[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,59,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053229","phase-2-bpl-1357-against-h1n1-influenza-virus-challenge-100053229",false,"NCT07215858","BPL-1357 Against H1N1 Influenza Virus Challenge","Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BPL-1357 Against H1N1 Influenza Virus Challenge","* INCLUSION CRITERIA:\n\nIndividuals must meet all of the following criteria to be eligible for study participation:\n\n1. Adults \\>=18 and \\\u003C= 55 years of age at the time of consent.\n2. Able to provide written informed consent.\n3. Non-smoker (i.e., tobacco and cannabis) and does not use vape or e-cigarette products currently. Also, must not have used any of these products extensively in the past (regular use more than 5 times per week, more than 6 months lifetime total).\n4. Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza vaccination of any type until after the end of study participation (PBD63).\n5. Has not received any other vaccination of any type within 4 weeks prior to enrollment and consents to not receive any unlicensed vaccine until after the end of the study (PBD63).\n6. Has not received any broadly protective influenza vaccine in the past.\n7. Participants of childbearing potential must meet one of the following criteria through the end of study participation (PBD63):\n\n   1. Is infertile, including postmenopausal status (as defined by age .45 years plus no menses for \\>= 1 year without an alternative medical cause) or history of hysterectomy or bilateral oophorectomy.\n   2. Agrees that, when engaging in intercourse that can result in pregnancy, they will use an acceptable or highly effective form of contraception, and their male partner will use a condom with spermicide. Acceptable methods of female contraception include\n\n   the following:\n   * Bilateral tubal ligation\n   * Implant of levonorgestrel\n   * Injectable progestogen\n   * Oral contraceptive pills\n   * Diaphragm with spermicide\n   * Intrauterine device (IUD)\n   * Sexual abstinence\n   * Vasectomized partner\n8. Able to speak and understand English (NIH).\n9. Able to speak and understand English and\u002For Spanish (UTMB).\n10. A negative HIV test within 6 months before enrollment.\n11. Has not used IN medications (including but not limited to nasal sprays, sinus rinses), and has not routinely used over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John's Wort) within 14 days (about 2 weeks) prior to study enrollment and agrees not to use these medications until after the end of study participation (PBD63), unless approved by the investigator.\n12. Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63).\n13. Not planning on cohabitating with any high-risk individuals (e.g., infants, elderly, those with high-risk conditions (e.g., pregnancy, medical conditions such as those outlined in exclusion criterion 1) for at least 2 weeks after discharge from the inpatient portion of this study.\n14. Participant is willing and able to comply with all trial procedures.\n\nEXCLUSION CRITERIA\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. Current medical conditions (self-reported or medically documented) including but not limited to:\n\n   1. Chronic pulmonary disease (e.g., asthma, emphysema).\n   2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).\n   3. Chronic medical conditions requiring close medical follow-up or hospitalization (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).\n   4. Immunosuppression, immune deficiency, or ongoing malignancy.\n   5. Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures).\n2. Body mass index (BMI) \\\u003C18 and \\>35.\n3. Pregnant or breastfeeding.\n4. History of postinfectious or postvaccine neurological sequelae including GBS.\n5. History of stroke within the past 5 years.\n6. Acute illness within 7 days prior to enrollment (PAD0).\n7. Known allergy to influenza vaccination or components contained in the influenza vaccine being used.\n8. Known allergy to influenza treatments (including oseltamivir or nonsteroidal anti-inflammatory medications).\n9. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).\n10. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.\n11. Receipt of any unlicensed drug or investigational agent within 3 months or 5.5 half-life (whichever is greater) prior to enrollment.\n12. Receipt of any unlicensed vaccine within 6 months prior to enrollment.\n13. Self-reported or known history of alcoholism or drug abuse or use within 6 months prior to enrollment, or positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to vaccination on PAD0.\n14. Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a contraindication to protocol participation.\n15. History of angioedema or anaphylaxis.\n16. Study site staff who directly report to the study or site PI are excluded from participation.\n17. Any condition, event or lab value that, in the judgment of the investigator, is a contraindication to protocol participation or would place the participant at increased risk for participation.\n18. Any condition or event that, in the judgment of the investigator, impairs the participant's ability to give informed consent.\n\nIndividuals meeting any of the following criteria will be excluded from participation in Phase B:\n\n1. Positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to inoculation (PBD0).\n2. Acute illness within 7 days prior to inoculation with the human challenge virus (PBD0).\n3. Grade 3 or greater sign, symptom, or lab abnormality that is clinically significant and (in the opinion of the site PI) puts the participant at higher risk of adverse effects with influenza challenge.\n4. Pregnant or breastfeeding.\n5. Positive test for influenza within 8 weeks prior to challenge.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},129,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nInfluenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics.\n\nObjective:\n\nTo test an experimental flu vaccine.\n\nEligibility:\n\nHealthy people aged 18 to 55 years.\n\nDesign:\n\nThe study will last 5 to 8 months and has 2 phases, A and B.\n\nThe study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients.\n\nPhase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine.\n\nPhase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row.\n\nThey will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.\n\n...",[28,29],"Influenza","Human",[28,31,32],"Vaccine","Human Challenge","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":22},"2026-07-16",{"date":41,"type":22},"2028-03-01",{"name":43,"class":44},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",2,{"id":47,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":49,"briefSummary":26,"conditions":50,"keywords":51,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":58,"locationsCount":45},"100609536",{"count":21,"type":22},[25],[28,29],[28,31,32],"2026-07-01",{"date":54,"type":37},"2026-07-02",{"date":56,"type":22},"2026-07-07",{"date":41,"type":22},{"name":43,"class":44},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":16,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100409599","scottish-advanced-fetal-research-study-100409599","NCT04613583","Scottish Advanced Fetal Research Study","Normal Development of the Human Fetus and the Influences and Mechanisms by Which That Development Occurs and is Perturbed","SAFeR","Inclusion Criteria:\n\n* Women at 7-20 weeks of gestation (critical stage of fetal development).\n* Women aged 16 years and older, deemed capable of making a rational decision.\n* Absence of fetal anomaly at ultrasound scan (only normal fetuses are required).\n* Women who are fluent English speakers. This is in order to ensure the woman understands that fetal tissues will be collected.\n\nExclusion Criteria:\n\n* Women exhibiting considerable emotional distress.\n* Fetal anomalies identified at ultrasound scan.","16 Years",{"count":69,"type":22},1200,"OBSERVATIONAL","In-utero exposure to drugs and chemicals through maternal smoking, alcohol use, drug abuse, prescription medicines and occupational\u002Flifestyle exposures is widespread. Such exposures can alter fetal development and programming, leading to the effects becoming \"locked in\" from birth and causing long-term adverse consequences for the individual. These include costly and widespread conditions such as obesity, hypertension, metabolic syndrome and infertility. The weight of evidence linking these conditions to fetal recreational drug or environmental chemical exposures, including cigarettes, alcohol, air pollution, food contact materials, is overwhelming. What is lacking is an understanding of how fetal drug exposure translates to adult ill-health and this is due, largely, to an inability to study the problem directly in affected human fetuses. The investigators, and others, have shown that human fetal development, which lays the foundations of adult health and function (fetal programming), is quite different from the rodent and frequently exhibits surprising aspects. It has become evident that the close interconnectivity of the developing fetal organs and also the placenta, means that a much more holistic approach to research aiming to understand human fetal development and the challenges posed to programming for a health adulthood is critical. To that end the investigators have established a carefully considered gestational age range (7-20 weeks of gestation) of fetuses we can study together with multiple fetal organs and body fluids collected and maternal information recorded.\n\nThe overarching objective of the study is to intensively and systematically study the human fetus during a normal pregnancy and pregnancies where aspects of maternal lifestyle and environment will challenge the fetus. The investigators aim to provide fundamental information to better understand the mechanisms involved and to detect and treat or ameliorate adverse effects during pregnancy (such as maternal smoking\u002Fdrinking, deprivation, exposure to pollution). In the long term findings from this research will be important for future studies aimed at enabling better health in later life.",[73,74,29,75],"Fetal Developmental Abnormality","Fetal Development","Life Style",[77,78,79,80,81,82,83,84,85,86,87,88,89,90],"fetal","human","gestation","development","congenital","exposures","maternal","life style","exogenous chemicals","obesity","deprivation","alcohol","cigarette","endocrine disruption","2026-05-04",{"date":93,"type":37},"2026-05-05",{"date":95,"type":37},"2016-05-01",{"date":97,"type":22},"2028-10-01",{"name":99,"class":100},"University of Aberdeen","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":101},"100504038","the-stereo-dbs-study-7-tesla-mri-brain-network-analysis-for-deep-brain-stimulation-100504038","NCT05843084","The STEREO-DBS Study: 7-Tesla MRI Brain Network Analysis for Deep Brain Stimulation","STEREO-DBS","1.2 Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age \\> 18 years;\n* Idiopathic PD who underwent STN DBS\n\n1.3 Exclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Legally incompetent adults;\n* No written informed consent.",{"count":110,"type":22},500,"Rationale: Deep brain stimulation (DBS) of the nucleus subthalamicus (STN) is an effective surgical treatment for the patients with advanced Parkinson's disease, despite optimal pharmacological treatment. However, individual improvement after DBS remains variable and 50% of patients show insufficient benefit. To date, DBS-electrode placement and settings in the highly connected STN are based on 1,5-Tesla or 3-Tesla MR-images. These low resolution and solely structural modalities are unable to visualize the multiple brain networks to this small nucleus and prevent electrode activation directed at its cortical projections. By using structural 7-Tesla MRI (7T MRI) connectivity to visualize (malfunctioning) brain networks, DBS-electrode placement and activation can be individualized.\n\nObjective: Primary objective of the study is to determine whether visualisation of cortical projections originating in the STN and the position of the DBS electrode relative to these projections using 7T MRI improves motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III).\n\nSecondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden.\n\nStudy design: The study will be a single center prospective observational study.\n\nStudy population: Enrollment will be ongoing from April 2022. Intervention (if applicable): No intervention will be applied. Application of 7T MRI for DBS is standard care and outcome scores used will be readily accessible from the already existing advanced electronic DBS database.\n\nMain study parameters\u002Fendpoints: The primary outcome measure is the change in motor symptoms as measured by the disease-specific Unified Parkinson's Disease Rating Scale (UPDRS-III). This is measured after 6 months of DBS as part of standard care. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Parkinson's Disease Questionnaire 39, Starkstein apathy scale, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The proposed observational research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Participation in this study constitutes negligible risk according to NFU criteria for human research.",[113,114,115,116,117,29,118],"Parkinson Disease","Diffusion Magnetic Resonance Imaging","Brain","Subthalamic Nucleus","Deep Brain Stimulation","Treatment Outcome","2025-07-22",{"date":121,"type":37},"2025-07-25",{"date":123,"type":37},"2022-04-11",{"date":125,"type":22},"2033-04-11",{"name":127,"class":100},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]