64 years old who have not had an influenza vaccination prior to the study., 0, 30, and 90 days post-vaccination
Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
NCT Number: NCT06567821
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Maxillary Rhinosinusitis
Interventions: DEVICE: RELIEVA SPINPLUS® NAV Balloon Sinusplasty System
Sponsor: Cedars-Sinai Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-11
Completion Date: 2025-12-31

Summary:
The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.

Primary Outcome Measures: Success Rate, There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices., 12 months
Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
NCT Number: NCT06567808
Acronym: PICS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Infection, Surgical Site
Interventions: DRUG: Cefazolin|DRUG: Vancomycin
Sponsor: Hamilton Health Sciences Corporation
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38000
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-12-31
Completion Date: 2028-07-30

Summary:
The goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.

Primary Outcome Measures: Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN), Sternal surgical site infections are defined by clinical and microbiological criteria of infection at the surgical site that are associated with the operative procedure occurring within 90 days after surgery., 3 months post-surgery
Secondary Outcome Measures: All types of sternal surgical site infections (superficial, deep, organ; (CDC/NHSN), Sternal surgical site infections are defined by clinical and microbiological criteria of infection at the surgical site that are associated with the operative procedure occurring within 90 days after surgery., 3 months post-surgery|Clostridium difficile infection, Laboratory confirmed, 3 months post-surgery|Mortality, Mortality in participants with an active infection, 3 months post-surgery|Acute kidney injury, following the Acute Kidney Injury Network definition, 7 days post surgery|Sternal revision surgery, For suspected sternal surgical site infection, 3 months post surgery|Microbiology of sternal surgical site infections, including relevant susceptibilities and stratified by study arm, 3 months post-surgery
Phase 1 Study of GC1130A in Pediatric Patients With Sanfilippo Syndrome Type A (MPS IIIA)
NCT Number: NCT06567769
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Sanfilippo Syndrome Type A
Interventions: DRUG: GC1130A
Sponsor: GC Biopharma Corp
Collaborators: Novel Pharma Inc.
Sex: ALL
Age: CHILD
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2027-06

Summary:
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of recombinant human heparan N-sulfatase (rhHNS, GC1130A) administered via intracerebroventricular access device in pediatric patients with Sanfilippo Syndrome Type A (MPS IIIA).

Primary Outcome Measures: Incidences and characteristics of adverse events, up to 108 weeks
Secondary Outcome Measures: Maximum concentration in cerebrospinal fluid (CSF), GC1130A PK parameters, up to 104 weeks|Area under the concentration-time curve in CSF, GC1130A PK parameters, up to 104 weeks|Maximum concentration in serum, GC1130A PK parameters, up to 104 weeks|Area under the concentration-time curve in serum, GC1130A PK parameters, up to 104 weeks|Change from baseline in CSF heparan sulfate concentration, up to 104 weeks|Change from baseline in serum heparan sulfate concentration, up to 104 weeks|Incidence of anti-drug and neutralizing antibodies of GC1130A in CSF, up to 104 weeks|Incidence of anti-drug and neutralizing antibodies of GC1130A in serum, up to 104 weeks|Change from baseline in raw scores in cognitive domain of Bayley Scales of Infant and Toddler Development Scores-3rd edition (BSID-III), up to 104 weeks
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in NMIBC
NCT Number: NCT06567743
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: High-Risk Non-Muscle-Invasive Bladder Cancer
Interventions: DRUG: Cretostimogene Grenadenorepvec
Sponsor: CG Oncology, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2027-12-30

Summary:
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer

Primary Outcome Measures: Complete response (CR) rate, Determine the complete response (CR) rate at any time following treatment with cretostimogene in participants with Bacillus Calmette-Guerin (BCG)-naïve carcinoma in situ (CIS) with or without concomitant high-grade (HG) Ta or T1 disease at baseline, At 24 weeks
Secondary Outcome Measures: Compare cretostimogene instillation methods, Compare cretostimogene genome and GM-CSF levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation in participants with pathologically confirmed CIS-containing high-risk NMIBC who are naïve to BCG treatment., At 12 and 24 weeks|Duration of response (DoR), Assess duration of response (DoR) in participants with CIS with or without concomitant HG Ta/T1 disease at baseline, At 12 and 24 weeks
Comparison of Canine Retraction Using Ni-ti Closed-coil Springs Vs Elastomeric Power Chains During Orthodontic Treatment
NCT Number: NCT06567730
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Root Resorption|Plaque Accumulation|Gingivitis
Interventions: OTHER: Ni-ti Closed-coil Spring|OTHER: Elastomeric Power chain
Sponsor: Munnal Gulzar
Sex: ALL
Age: CHILD, ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-01

Summary:
The objective of this study is to compare the canine retraction rate (in mm with a 100 mm marked scale) using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months.

After the extraction of all first premolars under local anesthesia. For canine retraction, Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches.

Radiographic measurement (root resorption) and clinical measurements (canine retraction, plaque accumulation and gingival health) will be recorded at four points in time. First, at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3).

Primary Outcome Measures: Canine retraction rate, The retraction rate of canine will be the distance travelled divided by the time interval needed for closure of spaces. It will be noted at four-time intervals i.e at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3)., 3 months
Secondary Outcome Measures: Root resorption, Root resorption is a decrease in root length and width due to an inflammatory process. In orthodontics, during tooth movement, areas of necrosis develop called hyalinized areas, which result in root resorption. Periapical radiographs will be taken to assess the amount of root resorption by determining the length of the tooth from the cusp tip to the root apex, 3 months|Gingival health, Gingival index is a grading system that is used to assess the health of the gingiva. It consists of four grades including, Grade 0, 1, 2 and 3. The increase in grade indicates the compromised gingival health of the teeth., 3 months|Plaque index, Plaque index is a grading system used to assess the amount of plaque present at the gingival margins and helps in assessing oral health. It consists of four grades including, Grade 0, 1, 2 and 3. The increase in grade indicates the increased amount of plaque along the gingiva., 3 months
Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis
NCT Number: NCT06567717
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: DRUG: Zinc|OTHER: Placebos for zinc and nicotinamide riboside|DRUG: Nicotinamide riboside
Sponsor: Cedars-Sinai Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2026-06
Locations: Cedars-Sinai, Los Angeles, California, 90048, United States

Summary:
The goal of this clinical trial is to learn if a clinical trial for idiopathic pulmonary fibrosis (IPF) can recruit and retain participants from their home to study whether a combination of zinc and nicotinamide riboside can treat iIPF. The main questions are:

Can the investigators recruit participants, and can participants complete study procedures without physically coming into specific clinical trial sites? Can people with IPF experience improvement in symptoms, quality of life, or functioning if they are take these supplements? The investigators will compare zinc and nicotinamide riboside to matched placebos (look-alike substances that contain no drug) to see if these supplements treat symptoms or lung function in people with IPF.

Participants will:

Take drug these supplements twice a day for 24 weeks. Complete pulmonary function testing and six minute walk tests with their own pulmonologists every 12 weeks. Complete a high resolution CT scan at the start and end of the study. Complete video study visits with the research team every 4 weeks. Complete surveys about their symptoms and the number of times they take the medication.

Primary Outcome Measures: Feasibility of Retention, Feasibility is defined as 80% or more of the enrolled patients complete the 24-week treatment Additional feasibility assessments include the recruitment rate over 52 weeks and the retention rate, From study activation to 78 weeks
Secondary Outcome Measures: Recruitment Rate, Number of participants who are recruited over 52 weeks divided by 60, expressed as a percent, From study activation to 52 weeks
Other Outcome Measures: Change in forced vital capacity, Change in the percent-predicted forced vital capacity, From enrollment to 24 weeks|Change in 6 minute walk distance, Change in the 6 minute walk distance as expressed in meters, From enrollment to 24 weeks|Change in quality of life surveys, Change in the score on the Living with Pulmonary Fibrosis-Symptoms and Living with Pulmonary Fibrosis-Impacts surveys, From enrollment to 24 weeks|Change in diffusion capacity of the lung, Change in the percent-predicted diffusion capacity, From enrollment to 24 weeks
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
NCT Number: NCT06567704
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer
Interventions: BEHAVIORAL: Interviews
Sponsor: Wake Forest University Health Sciences
Collaborators: Atrium Health Levine Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-08-30
Locations: Atrium Health Levine Cancer, Charlotte, North Carolina, 28204, United States

Summary:
The purpose of this research is to understand cancer related fatigue in patients with non-small cell lung cancer (NSCLC), who are being treated with an immune checkpoint inhibitor.

Primary Outcome Measures: Themes from qualitative interviews with patients, Two semi-structured qualitative interviews will be conducted with 20 patients. Themes will be determined through inductive analysis and will focus on key aspects of symptomatic fatigue, including but not limited to the frequency, duration, and severity of CRF and resulting functional impairments. In addition, history of physical activity before diagnosis, preferences for physical activity to treat CRF, and support needed to adhere to physical activity regimens will be considered. Themes from the first and second interviews will be synthesized to capture changes in fatigue and views on physical activity., At 3 months
Secondary Outcome Measures: Severity and impact of cancer-related fatigue (CRF), The severity of CRF and its impact on day-to-day function will be measured using the PROMIS® Fatigue-Short Form 7a (F-SF) questionnaire., At 3 months|Themes from qualitative interviews with caregivers, Two semi-structured qualitative interviews will be conducted with 20 caregivers. Themes will be determined through inductive analysis and will focus on the caregiver perspective of CRF severity and functional impacts on the patient. In addition, the role caregivers play in CRF treatments will be explored. Themes from the first and second interviews will be synthesized to capture changes in caregiver perspectives on fatigue and views on physical activity., At 3 months|Cancer caregiving tasks, consequences, and needs, The extent of cancer caregivers' perceptions of tasks, consequences, and needs will be assessed using the Cancer Caregiving Tasks, Consequences, and Needs Questionnaire (CaTCoN)., At 3 months
Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy
NCT Number: NCT06567691
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malignant Gastric Outlet Obstruction
Interventions: PROCEDURE: EUS Gastrojejunostomy|PROCEDURE: Surgical Gastrojejunostomy|OTHER: Gastric Outlet Obstruction Scoring System (GOOSS)
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2026-10
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37212, United States

Summary:
Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.

EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach \[4\]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.

Primary Outcome Measures: Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy, A GOOSS score of 0 will be defined as intolerant of oral intake, while any GOOSS score greater than 0 will be defined as tolerant of oral intake.

0: no oral intake

1. oral liquids only
2. soft solids
3. low residue or full diet This will be given to subjects, 1 day post-operative|Compare post procedure length of hospital stay, This outcome will be measured as the length of hospital stay (in days) from study intervention to discharge. Any accrued hospital stay from admission prior to study intervention will not be included in this assessment., 14 days post-operative
The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease
NCT Number: NCT06567678
Acronym: ECLIPSE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Coronary Artery Disease
Interventions: DRUG: Colchicine 0.5 MG oral tablet twice daily
Sponsor: The University of The West Indies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2024-11
Locations: The University of The West Indies, Saint Augustine, Trinidad and Tobago

Summary:
The effects of colchicine on cardiovascular health in patients with stable coronary artery disease have been shown to be beneficial due to its anti-inflammatory properties. This present study aims to explore the effects of colchicine on platelet reactivity in patients with coronary artery disease on dual antiplatelet therapy.

Primary Outcome Measures: P2Y12 reaction units and Aspirin reaction units, P2Y12 and Aspirin reaction units pre and post colchicine 0.5mg twice daily oral dose., two weeks
Leucine Supplementation Strategies to Enhance Muscle Anabolic Responses in Older Age
NCT Number: NCT06567665
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Muscle Protein Synthesis
Interventions: DIETARY_SUPPLEMENT: Leucine
Sponsor: University of Nottingham
Sex: MALE
Age: OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-05
Completion Date: 2026-08-05
Locations: University of Nottingham, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Summary:
Sarcopenia describes the progressive decline of muscle mass and strength with advancing age and is associated with increased frailty and morbidity, however we do not currently have an effective treatment. Protein feeding and exercise is known to increase muscle mass, but aged muscle shows a lower response to these stimuli leading to muscle loss over time. We do know that ingesting leucine, a building block of protein, can overcome this reduced response to protein feeding and exercise leading to increased muscle mass in older people. However, we do not understand when the optimum time to ingest leucine is to maximise muscle mass after exercise in older people. In this study we will examine the effect of feeding leucine after exercise either with a meal or between meals.

Primary Outcome Measures: Muscle protein synthesis in response to leucine feeding, To quantify muscle protein synthesis in response to feeding leucine with a meal or in-between meals using mass spectrometry., 7 days
Secondary Outcome Measures: Measure muscle anabolic and catabolic signalling pathways in response to leucine feeding, To determine the impacts of leucine feeding timings on muscle anabolic and catabolic signalling pathways using western blotting techniques., 7 days