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<\|newrecord\|> nctId: NCT06334640 id: 37C302 briefTitle: Sleeping Quality and Chronic Ocular Diseases acronym: SONNO-OCU overallStatus: RECRUITING date: 2023-10-17 date: 2024-10-17 date: 2025-10-17 date: 2024-03-28 date: 2024-03-28 name: Istituto Auxologico Italiano class: OTHER briefSummary: To assess the impact of sleep quality on chronic eyes diseases conditions: Sleep Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 186 type: ESTIMATED name: Three questionaires measure: Proportion of sleep disorders in patients and healthy volunteers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan zip: 20145 country: Italy name: Paolo Milani, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06334627 id: ENREACH briefTitle: Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania acronym: EN-REACH overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-03 date: 2024-04-15 date: 2024-09-15 date: 2024-03-28 date: 2024-03-28 name: London School of Hygiene and Tropical Medicine class: OTHER name: International Centre for Diarrhoeal Disease Research, Bangladesh name: Golden Community, Nepal name: Muhimbili University of Health and Allied Sciences name: University of Glasgow briefSummary: The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. The main question it aims to answer are:
* What is the impact of a parent group intervention on primary school readiness in children aged 5-6 years old in three LMICs?
* What is the feasibility and accessibility of a parent group intervention for these children?
Participants will attend parent group sessions every two weeks for a total of 9 sessions. Researchers will compare a control group to see if there are impacts on school readiness and child development. conditions: Child Development conditions: Child Development Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1651 type: ACTUAL name: Pre-Primary Intervention measure: Measuring Early Learning Quality and Outcomes (MELQO Tool) measure: The Pediatric Evaluation of Disability Inventory measure: Washington Group Questionnaire measure: The Wechsler Preschool & Primary Scale of Intelligence measure: Pre-school Register measure: Mental Health Questionnaire measure: Pediatric Quality of Life Inventory (PEDSQL Tool) sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: International Centre for Diarrheal Disease Research, Bangladesh city: Dhaka country: Bangladesh lat: 23.7104 lon: 90.40744 facility: Golden Community city: Lalitpur country: Nepal lat: 27.67658 lon: 85.31417 facility: Muhimbili University of Health and Allied Sciences city: Dar Es Salaam country: Tanzania lat: -6.82349 lon: 39.26951 hasResults: False
<\|newrecord\|> nctId: NCT06334614 id: IIT_iReach briefTitle: iReach: a Rehabilitative Medical Device overallStatus: NOT_YET_RECRUITING date: 2024-12-08 date: 2025-05-08 date: 2025-12-08 date: 2024-03-28 date: 2024-03-28 name: Istituto Italiano di Tecnologia class: OTHER briefSummary: The broad goal of this clinical trial is to demonstrate whether a one-month rehabilitative training with our medical device, iReach, can promote the recovery of spatial and sensorimotor abilities and the cortical reorganization process in children with visual impairment between 3 and 36 months of age. conditions: Blindness conditions: Visual Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participant masking because the clinical trial involves infants whoMasked: PARTICIPANT count: 55 type: ESTIMATED name: iReach measure: Incidence of Device Adverse Events measure: Change in motor skills after training with iReach medical device measure: Perceptual responses to multisensory stimuli measure: Change in motor abilities following the rehabilitation with the iReach medical device measure: Variation in the power of the cortical activity following the rehabilitation with the iReach medical device sex: ALL minimumAge: 3 Months maximumAge: 36 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06334601 id: 09C333 briefTitle: Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness acronym: Muscle-OSA overallStatus: RECRUITING date: 2023-01-15 date: 2025-12-31 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Istituto Auxologico Italiano class: OTHER briefSummary: In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness. conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 66 type: ESTIMATED name: Tests of upper airway collapsibility and muscle responsiveness. measure: Upper airway collapsibility measure: Upper airway muscle responsiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano,Ospedale San Luca status: RECRUITING city: Milano zip: 20145 country: Italy name: Elisa Perger, MD role: CONTACT phone: +390261911 phoneExt: 2705 email: e.perger@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06334588 id: APHP240105 id: 2023-A02668-37 type: REGISTRY domain: ID-RCB briefTitle: Understanding the Mechanisms of Autism : an MRI and Social Cognition Study acronym: ECLAT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2031-04 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: MRI name: Eye-tracking name: Clinical Scales name: Research of genetic anomalies measure: Rest cerebral blood flow (CBF) measure: Measurements of white matter microstructure - fractional anisotropy measure: Measurements of white matter microstructure - mean diffusivity measure: Measurements of white matter microstructure - radial diffusivity measure: Measurements of white matter microstructure - axial diffusivity measure: Measurements of resting state functional connectivity measure: Correlation between social perception and multimodal brain imaging measure: Correlation between clinical severity and multimodal brain imaging measure: Imaging abnormalities associated with known genetic mutations measure: Social perception abnormalities associated with known genetic mutations measure: Anatomic changes over time - study of developmental trajectory measure: Social perception changes over time - study of developmental trajectory measure: Brain imaging in young children associated with ASD measure: Early data on social perception sex: ALL minimumAge: 3 Months maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Nathalie BODDAERT, MD, PhD role: CONTACT phone: +33 1.71.39.65.30 email: nathalie.boddaert@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06334575 id: 2023-505245-13-00 briefTitle: Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels acronym: 3TR-ICS-COPD overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-12 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Maria Joyera Rodríguez class: OTHER briefSummary: The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or \> 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 135 type: ESTIMATED name: Budesonide measure: Significant molecular changes in COPD stratified by their blood eosinophil counts. measure: Significant molecular changes in COPD with different airflow limitation severities. sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Philips University of Marburg city: Marburg country: Germany name: Peter Alter role: CONTACT lat: 50.80904 lon: 8.77069 facility: Academisch Ziekenhuis Groningen city: Groningen country: Netherlands name: Marteen van den Berge role: CONTACT lat: 53.21917 lon: 6.56667 facility: Clínic Barcelona city: Barcelona zip: 08036 country: Spain name: Alvar Agustí role: CONTACT lat: 41.38879 lon: 2.15899 facility: Son Espases city: Palma De Mallorca zip: 07120 country: Spain name: Francisco de Borja Cosio role: CONTACT lat: 39.56939 lon: 2.65024 facility: University of Leicester city: Leicester country: United Kingdom name: Christopher Brightling role: CONTACT lat: 52.6386 lon: -1.13169 facility: Imperial College London city: London country: United Kingdom name: Lydia J Finney role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06334562 id: KY-2023-112 briefTitle: The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-08-31 date: 2024-03-28 date: 2024-03-28 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: This study aims to compare the use of sugammadex (domestic) and neostigmine for antagonism after thoracic surgery, and observe the effect of sugammadex (domestic) on neuromuscular blockade antagonism after thoracic surgery, in order to provide a basis for optimizing the use of muscle relaxants and their antagonists during anesthesia. conditions: Neuromuscular Blockade studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: SUGAMMADEX SODIUM 100 Mg in 1 mL name: Neostigmine measure: Muscle relaxation recovery time sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334549 id: LSKY2023-107-01 briefTitle: A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-05 date: 2024-12-05 date: 2024-03-28 date: 2024-03-28 name: Dalian Municipal Central Hospital class: OTHER briefSummary: The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane. conditions: Hypotension Drug-Induced studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 180 type: ESTIMATED name: Ephedrine-P name: Phenylephrine-P name: Norepinephrine-P name: Ephedrine-S name: Phenylephrine-S name: Norepinephrine-S measure: Continual changes in Cerebral Oxygen Saturation measure: Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) measure: Continual changes in heart rate (HR) measure: Continual changes in stroke volume (SV) measure: Continual changes in cardiac output (CO) measure: Continual changes in systemic vascular resistance (SVR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dalian Municipal Central Hospital status: RECRUITING city: Dalian state: Liaoning zip: 116033 country: China name: Liping Han, M.D. role: CONTACT lat: 38.91222 lon: 121.60222 hasResults: False
<\|newrecord\|> nctId: NCT06334536 id: 0832/66 briefTitle: Multi-country Survey on Violence Against Women Among Medical Staff overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-28 date: 2024-03-28 name: Chulalongkorn University class: OTHER name: Asia and Oceania Federation of Obstetrics and Gynaecology briefSummary: The goal of this observational study is to investigate the knowledge, attitude, and practice (KAP) towards violence against women (VAW) among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries
The main question it aims to answer is:
* the KAP towards VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries
* the KAP towards support service of VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries
Participants will be asked to complete the online self-administrated questionnaire. conditions: Violence Against Women studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: KAP towards VAW measure: KAP towards support service of VAW sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334523 id: Volem briefTitle: Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout acronym: Volem overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-30 date: 2027-12-31 date: 2024-03-28 date: 2024-03-28 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional ventilation to reduce or even cancel dead space due to respiratory prostheses. This objective is particularly interesting in the smallest preterm infants in which the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/min at tip of endotracheal tube to purge expired CO2 trapped in the prostheses to have a CO2-free volume of gas available for subsequent insufflation. conditions: Extremely Low Birthweight Infant conditions: Continuous Tracheal Gas Insufflation conditions: Medical Device conditions: Lung Protection conditions: Ventilator-Induced Lung Injury studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: ventilation measure: cumulative duration of non-invasive ventilation periods in living patients measure: The pressure gradient of the ventilation measure: The age at the definitive withdrawal of any ventilatory support (PPS) measure: Definitive weaning age of invasive ventilation measure: Definitive O2 weaning age measure: the death rate measure: The rate of recourse to the HFO measure: The level of pneumothorax measure: The rate of bronchopulmonary dysplasia (BPD) diagnosed measure: Rate of postnatal systemic corticosteroid therapy measure: Duration of exposure to systemic sedatives measure: The cumulative day invasive ventilation measure: Non-programmed extubation rate measure: Rate of secondary blooddstream infection measure: neuroimaging complication measure: Neurodevelopmental monitoring measure: Pulmonary inflammation by cytokine dosage for intubated patients measure: Pulmonary inflammation by cytokine dosage for intubated patients measure: Pulmonary inflammation by cytokine dosage for intubated patients measure: rate of Retinopathy rank >1 measure: severe hypoxemia measure: Additional dose of surfactant sex: ALL minimumAge: 23 Weeks maximumAge: 26 Weeks stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06334510 id: HL-SJLG-2021-Ⅳ-01 briefTitle: Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations. overallStatus: COMPLETED date: 2021-11-17 date: 2023-01-20 date: 2023-03-28 date: 2024-03-28 date: 2024-03-28 name: Hualan Biological Bacterin Co. Ltd. class: INDUSTRY briefSummary: To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰. conditions: GCP studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4900 type: ACTUAL name: One dose of quadrivalent influenza virus split vaccine was administered measure: To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰. measure: To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years. sex: ALL minimumAge: 3 Years maximumAge: 74 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kou Zengqiang city: Jinan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06334497 id: APH220791 id: 2023-506216-40-00 type: OTHER domain: EU CT briefTitle: Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections acronym: LUCY-1 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-03-28 date: 2024-03-28 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment. conditions: Cytomegalovirus Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Letermovir name: Valganciclovir name: Letermovir placebo measure: Virological response to treatment on week-3 measure: Eradication of CMV DNAemia (< 200 IU/ml) before Week-12 measure: Number of days between baseline and first measure of CMV DNAemia < 200 IU/mL measure: Absence of CMV-related symptoms at baseline and each visit measure: Adverse event (AE) occurence measure: Sequencing of whole UL97, UL54, UL56, UL89 and UL51 genes measure: Ganciclovir plasma concentration measure: Letermovir plasma concentration measure: Measure of the CMV specific T-cell immunity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Laurence BUSSIERES, PhD role: CONTACT phone: +33 6 62 08 19 58 email: laurence.bussieres@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06334484 id: 6413 briefTitle: Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics acronym: TiTR_GR1DM overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2025-09-26 date: 2026-03-26 date: 2024-03-28 date: 2024-03-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions.
Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control.
The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Advanced hybrid closed loop systems measure: change in time spent in tighter glucose range after 24 months of hybrid closed loop system sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: DARIO PITOCCO role: CONTACT phone: +390630155701 email: dario.pitocco@policlinicogemelli.it name: DARIO PITOCCO role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06334471 id: INCS_WGS_B-001 briefTitle: Whole Genome Sequencing in Breast Cancer acronym: WGS SIT overallStatus: RECRUITING date: 2022-08-02 date: 2025-08-02 date: 2030-12-31 date: 2024-03-28 date: 2024-04-03 name: Inocras Korea Inc. class: INDUSTRY briefSummary: This study aims to conduct whole genome sequencing in breast cancer patients to elucidate individual genetic characteristics and their correlation with breast cancer subtypes. The primary objective is to establish new treatment guidelines aligned with the paradigm shift in precision medicine. The study will include both prospective and retrospective cohorts totaling 1200 participants. Prospective participants must provide consent and be eligible for tissue collection, while retrospective participants must have histologically confirmed breast cancer and available tissue samples from Samsung Medical Center Biobank. The study period spans 3 years for subject enrollment and 5 years for follow-up observations, with an expected completion date of December 31, 2030. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1200 type: ESTIMATED name: no intervention needed measure: Establishing individual genetic characteristics of breast cancer patients through WGS measure: Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Yeon Hee Park, MD role: CONTACT name: Yeon Hee Park, MD role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06334458 id: IEO 1910 briefTitle: Epigenomic and Machine Learning Models to Predict Pancreatic Cancer acronym: IMAGene overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-03 date: 2024-02-21 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile.
The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 170 type: ACTUAL name: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups measure: Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm measure: Identification of one or more abnormal methylation changes present in blood cells of participants with suspicious lesions versus methylation profiles of participants with no identified lesions measure: Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toulouse University Hospital city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: European Institute of Oncology city: Milan country: Italy lat: 45.46427 lon: 9.18951 facility: Oncological Institute "Prof. Dr. Ion Chiricuta" city: Cluj-Napoca country: Romania lat: 46.76667 lon: 23.6 facility: Catalan Institute of Oncology city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06334445 id: IEO 1874 briefTitle: CARDIOCARE Prospective Clinical Study acronym: CARDIOCARE overallStatus: RECRUITING date: 2023-09-14 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective observational study to refine and validate risk stratification algorithms aimed at identifying elderly patients at higher risk of developing cardiotoxicity (us-ing risk factors and potential blood and stool biomarkers) and at assessing whether integrated patient-oriented behavioral and psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 736 type: ESTIMATED name: Control group name: Intervention group measure: Evaluation of the onset of cardiotoxicity measure: Intra-patient assessment of major adverse cardiac events (MACEs) measure: Intra-patient assessment of plasma Troponin I measure: Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation measure: Percentage in the two arm of hospital admission measure: Number of Cardiovascular death in the two arms measure: Number of Non-cardiovascular death in the two arms measure: Evaluation of Health Related Quality of Life in the two arms measure: Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-adjusted life-years (QALYs) in the two arms sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06334432 id: NUV-1511-01 briefTitle: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03 date: 2027-03 date: 2027-10 date: 2024-03-28 date: 2024-03-28 name: Nuvation Bio Inc. class: INDUSTRY briefSummary: NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors. conditions: Advanced Solid Tumor conditions: HER2-negative Breast Cancer conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC) conditions: Pancreatic Cancer conditions: Platinum-resistant Ovarian Cancer (PROC) studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 466 type: ESTIMATED name: NUV-1511 measure: Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors measure: Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s)) measure: Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s) measure: Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development measure: Phase 2: Confirm the optimal NUV-1511 target tumor types for further development measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Characterize the PK profile of NUV-1511 measure: Characterize the PK profile of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Evaluate drug exposure-response relationship measure: Evaluate drug exposure-response relationship sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: Irving state: Texas zip: 75038 country: United States name: Naga Koteswari Cheedella role: CONTACT phone: 214-645-4673 email: ncheedella@nextoncology.com lat: 32.81402 lon: -96.94889 facility: START Mountain status: RECRUITING city: Salt Lake City state: Utah zip: 84124 country: United States name: William McKean role: CONTACT phone: 801-581-2121 email: William.McKean@hci.utah.edu lat: 40.76078 lon: -111.89105 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alex Spira role: CONTACT phone: 210-580-9500 email: aspira@nextoncology.com lat: 38.84622 lon: -77.30637 hasResults: False
<\|newrecord\|> nctId: NCT06334419 id: 2023-0795 briefTitle: Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS) overallStatus: RECRUITING date: 2024-01-29 date: 2024-09-30 date: 2024-09-30 date: 2024-03-28 date: 2024-03-28 name: Craig Erickson class: OTHER name: Healx Limited briefSummary: This is a single dose, placebo-controlled study. Male subjects aged 18 to 40 years (inclusive) with a diagnosis of FXS. Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart, for a total of four visits. Subjects will be given single dose gaboxadol (10 mg) or matched placebo at each of these visits to take orally. Thus, all enrolled subjects will receive placebo at home and in clinic and receive gaboxadol at home and in clinic in a blinded fashion. conditions: Fragile X Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study was designed as a 2-intervention crossover, with all study participants receiving all possible interventions. These are placebo and Gaboxadol. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Quadruple masking (participant, care provider, investigator and outcomes assessor) count: 10 type: ESTIMATED name: Gaboxadol name: Placebo measure: To evaluate target engagement of gaboxadol treatment on high density EEG recordings measure: To investigate the feasibility of home research visits and procedures in adult males with FXS measure: To investigate the feasibility of high density EEG recording at home in adult males with FXS measure: To potentially explore the pharmacokinetics of gaboxadol treatment in single-dose trial design measure: To investigate the effect of gaboxadol treatment on neuropsychological assessments measure: To investigate the effect of gaboxadol treatment on eye tracking assessments measure: To investigate the effect of gaboxadol treatment on clinician-rated measures measure: To determine whether FMRP levels predict treatment response sex: MALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Ashley Dapore role: CONTACT phone: 513-517-1580 email: ashley.dapore@cchmc.org name: Hannah J Sachs, MPA role: CONTACT phone: 513-636-2592 email: hannah.sachs@cchmc.org name: Craig A Erickson, MD role: PRINCIPAL_INVESTIGATOR name: Kelli Dominick, MD, PhD role: SUB_INVESTIGATOR name: Meredith Nelson, PhD role: SUB_INVESTIGATOR name: Ernest Pedapati, MD role: SUB_INVESTIGATOR name: Debra Reisinger, PhD role: SUB_INVESTIGATOR name: Lauren Schmitt, PhD role: SUB_INVESTIGATOR lat: 39.12713 lon: -84.51435 hasResults: False
<\|newrecord\|> nctId: NCT06334406 id: 098 DRC 210 ER03 012 briefTitle: Antitumor T Cell Responses in Patients With Bladder Cancer acronym: immunoBLAD overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2026-04-02 date: 2026-04-02 date: 2024-03-28 date: 2024-03-28 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 33 type: ESTIMATED name: Biological samples measure: Tumor antigen specific T-cell responses measure: Monitoring of T cells in the blood measure: Monitoring of immune cell death parameters in the blood measure: Monitoring of immune suppressive cells in the blood measure: Overall survival measure: Progression-free survival measure: Local progression-free survival measure: Transcriptomic analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334393 id: VLA1601-102 briefTitle: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults overallStatus: RECRUITING date: 2024-03-25 date: 2024-12-31 date: 2025-12-28 date: 2024-03-28 date: 2024-03-28 name: Valneva Austria GmbH class: INDUSTRY briefSummary: This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29).
The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immune response of the vaccine candidate will be monitored throughout the trial. conditions: Zika conditions: Zika Virus Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: VLA1601 name: CpG 1018® name: 3M-052-AF measure: Solicited Adverse Events measure: Solicited Adverse Events measure: Neutralizing antibodies against ZIKA virus (ZIKV) measure: Solicited Adverse Events measure: Solicited Adverse Events measure: Unsolicited AEs measure: Unsolicited AEs measure: Vaccine-related unsolicited AEs measure: Vaccine-related unsolicited AEs measure: Any AEs measure: Any AEs measure: any vaccine-related AEs measure: Vaccine-related unsolicited AEs measure: Adverse Events of Special Interest (AESI) measure: Adverse Events of Special Interest (AESI) measure: Vaccine-related Adverse Events of Special Interest (AESI) measure: Vaccine-related Adverse Events of Special Interest (AESI) measure: Serious Adverse Events (SAE) measure: Serious Adverse Events (SAE) measure: Vaccine-related Serious Adverse Events (SAE) measure: Vaccine-related Serious Adverse Events (SAE) measure: ZIKV-specific neutralizing antibodies measure: Seroconversion rate (SCR) measure: Geometric Mean Fold Increase (GMFI) sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Flourish Research status: RECRUITING city: Chicago state: Illinois zip: 60640 country: United States name: Rupal Trivedi, MD role: CONTACT lat: 41.85003 lon: -87.65005 facility: Velocity Clinical Research status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States name: Frederick Raiser, MD role: CONTACT lat: 41.25626 lon: -95.94043 hasResults: False
<\|newrecord\|> nctId: NCT06334380 id: 73688 briefTitle: VR for Surgical Prehabilitation and Rehabilitation acronym: VR-PREP overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-04-25 name: Stanford University class: OTHER briefSummary: This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery. conditions: Breast Cancer conditions: Frailty conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance. primaryPurpose: OTHER masking: SINGLE maskingDescription: Blinded assessor will conduct adherence calls. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Virtual Reality Modules Only name: Virtual Reality Modules + Live Physical Therapist Support measure: VR for remote Physical Therapy (PT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Hospital and Clinics city: Palo Alto state: California zip: 94305 country: United States lat: 37.44188 lon: -122.14302 hasResults: False
<\|newrecord\|> nctId: NCT06334367 id: SWYX:NO.2022-1028 briefTitle: Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2026-03-26 date: 2026-03-26 date: 2024-03-28 date: 2024-03-28 name: Wang Xin class: OTHER_GOV briefSummary: The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition. conditions: GVHD studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: CD25 treatment name: low-dose ATG measure: The incidence of aGVHD measure: The incidence of cGVHD measure: the time of immune reconstitution in haploidentical transplant measure: the time of infection occurrence measure: the time of donor cell engraftment measure: the time of disease relapse measure: the time of death of transplant patient sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University city: Jinan state: Shandong zip: 250021 country: China name: Xin Wang, MD, PHD role: CONTACT phone: 86-531-68778331 email: xinw007@126.com name: Xiaosheng Fang, MD, PHD role: CONTACT phone: 8615168889703 email: fxsh_1010@126.com lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06334354 id: 23-320 briefTitle: A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC) acronym: TRAC overallStatus: RECRUITING date: 2024-03-19 date: 2029-03 date: 2029-03 date: 2024-03-28 date: 2024-04-26 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to look at how differences in cognitive (mental) function develop over time in breast cancer survivors compared to volunteers without a history of cancer (healthy volunteers). Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so the researchers can compare the results of neurocognitive testing (which looks at memory, attention, and information processing) on each group of participants. conditions: Breast Cancer Survivors studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 420 type: ESTIMATED name: Assessments name: Assessment (Survivors Only) name: APOE and DNA Isolation measure: examine cognitive effects measure: measure levels of smoking exposure sex: FEMALE minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (All protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (All Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (All Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center status: RECRUITING city: New York state: New York zip: 10065 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 name: Tim Ahles, PhD role: CONTACT phone: 646-888-0048 name: James Root, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (All Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: James Root, PhD role: CONTACT phone: 646-888-0035 lat: 40.70038 lon: -73.59291 hasResults: False
<\|newrecord\|> nctId: NCT06334341 id: R01MD018523-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD018523-01A1 briefTitle: A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP) acronym: MOST:PrEP overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2028-04 date: 2028-04 date: 2024-03-28 date: 2024-03-28 name: Henry Ford Health System class: OTHER name: University of South Florida name: New York University briefSummary: What is known: There are 1.2 million people in the US who meet the indications for PrEP; yet, disparities exist in uptake. For example, only 9% of Black and 16% of Latino individuals, compared to 65% of White individuals, have been prescribed PrEP. At Henry Ford Health (HFH) system, only 10% of eligible patients have been prescribed PrEP. Primary care is an ideal setting for PrEP to be offered as an HIV prevention method since providers see large numbers of patients who are HIV negative, with some who are at increased risk for HIV, and the primary care setting is often the point of entry to the healthcare system. The multiphase optimization strategy (MOST) framework is a novel, innovative way to identify an efficient intervention. What will be done: In this optimization trial, the investigators will test the effectiveness of intervention components, alone and in combination, on new PrEP prescriptions in primary care at HFH. First, feedback will be generated on context-specific (system and individual level) factors for intervention component delivery via focus groups with providers (n=15) and patients eligible for PrEP (n=30). Then, four intervention components will be tested in an optimization trial, with 16 conditions being implemented at 32 clinics. Finally, feedback will be generated on the factors that affected implementation via semi-structured interviews with providers (n=30) and patients (n=30). Participants will be primary care providers (PCPs) and patients eligible for PrEP in Henry Ford Health System. Clinics will be randomized (yes/no) to receive any combination of provider and patient intervention components. Provider intervention components include computer-based simulation training and/or best practice alerts delivered via the electronic health record (EHR). Patient intervention components include HIV risk assessment and/or PrEP informational video - both delivered via the EHR. Primary outcome is the rate of new PrEP prescriptions at the clinic level. Secondary outcomes will include PrEP maintenance, number of HIV tests ordered by a PCP, and number of PCPs trained. Sub analyses will test which factors moderate (e.g., patient sex, race, age, gender, sexual orientation) or mediate (e.g., perceived HIV risk, provider and patient PrEP knowledge) PrEP uptake, focusing on priority populations and disparities in rates of PrEP prescription. Implications: 1) Understanding which intervention components lead to increased PrEP prescriptions will represent an important advance in HIV prevention efforts. 2) Optimizing a multi-level intervention for providers and patients to increase PrEP prescriptions would lead to a new, efficient, evidence-based option. 3) Determining what factors are related to PrEP uptake will help reduce disparities in PrEP initiation among those most in need. 4) Understanding the context specific factors related to intervention component implementation will help identify best methods for replication/adaptation in other healthcare systems. conditions: HIV Seropositivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 1380 type: ESTIMATED name: Computer-based simulation training for providers name: Best Practice Alert name: HIV Risk Assessment name: PrEP Informational Video measure: Clinic-Level PrEP Prescription measure: PrEP Knowledge measure: PrEP awareness measure: PrEP prescribing comfort measure: PrEP prescribing intentions measure: Perceived HIV risk measure: Preferences for patient- provider communication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henry Ford Health city: Detroit state: Michigan zip: 48202 country: United States lat: 42.33143 lon: -83.04575 hasResults: False
<\|newrecord\|> nctId: NCT06334328 id: 2205009237 briefTitle: Virtual Reality-based Mindful Movement Therapy for Seniors overallStatus: COMPLETED date: 2022-08-15 date: 2023-09-30 date: 2024-01-31 date: 2024-03-28 date: 2024-03-28 name: Drexel University class: OTHER briefSummary: The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach. conditions: Cognitive Decline conditions: Physical Activity conditions: Psychological Wellbeing studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 12 type: ACTUAL name: Virtual reality based mindful movement therapy measure: Treatment adherence measure: Treatment acceptability measure: Treatment satisfaction measure: Qualitative feedback measure: Safety measure: Montreal Cognitive Assessment (MoCA) measure: Trail making test measure: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) measure: Physical Activity Scale for the Elderly (PASE) measure: Physical Performance Battery (SPPB) measure: General Self-Efficacy Scale measure: Positive Affect and Negative Affect Scale (PANAS) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Drexel Universitsy city: Philadelphia state: Pennsylvania zip: 19102 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06334315 id: 2000037337 id: R01HD111436 type: OTHER_GRANT domain: NIH briefTitle: Oral Contraceptive Pill (OCP) Pharmacogenomics overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2028-05 date: 2024-03-28 date: 2024-03-28 name: Yale University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how our bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. We also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are:
* Do individuals with the CYP3A7\*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill?
* Do individuals with the CYP3A7\*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill?
* What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users?
Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures:
* Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill
* Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill
* Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill
* A transvaginal ultrasound to measure any ovarian follicles (optional procedure) conditions: Contraception conditions: Pharmacogenomic Drug Interaction studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 700 type: ESTIMATED name: Desogestrel / Ethinyl Estradiol Pill measure: Serum etonogestrel concentration measure: Serum ethinyl estradiol concentration measure: Serum estradiol concentration measure: Serum progesterone concentration measure: Modified Hoogland score measure: Positive and Negative Affect Scheduled measure: Sex hormone binding globulin levels measure: Serum albumin concentration sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Yale city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 hasResults: False
<\|newrecord\|> nctId: NCT06334302 id: RMC0362-23ctil briefTitle: The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID overallStatus: RECRUITING date: 2024-03-25 date: 2024-04-25 date: 2024-04-25 date: 2024-03-28 date: 2024-04-12 name: Rabin Medical Center class: OTHER name: Omega 3 Galilee briefSummary: Omega Galil has developed a novel fatty sweetener that allows the use of up to 80% less sugar (particularly sucrose) and yet achieves a natural sweet flavor, using a novel technology of milling the natural sucrose crystals together with oil and thus creating a micro-suspension of sugar in oil or fat. The suspension increases the surface area of the sugar particles and thus a lower quantity of sugar is required in order to reach an enhanced perception of sweetness at the sweet taste receptors in the mouth. Omega Galil provides fatty food products that use up to 80% less sucrose, while tasting as sweet as regular sugar sweetened foods, with no aftertastes of sugar substitutes, and no chemical modifications or additives.
Postprandial glucose (PPG) excursions in Type 1 Diabetes happen mainly due to a delay in subcutaneous insulin absorption and action, but also among other factors, depend on the meal composition. The glycemic index (GI) ranks foods based on acute glycemic response over a 2-h period of 50 g of available carbohydrates (CHO) of a test food compared with the reference standard glucose. Glycemic Load (GL) is a GI-weighted measure of carbohydrate content, which estimates the impact of carbohydrate intake using the GI while taking into account the amount of carbohydrates that are eaten in a serving. Several studies have demonstrated differences in PPG after consumption of low versus high GI meals, with rapid glucose spikes following high GI meals . Helping people with T1D achieve a diet with a lower glycemic load can improve both their quality of life and their diabetes-associated complications.
The proposed randomized, double blind, cross-over, active control, clinical trial aims to:
1. compare the glycemic response of T1D subjects to 20 grams of the O'Sweet sugar-reduced spread containing 8% sugar and a total of 1.6 grams of sucrose per meal, with their glycemic response to 20 grams of control Nutella spread, containing 56% sugar and a total of 11 grams sucrose per meal.
2. compare the acceptance ("Not sweet enough, just right or too sweet") Labeled Magnitude score of O'Sweet compared to the control spread (Nutella). conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" name: Active Control-Nutella hazelnut cocoa spread measure: Delta postprandial glucose level measure: Incremental area under the curve (iAUC) measure: Peak postprandial glucose level measure: Time in range (TIR) of 70-180 mg/dl measure: Percentage of subjects who reached the desired glucose target measure: The percentage of time spent above 180 mg/dl measure: The percentage of time spent above 250 mg/dl measure: The percentage of time spent above 350 md/dl measure: Labeled Magnitude Scale (gLMS) sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Schneider Children Medical Center of Israel status: RECRUITING city: Petach-Tikva country: Israel name: Alona Hamou, MSc role: CONTACT phone: 972-545-950-277 email: alonah@clalit.org.il lat: 32.08707 lon: 34.88747 hasResults: False
<\|newrecord\|> nctId: NCT06334289 id: YXLL-KY-2024(017) briefTitle: A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: Qianfoshan Hospital class: OTHER briefSummary: Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Perioperative neurocognitive impairment (PND) is attracting increasing attention, but its exact mechanism is still unclear. The diagnosis of PND lacks the gold standard, so it is difficult to determine the incidence rate. At present, the diagnosis is mainly conducted through the scale. Therefore, this study aims to explore the correlation between peripheral blood biomarkers and PND in elderly frail patients undergoing gastrointestinal surgery. conditions: Perioperative Neurocognitive Disorders conditions: Frail Elderly studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 338 type: ESTIMATED measure: Postoperative 7-day incidence of PND sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334276 id: DROWN_INHOS briefTitle: Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016 acronym: DROWN_INHOS overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Prehospital Center, Region Zealand class: OTHER briefSummary: This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016. conditions: Drowning conditions: Drowning, Near conditions: Drowning; Asphyxia conditions: Drowning and Nonfatal Submersion conditions: Drowning or Immersion of Unknown Intent conditions: Drowning and Submersion, Undetermined Intent conditions: Drowning and Submersion While in Bath-Tub conditions: Drowning and Submersion While in Natural Water conditions: Drowning and Submersion While in Swimming-Pool studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Drowning measure: 30-day mortality measure: Neurological outcome measure: Hospital length of stay measure: Intensive care unit admission measure: Intensive care unit length of stay measure: Need for mechanical ventilation measure: Duration of mechanical ventilation measure: Survival to hospital discharge sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False
<\|newrecord\|> nctId: NCT06334263 id: 332302 briefTitle: Splenic Embolisation Decisions acronym: SPEED overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-30 date: 2025-09-30 date: 2024-03-27 date: 2024-03-27 name: University Hospital Plymouth NHS Trust class: OTHER briefSummary: The spleen is often injured when the body sustains trauma. This leads to bleeding. The bleeding can be stopped by a big operation cutting open the belly or a small hole in your groin where a blood vessel can be accessed and through which the bleeding can be stopped. We do not know what types of injuries it is best to use this procedure. We do not know why we do not use the smaller technique in some instances. We also do not know exactly which of a number of ways to stop the bleeding could be better. We have a big data set in the trauma and audit research network (TARN) which we would like to use to help answer these questions and design further studies to better answer the questions. Adding a few other pieces of data, we are able to answer key questions into how the spleen will best be treated in trauma. conditions: Trauma conditions: Spleen Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 8000 type: ESTIMATED measure: To determine if service design significantly affects splenic embolisation (SE) rates in AAST grade 2-5 acute traumatic splenic injuries (ATSI) across the 22 Major Trauma Centres (MTCs) in the UK. measure: To determine if variation in treatment affects SE outcomes in ATSI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334250 id: IRAS:327077 briefTitle: Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial acronym: PLANET-AF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Liverpool Heart and Chest Hospital NHS Foundation Trust class: OTHER briefSummary: Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk. In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming. There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting. Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. In this randomised controlled trial, patients referred for LAAO will be randomised to receive LAAO+PFA (intervention) or LAAO alone (control). Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ESTIMATED name: Catheter ablation of atrial fibrillation using Pulsed Field Ablation name: Left atrial appendage occlusion measure: Change in quality of lfie measure: Time to atrial fibrillation recurrence measure: Requirement for unplanned further ablation or cardioversion procedures measure: Procedural metrics measure: Procedural safety outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Liverpool Heart and Chest Hospital city: Liverpool state: Merseyside zip: L14 3PE country: United Kingdom name: Mark Mills role: CONTACT phone: +441516001616 email: mark.mills@lhch.nhs.uk lat: 53.41058 lon: -2.97794 hasResults: False
<\|newrecord\|> nctId: NCT06334237 id: Y_113_0009 briefTitle: Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-21 date: 2026-02-21 date: 2024-03-27 date: 2024-03-27 name: Changhua Christian Hospital class: OTHER briefSummary: This research project aims at exploring the psychosomatic factors that influence and moderate the efficacy of holistic care and personalized treatment for migraine patients. It is a prospective longitudinal observational study. The project's goal is to understand how physical, psychological, spiritual, and social factors affect the care and treatment outcomes for migraineurs. The study will include participants aged 18 to 65, who meet the International Headache Society's criteria for migraines. It will utilize a range of methodologies including questionnaires, interviews, and medical records to collect data on various factors like lifestyle, psychological state, and social support. The project will assess the effectiveness of treatments, compliance, and other outcomes such as emotional and sleep conditions. conditions: Migraine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: personalized treatment measure: Migraine attack frequency measure: Migraine attack intensity measure: Migraine attack duration measure: Effectiveness of acute medication measure: Compliance rate of migraine diary measure: Compliance rate of lifestyle modification measure: depression measure: anxiety measure: well-being measure: Pain Resilience sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhua Christian Hospital city: Chang Hua zip: 500 country: Taiwan name: Yen-Yu Chen, MD role: CONTACT phone: +886-4-7238595 email: 107281@cch.org.tw lat: 24.07327 lon: 120.56276 hasResults: False
<\|newrecord\|> nctId: NCT06334224 id: 2242/MODREC/23 briefTitle: Acute Physiological Responses to Twice Daily Blood Flow Restriction Training overallStatus: RECRUITING date: 2023-11-06 date: 2024-09 date: 2024-09 date: 2024-03-27 date: 2024-03-27 name: Defence Medical Rehabilitation Centre, UK class: OTHER_GOV name: University of Bath briefSummary: The Academic Department of Military Rehabilitation (ADMR) is currently conducting a pan-defence, randomised control trial (RCT) investigating the utility of twice daily blood flow restriction training in UK military personnel with persistent knee pain (NCT05719922). Due to logistical confinements, this pan-defence RCT is confined to collecting outcome data pre and post-intervention. Therefore, the acute physiological mechanisms which underpin adaptation will remain unknown.
Consequently, ADMR is undertaking an additional, single centre RCT which will compare the acute physiological responses to low load resistance training with and without the addition of blood flow restriction. Specifically, this study will elucidate the effect of twice daily blood flow restriction training on measures of muscle swelling, muscle damage and inflammation. This data may aid in the optimisation of blood flow restriction exercise prescription within UK Defence Rehabilitation and elsewhere. conditions: Muscle Weakness conditions: Muscle Damage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two arm randomised control trial primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research. count: 18 type: ESTIMATED name: Low load resistance training with blood flow restriction name: Low load resistance training measure: Maximum isometric voluntary contraction of knee extensor muscles measure: Vastus lateralis muscle thickness measure: Venous blood sampling for markers of exercise induced muscle damage measure: Delayed onset muscle soreness measure: Quadriceps discomfort measure: Discomfort caused by the BFR cuff measure: Rating of perceived exertion measure: Knee joint range of motion measure: Daily wellness questionnaire measure: Venous blood sampling for inflammatory markers sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Defence Medical Rehabilitation Centre status: RECRUITING city: Loughborough zip: LE12 5QW country: United Kingdom name: Kieran M Lunt, MSc role: CONTACT phone: +44(0) 1509 251 500 phoneExt: 3401 email: kieran.lunt103@mod.gov.uk name: Peter Ladlow, PhD role: CONTACT phone: +44(0) 1509 251 500 phoneExt: 3407 email: peter.ladlow100@mod.gov.uk name: Kieran M Lunt, MSc role: PRINCIPAL_INVESTIGATOR lat: 52.76667 lon: -1.2 hasResults: False
<\|newrecord\|> nctId: NCT06334211 id: FP-020C-23-001 briefTitle: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-09-30 date: 2025-01-31 date: 2024-03-27 date: 2024-04-11 name: Foresee Pharmaceuticals Co., Ltd. class: INDUSTRY name: InClin, Inc. briefSummary: This is a study to Investigate the Safety, Tolerability, and Pharmacokinetics, of Single (including Food Effect) and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FP-020 in Healthy Volunteers primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind (placebo appears the same as active FP-020) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 74 type: ESTIMATED name: FP-020 name: placebo measure: The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs). measure: Clinically significant abnormalities. measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2 measure: Evaluate the food effect on the PK profile of FP-020 - Cmax measure: Evaluate the food effect on the PK profile of FP-020 - Tmax measure: Evaluate the food effect on the PK profile of FP-020 - AUC measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24 measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2 measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Scientia Clinical Research Ltd city: Randwick state: New South Wales zip: 2031 country: Australia name: Christopher Argent, MD role: CONTACT lat: -33.91439 lon: 151.24895 hasResults: False
<\|newrecord\|> nctId: NCT06334198 id: Naldemedine_OIBD id: 2023-507744-36-00 type: CTIS briefTitle: The Effect of Naldemedine on Opioid-induced Bowel Dysfunction overallStatus: RECRUITING date: 2024-03-12 date: 2025-03 date: 2025-03 date: 2024-03-27 date: 2024-03-28 name: Asbjørn Mohr Drewes class: OTHER briefSummary: Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol conditions: Opioid-Induced Bowel Dysfunction conditions: Constipation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Naldemedine name: Placebo name: Tramadol measure: Total gastrointestinal transit time measure: Colorectal transit time measure: Constipation symptoms measure: Bowel movement frequency measure: Stool consistency measure: Gastrointestinal symptoms measure: Opioid-induced constipation measure: Diagnostic evaluation of opioid-induced constipation measure: Colonic motility patterns measure: Opiate withdrawal symptoms measure: Colon volume measure: Colonic water content measure: Defecation assessment sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Aalborg University Hospital status: RECRUITING city: Aalborg zip: 9000 country: Denmark name: Asbjørn Mohr Drewes role: CONTACT lat: 57.048 lon: 9.9187 hasResults: False
<\|newrecord\|> nctId: NCT06334185 id: pVax briefTitle: Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection. acronym: pVax overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-07-01 date: 2024-03-27 date: 2024-03-28 name: Azienda Ospedaliera di Lecco class: OTHER name: IRCCS Ospedale San Raffaele briefSummary: Respiratory tract infections are among the leading causes of death worldwide and many of these infections are preventable through vaccination. One of the most important bacteria from an etiological and mortality point of view regarding respiratory and systemic infections is the gram-positive Streptococcus pneumoniae. Four types of vaccines are currently available for this pathogen: three pneumococcal conjugate vaccines (PCV13, PCV15, and PCV20) and one polysaccharide vaccine (PPSV23). In Italy, people over 65 years of age and people suffering from chronic pathologies with effects on the immune system would be advised to be vaccinated with the pneumococcal conjugate vaccine and with the polysaccharide vaccine as a second dose.
However, there are no data available in Italy on vaccination coverage in these population categories and above all the vaccination rates in patients who have a history of an episode of invasive pneumococcal infection are not known. The aim of the study is to measure how many patients are vaccinated for S. pneumoniae after hospitalization for a systemic pneumococcal infection in order to understand patients' awareness of preventing this infection after receiving a first diagnosis. conditions: Invasive Pneumococcal Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 320 type: ESTIMATED measure: Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019. measure: Rate of pneumococcal serotype that caused the invasive infection in patients vaccinated prior to the infectious event sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334172 id: H-23071221 briefTitle: The Role of Oxytocin in Regulating Blood Glucose acronym: GLOXY-1 overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-27 date: 2024-04-04 name: University Hospital, Gentofte, Copenhagen class: OTHER briefSummary: Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose. conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: The randomized order of infusions is blinded to both participant and investigator whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Oxytocin name: Placebo measure: Insulin secretion - c-peptide measure: Glucose measure: Insulin measure: Glucagon measure: GIP measure: GLP-1 measure: Lipids measure: Cross-linked C-telopeptide of type I collagen( CTX) measure: Procollagen type I N-terminal propeptide (P1NP) sex: MALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Clinical Metabolic Research, Gentofte Hospital status: RECRUITING city: Hellerup state: Capital Region zip: 2900 country: Denmark name: Filip K Knop, MD, PhD role: CONTACT phone: 004538674266 email: filip.krag.knop.01@regionh.dk lat: 55.73204 lon: 12.57093 hasResults: False
<\|newrecord\|> nctId: NCT06334159 id: PER-ECL-2019-08 briefTitle: Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes overallStatus: RECRUITING date: 2020-11-05 date: 2025-07-20 date: 2027-07-20 date: 2024-03-27 date: 2024-03-27 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months. conditions: Bone Resorption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane name: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane measure: Horizontal Bone Gain measure: Bone Width Gain measure: Horizontal Dimensional Stability measure: Post-surgical complications measure: Patient's satisfaction measure: Histologic examination of the augmented bone at 6 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Georgios Markantonatos status: RECRUITING city: Barcelona state: Sant Cugat Del Vallès zip: 08195 country: Spain name: Georgios Markantonatos, DDS role: CONTACT phone: +34666022568 email: giorgosmark@uic.es name: Cristina Vallès, DDS, MS, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06334146 id: UNLV-2023-62 briefTitle: Tap Dance for Adults With Lower Limb Amputation overallStatus: RECRUITING date: 2024-03-04 date: 2025-05 date: 2025-05 date: 2024-03-27 date: 2024-03-27 name: University of Nevada, Las Vegas class: OTHER briefSummary: The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence.
There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA.
Participants will be asked to:
* come to 1 hour dance classes, once per week, for 8 weeks.
* do mobility tests before and after the program
* complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks. conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Tap dance program measure: Session Adherence measure: Physical Activities Enjoyment Scale (PACES) measure: Change in Timed Up-and-Go test score measure: Change in Four Square Step Test score measure: Change in Berg Balance Scale score measure: Change in Activities-Specific Balance Confidence Scale score measure: Physical Activities Enjoyment Scale (PACES) score - Mid program measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) functional activity restriction subscale score measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) social activity restriction subscale score measure: Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) athletic activity restriction score measure: Use of assistive devices per session measure: Session completion per session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nevada Las Vegas status: RECRUITING city: Las Vegas state: Nevada zip: 89154 country: United States name: Jenny Kent, PhD role: CONTACT phone: 702-895-5949 email: jenny.kent@unlv.edu lat: 36.17497 lon: -115.13722 hasResults: False
<\|newrecord\|> nctId: NCT06334133 id: TTP399-302 briefTitle: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes acronym: CATT1 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2026-03 date: 2024-03-27 date: 2024-04-01 name: vTv Therapeutics class: INDUSTRY briefSummary: This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus. conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Cadisegliatin 800 mg QD name: Cadisegliatin 800 mg BID name: Placebo measure: Change in incidence of Level 2 or Level 3 hypoglycemia measure: To assess the change in HbA1c measure: To assess the effects of treatment on CGM-based metrics for glycemic control measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis measure: To assess the effects of treatment on insulin dosing measure: To assess the effects of treatment on body weight measure: To assess the incidence of adverse events measure: Change in incidence of Level 2 or Level 3 hypoglycemia measure: To assess the change in HbA1c measure: To assess the effects of treatment on CGM-based metrics for glycemic control measure: To assess the incidence of adverse events measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis measure: To assess the effects of treatment on insulin dosing measure: To assess the effects of treatment on body weight measure: High sensitivity C-reactive protein measure: N-terminal pro brain [or B-type] natriuretic peptide measure: Urinary albumin excretion ratio measure: Estimated glomerular filtration rate measure: Gold hypoglycemia awareness score measure: Item 7 of Clarke hypoglycemia awareness scale measure: Snyder's 1-item quality of sleep questionnaire measure: World Health Organization-5 Well-Being Index measure: 8-item Diabetes Distress Scale (participant and partner or family member) measure: Hypoglycemia Confidence Scale for participant and partner or family member measure: 11-item/Short Form Hypoglycemia Fear Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334120 id: 20654 briefTitle: An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-09-30 date: 2026-03-31 date: 2024-03-27 date: 2024-03-27 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.
This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.
To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.
During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.
Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events. conditions: Non-metastatic Castration-resistant Prostate Cancer conditions: Metastatic Hormone-sensitive Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Darolutamide (Nubeqa, BAY1841788) measure: Number, severity of adverse events (including SAEs) measure: Number, severity of adverse drug reactions (including SADRs) measure: The outcome of (serious) adverse events measure: The outcome of (serious) adverse drug reactions measure: Metastasis-free survival (MFS) measure: Time to symptomatic skeletal event (SSE) measure: Time to prostate-specific antigen (PSA) progression measure: Number of patients with metastasis of castration-resistant prostate cancer (mCRPC) measure: Overall survival measure: Duration of Darolutamide treatment measure: Reasons for ending Darolutamide measure: Dosage and dose modification of Darolutamide sex: MALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Multiple locations city: Multiple Locations country: Korea, Republic of hasResults: False
<\|newrecord\|> nctId: NCT06334107 id: 24AIREA1191995 briefTitle: Mitochondrial DNA Signatures of Poor Aerobic Exercise Trainability in Young Adults Born Preterm overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2025-12-31 date: 2024-03-27 date: 2024-03-27 name: Texas Tech University class: OTHER briefSummary: Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem.
One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals.
To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability.
Questions:
1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm?
2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term?
The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life. conditions: Preterm Birth studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 45 type: ESTIMATED name: Exercise measure: Mitochondrial DNA heteroplasmy measure: Mitochondrial DNA sequence variants measure: Change in maximal aerobic capacity measure: Change in mitochondrial oxidative capacity in peripheral blood mononuclear cells measure: Daily sleep habits sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06334094 id: IRB-23-486 id: IM047-1054 type: OTHER_GRANT domain: Bristol Myers Squibb briefTitle: Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-03-31 date: 2028-05-31 date: 2024-03-27 date: 2024-03-27 name: The University of Texas at Dallas class: OTHER name: Texas Institute for Neurological Disorders briefSummary: The primary objective of this study is to investigate the cognitive benefits of ozanimod in individuals with Multiple Sclerosis (MS). The study aims to understand the neural basis of cognitive improvement in Relapsing-Remitting MS patients under ozanimod treatment using neuroimaging and behavioral techniques to characterize the brain and behavioral changes due to ozanimod treatment. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ozanimod measure: Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance measure: Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) measure: Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) measure: Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) measure: Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging measure: Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Brain Health city: Dallas state: Texas zip: 75228 country: United States name: Jessica Ma, BS role: CONTACT phone: 972-883-3414 email: jxm180043@utdallas.edu name: Ashley M Campos, MA role: CONTACT email: amc230006@utdallas.edu name: Bart Rypma, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
<\|newrecord\|> nctId: NCT06334081 id: A02040230S briefTitle: Different Surgical Drilling Protocols in Posterior Maxilla overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-29 date: 2023-12-30 date: 2024-06-30 date: 2024-03-27 date: 2024-03-27 name: Mansoura University class: OTHER briefSummary: Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants conditions: Missing Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ACTUAL name: undersized drilling technique name: single drilling technique measure: bone density measurement measure: marginal bone loss sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Heba Elsheikh city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06334068 id: MS.24.03.2725 briefTitle: SHOrt-term Glycemic Control for Reducing Post-SURGical Complications acronym: Surg-ShoGR overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-27 date: 2024-03-27 name: Mansoura University class: OTHER briefSummary: Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.
There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.
Consequently, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. conditions: Diabetes conditions: Uncontrolled Diabtetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients in the preoperative anesthesia clinic are divided into one of the following groups:
1. Short-term glycemic control group:
Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.
2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Short-term glycemic control group name: Standard-of-care group measure: Number of days at home after surgery (DAH-30). measure: Loss of follow-up after surgery measure: Loss of follow up after the clinic preoperative assessment measure: 30-day mortality measure: Length of hospital stay measure: incidence of postoperative complications measure: Quality of Recovery15 (QoR-15) measure: Time to resumption of normal diabetes therapy measure: Incidence of diabetic ketoacidosis or hypoglycemia measure: Incidence of use of intravenous insulin infusion therapy measure: Duration of use of intravenous insulin infusion therapy measure: Change in diabetic management at 30 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moataz Maher Emara city: Mansoura state: Aldakahlia zip: 35516 country: Egypt name: Moataz M Emara, MD, EDAIC role: CONTACT phone: 01064048848 email: mm.emara@mans.edu.eg lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06334055 id: CIP-1091 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-27 date: 2024-03-27 name: [Redacted] hasResults: False
<\|newrecord\|> nctId: NCT06334042 id: GO 23/488 briefTitle: Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-01 date: 2024-09-01 date: 2024-03-27 date: 2024-03-27 name: Oguzhan Kahveci class: OTHER briefSummary: The goal of this observational study is to learn about the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.
Participants will give a single blood sample (into trace element serum tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit. conditions: Chromium Deficiency conditions: Diabetes Mellitus conditions: Hyperlipidemias conditions: Hypercholesterolemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 350 type: ESTIMATED name: Serum Chromium Level measure: Serum Chromium Level measure: HbA1c measure: Blood Glucose measure: Lipid Profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University status: RECRUITING city: Ankara zip: 06230 country: Turkey name: Oguzhan Kahveci, MD role: CONTACT phone: +903123051207 email: oguzhan.kahveci@hacettepe.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06334029 id: 12.2022 briefTitle: Observational Study of the Structural-functional Connectome in Patients With Epilepsy overallStatus: RECRUITING date: 2023-06-22 date: 2026-11-22 date: 2026-12-31 date: 2024-03-27 date: 2024-03-27 name: IRCCS Eugenio Medea class: OTHER briefSummary: Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains. conditions: Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Functional and structural Connectome measure: Identification of regional alteration in the value of functional connectivity measure: Measuring the spread of the epileptogenic network measure: Correlation between the Rey Complex figure test and the regional functional alteration sex: ALL minimumAge: 6 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS E.Medea status: RECRUITING city: Conegliano state: Treviso zip: 31015 country: Italy name: Duma Gian Marco, PhD role: CONTACT phone: +39 0438414248 email: gianmarco.duma@lanostrafamiglia.it lat: 45.88805 lon: 12.30201 hasResults: False
<\|newrecord\|> nctId: NCT06334016 id: I-3597023 id: NCI-2024-01556 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3597023 type: OTHER domain: Roswell Park Cancer Institute id: R01DA057228 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA057228 briefTitle: Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream overallStatus: NOT_YET_RECRUITING date: 2025-03-27 date: 2028-03-01 date: 2028-03-01 date: 2024-03-27 date: 2024-03-27 name: Roswell Park Cancer Institute class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety. conditions: Cannabis Dependence studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Within-subject crossover study primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: Both participants and clinical personnel will be blinded to the nicotine product sequence (active vs. placebo). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Biospecimen Collection name: Cannabis sativa Extract name: Nicotine name: Placebo Administration name: Questionnaire Administration measure: Maximum concentration of THC in plasma (Cmax) measure: Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360) measure: Time to maximum concentration of THC in plasma (Tmax) measure: Incidence of adverse events (AEs) measure: Puffing behaviors measure: Puffing behaviors measure: Short-term drug effects measure: Marijuana Withdrawal Checklist [MWC) measure: Digit Symbol Substitution Task (DSST) measure: Paced Auditory Serial Addition Task (PASET) measure: Tobacco Craving Questionnaire (Short Form) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Danielle M. Smith role: CONTACT phone: 716-845-8403 email: Danielle.Smith@RoswellPark.org name: Danielle M. Smith role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False
<\|newrecord\|> nctId: NCT06334003 id: H-23071266 briefTitle: Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology acronym: COMPART overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-12-01 date: 2024-03-27 date: 2024-03-27 name: Rigshospitalet, Denmark class: OTHER name: Herlev Hospital briefSummary: The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC. conditions: ART conditions: IVF conditions: Children, Only conditions: Cardiovascular Disease Other studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Offspring body composition measure: Maternal cardiometabolic profile measure: Epigenetic in placenta and cord blood measure: Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS) measure: Telomere length in children born after FET, fresh-ET and NC children sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Fertility Clinic, Rigshospitalet, Copenhagen University Hospital city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Dept. of Paediatric and Adolescent Medicine, Herlev Hospital city: Copenhagen country: Denmark name: Rikke B. Jensen, MD, Ass. Prof role: CONTACT name: Maria L. Vestager, MD, PhD-student role: CONTACT email: maria.linander.vestager.01@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06333990 id: 20220796HU briefTitle: Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-03 date: 2028-03 date: 2024-03-27 date: 2024-03-27 name: Foundation for Advancing Veterans' Health Research class: OTHER name: The University of Texas Health Science Center at San Antonio name: Biomedical Research Institute of New Mexico briefSummary: A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD). conditions: Mild Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Quetiapine Fumarate name: TAU measure: Neurobehavioral Symptom Inventory measure: World Health Organization Disability Assessment Scale measure: World Health Organization Quality of Life BREF sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06333977 id: LG-GQCL001 briefTitle: A Study of LC542019 in Healthy Subjects and Subjects With T2DM overallStatus: COMPLETED date: 2022-03-25 date: 2023-12-14 date: 2023-12-14 date: 2024-03-27 date: 2024-03-27 name: LG Chem class: INDUSTRY briefSummary: to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM). conditions: Healthy conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: LC542019 name: Placebo measure: Incidence, severity of adverse events measure: Maximum Concentration (Cmax) in Plasma measure: Renal Clearance (CLR) in urine measure: Cardiodynamic evaluation measure: Fasting Plasma Glucose measure: HbA1c sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PPD Development, LP (PPD Clinical Research Unit, Las Vegas) city: Las Vegas state: Nevada zip: 89113 country: United States lat: 36.17497 lon: -115.13722 hasResults: False
<\|newrecord\|> nctId: NCT06333964 id: AST-001P_P301_ASD briefTitle: Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children overallStatus: RECRUITING date: 2023-08-29 date: 2024-09-30 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Astrogen, Inc. class: INDUSTRY briefSummary: 1. Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD.
2. Background: ASD is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. There are no approved medicines to treat the core symptom of ASD. Although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. AST-001 is developed to treat the core symptom of ASD.

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