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Patients with head and neck cancer (H\&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities. |
The most important protective factor for psychopathology is psychological resilience, which is "the capacity of a person to protect themselves and their mental health when facing life adversities," such as a GBM or H\&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life. |
To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature. |
Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H\&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations. |
The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H\&N-C and GBM patients. conditions: Glioblastoma conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 207 type: ESTIMATED name: Psychological Tests' administration measure: Distress Thermometer measure: Brief Psychiatric Rating Scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: LOREDANA DINAPOLI role: CONTACT phone: +390630154428 email: [email protected] name: Loredana Dinapoli role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06385119 id: F8394-101 briefTitle: A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers. overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-10-31 date: 2024-11-25 date: 2024-04-25 date: 2024-04-25 name: Fore Biotherapeutics class: INDUSTRY briefSummary: The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine: |
* The effect of food on the single dose PK of plixorafenib administered with cobicistat. |
* The effect of cobicistat administration on the single dose PK of plixorafenib. |
* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Plixorafenib name: Cobicistat measure: Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t). measure: AUC from time 0 extrapolated to infinity (AUC0-inf). measure: Maximum observed plasma concentration (Cmax). measure: Time to maximum observed plasma concentration (Tmax). measure: Terminal elimination rate constant (Kel). measure: Terminal phase half-life (t1/2). measure: Apparent oral clearance (CL/F). measure: Apparent volume of distribution (Vd/F). measure: Terminal rate constant calculated from the terminal slope of the log-linear regression of concentration with time (z). measure: Cumulative amount of plixorafenib excreted in urine, calculated as the sum of the product of urine concentration and urine volume (Ae). measure: Percent of dose excreted in urine in 48 hours calculated as 100*Ae/Dose. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PPD - Austin Research Unit city: Austin state: Texas zip: 78744 country: United States name: Kristie Miller, MD role: CONTACT phone: 877-362-2608 lat: 30.26715 lon: -97.74306 hasResults: False |
<|newrecord|> nctId: NCT06385106 id: rTMS in AD briefTitle: Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-01 date: 2024-04-25 date: 2024-04-25 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD). conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Real repetitive transcranial magnetic stimulation name: Sham repetitive transcranial magnetic stimulation measure: Cognitive funtion measure: Sleep parameters measure: glymphatic system sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385093 id: EDR-IIS-003 briefTitle: A Study on the Prevention and Treatment of GIOP With Eldecalcitol acronym: ELEGANT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-04-25 date: 2024-04-25 name: Chinese SLE Treatment And Research Group class: OTHER name: Beijing Life oasis public service center briefSummary: The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients. conditions: Rheumatoid Arthritis conditions: Osteoporosis conditions: Osteopenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 314 type: ESTIMATED name: Eldecalcitol capsules name: Alfacalcidol tablets name: Calcium carbonate tablets measure: Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD) measure: Percent change from baseline to month 6 in lumbar spine (L1-4) BMD measure: Percent change from baseline in total hip BMD measure: Percent change from baseline in femoral neck BMD measure: Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS) measure: Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP) measure: Percent change from baseline in Type 1 Collagen C-telopeptide (CTX) measure: Percentage of patients diagnosed with osteoporosis at month 12 measure: Incidence of new vertebral fracture measure: Change from baseline in Quality of Life assessed using EQ-5D-5L measure: Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) measure: Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score measure: Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) measure: Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) measure: Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Ying Jiang, MD role: CONTACT phone: +86-13391701765 email: [email protected] lat: 39.9075 lon: 116.39723 facility: Aerospace Central Hospital city: Beijing state: Beijing country: China name: Jian Liu role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Luhe hospital, Capital Medical University city: Beijing state: Beijing country: China name: Baoyu Zhang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shijingshan Hospital city: Beijing state: Beijing country: China name: Lian'na Xu role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shijitan Hospital city: Beijing state: Beijing country: China name: Yuhua Wang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shunyi hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing country: China name: Yi Zhao role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06385080 id: 61186372HNC2002 briefTitle: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer acronym: OrigAMI-4 overallStatus: RECRUITING date: 2024-04-22 date: 2026-07-17 date: 2026-07-17 date: 2024-04-25 date: 2024-04-25 name: Janssen Research & Development, LLC class: INDUSTRY briefSummary: The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: Amivantamab name: Pembrolizumab name: Paclitaxel measure: Cohorts 1, 2, and 3B: Objective Response Rate measure: Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT) measure: Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity measure: Cohorts 1, 2, and 3B: Duration of Response (DoR) measure: Cohorts 1, 2, and 3B: Clinical Benefit Rate (CBR) measure: Cohorts 1, 2, and 3B: Progression-free Survival (PFS) measure: Cohorts 1, 2, and 3B: Overall Survival (OS) measure: Cohorts 1, 2, and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity measure: Cohort 1: Maximum Observed Serum Concentration (Cmax) of Amivantamab measure: Cohort 1: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab measure: Cohort 1: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab measure: Cohort 1: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab measure: Cohort 1: Trough Serum Concentration (Ctrough) of Amivantamab measure: Cohort 1: Accumulation Ratio (R) of Amivantamab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 hasResults: False |
<|newrecord|> nctId: NCT06385067 id: JW-PM-DCB-2024 briefTitle: Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-12-30 date: 2026-12-30 date: 2024-04-25 date: 2024-04-25 name: JW Medical Systems Ltd class: INDUSTRY briefSummary: The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world. |
The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Biolimus Coated Coronary Artery Balloon Dilation Catheter measure: Target lesion failure rate (TLF) measure: Interventional success rate measure: Device-related cardiovascular clinical composite endpoint measure: Patient-related cardiovascular clinical composite endpoint measure: Major adverse cardiac events (MACEs) measure: Incidence of thrombotic events as defined by ARC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06385054 id: L-027 id: 2023-A02612-43 type: REGISTRY domain: ID-RCB id: PEC23063 type: OTHER domain: Biofortis briefTitle: Effect of Probiotics on Infantile Colic Symptoms acronym: EPIC overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-02 date: 2027-02 date: 2024-04-25 date: 2024-04-29 name: Lallemand Health Solutions class: INDUSTRY name: BioFortis briefSummary: The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention. conditions: Infantile Colic studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Probiotic name: Placebo measure: Change in daily crying duration measure: Change in crying patterns measure: Change in sleep duration measure: Change in maternal quality of life measure: Change in bowel habits measure: Change in gut microbiota composition measure: Probiotic strain recovery measure: Safety and tolerability of the intervention measure: Change in fecal immune markers and proteins sex: ALL maximumAge: 8 Weeks stdAges: CHILD facility: Centre Hospitalier de Boulogne-sur-Mer city: Boulogne-sur-Mer zip: 62200 country: France name: Mohamad Hage, MD role: PRINCIPAL_INVESTIGATOR lat: 50.71667 lon: 1.61667 facility: Cabinet privé Dr Regimbart-Trubuil Christine city: Bécon-les-Granits zip: 49370 country: France name: Christine Regimbart-Trubuil, MD role: PRINCIPAL_INVESTIGATOR lat: 47.50134 lon: -0.8 facility: CHU Caen Normandie city: Caen zip: 14033 country: France name: Edouard Lacotte, MD role: PRINCIPAL_INVESTIGATOR lat: 49.18585 lon: -0.35912 facility: CHU Grenoble Alpes city: La Tronche zip: 38700 country: France name: Ellen Katranji, MD role: PRINCIPAL_INVESTIGATOR lat: 45.20429 lon: 5.73645 facility: Hôpital Saint Vincent de Paul city: Lille zip: 59000 country: France name: Pr. Nicholas Kalach, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Centre Hospitalier de Montauban city: Montauban zip: 82000 country: France name: Sabine Charpentier, MD role: PRINCIPAL_INVESTIGATOR lat: 44.01667 lon: 1.35 facility: CHU de NANTES city: Nantes zip: 44000 country: France name: Hugues Piloquet, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 facility: Biofortis, Unité d'investigation Clinique city: Paris zip: 75012 country: France name: Stéphanie Cavigoli, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Biofortis, Unité d'investigation Clinique city: Saint-Herblain zip: 44800 country: France name: Isabelle Metreau, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21765 lon: -1.64841 facility: Centre Hospitalier du val d'Ariège city: Saint-Jean-de-Verges zip: 09000 country: France name: Lucas Percheron, MD role: PRINCIPAL_INVESTIGATOR lat: 43.01371 lon: 1.61076 hasResults: False |
<|newrecord|> nctId: NCT06385041 id: BE-2-83 briefTitle: Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery overallStatus: RECRUITING date: 2021-05-12 date: 2025-09-01 date: 2025-09-01 date: 2024-04-25 date: 2024-04-25 name: Vitalija Stonkuvienė class: OTHER briefSummary: The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation. conditions: Frailty Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: Intervention group 1 name: Intervention group 2 measure: Collecting data from the medical history measure: Frailty level by Edmonton frail scale score measure: Fear of Falling by Falls Efficacy Scale International; FES-I). measure: Quality of life by EuroQoL FiveDimensionsEQ-5D-5L. measure: Motivation by Multidimensional Health Locus of Control scale measure: Change from baseline functional capacity by six minutes walking test (6MWT) measure: Change from baseline physical performance by Short Physical Performance Battery (SPPB) measure: Change from baseline muscular strength by one repetition maximum test (1RM) measure: Change from baseline grip strength by hydraulic hand dinanometer measure: Change from baseline balance parameters by Biodex Balance System SD measure: Change from baseline stance and gait parameters by Zebris Medical GmbH measure: Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt) measure: Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva status: RECRUITING city: Kaunas country: Lithuania name: Vitalija Stonkuvienė role: CONTACT lat: 54.90272 lon: 23.90961 hasResults: False |
<|newrecord|> nctId: NCT06385028 id: 20230213_PIANISSIMO briefTitle: Physical Activity Promotion in Osteoarthritis Patients acronym: PIANISSIMO overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2026-03-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Luxembourg Institute of Health class: OTHER_GOV name: Œuvre Nationale de Secours Grande Duchesse Charlotte briefSummary: The main purpose of this project is to promote physical activity in patients with osteoarthritis. More specifically, this study aims to test the acceptability of an app to promote physical activity in the target population, and consequently the feasibility of such an approach. |
A mobile phone application - namely PIANISSIMO - will be developed specifically for this project. It aims to spread knowledge on the benefits of physical activity and collect data on how this knowledge can induce behavior changes toward a more physically active lifestyle. |
The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week. conditions: Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pilot feasibility study primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Physical activity promotion measure: Weekly number of connections to the application over time measure: Response rate to the weekly questionnaires over time measure: Evolution of physical activity metrics measure: influence of pain on physical activity practice measure: influence of physical activity on pain report measure: long-term evolution of daily steps sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luxembourg Institute of Health city: Strassen zip: 1445 country: Luxembourg lat: 49.62056 lon: 6.07333 hasResults: False |
<|newrecord|> nctId: NCT06385015 id: IRB#23-001257 briefTitle: T-UP: Engaging Vulnerable Students in Diabetes Prevention overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-04 date: 2024-05 date: 2025-06 date: 2024-04-25 date: 2024-04-26 name: University of California, Los Angeles class: OTHER name: American Diabetes Association briefSummary: The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. |
The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. |
The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey. conditions: Diabetes Mellitus, Type 2 conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 80 type: ACTUAL name: Tailored DPP Intervention measure: Change in weight (pounds, lbs) between baseline and 9-month follow-up measure: Change in self-reported quality of life (Centers for Disease Control and Prevention Health-Related Quality of Life-14 item (CDC HRQOL-14)) between baseline and 9-month follow-up sex: ALL minimumAge: 17 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: University of California, Los Angeles city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-22 uploadDate: 2024-01-23T16:50 filename: ICF_000.pdf size: 203319 hasResults: False |
<|newrecord|> nctId: NCT06385002 id: 2024-0158 briefTitle: Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-05-31 date: 2025-05-31 date: 2024-04-25 date: 2024-04-26 name: Pusan National University Yangsan Hospital class: OTHER briefSummary: Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone. conditions: Gynecological Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Remimazolam measure: time to emergence measure: time to tracheal extubation measure: usage of vasopressors measure: severity of cough measure: time to discharge from the recovery room measure: postoperative pain scores measure: scores for postoperative nausea and vomiting sex: FEMALE minimumAge: 19 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384989 id: MinnesotaHealthSolutions_LL briefTitle: Safety-Enhancing Motor Vehicle Child Safety Seat overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2024-08-15 date: 2024-04-25 date: 2024-04-25 name: Minnesota HealthSolutions class: INDUSTRY briefSummary: This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design. conditions: Motor Vehicle Injury conditions: Safety Issues studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Child restraint system with load leg feature measure: Correct use of load leg measure: Load leg error types measure: Other installation errors measure: Opinion on load leg design and instructions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43210 country: United States name: Julie Mansfield, PhD role: CONTACT phone: 614-366-2101 email: [email protected] lat: 39.96118 lon: -82.99879 hasResults: False |
<|newrecord|> nctId: NCT06384976 id: KYV101-007 briefTitle: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2029-01 date: 2024-04-25 date: 2024-04-25 name: Kyverna Therapeutics class: INDUSTRY briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis conditions: Multiple Sclerosis, Primary Progressive conditions: Multiple Sclerosis, Secondary Progressive conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: KYV-101 name: Standard lymphodepletion regimen name: Anti-CD20 mAB measure: To evaluate efficacy of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To evaluate efficacy of KYV-101 measure: To characterize the pharmacokinetics (PK) measure: To characterize the pharmacokinetics (PK) measure: To characterize the Pharmacodynamics (PD) measure: To characterize the Pharmacodynamics (PD) measure: To evaluate the immunogenicity (humoral response) of KYV-101 sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06384963 id: Cer22/02 briefTitle: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF acronym: RSA-PACE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-25 date: 2024-04-25 name: Ceryx Medical Australia class: INDUSTRY name: Avania briefSummary: The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. |
The main questions the trial aims to answer are: |
* Is the new type of pacemaker safe? |
* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? |
Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients. conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Atrial pacing with respiratory sinus arrhythmia (RSA) variability name: Monotonic right atrial overdrive pacing measure: Number of arrhythmia episodes per patient during pacing sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Waikato Hospital city: Hamilton zip: 3240 country: New Zealand name: Martin Stiles, MB ChB role: CONTACT phone: +64 07 957 6080 email: [email protected] name: Kelly Henderson, BSc role: CONTACT phone: +64 0272564243 phoneExt: 25015 email: [email protected] lat: -37.78333 lon: 175.28333 hasResults: False |
<|newrecord|> nctId: NCT06384950 id: 2023-11-005A briefTitle: Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-03-22 date: 2024-11-29 date: 2025-03-21 date: 2024-04-25 date: 2024-04-25 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the "Barcelona Clinic Liver Cancer (BCLC)" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals. |
The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction. conditions: Carcinoma, Hepatocellular studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the educational effectiveness of a chatbot integrated with health education information to traditional health education methods. This comparison encompassed aspects such as the patient's health literacy and clinical satisfaction. Based on the findings, recommendations and improvements would be proposed to promote the application and development of large language models in the medical field. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined. whoMasked: PARTICIPANT count: 450 type: ESTIMATED name: ChatGPT name: patient education with traditional methods. measure: Health literacy score of patients measure: Satisfaction score with medical care measure: Degree of patient anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei state: Beitou District zip: 11217 country: Taiwan name: Chun-Ying Wu role: CONTACT phone: +886-28712121 phoneExt: 4190 email: [email protected] name: HSIAO-PING CHEN role: CONTACT phone: +886-28712121 phoneExt: 4190 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06384937 id: GCA-PRO-2022-001-01 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-25 date: 2024-04-25 name: [Redacted] hasResults: False |
<|newrecord|> nctId: NCT06384924 id: SBU-RAMAN-SKINCANCER briefTitle: Raman Spectroscopy and Skin Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2025-04-30 date: 2024-04-25 date: 2024-04-25 name: Renee Cattell class: OTHER briefSummary: The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is: |
-Can Raman Spectroscopy help figure out how far a tumor spreads? |
This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin. conditions: Skin Cancer conditions: Basal Cell Carcinoma conditions: Squamous Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Raman Spectroscopy handheld probe (EmVision, FL, USA) name: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA) measure: Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin. measure: Compare the size of clinically defined margin and Raman-defined margin measure: Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stony Brook Hospital city: Stony Brook state: New York zip: 11794 country: United States name: Renee Cattell, PhD role: CONTACT email: [email protected] name: Renee Cattell, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.92565 lon: -73.14094 hasResults: False |
<|newrecord|> nctId: NCT06384911 id: STUDY00004543 briefTitle: InvesT1D: Promoting Adolescent Investment in Diabetes Care overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-08 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Seattle Children's Hospital class: OTHER name: Harvard Pilgrim Health Care briefSummary: The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes. |
Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels and person-reported outcomes between groups. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Financial Incentives Program measure: Time In Range measure: Time Above Range measure: Time Below Range measure: Hemoglobin A1c (HbA1c) measure: Diabetes Distress measure: Diabetes Family Conflict measure: Adolescent Quality of Life measure: Caregiver Quality of Life measure: Diabetic Ketoacidosis measure: Severe Hypoglycemia measure: Insulin Adminstration sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06384898 id: STUDY00002259 id: UH3AT012413 type: OTHER_GRANT domain: National Center for Complementary and Integrative Health briefTitle: Remote Tai Chi for Knee Osteoarthritis acronym: TAICHIKNEE overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-10 date: 2024-04-25 date: 2024-04-25 name: Tufts Medical Center class: OTHER name: Boston Medical Center name: University of California, Los Angeles name: The Cleveland Clinic name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are: |
* Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes) |
* Does remote tai chi decreases healthcare utilization? |
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: Remote Tai Chi measure: PROMIS Pain Interference score measure: PROMIS Pain Interference score measure: PROMIS Pain Interference score measure: WOMAC total score measure: WOMAC total score measure: WOMAC total score measure: SF-12 PCS score measure: SF-12 PCS score measure: SF-12 PCS score measure: Number of knee joint injections measure: WOMAC Pain Score measure: WOMAC Pain Score measure: WOMAC Pain Score measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC function score measure: WOMAC function score measure: WOMAC function score measure: WOMAC stiffness score measure: WOMAC stiffness score measure: WOMAC stiffness score measure: Patient's global assessment score measure: Patient's global assessment score measure: Patient's global assessment score measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: Beck Depression Inventory-II score measure: Beck Depression Inventory-II score measure: Beck Depression Inventory-II score measure: SF-12 MCS score measure: SF-12 MCS score measure: SF-12 MCS score measure: Receipt of knee surgery measure: OMERACT/OARSI responder measure: OMERACT/OARSI responder measure: OMERACT/OARSI responder measure: Pain medication use measure: Pain medication use measure: Pain medication use sex: ALL minimumAge: 50 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts Medical Center city: Boston state: Massachusetts zip: 02111 country: United States name: Sherwood Alexis, MHA, MBA role: CONTACT phone: 617-636-5405 email: [email protected] name: Chenchen Wang, MD role: PRINCIPAL_INVESTIGATOR name: Tim McAlindon, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06384885 id: 2024-079 briefTitle: Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes acronym: SIPE overallStatus: RECRUITING date: 2024-04-15 date: 2025-06-01 date: 2025-12-01 date: 2024-04-25 date: 2024-04-25 name: Rocky Vista University, LLC class: OTHER briefSummary: Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality. conditions: Swimming Induced Pulmonary Edema studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Ultrasound measure: Lung ultrasound sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Vista University status: RECRUITING city: Parker state: Colorado zip: 80012 country: United States name: Kathryn A Vidlock, MD role: CONTACT phone: 651-226-1642 email: [email protected] name: Brady Patterson role: PRINCIPAL_INVESTIGATOR name: Harrison Steins role: PRINCIPAL_INVESTIGATOR lat: 39.5186 lon: -104.76136 hasResults: False |
<|newrecord|> nctId: NCT06384872 id: 230042_RRI_Interv5 briefTitle: Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk acronym: RRI_Interv5 overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-09-30 date: 2025-12-31 date: 2024-04-25 date: 2024-04-26 name: Luxembourg Institute of Health class: OTHER_GOV name: DECATHLON SA briefSummary: The main purpose of this project is to investigate the influence of cushioning material at both the rear and the forepart of running shoes on musculoskeletal complaints in leisure-time runners. Therefore, the objectives are to investigate if |
1. "Extra soft" cushioning materials can reduce injury risk compared to stiffer materials; |
2. Cushioning under the forepart of the shoe also influences injury risk, independently of the cushioning at the rear part; |
3. Effects of cushioning material and position depend on the runner's body mass; |
4. Perception of cushioning is related to both shoe cushioning and injury risk; |
5. Other weight-bearing locomotion activities (i.e., number of steps per day besides running practice) represents an independent risk factor for running-related injury. |
This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule. Before the beginning of the study, the participants will receive a pair of running shoes. The three running shoe models will be exactly the same, except for their foam properties at the rear and forepart of the shoe, which will differ by 33 and 37%, respectively. The study shoes will be administered through random allocation. The participants will be required to use these shoes for all running sessions, and only for running activities. |
Participants will first fill out a baseline questionnaire. During the intervention, data on running practice will be downloaded from sports watches and their respective app via Strava. Information on the use of the study shoes will be collected via a weekly questionnaire. Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days. A questionnaire on the perception of cushioning will be filled in by the participants at three time points (after 5h of running, 25h of running, and at the end of follow-up). |
Primary hypothesis: |
- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners. |
Secondary hypothesis: |
* Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners. |
* Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties. |
* Greater perceived cushioning is related to lower injury risk. conditions: Running-related Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Participants will be stratified according to their sex. Two pre-established randomization list will be prepared by a statistician not involved in any other part of the study before the beginning of the study. To ensure allocation concealment, the study groups as well as the shoes will be coded and the randomization lists will be uploaded in the electronic system by an IT specialist who will not be involved in any other part of the study. The electronic system will provide the investigator with a study group code for each participant, according to the randomization lists. The investigator will upload the shoe ID according to shoe size and study group so that a cross validation will be performed by the electronic system. The investigators in charge of the recruitment, follow-up and data validity check, as well as the participants, will be blinded regarding the shoe version distributed. The shoe code will be broken after completion of data analysis. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1068 type: ESTIMATED name: Shoe Cushioning Position and Properties measure: First running-related injury with a duration of minimum one week measure: First one-day time loss running-related injury measure: First running-related musculoskeletal complaint to the lower limb measure: First substantial running-related injury measure: First overuse running-related injury sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luxembourg Institute of Health city: Strassen zip: 1445 country: Luxembourg name: Laetitia Garcia, Msc role: CONTACT phone: +352 26970957 email: [email protected] lat: 49.62056 lon: 6.07333 hasResults: False |
<|newrecord|> nctId: NCT06384859 id: Pending briefTitle: Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-25 date: 2024-04-25 name: Mahidol University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are: |
Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment? |
Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy. |
Participants will: |
* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks |
* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score conditions: Insertional Achilles Tendinopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: ESWT name: PRP measure: VAS measure: VAS-FA measure: FFI measure: FAAM sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ramathibodi hospital city: Ratchathewi state: Bangkok zip: 10400 country: Thailand name: Prapan Wongrungrote, MD role: CONTACT phone: +66 0810688654 email: [email protected] name: Sukij Laohajaroensombat, MD role: CONTACT phone: +66 022011589 email: [email protected] lat: 13.759 lon: 100.53358 hasResults: False |
<|newrecord|> nctId: NCT06384846 id: AI ACS briefTitle: AI Algorithms in Prediction of ACS Based on Leukocyte Properties overallStatus: RECRUITING date: 2024-02-01 date: 2026-07-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: RobotDreams GmbH class: INDUSTRY briefSummary: The goal of this observational study is to find out if artificial intelligence (AI) can accurately predict acute coronary syndrome (ACS) using data on white blood cells in adults. The main question it aims to answer is: |
- Can AI algorithms based on white blood cell data predict ACS with accuracy comparable to that of high-sensitivity cardiac troponin (hs-cTn)? Researchers will look at how the AI model's predictions stack up against the standard hs-cTn blood tests to see which is more accurate in diagnosing ACS. |
Participants in this study will have already had blood tests as part of their usual care. Their previously collected health information and blood test results will be used to help train and test the AI algorithms. Participants will not undergo any new procedures for the study itself. conditions: Acute Coronary Syndrome conditions: Angina Pectoris conditions: NSTEMI - Non-ST Segment Elevation MI conditions: STEMI - ST Elevation Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2700 type: ESTIMATED measure: Training of AI models measure: Testing of AI models measure: Training of AI models measure: Testing of AI models: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Landeskrankenhaus-Universitätsklinikum Graz status: RECRUITING city: Graz state: Styria / Steiermark zip: 8036 country: Austria name: Heiko Bugger, MD role: CONTACT phone: +43 316 385 30177 email: [email protected] lat: 47.06667 lon: 15.45 hasResults: False |
<|newrecord|> nctId: NCT06384833 id: Rama briefTitle: Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-09-01 date: 2026-05-01 date: 2024-04-25 date: 2024-04-25 name: Mahidol University class: OTHER briefSummary: The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are: |
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