hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06305091 id: 1681559 briefTitle: DNA Methylation Markers in Veterans Exposed to Open Burn Pits overallStatus: RECRUITING date: 2023-03-13 date: 2027-03-31 date: 2027-03-31 date: 2024-03-12 date: 2024-03-12 name: Central Arkansas Veterans Healthcare System class: FED name: United States Department of Defense name: University of Arkansas briefSummary: Background: The VA and DoD estimate that 3.5 million Veterans and Service Members were exposed to open burn pits used for waste disposal during military deployments to countries such as Kuwait, Afghanistan, and Iraq since 1990. Since the lasting adverse effects of this exposure on health are unknown, the VA Airborne Hazards and Open Burn Pit Registry (AHOBPR) was created. More than 209,000 participants to date have answered the registry questionnaire about the extent of exposure to burn pits and other airborne hazards. The questions attempted to quantify the duration of exposure, the severity of acute health effects, and the relative timing of onset or worsening of chronic respiratory, cardiovascular, neurological, and other illnesses. However, the AHOBPR interview lacks specific inquiry about mental health and biomarkers. The proposed study will recruit AHOBPR participants and non-participant for a follow-up enhanced evaluation of their health in a translational research study to better characterize their psychological, physical health profile, and potentially harmful epigenetic and biochemical exposure-related alterations.
Specific Aims: (1) Describe and quantify relationships of the intensity and duration of exposure with persistent organic chemicals/metals in the registry participants and ascertain their relationships with health outcomes linked to burn pit exposure. (2) Discover and validate DNA methylation marks that best distinguish between individuals exposed to burn pits and those not; then describe and quantify the relationships between DNA methylation, intensity and duration of exposure, and health outcomes. Completion of these aims will allow quantitation of the relationships between toxic chemicals, DNA methylation, and individual health problems.
Study Design: A clinical study will be conducted at the Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences. The AHOBPR registry and non-specific recruitment will be used to enroll OBP exposed (N=220) and age and gender-matched unexposed (N=110) veterans. The unexposed veterans will be given the same questions as in the AHOBPR to determine their open burn pit exposure status with a confirmation of no exposure. A single study visit per participant will strengthen the registry by validating its contents using the electronic patient record and adding new study data on physical and mental function, including effects of epigenetic and toxicant measures obtained from blood and urine samples. Linear and logistic regression modeling will be used to determine the relationships described by the study aims while controlling for confounding variables and false discovery rates.
Long-term and Short-term Impact on Patient Populations: The immediate goal of the study is to measure exposure-related differences in levels of potentially toxic chemicals present in blood and urine and differences in DNA methylation. The study will then determine the relationships between exposure, the biochemical and molecular measures, and the presence of health problems. The value of this information is high since the effects of burn pit exposure are largely unknown but potentially serious. The longer-term goal for this line of investigation is to enable personalized and tailored health management for exposed individuals. The investigators believe that the biochemical and molecular measures may become novel biomarkers that enable the prediction of risk for disease and adverse disease outcomes such that preventative measures can be employed. Furthermore, the results will be highly relevant to other occupations in which exposure to airborne pollutants is high. conditions: Open Burn Pit Exposure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 330 type: ESTIMATED name: Health survey for physical and mental health comorbidities, epigenetic marker and heavy metals in blood and urine samples measure: DNA methylation markers and heavy metals measure: Physical and mental health comorbidities sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Arkansas Veterans Healthcare System (3J/NLR) status: RECRUITING city: North Little Rock state: Arkansas zip: 72114 country: United States name: Kalpana Padala, MD role: CONTACT phone: 501-257-2044 email: kalpana.padala@va.gov name: Trent Trice, BS role: CONTACT phone: 501-257-2403 email: trent.trice@va.gov name: Kalpana Padala, MD role: PRINCIPAL_INVESTIGATOR lat: 34.76954 lon: -92.26709 hasResults: False
nctId: NCT06305078 id: 2023-0528 briefTitle: Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study overallStatus: RECRUITING date: 2023-11-10 date: 2024-08-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open Label Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: None (open-label) count: 30 type: ESTIMATED name: Personalized ADHD Medication Experiment measure: Decision-Making Involvement Scale measure: Decisional Conflict Scale (DCS) measure: Behavioral Intention Questions measure: System Usability Scale measure: Implementation of Decision sex: ALL minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45220 country: United States name: William Brinkman, MD role: CONTACT phone: 513-636-2576 email: bill.brinkman@cchmc.org name: William Brinkman, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-10 uploadDate: 2024-01-26T17:55 filename: Prot_SAP_000.pdf size: 1393239 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-10 uploadDate: 2024-01-26T18:00 filename: ICF_001.pdf size: 1084823 hasResults: False
nctId: NCT06305065 id: 2024.089 briefTitle: Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-05 date: 2024-03-12 date: 2024-03-19 name: Chinese University of Hong Kong class: OTHER briefSummary: REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.
Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.
The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments. conditions: Knee Osteoarthritis conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Subjects will be randomly assigned to the KUNWU navigational or CORI Surgical System or conventional manual instrumentation groups according to a balanced randomization procedure using a 1:1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded. count: 90 type: ESTIMATED name: KUNWU Navigation TKA procedure name: CORI Surgical System TKA procedure name: Conventional TKA procedure measure: Post-operative leg alignment - Hip-knee-ankle axis (HKA axis) measure: Lateral View measure: Standard Radiographic Evaluation - Femoral coronal alignment (FCA) measure: Standard Radiographic Evaluation - Femoral sagittal alignment (FSA) measure: Standard Radiographic Evaluation - Femoral component rotation (FCR) measure: Standard Radiographic Evaluation - Tibial coronal alignment (TCA) measure: Standard Radiographic Evaluation - Tibial slope measure: Standard Radiographic Evaluation - Joint line distance measure: Knee Society Score (KSS) measure: Oxford Knee Score (OKS) measure: HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L measure: Forgotten Joint Score (FJS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
nctId: NCT06305052 id: estimulation-taste-olfactory id: 65635922.0.0000.5201 type: OTHER domain: CAAE (Certificate of Presentation of Ethical Review) briefTitle: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-04 date: 2024-04 date: 2024-04 date: 2024-03-12 date: 2024-03-13 name: Professor Fernando Figueira Integral Medicine Institute class: OTHER briefSummary: The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks.
The main question researchers want to resolve is: • Does olfactory and gustatory stimulation in these newborns reduce the time spent with an oral or nasogastric feeding tube and bring forward oral feeding? Participants will be stimulated with milk or water depending on the randomly chosen group. 1: the olfactory stimulus (with smell) will be performed with a sterile cotton swab close to the nostrils immediately before feeding through the tube, 2: the gustatory stimulus (taste) will be performed with a sterile cotton swab on which a drop of milk or water will be applied on the newborn's tongue if they are awake or on their lips if they are sleeping, and is performed immediately before tube feeding. conditions: Weight, Birth conditions: Premature Birth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 63 type: ACTUAL name: Milk name: Water measure: Comparison of the period between the beginning of the intervention and enteral feeding. measure: Describe the gestational age of the newborn measure: Describe the sex of the newborn. measure: Describe the type of birth. measure: Describe the APGAR score. measure: Describe birth weight and birth weight z-score. measure: Describe head circumference at birth and head circumference z-score at birth measure: Describe birth length and birth length z-score. measure: Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h. measure: Compare the time, in days, of feeding via oral/nasal gastric tube. measure: Compare the total duration, in days, of parenteral nutrition (TPN) use. measure: Compare the type of food at discharge (natural, artificial or mixed). measure: Compare weight gain and weight Z score, at 28 days of life and at discharge from the neonatal ICU, as well as anthropometric parameters: head circumference and length with their respective Z score at discharge from the NICU. measure: Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU. measure: Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis. measure: Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours. sex: ALL minimumAge: 28 Weeks maximumAge: 32 Weeks stdAges: CHILD facility: Instituto de Medicina Integral Professor Fernando Figueira city: Recife state: Pernambuco zip: 50070-550 country: Brazil lat: -8.05389 lon: -34.88111 hasResults: False
nctId: NCT06305039 id: 2089705 id: 1R01DC020506-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DC020506-01A1 briefTitle: Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments overallStatus: ENROLLING_BY_INVITATION date: 2023-12-19 date: 2028-05-31 date: 2028-05-31 date: 2024-03-12 date: 2024-03-12 name: University of Maryland, College Park class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) name: Walter Reed National Military Medical Center name: Vanderbilt University briefSummary: Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs. conditions: Hearing Loss conditions: Hearing Loss, Sensorineural conditions: Cochlear Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 300 type: ESTIMATED name: Diagnostic tests of cochlear implant or acoustic hearing function name: Targeted aural rehabilitation of the poorer performing ear measure: Perceptual responses to sound level measure: Speech understanding in the presence of masking sounds measure: Computed-tomography scan measure: Electrode impedance (transelectrode impedance matrix) measure: Electrically evoked compound action potentials (ECAPs) measure: Sound Localization measure: Perceptual Fusion measure: Spectrotemporal ripple sensitivity sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center city: Bethesda state: Maryland zip: 20889 country: United States lat: 38.98067 lon: -77.10026 facility: University of Maryland, College Park city: College Park state: Maryland zip: 20742 country: United States lat: 38.98067 lon: -76.93692 hasResults: False
nctId: NCT06305026 id: S-20190160 briefTitle: Protocol for a Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia overallStatus: RECRUITING date: 2024-02-07 date: 2024-08-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: Hospital of South West Jutland class: OTHER name: Odense University Hospital briefSummary: Background: Chronic widespread pain is challenging in the management of the patient with rheumatoid arthritis (RA), affecting approximately one third of this patient population. However, pain is not always caused by disease activity (inflammation) but can be associated to central pain mechanisms as seen in fibromyalgia (FM). FM is characterized by widespread pain and tenderness; often accompanied by disturbed sleep, fatigue, cognitive impairment, emotional distress and multiple symptoms from various organ systems. Among patients with RA the prevalence of concomitant FM is reported to be 12-17% compared to 1-3% in the general population. In general the pain, felt by the fibromyalgia patients is considered to be due to lower pain thresholds because of abnormal central pain processing. Pain reported by RA patients with concomitant FM could potentially be explained by this phenomenon. Little is known about RA patients fulfilling criteria for FM. Muscles-studies of FM patients have not found any histopathological explanation of the pain felt, however an old study of muscle changes in RA patients found changes that could explain muscle pain. Small fiber neuropathy (SFN) is a condition associated with autoimmune diseases, and evidence suggests that SFN is likely to contribute to the pain observed in FM.
Eligibility criteria for participants and settings where the data will be collected: RA patients will be assessed in the daily clinic in Esbjerg and Odense and examined for concomitant FM (I.e. satisfying the 2016 criteria for FM). Patients will afterwards be invited to participate in the study. Inclusion will continue until 25 RA patients fulfilling FM criteria and thus based on the expected prevalence at least 25 (- and maximum 50) RA patients not fulfilling FM critieria has undergone the index tests.
Estimates of diagnostic accuracy and their precision: Regarding muscle- and skin biopsies sensitivity, specificity and positive predictive value will be calculated using two times two table. Regarding skin biopsies, median values in the two groups (RA +/- FM) will be compared using a two-sample t-test. conditions: Rheumatoid Arthritis conditions: Fibromyalgia, Secondary conditions: Widespread Chronic Pain conditions: Muscle Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Muscle- and skin biopsies measure: Muscle pathology measure: Skin biopsies measure: Cold pressure test measure: Pain pressure threshold (PPT) measure: Computerized Cuff pressure algometry (CPA) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Esbjerg Hospital status: RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Philip R LageHansen, MD role: CONTACT phone: +4530114582 email: philip.rask.lage-hansen3@rsyd.dk name: Philip LageHansen, MD role: PRINCIPAL_INVESTIGATOR name: Torkell Ellingsen, Professor role: PRINCIPAL_INVESTIGATOR lat: 55.47028 lon: 8.45187 hasResults: False
nctId: NCT06305013 id: SIMU PEA 2024 briefTitle: PEA: The Ability of Nurses To Recognize It (PEA: ANTRI) acronym: PEARECOG overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-06-01 date: 2024-03-12 date: 2024-04-19 name: Brno University Hospital class: OTHER name: Department of Simulation Medicine, Faculty of Medicine, Masaryk University briefSummary: The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals should be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowledge of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk university and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized. conditions: Pulseless Electrical Activity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Pulseless electrical activity recognition measure: Pulseless electrical activity recognition, sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty hospital Brno status: RECRUITING city: Brno state: Jihomoravský Kraj zip: 62500 country: Czechia name: Martina Kosinova, MD., Ph.D. role: CONTACT phone: 532234692 phoneExt: 00420 email: kosinova.martina@fnbrno.cz lat: 49.19522 lon: 16.60796 hasResults: False
nctId: NCT06305000 id: 2015-KAEK-80-23-25 briefTitle: Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2025-03-10 date: 2025-05-10 date: 2024-03-12 date: 2024-03-27 name: Biruni University class: OTHER briefSummary: This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:
Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.