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What does the study do?
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It collects information on Italian patients with Familial Hypercholesterolaemia (FH), following them in their normal clinical examination without adding extra procedures.
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It uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia, examining how it is diagnosed clinically and by genetic testing, and evaluating the effectiveness of different treatments.
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It seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias, helping to choose the most effective treatments.
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It evaluates the impact of long-term treatments and patient adherence to medication, as well as monitoring the incidence of cardiovascular events and other important outcomes.
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Who can participate?
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The study is aimed at people of all ages, from children to adults, with familial hypercholesterolaemia or other genetic dyslipidaemia.
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More than 50 centres throughout Italy are involved, making the study accessible to many.
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What does participation entail?
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Participants will continue with their normal clinical practice.
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Data such as family history, personal clinical findings and genetic information will be collected, without additional procedures.
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For some, further evaluations, such as ultrasounds, may be required to better study their condition.
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The LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients\' lives through more precise diagnosis and personalised treatments. conditions: Familial Hypercholesterolemia conditions: Genetic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10000 type: ESTIMATED name: Lipid-lowering treatments measure: Lipid profile of patients with genetic dyslipidemia measure: Genetic profile of patients with genetic dyslipidemia sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Multimedica status: RECRUITING city: Sesto san Giovanni state: Milano zip: 20099 country: Italy name: Fabio Pellegatta, MD role: CONTACT phone: 00390224209593 email: [email protected] name: Fabio Pellegatta, MD role: PRINCIPAL_INVESTIGATOR lat: 45.53329 lon: 9.22585 hasResults: False
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<|newrecord|> nctId: NCT06362460 id: RAY1216-23-03 briefTitle: Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China overallStatus: COMPLETED date: 2023-09-18 date: 2023-11-01 date: 2023-11-15 date: 2024-04-12 date: 2024-04-16 name: Guangdong Raynovent Biotech Co., Ltd class: INDUSTRY briefSummary: This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216. conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ACTUAL name: [14C] RAY1216 measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae) measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu country: China lat: 32.94083 lon: 117.36083 hasResults: False
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<|newrecord|> nctId: NCT06362447 id: RC31/22/0320 briefTitle: Efficacy of Injectable Gentamicin in Hereditary Ichthyosis acronym: GENTIC overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2026-04-01 date: 2027-04-01 date: 2024-04-12 date: 2024-04-12 name: University Hospital, Toulouse class: OTHER briefSummary: This study will evaluate the efficacy and safety of intravenous gentamicin in congenital ichthyosis due to a non-sens mutation. The primary objective is the severity of scales and erythema at the third month, compared to baseline. Secondary objectives will include: the importance of itching, trans epidermal water loss, cutaneous expression of the targeted protein, the security of the drug and patients' satisfaction. conditions: Ichthyosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Gentamicin Injectable Solution measure: Gentamicin efficacity measure: Gentamicin efficacity measure: Gentamicin efficacity on quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Saint-Louis APHP city: Paris zip: 75010 country: France name: BOURRAT Emmanuelle, MD role: CONTACT phone: 01 42 49 90 90 phoneExt: 33 email: [email protected] lat: 48.85341 lon: 2.3488 facility: CHU de Toulouse city: Toulouse zip: 31059 country: France name: SEVERINO-FREIRE Maella, MD role: CONTACT phone: 05 67 77 81 41 phoneExt: 33 email: [email protected] name: TEXIER Hélène role: CONTACT phone: 05 67 77 81 80 phoneExt: 33 email: [email protected] name: MAZEREEUW-HAUTIER Juliette, MD, PhD role: SUB_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06362434 id: UHN-HHREHAB-24-xxxx briefTitle: Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour acronym: HHREHAB overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-06-01 date: 2024-04-12 date: 2024-04-12 name: University Health Network, Toronto class: OTHER name: Alberta Children's Hospital name: St. Justine's Hospital name: The Hospital for Sick Children name: British Columbia Children's Hospital briefSummary: Brain malignancies are the most common cause of death from cancer in the pediatric population and a major source of morbidity amongst survivors. Many children with a brain tumour often suffer from visual field defects (hemianopia) dramatically impacting their daily life with poorer social interaction, difficulties learning, playing sports and engaging with peers. Practically, they bump into people and objects and have problems in finding their way in unfamiliar places and in detecting incoming objects in their blind field. There is growing recognition of the diverse and deep impact of hemianopia on physical and mental health, quality of life, and social outcomes of the affected individuals and their family. However, despite the frequent impact of brain tumours on the visual function and functional vision, ophthalmologic evaluations are not standard of care for all brain tumour patients and there are no standardized protocols of vision loss management in the pediatric population with hemianopia. There is an unmet need of restoring perception in the blind field in individuals with hemianopia consecutive to pediatric brain tumor.
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Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality. Participants perform audiovisual stimulation at home in a headset, with remote control from the laboratory. Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision program on visual fields, visual perception and quality of life.
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Our objective is to evaluate the effectiveness of Re:Vision, an 8-week visual telerehabilitation program, on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIa/b multi-centric clinical study across Canada.
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This intervention provides more equitable access to individuals, with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional, meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision. This is the first study that could lead to a major change in the management of these patients. It could open the door for visual rehabilitation strategies to other population of visually impaired children, significantly impacting public health strategies. conditions: Hemianopsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Audiovisual stimulation measure: Binocular Visual Field measure: Patient-related Outcome Measures - National Eye Institute - Visual Function Questionnaire - 25 measure: Patient-related Outcome Measures - World Health Organization - Quality of Life questionnaire - BREF measure: Reading Speed measure: Fixation Stability measure: Contrast Sensitivity measure: Brain Activity - Visually-evoked potentials measure: Retinal Integrity measure: Brain imaging - Tractography measure: Brain imaging - Retinotopy measure: Head tracking measure: Eye tracking sex: ALL minimumAge: 10 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta zip: T3B 6A8 country: Canada name: Lucie Lafay-Cousin, MD role: CONTACT phone: 403-955-7272 email: [email protected] name: Lucie Lafay-Cousin, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: British Columbia Children's Hospital city: Vancouver state: British Columbia zip: V6H 3N1 country: Canada name: Sylvia Cheng, MD role: CONTACT phone: 604-875-2406 email: [email protected] name: Sylvia Cheng, MD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 facility: The Hospital for Sick Children city: Toronto state: Ontario zip: M5G 1E8 country: Canada name: Eric Bouffet, MD role: CONTACT phone: 416-813-7500 email: [email protected] name: Eric Bouffet, MD role: PRINCIPAL_INVESTIGATOR name: Uri Tabori, MD role: SUB_INVESTIGATOR name: Inci Yaman Bajin, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre Hospitalier Universitaire Sainte-Justine city: Montreal state: Quebec zip: H3T 1C5 country: Canada name: Sebastien Perreault, MD role: CONTACT phone: 514-345-2372 email: [email protected] name: Sebastien Perreault, MD role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: CHU de Québec city: Québec state: Quebec zip: G1J 1Z4 country: Canada name: Valerie Larouche, MD role: CONTACT phone: 418-654-2282 email: [email protected] name: Valerie Larouche, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False
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<|newrecord|> nctId: NCT06362421 id: ONC-HN-2402 briefTitle: Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-07 date: 2024-04-12 date: 2024-04-12 name: Wake Forest University Health Sciences class: OTHER name: InnoTech Precision Medicine briefSummary: The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer. conditions: Oropharyngeal Squamous Cell Carcinoma conditions: Human Papillomavirus Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Pre-Radiation Dental Evaluation/Sample Collection name: Pre-Study Visit name: Oral Medicine Consultation Visit/Sample Collection measure: Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB measure: Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB measure: Overall Accuracy - All Participants sex: ALL minimumAge: 39 Years maximumAge: 59 Years stdAges: ADULT facility: Hayworth Cancer Center city: High Point state: North Carolina zip: 27262 country: United States name: Study Coordinator role: CONTACT phone: 336-713-1790 email: [email protected] lat: 35.95569 lon: -80.00532 facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Study Coordinator role: CONTACT phone: 336-713-1790 email: [email protected] name: Muhammad A Shazib, DMD role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False
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<|newrecord|> nctId: NCT06362408 id: PLAGH-DEX-PSM/IPTW-001 briefTitle: Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-25 date: 2023-06-01 date: 2024-04-12 date: 2024-04-12 name: Chinese PLA General Hospital class: OTHER name: Beijing Tiantan Hospital name: First Affiliated Hospital of Guangxi Medical University name: The Affiliated Hospital Of Guizhou Medical University name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School name: Wuhan Union Hospital, China name: Fudan University briefSummary: China's aging population is causing an increase in the number of senior persons undergoing surgery. More and more clinicians are paying attention to the postoperative survival and mental health of elderly surgical patients.
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Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. DEX has the potential to prevent and treat postoperative anxiety and depression in elderly patients undergoing non-cardiac surgery.
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Further exploration of evidence for evidence-based medicine is needed. Based on the above research background, this hypothesis is proposed: in elderly patients undergoing noncardiac surgery, intraoperative DEX is associated with a reduction in short-term postoperative mental disorders and a reduction in long-term postoperative mortality. conditions: Cohort Studies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 6000 type: ACTUAL name: Dexmedetomidine measure: Postoperative mortality rate measure: The incidence of postoperative delirium measure: The incidence of postoperative anxiety measure: The incidence of postoperative depression measure: Postoperative sleep disorders measure: Surgical related complications measure: Postoperative quality of life evaluation sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362395 id: 24-5022 briefTitle: Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction acronym: ULTRAS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2030-06 date: 2030-06 date: 2024-04-12 date: 2024-04-12 name: University Health Network, Toronto class: OTHER briefSummary: This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles.
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Liver metastases are common in several cancers, but surgery is often not feasible for many patients. Stereotactic body radiotherapy (SBRT), which delivers focused radiation to tumors, is an alternative treatment option. Previous studies have shown promising results with SBRT, but the optimal radiation dose for liver metastases is still uncertain.
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This study will look at patients with specific types of primary cancers known to respond well to SBRT. Treatment effectiveness will be assessed by monitoring tumor control, overall survival, and quality of life.
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By comparing ultra-high dose SBRT with standard high dose, the study aims to determine if the former can provide better tumor control with fewer side effects. If successful, this approach could offer a significant advancement in the treatment of liver metastases, potentially improving outcomes and quality of life for patients. conditions: Liver Metastases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 114 type: ESTIMATED name: Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT) measure: Local control (LC) of treated target lesion compared to high dose MR-guided stereotactic single-fraction radiation. measure: Overall survival (OS) measure: Progression free survival (PFS) measure: Intra-hepatic progression measure: Widespread progression. measure: Physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5. measure: Patients-reported toxicity: Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1. measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, Core 15 for Palliative Care (EORTC QLQ-C15-PAL) measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, liver metastases (EORTC QOQ-LM21). measure: Changes in the levels of circulating biomarkers (cell-free tumor DNA) in response to SBRT. measure: Changes in the levels of circulating biomarkers (cytokines) in response to SBRT. measure: Changes in the levels of circulating biomarkers (metabolites) in response to SBRT. measure: Changes in the levels of circulating biomarkers (immune cell populations) in response to SBRT. measure: Identification of MR imaging biomarkers in response to SBRT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362382 id: 2024-zxm-01 briefTitle: Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-04-22 date: 2026-05-01 date: 2024-04-12 date: 2024-04-12 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn the effectiveness of remote home-based exercise rehabilitation using mobile Internet technology for patients with pulmonary hypertension，especically providing early and mid-term results of its effectiveness. The main questions it aims to answer are:
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Dose tele-rehabilitation training improves prognostic function and quality of life in patients with pulmonary hypertension？ Researchers will compare tele-rehabilitation training group to a control group (receive health propaganda and education, and then follow their daily routine after discharge from the hospital) to see if tele-rehabilitation training works to improve prognosis.
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Participants will:
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During their stay in the hospital, the patients of tele-rehabilitation training group were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training. The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved. After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily training sessions and intensive supervision and management by the online community at least once a week.
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Visit the clinic at the 3rd month of the study. Extended follow-up up to 6 months may be considered if patients are cooperative and could complete the training program in the first 3 months. conditions: Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: tele-rehabilitation training name: health propaganda and education measure: changes in 6MWD after 3 months measure: changes in muscle mass after 3 months measure: peak VO2 measure: VO2peak% measure: VE/VCO2 slope measure: PET CO2 measure: Changes in muscle mass evaluated by CT measure: Changes in grip strength measure: the time for 5 sit-to-stand test measure: Quality of life measured by SF-36 after 3 months measure: Quality of life measured by SF-36 after 6 months measure: Quality of life measured by emPHasis-10 after 3 months measure: Quality of life measured by emPHasis-10 after 6 months measure: Changes in WHO Cardiac Function Classification measure: Change in NT-proBNP measure: Change in TAPSE by cardiac doppler ultrasound measure: Changes in hemodynamic indice after 6 months measure: Changes in sleep quality score after 3 months measure: Changes in sleep quality score after 6 months measure: Changes in psychosocial score after 3 months measure: Changes in psychosocial score after 6 months measure: All-cause mortality in 3 months measure: All-cause mortality in 6 months measure: The occurrence rate of primary events in pulmonary hypertension in 3 months measure: The occurrence rate of primary events in pulmonary hypertension in 6 months sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Fuwai Hospital city: Beijing state: Beijing zip: 100037 country: China name: Xiaoming Zhou, MD role: CONTACT phone: +86 88396992 email: [email protected] name: Xiaoming Zhou, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362369 id: 7HP-111 briefTitle: A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-12-31 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: 7 Hills Pharma, LLC class: INDUSTRY briefSummary: This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.
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Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b conditions: Advanced Cancer conditions: Advanced Solid Tumor conditions: Melanoma conditions: Metastasis conditions: Pleural Mesothelioma conditions: Renal Cell Carcinoma conditions: MSI-High conditions: Mismatch Repair Deficiency conditions: Colorectal Cancer conditions: Hepatocellular Carcinoma conditions: Hepatocellular Cancer conditions: Renal Cell Cancer conditions: Kidney Cancer conditions: Skin Cancer conditions: Non Small Cell Lung Cancer conditions: NSCLC conditions: Anaplastic Lymphoma Kinase Genomic Tumor Aberrations conditions: ALK Genomic Tumor Aberrations studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE maskingDescription: Phase 1b - Open Label count: 126 type: ESTIMATED name: Alintegimod name: Ipilimumab name: Nivolumab measure: Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0 measure: Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0 measure: Define RPTDs for Alintegimod measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax) measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC) measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax) measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC) measure: Determine Progression Free Survival (PFS) response in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 tumor assessment criteria. measure: Determine Overall Response Rate (ORR) in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 response assessment criteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida Cancer Specialists city: Lake Mary state: Florida zip: 32746 country: United States name: Study Coordinator role: CONTACT phone: 407-804-6133 name: Alexander Philipovskiy, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 28.75888 lon: -81.31784 facility: Dartmouth Hitchcock city: Lebanon state: New Hampshire zip: 03756 country: United States name: Study Coordinator role: CONTACT phone: 603-650-6345 name: Konstantin H Dragnev, MD role: PRINCIPAL_INVESTIGATOR lat: 43.64229 lon: -72.25176 facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Study Coordinator role: CONTACT phone: 713-792-4259 name: Apostolia-Maria Tsimberidou, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06362356 id: 24-106 briefTitle: Microbial Metabolites and Outcomes of Pregnancy Study acronym: MMOPS overallStatus: RECRUITING date: 2024-03-05 date: 2026-12-31 date: 2026-12-31 date: 2024-04-12 date: 2024-04-18 name: The Cleveland Clinic class: OTHER briefSummary: Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction.
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Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants.
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Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes. conditions: Hypertensive Disorder of Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: TMAO level measure: TMAO level measure: TMAO level sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Cara Dolin, M.D. role: CONTACT phone: 440-312-2229 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06362343 id: PUMCH-Rivaroxaban-Monitoring briefTitle: The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics overallStatus: RECRUITING date: 2024-01-01 date: 2026-10-30 date: 2027-01-30 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER name: Ruijin Hospital name: Xiangya Hospital of Central South University name: China-Japan Friendship Hospital briefSummary: 1. Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs).
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2. Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes.
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3. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process. conditions: Pulmonary Embolism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Rivaroxaban measure: Bleeding events measure: Recurrent thromboembolic events sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Juhong Shi, M.D role: CONTACT phone: +8613701178492 email: [email protected] name: Min Peng, M.D role: CONTACT phone: +8613581888792 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362330 id: 2022-SR-471 briefTitle: Multi-parametric MRI in Patients of Bladder Cancer overallStatus: RECRUITING date: 2021-07-01 date: 2024-05-30 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. The investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(MRI). conditions: Muscle-invasive Bladder Cancer conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: magnetic resonance imaging measure: Muscle-invasive bladder cancer measure: Non-muscle-invasive bladder cancer sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yu-Dong Zhang status: RECRUITING city: Nanjing zip: 210029 country: China name: Yu-Dong Zhang, MD;PHD role: CONTACT phone: 15805151704 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06362317 id: K5247 briefTitle: Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer overallStatus: RECRUITING date: 2024-03-06 date: 2025-03-06 date: 2026-03-06 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers conditions: Biliary Tract Neoplasms Immunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Toripalimab name: Lenvatinib name: Gemox Chemotherapy（Gemox or GC） measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Overall survival measure: Duration of response measure: Clinical benefit rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) status: RECRUITING city: Beijing state: Beijing zip: 100005 country: China name: Haitao Zhao, Professor role: CONTACT phone: +861069156042 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362304 id: 2024-DG-01 briefTitle: 99mTc-CNDG SPECT/CT in Brain Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-04 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:
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1. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?
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2. What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?
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Participants will:
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Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard. conditions: Intracranial Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: 99mTc-CNDG SPECT/CT measure: SUVmax sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362291 id: 2023IR27 briefTitle: Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial overallStatus: RECRUITING date: 2023-08-01 date: 2024-07-31 date: 2025-04-30 date: 2024-04-12 date: 2024-04-12 name: Peking University First Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:
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Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy?
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Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
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Participants will:
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Receive AI-cTB or routine cTB. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: MRI-AI guided cognitive prostate targeted biopsy name: Routine cognitive prostate targeted biopsy measure: The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB) measure: The PCa detection rate measure: The Gleason score (GS) of the biopsy sample measure: The GS of radical prostatectomy (RP) specimens sex: MALE minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Baowei Zhang role: CONTACT phone: +86 83572466 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06362278 id: 026 briefTitle: A Multi-omics Study of "Healthy" Premature CAD Patients overallStatus: RECRUITING date: 2024-03-20 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach.
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The main questions it aims to answer are:
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* Genetic risk factors \& metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown.
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* How to optimize current primary prevention strategy for this rare CAD subgroup？ conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 160 type: ESTIMATED name: multi-omics studies measure: common & rare variants associated with "healthy" pre-mature CAD phenotype measure: Unique metabolomic fingerprints associated with "healthy" pre-mature CAD phenotype sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Chunjian Li, Phd、MD role: CONTACT phone: +86 13701465229 email: [email protected] lat: 32.06167 lon: 118.77778 facility: Qilu Hospital of Shangdong University status: ACTIVE_NOT_RECRUITING city: Jinan state: Shandong zip: 250012 country: China lat: 36.66833 lon: 116.99722 facility: The Second Affiliated Hospital of Zhejiang University Medical College status: ACTIVE_NOT_RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06362265 id: 18437 id: I8H-MC-BDDB type: OTHER domain: Eli Lilly and Company briefTitle: A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-11 date: 2026-11 date: 2024-04-12 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 22 type: ESTIMATED name: LY3209590 measure: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 measure: PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590 measure: Change from Baseline in Fasting Glucose sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Honor Health Research Institute city: Scottsdale state: Arizona zip: 85258 country: United States lat: 33.50921 lon: -111.89903 facility: Children's Hospital Los Angeles city: Los Angeles state: California zip: 90027 country: United States lat: 34.05223 lon: -118.24368 facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics city: Atlanta state: Georgia zip: 30329 country: United States lat: 33.749 lon: -84.38798 facility: University of Louisville, Norton Children's Research Institute city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Johns Hopkins University School of Medicine city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 facility: Joslin Diabetes Center city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: UBMD Pediatrics city: Buffalo state: New York zip: 14203 country: United States lat: 42.88645 lon: -78.87837 facility: NYU Langone city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06362252 id: DS7300-189 id: 2023-509629-36 type: OTHER domain: EU CT briefTitle: A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2026-11-30 date: 2026-12-30 date: 2024-04-12 date: 2024-04-12 name: Daiichi Sankyo class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting. conditions: Extensive Stage-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 149 type: ESTIMATED name: Ifinatamab deruxtecan name: Atezolizumab name: Carboplatin name: Etoposide measure: Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A) measure: Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Duration of Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Clinical Benefit Rate as Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Time to Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd measure: The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362239 id: STUDY00003853 briefTitle: Prospective Home-Based Palliative Care and Hospice Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-10 date: 2027-10 date: 2024-04-12 date: 2024-04-12 name: Steven Smith class: OTHER name: Akron Children's Hospital name: Medical University of South Carolina name: Nemours Children's Hospital name: Baylor College of Medicine briefSummary: The purpose of this study is to test the hypothesis that the addition of home-based hospice and palliative care (HBHPC) will provide a reduction in health care utilization, improve quality of life, and facilitate goal-concordant care that is superior to inpatient and clinic pediatric palliative care (PPC) alone. conditions: Pediatric Palliative Care studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Study Surveys measure: Hospital Utilization Differences measure: Demographic Differences measure: Location of death differences sex: ALL maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06362226 id: HM20029491 briefTitle: OPTIMIZING OCULAR OUTCOMES: A DUAL-ARMED STUDY FOR PERIORBITAL BURN MANAGEMENT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-08 date: 2026-10 date: 2024-04-12 date: 2024-04-12 name: Virginia Commonwealth University class: OTHER briefSummary: The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& antibiotic ointment with vitamin E as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns. conditions: Periorbital Burns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Steroid/Antibiotic name: 5-FU/Kenalog measure: Comparison of wound healing time measure: Comparison of infection rate measure: Comparison of complication rates measure: Comparison of pain level measure: Comparison of quality of life measure: Comparison of cosmetic outcome through the Vancouver scar scale (VSS) measure: Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362213 id: NL76924.029.22 briefTitle: Gaining Insight Into Dual Sensory Loss acronym: DSL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04 date: 2025-04 date: 2024-04-12 date: 2024-04-12 name: Amsterdam UMC, location VUmc class: OTHER name: Royal Dutch Visio briefSummary: The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is:
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• What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue.
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