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protocolSection identificationModule nctId: NCT06335459, orgStudyIdInfo id: Epidemiology of bunion, briefTitle: Epidemiology of Bunion and Risk Factors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-24, primaryCompletionDateStruct date: 2025-04-05, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Analysis of the collected data to determine:* Prevalence.* Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus, conditionsModule conditions: Hallux Valgus and Bunion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: epidemiology, outcomesModule primaryOutcomes measure: History taken and well clinical examination and AP Foot standing position of 2000 randomly case with determination of Hallux Valgus angles knowing if It's Hallux Valgus or not calculating The prevalence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335446, orgStudyIdInfo id: 011040- AT validation phase, secondaryIdInfos id: PG/16/10/32016, type: OTHER_GRANT, domain: British Heart Foundation, briefTitle: Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-10, primaryCompletionDateStruct date: 2019-10, completionDateStruct date: 2019-10, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Barts & The London NHS Trust, class: OTHER, descriptionModule briefSummary: Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF.STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT., conditionsModule conditions: Atrial Tachycardia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Novel mapping algorithm, outcomesModule primaryOutcomes measure: STAR maps compared to conventional maps, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barts Heart Centre, city: London, zip: EC1A 7BE, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06335433, orgStudyIdInfo id: RM_30_06_22b, briefTitle: Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Swansea University, class: OTHER, descriptionModule briefSummary: Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021, Toohey et al, 2018).Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure.Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Training (Isometric Handgrip Exercise), outcomesModule primaryOutcomes measure: Office measured supine and seated systolic, diastolic and mean arterial pressure, secondaryOutcomes measure: Office measured central systolic, diastolic and mean arterial pressure, secondaryOutcomes measure: 24-h mean ambulatory systolic, diastolic, and mean arterial pressure, secondaryOutcomes measure: Daytime ambulatory systolic, diastolic, and mean arterial pressure, secondaryOutcomes measure: Sleeping ambulatory systolic, diastolic and mean arterial pressure, secondaryOutcomes measure: Carotid-Femoral Pulse Wave Velocity, secondaryOutcomes measure: Affective Valence (Feeling Scale), secondaryOutcomes measure: Ratings of perceived exertion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Swansea University, status: RECRUITING, city: Swansea, state: Wales, zip: SA18EN, country: United Kingdom, contacts name: Richard Metcalfe, PhD, role: CONTACT, phone: 01792205678, phoneExt: 4779, email: r.s.metcalfe@swansea.ac.uk, geoPoint lat: 51.62079, lon: -3.94323, hasResults: False
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protocolSection identificationModule nctId: NCT06335420, orgStudyIdInfo id: 324-2023-GB, briefTitle: Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps, acronym: Px7, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Umeå University, collaborators name: Uppsala University Hospital, collaborators name: Sahlgrenska University Hospital, Sweden, collaborators name: Svendborg Hospital, descriptionModule briefSummary: The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel.The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.Researchers will compare the group with ingestion of FaOH/FaDOH rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients., conditionsModule conditions: Colorectal Cancer Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Carrot juice from Yellowstone carrots cultivars, interventions name: Placebo juice, outcomesModule primaryOutcomes measure: Number and size of polyps found at the one-year follow up colonoscopy, secondaryOutcomes measure: Polyp number and size in relation to carrot consumption measurement, secondaryOutcomes measure: Compliance rate (Juice consumption level), secondaryOutcomes measure: Side effects, secondaryOutcomes measure: Acceptability of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery, Odense University Hospital, city: Odense, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False
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protocolSection identificationModule nctId: NCT06335407, orgStudyIdInfo id: AS210006-A08, secondaryIdInfos id: W81XWH-21-2-0026, type: OTHER_GRANT, domain: DoDCongressionally Directed Medical Research Program, briefTitle: Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-10-29, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, class: OTHER, collaborators name: United States Department of Defense, collaborators name: Congressionally Directed Medical Research Programs, collaborators name: VA Connecticut Healthcare System, collaborators name: BioXcel Therapeutics Inc, collaborators name: Yale University, collaborators name: RTI International, descriptionModule briefSummary: The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials., conditionsModule conditions: Alcohol Use Disorder (AUD), conditions: Post Traumatic Stress Disorder (PTSD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Participants will receive 40µg on days 1-2. On days 3 and 4, participants will receive 40µg twice per day. On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening. If dosing is tolerated, per clinical judgement, participants will begin to receive 80µg twice per day on days 7-28., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: no one will be masked, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, interventions name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, outcomesModule primaryOutcomes measure: Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28., primaryOutcomes measure: Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28., primaryOutcomes measure: Number and Proportion of Adverse Events, secondaryOutcomes measure: Change in PTSD symptoms (measured via the PTSD Checklist for Diagnostic and Statistical Manual (DSM-5) - Posttraumatic Stress Disorder Checklist (PCL-5) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28., secondaryOutcomes measure: Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Connecticut Healthcare System, city: West Haven, state: Connecticut, zip: 06516, country: United States, contacts name: Jenelle Newcomb, BA, role: CONTACT, phone: 203-932-5711, phoneExt: 12874, email: jenelle.leblanc@yale.edu, contacts name: Ismene Petrakis, MD, role: CONTACT, phone: (203) 932-5711, phoneExt: 12244, email: ismene.petrakis@yale.edu, contacts name: Ismene Petrakis, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: John Krystal, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.27065, lon: -72.94705, hasResults: False
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protocolSection identificationModule nctId: NCT06335394, orgStudyIdInfo id: NVD003-CLN01, briefTitle: Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-08-02, primaryCompletionDateStruct date: 2022-04-27, completionDateStruct date: 2028-05-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Novadip Biosciences, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion., conditionsModule conditions: Recalcitrant Lower Limb Nonunion, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 11, type: ACTUAL, armsInterventionsModule interventions name: NVD003, outcomesModule primaryOutcomes measure: Safety - Adverse Events, primaryOutcomes measure: Safety - Abnormalities of vital signs, primaryOutcomes measure: Safety - Abnormalities of vital signs, primaryOutcomes measure: Safety - Abnormalities of physical examination, primaryOutcomes measure: Safety - Abnormalities of physical examination, primaryOutcomes measure: Safety - Abnormalities of physical examination, primaryOutcomes measure: Safety - Abnormalities of laboratories, primaryOutcomes measure: Safety - Abnormalities of laboratories, primaryOutcomes measure: Safety - Abnormalities of laboratories, secondaryOutcomes measure: Healing efficacy: plain X-ray, secondaryOutcomes measure: Healing efficacy: CT-scan, secondaryOutcomes measure: Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing, secondaryOutcomes measure: Healing efficacy: investigator assessed clinical healing, secondaryOutcomes measure: Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing, secondaryOutcomes measure: Grafting Surgery parameters, secondaryOutcomes measure: Grafting Surgery parameters, secondaryOutcomes measure: Complications: rate of subsequent surgical interventions, secondaryOutcomes measure: Quality of Life: pain evaluation, secondaryOutcomes measure: Quality of Life: questionnaire EuroQol-5 Dimensions, secondaryOutcomes measure: Quality of Life: overall treatment effect, secondaryOutcomes measure: General Pre-graft implantation safety: all SAEs, AESI and PRAE, secondaryOutcomes measure: All SAEs during the extended safety follow-up period, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Interregional Edith Cavel (CHIREC) - Clinique Ste Anne-St Remi, city: Anderlecht, zip: 1070, country: Belgium, geoPoint lat: 50.83619, lon: 4.31454, locations facility: Algemeen Ziekenhuis (AZ) Sint-Jan Brugge - Oostende AV - Campus Sint-Jan, city: Brugge, zip: 8000, country: Belgium, geoPoint lat: 51.20892, lon: 3.22424, locations facility: Centre Hospitalier Universitaire CHU/UVC Brugmann (Site Horta), city: Brussel, zip: 1020, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Grand Hôpital De Charleroi, city: Charleroi, country: Belgium, geoPoint lat: 50.41136, lon: 4.44448, locations facility: Ziekenhuis Oost-Limburg (ZOL), city: Genk, zip: 3600, country: Belgium, geoPoint lat: 50.965, lon: 5.50082, locations facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg, city: Leuven, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, locations facility: CHU Ambroise Paré, city: Mons, zip: 7000, country: Belgium, geoPoint lat: 50.45413, lon: 3.95229, locations facility: Centre Hospitalier Regional De Namur, city: Namur, zip: 5000, country: Belgium, geoPoint lat: 50.4669, lon: 4.86746, locations facility: Centre Hospitalier de Luxembourg, city: Luxembourg, zip: 1210, country: Luxembourg, geoPoint lat: 49.61167, lon: 6.13, locations facility: University Hospital Basel, city: Basel, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
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protocolSection identificationModule nctId: NCT06335381, orgStudyIdInfo id: 24-0131, secondaryIdInfos id: 1R01NR021134-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01NR021134-01, briefTitle: MOMs Chat and Care Study, acronym: MOMs-CC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Northwell Health, class: OTHER, collaborators name: National Institute of Nursing Research (NINR), descriptionModule briefSummary: The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black birthing people (n = 674) will be recruited and randomized to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities., conditionsModule conditions: Severe Maternal Morbidity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be assigned to one of two groups in parallel for the duration of the study., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The Principal Investigator and Biostatistician will be masked., whoMasked: INVESTIGATOR, enrollmentInfo count: 674, type: ESTIMATED, armsInterventionsModule interventions name: Northwell Pregnancy & Peds Chats, interventions name: Prenatal Telehealth Visits, interventions name: Postpartum Telehealth Visits, interventions name: Home Blood Pressure Monitor, interventions name: Fitbit, outcomesModule primaryOutcomes measure: Severe maternal morbidity (SMM), secondaryOutcomes measure: Preeclampsia, secondaryOutcomes measure: Informational Support, secondaryOutcomes measure: Emotional Support, secondaryOutcomes measure: Tangible Support, otherOutcomes measure: Minutes of Physical Activity, otherOutcomes measure: Barriers to Exercise, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Northwell Health, city: Manhasset, state: New York, zip: 11030, country: United States, contacts name: Stephanie L Fitzpatrick, PhD, role: CONTACT, geoPoint lat: 40.79788, lon: -73.69957, hasResults: False
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protocolSection identificationModule nctId: NCT06335368, orgStudyIdInfo id: 201512178RINC, briefTitle: Assessment of Nutritional and Growth Status in Rett Syndrome Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-03-09, primaryCompletionDateStruct date: 2016-05-23, completionDateStruct date: 2020-10-26, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan., conditionsModule conditions: Rett Syndrome, conditions: Neurologic Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Nutrition and Growth Status, outcomesModule primaryOutcomes measure: gender, age, disease history checklist, primaryOutcomes measure: Change in Body height, primaryOutcomes measure: Change in Body weight, primaryOutcomes measure: Change in knee height, primaryOutcomes measure: Change in arms height, primaryOutcomes measure: Change in waist, primaryOutcomes measure: Change in hip circumferences, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06335355, orgStudyIdInfo id: SHR-1316-307, briefTitle: A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-10, completionDateStruct date: 2030-10, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Shanghai Shengdi Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations, conditionsModule conditions: Non-squamous Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 401, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin, interventions name: Camrelizumab + Pemetrexed + Carboplatin, interventions name: Adebrelimab + Pemetrexed + Carboplatin, outcomesModule primaryOutcomes measure: Investigator-assessed Objective Response Rate (Phase One), primaryOutcomes measure: Overall Survival (Phase Two), secondaryOutcomes measure: The incidence and severity of Adverse Events (AEs) (Phases One and Two), secondaryOutcomes measure: Duration of Response (DoR) based on Investigator Assessment (Phases One and Two), secondaryOutcomes measure: Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two), secondaryOutcomes measure: Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two), secondaryOutcomes measure: Overall Survival (OS) (Phase One), secondaryOutcomes measure: Objective Response Rate (ORR) based on Investigator Assessment (Phase Two), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Tumor Hospital of Shandong First Medical University, city: Jinan, state: Shandong, zip: 250117, country: China, contacts name: Jinming Yu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06335342, orgStudyIdInfo id: IEO 0726, briefTitle: Radiotherapy Treatments for Neoplasms in the Head and Neck Region, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region.Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region., conditionsModule conditions: Head and Neck Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 4050, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall Survival, primaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Barbara Alicja Jereczek, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06335329, orgStudyIdInfo id: Pro00133616, briefTitle: Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, descriptionModule briefSummary: Vaping has emerged as a prominent public health crisis in recent years. In 2023, the National Youth Tobacco Survey found that more than 2.1 million adolescents endorse vaping, with 25% of those endorsing daily use. Many adolescents also perceive vapes as safer than cigarettes, and more acceptable to use both indoors and outdoors compared to cigarettes. Vapes are available in numerous device and delivery systems, with the psychoactive agent commonly including nicotine or cannabis, although these can be of a wide variety of concentrations and formulations. They may be ultra-compact and allow for ease of concealment. In addition, they are produced in a variety of appealing flavorings such as candy, desserts, and fruits. Other constituents include the liquids and aerosolized components of the vaping cartridges, including formaldehyde, acetone, glycerol, propylene glycol, acetaldehyde, and heavy metals. Many of the flavoring concentrates, as well as the vaporized solvents, have not been evaluated for long term safety. One of these additives, vitamin E acetate, present in primarily illicit vaping devices, rose to national attention in 2019 for a suspected link to the dramatic increase in vaping/e-cigarette associated lung injury (EVALI) cases, with over 60 confirmed deaths since that time.To our knowledge, there are no studies evaluating the lung ultrasound findings of asymptomatic vapers. However, there is data to suggest that vaping can lead to pulmonary toxicity in in-vitro and animal models, including increased inflammatory cytokines, hyperreactivity, and oxidative stress. In addition, studies found the risk of bronchitic symptoms is twice as likely in current adolescent vapers, compared to those who have never vaped before. Given the potential pulmonary toxicity of vaping, as well as the increased percentage of adolescent vaping activity in recent years, investigators aim to evaluate baseline lung ultrasound findings in adolescents who vape. Concurrently, investigators will assess if observing their lung ultrasound findings can alter their attitudes and behaviors towards vaping. Prior adult studies have found that showing patients' their atherosclerosis plaque increased the motivation to quit and cessation rates. Additionally, data in pregnant patients found real-time ultrasound feedback of smoking effects on the fetus lead to near abstinence in light smokers. Given the frequent use of point-of-care ultrasound in the emergency department, investigators hope to assess an innovative intervention for cessation., conditionsModule conditions: Vaping, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: All participants will be randomized on a 1:1 ratio to be able to see and discuss their ultrasound results, or remain blinded to them., whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Discussion of point-of-care ultrasound lung findings, outcomesModule primaryOutcomes measure: Lung Ultrasound Findings, primaryOutcomes measure: Behavioral Changes, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29412, country: United States, contacts name: Kaitlyn Boggs, MD, role: CONTACT, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False
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protocolSection identificationModule nctId: NCT06335316, orgStudyIdInfo id: wallenburg sym, briefTitle: Effect of Stellate Nerve Block in Dysphagia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-05-04, completionDateStruct date: 2023-05-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 122, type: ACTUAL, armsInterventionsModule interventions name: Injection, interventions name: Lidocaine Hydrochloride, interventions name: Comprehensive therapy, interventions name: placebo, outcomesModule primaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Yale Pharyngeal Residue Severity Rating Scale, secondaryOutcomes measure: penetration-aspiration scale, secondaryOutcomes measure: The Swallowing Quality of Life Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huimin Hos., city: Pengfu, country: Taiwan, geoPoint lat: 24.98333, lon: 121.41667, hasResults: False
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protocolSection identificationModule nctId: NCT06335303, orgStudyIdInfo id: 1462-0004, secondaryIdInfos id: 2023-508395-11-00, type: OTHER, domain: CTIS, secondaryIdInfos id: U1111-1302-4283, type: OTHER, domain: WHO, briefTitle: A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-20, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: BI 1819479, interventions name: Placebo matching BI 1819479, outcomesModule primaryOutcomes measure: Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year], secondaryOutcomes measure: Absolute change from baseline in FVC at Week 24 [in milliLiter], eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335290, orgStudyIdInfo id: IEO 725, briefTitle: Radiotherapy Treatments for the Treatment of Thoracic District Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of thoracic radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the thoracic anatomical region., conditionsModule conditions: Thoracic Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 13200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Barbara Alicja Jereczek, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06335277, orgStudyIdInfo id: IEO 0727, briefTitle: Total Body Irradiation Treatments for Patients Treated at European Institute of Oncology, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Patients eligible undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplant., conditionsModule conditions: Leukemia, conditions: Leukemia, Chronic, conditions: Leukemia, Acute, conditions: Lymphoma, conditions: Aplastic Anemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall Survival, primaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Barbara Alicja Jereczek, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06335264, orgStudyIdInfo id: 2024-9987, briefTitle: Screening for Heart Failure Using a Multimodal Wearable Device, acronym: WEAR-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, collaborators name: HOP-Child Technologies Inc, descriptionModule briefSummary: The purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. To do this, the investigators will use a smartwatch that can measure multiple signals like the participant's heart rate and movement. Investigators will ask participants with and without heart failure to wear the Watch HOP (from HOP-Child Technologies Inc.) and sensors during physical tasks at their clinic visit at the McGill University Health Centre. Researchers will also record the participants' voices between their visits. The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Watch HOP, outcomesModule primaryOutcomes measure: Presence or absence of heart failure, secondaryOutcomes measure: left ventricular ejection fraction (LVEF), secondaryOutcomes measure: Natriuretic peptide (NT-proBNP) level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: McGill University Health Centre, status: RECRUITING, city: Montreal, state: Quebec, zip: H4A 3J1, country: Canada, contacts name: Abhinav Sharma, MD, role: CONTACT, phone: 514 934-1934, email: dreamcvlab@muhc.mcgill.ca, contacts name: Abhinav Sharma, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06335251, orgStudyIdInfo id: IEO 0728, briefTitle: Radiotherapy Treatments for Neoplasms of the Limbs, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: In this observational study patients treated at European Institute of Oncology with radiotherapy to limbs will be included, conditionsModule conditions: Bone Neoplasms, conditions: Bone Metastases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Barbara Alicja Jereczek, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06335238, orgStudyIdInfo id: IEO 0729, briefTitle: Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of abdominal-pelvic region radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the tabdominal-pelvic region., conditionsModule conditions: Abdominal Cancer, conditions: Pelvic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 7700, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Barbara Alicja Jereczek, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06335225, orgStudyIdInfo id: 2023-NHLHCRF-YXHZ-ZRMS-06, briefTitle: Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions., conditionsModule conditions: Prediabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Precise nutritional intervention, interventions name: Conventional nutritional intervention, outcomesModule primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Concentration of fasting plasma glucose, secondaryOutcomes measure: Concentration of 2-hour plasma glucose, secondaryOutcomes measure: Concentration of fasting insulin, secondaryOutcomes measure: Concentration of fasting C peptide, secondaryOutcomes measure: Concentration of TC, TG, LDL-C, and HDL-C, secondaryOutcomes measure: Concentration of ALT, AST, TBIL, secondaryOutcomes measure: Concentration of creatinine, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Waist hip ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China-Japan Friendship Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Xiao Ma, MD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06335212, orgStudyIdInfo id: IRBNET ID 1448963, briefTitle: Peripheral Defocus Profile of Multifocal Minus Contact Lenses, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-01, primaryCompletionDateStruct date: 2019-08-01, completionDateStruct date: 2019-08-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: State University of New York College of Optometry, class: OTHER, descriptionModule briefSummary: Purpose: Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. As such, multifocal soft contact lenses (MFCLs) have been utilized for myopia control in school-aged children, with variable efficacies. One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression. Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (SVCLs) and MFCLs of different Add powers.Methods: Subjects with -1.00 D to -10.00 D of myopia (SE, determined with manifest refraction) were custom fit with both single vision (SV) and MFCLs (+2.00 and +4.00 D Add; provided by Specialeyes) in both eyes. These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 8.0mm. Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia. Data in the right eye was used for analysis., conditionsModule conditions: Myopia, conditions: Refractive Errors, conditions: Contact Lens, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 19, type: ACTUAL, armsInterventionsModule interventions name: Single vision and multifocal contact lenses, outcomesModule primaryOutcomes measure: refractive power, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: State University of New York, College of Optometry, city: New York, state: New York, zip: 10036, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06335199, orgStudyIdInfo id: H24109, secondaryIdInfos id: 5P2CHD086844-09, type: NIH, link: https://reporter.nih.gov/quickSearch/5P2CHD086844-09, briefTitle: tVNS Responsiveness Testing With Pupil Size, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Georgia Institute of Technology, class: OTHER, collaborators name: Emory University, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: The goal of this study is to learn about the acute pupil response to transcutaneous vagus nerve stimulation (tVNS) in stroke survivors and healthy adults. The main question it aims to answer is whether pupil size response is greater with bilateral tVNS compared to unilateral tVNS. Participants will receive tVNS and sham at the outer ear unilaterally and bilaterally in resting condition. The pupil size of the participants will be recorded during tVNS., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Unilateral tVNS stimulation, interventions name: Bilateral tVNS stimulation, interventions name: Unilateral Sham stimulation, interventions name: Bilateral Sham stimulation, outcomesModule primaryOutcomes measure: Pupil size change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Human Neuromuscular Physiology Lab, city: Atlanta, state: Georgia, zip: 30318, country: United States, contacts name: Minoru Shinohara, Ph.D., role: CONTACT, phone: 404-894-1030, email: shinohara@gatech.edu, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06335186, orgStudyIdInfo id: Soh-Med-24-03-04MS, briefTitle: Predictive and Prognostic Significance of Age,Blood Tests,Comorbidities(ABC) Score,Cologne Watch(C-watch)Score and Rockall Score for Risk of Variceal Re-bleeding Among Cirrhotic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: IntroductionPortal hypertension is a common complication of liver cirrhosis and is often underestimated in clinical diagnosis. The incidence of portal hypertension is approximately 20% to 98% in patients with cirrhosis (Wu et al., 2022). It is the major driver in the transition from the compensated to the 'decompensated' stage of cirrhosis, defined by the presence of clinical complications, including ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, and hepatic encephalopathy (Berzigotti., 2017).Acute variceal bleeding is one of the most lifethreatening complications of liver cirrhosis. Twenty two percent to sixty one percent of cirrhotic patients receiving primary prophylaxis will develop first variceal bleeding during the first two years of follow up. Furthermore, variceal bleeding is associated with high risk of rebleeding and mortality (Tantai et al., 2019).Patients with cirrhosis, although much progress has been made in diagnosis and treatment using vasoactive drugs, preventive antibiotics, early endoscopy and interventional radiology, the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days. Therefore, the prognostic method of patients with acute variceal bleeding is to determine the risk of rebleeding and resistance to standard treatment (accounting for 20-30%) and mortality rate in order to be able to adopt more aggressive treatment measures. The prognosis is very important but also difficult, not only because of the bleeding status but also depending on the severity of the underlying cirrhosis (Huy et al., 2023).Many risk factors are known to influence the outcome in Upper Gastrointestinal Bleeding (UGIB) setting: Age, comorbidities, presence of shock, endoscopic diagnosis, haemoglobin values at the time of bleeding, stigmata of recent haemorhage and need for blood transfusion have all been described as significant risk factors for rebleeding and death (Monteiro S et al., 2016).Many risk assessment score systems, including pre-endoscopy and post-endoscopy evaluations, have been developed to predict outcomes such as the need for hospital-based intervention, endoscopic therapy, and admission to an intensive care unit (ICU), rebleeding, and mortality. Some studies showed that these scoring systems distinguish low-risk patients who can potentially be managed as outpatients, allowing more efficient use of resources. Other studies suggested that these score systems distinguish higher-risk patients who might require emergency endoscopy or management in an intensive care unit (Li et al., 2022).In 1993, the Rockall Scoring system was introduced to predict the mortality after UGIB and was validated for its use to identify the patients at high risk for re-bleed and mortality. Complete Rockall scoring system is based on an initial clinical score at the time of admission which consist of age (score 0-2), presence of shock (0-2), co-morbidities (score 0-3) and post endoscopic diagnosis (score 0-2) with stigmata of recent hemorrhages (score 0-2). Both clinical and post endoscopic scores added together gives a complete Rockall score with maximum score being 11 (Dewan et al., 2018).In 2020, Laursen S.B. and colleagues conducted a multicenter international study and developed a new prognostic scoring system for UGIB called the ABC score. This scoring system is based on three criteria: age, blood test results, and comorbidities. The score ranges from 0 to 18 points, categorizing the risk into low (≤3 points), moderate (4-7 points), and high (≥8 points) levels. The 30-day mortality rates for high-risk UGIB patients in these three risk groups were 1%, 7%, and 25%, respectively ( Ky et al., 2023)The new Cologne Watch (C-Watch) score was designed as a pre-endoscopic score for acute variceal and non-variceal UGIB and incorporates laboratory values only (c-reactive protein, white blood cell count, alanine-aminotransferase, thrombocytes, creatinine, and hemoglobin) with a minimum point value of 0 and a maximum point value of 8. Within the validation set, it predicted a composite endpoint consisting of recurrent bleeding, need for intervention (interventional radiology, surgery), or death within 30 days with an area under the receiver-operating characteristics curve (AUROC) of 0. About 38.7% of patients were within the high-risk group, i.e., ≥2 points, reached the composite endpoint, whereas no patient classified as low risk (≤1 point) (Allo et al., 2022)., conditionsModule conditions: Upper Gastrointestinal Variceal Bleeding in Cirrhotic Patients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: upper endoscopy, outcomesModule primaryOutcomes measure: ABC score., primaryOutcomes measure: Rockall score, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university Hospital, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06335173, orgStudyIdInfo id: ACU193-201, secondaryIdInfos id: 2023-509807-34-00, type: REGISTRY, domain: EU CT Number, briefTitle: A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD), acronym: ALTITUDE-AD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2031-01, completionDateStruct date: 2031-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Acumen Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2040, type: ESTIMATED, armsInterventionsModule interventions name: ACU193, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score, secondaryOutcomes measure: Change from Baseline in ADCS-iADL Score, secondaryOutcomes measure: Change from Baseline in ADAS-Cog13 Score, secondaryOutcomes measure: Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB), secondaryOutcomes measure: Change from Baseline in Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD), secondaryOutcomes measure: Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score, secondaryOutcomes measure: Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L), secondaryOutcomes measure: Change from Baseline in Resource Utilization in Dementia (RUD), secondaryOutcomes measure: Change from Baseline in Zarit Burden Interview (ZBI), secondaryOutcomes measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS, secondaryOutcomes measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL, secondaryOutcomes measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13, secondaryOutcomes measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB, secondaryOutcomes measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE, secondaryOutcomes measure: Percentage of Participants with No Clinical Progression at One Year, secondaryOutcomes measure: Number of Participants with Treatment-Related Adverse Events (TEAEs), secondaryOutcomes measure: Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Number of Participants who Discontinue or Withdraw due to TEAE, secondaryOutcomes measure: Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies, secondaryOutcomes measure: Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI), secondaryOutcomes measure: Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS), secondaryOutcomes measure: Serum Concentration of ACU193, secondaryOutcomes measure: Concentration of ACU193 in Cerebrospinal Fluid (CSF), secondaryOutcomes measure: CSF Concentrations of ACU193 in a Subset of Participants, secondaryOutcomes measure: Correlation Between ACU193 Exposure with Clinical Efficacy Measures, secondaryOutcomes measure: Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids, secondaryOutcomes measure: Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest, secondaryOutcomes measure: Target Engagement Assessed by Measurement of ACU193- Amyloid-β oligomer (AβO) Complex in CSF, secondaryOutcomes measure: Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers, secondaryOutcomes measure: Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants, secondaryOutcomes measure: Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers, secondaryOutcomes measure: Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Banner Alzheimer's Institute- Clinical Trials Department, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85006, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: IMA Clinical Research - Phoenix, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85012, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: The Neurology Center of Southern California - Carlsbad, status: NOT_YET_RECRUITING, city: Carlsbad, state: California, zip: 92011-4219, country: United States, geoPoint lat: 33.15809, lon: -117.35059, locations facility: Neurology Center of North Orange County, status: NOT_YET_RECRUITING, city: Fullerton, state: California, zip: 92835, country: United States, geoPoint lat: 33.87029, lon: -117.92534, locations facility: Irvine Medical Research, status: NOT_YET_RECRUITING, city: Irvine, state: California, zip: 92614, country: United States, geoPoint lat: 33.66946, lon: -117.82311, locations facility: Healthy Brain Research, status: NOT_YET_RECRUITING, city: Long Beach, state: California, zip: 90804, country: United States, geoPoint lat: 33.76696, lon: -118.18923, locations facility: Sharp Mesa Vista Hospital, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Syrentis Clinical Research, status: NOT_YET_RECRUITING, city: Santa Ana, state: California, zip: 92705, country: United States, geoPoint lat: 33.74557, lon: -117.86783, locations facility: CenExel - California Neuroscience Research Medical Group, Inc (CNR), status: NOT_YET_RECRUITING, city: Sherman Oaks, state: California, zip: 91403-2131, country: United States, geoPoint lat: 34.15112, lon: -118.44925, locations facility: Alpine Clinical Research Center, status: NOT_YET_RECRUITING, city: Boulder, state: Colorado, zip: 80301-1880, country: United States, geoPoint lat: 40.01499, lon: -105.27055, locations facility: The Mile High Research Center, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Yale School of Medicine - Alzheimer's Disease Research Unit (ADRU), status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510-3330, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Research Center for Clinical Studies, LLC, status: NOT_YET_RECRUITING, city: Norwalk, state: Connecticut, zip: 06851-4903, country: United States, geoPoint lat: 41.1176, lon: -73.4079, locations facility: Re:Cognition Health - Fairfax, status: NOT_YET_RECRUITING, city: Washington, state: District of Columbia, zip: 22031, country: United States, geoPoint lat: 38.89511, lon: -77.03637, locations facility: JEM Research Institute, status: RECRUITING, city: Atlantis, state: Florida, zip: 33462, country: United States, contacts name: Clinical Research Coordinator, role: CONTACT, phone: 561-968-2933, email: research@jemri.net, geoPoint lat: 26.5909, lon: -80.10088, locations facility: Bradenton Research Center, status: NOT_YET_RECRUITING, city: Bradenton, state: Florida, zip: 34205, country: United States, geoPoint lat: 27.49893, lon: -82.57482, locations facility: Gil Fernandez-Yera, MD, PA, status: NOT_YET_RECRUITING, city: Coral Gables, state: Florida, zip: 33135, country: United States, geoPoint lat: 25.72149, lon: -80.26838, locations facility: Brain Matters Research, status: NOT_YET_RECRUITING, city: Delray Beach, state: Florida, zip: 33445, country: United States, geoPoint lat: 26.46146, lon: -80.07282, locations facility: Coral Clinical Research, status: NOT_YET_RECRUITING, city: Homestead, state: Florida, zip: 33032, country: United States, geoPoint lat: 25.46872, lon: -80.47756, locations facility: K2 Medical Research - Villages, status: RECRUITING, city: Lady Lake, state: Florida, zip: 32159, country: United States, contacts name: Kylie Webster, role: CONTACT, phone: 352-565-7524, email: kylie.webster@k2med.com, geoPoint lat: 28.91749, lon: -81.92286, locations facility: Verus Clinical Research, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33125, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Finlay Medical Research, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33126, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Collier Neurologic Specialists (CNS), L.L.C., status: NOT_YET_RECRUITING, city: Naples, state: Florida, zip: 34105-8522, country: United States, geoPoint lat: 26.14234, lon: -81.79596, locations facility: Ocala Health - Family Care Specialists - Ocala I, status: NOT_YET_RECRUITING, city: Ocala, state: Florida, zip: 34470, country: United States, geoPoint lat: 29.1872, lon: -82.14009, locations facility: Progressive Medical Research, status: NOT_YET_RECRUITING, city: Port Orange, state: Florida, zip: 32127, country: United States, geoPoint lat: 29.13832, lon: -80.99561, locations facility: Alzheimer's Research and Treatment Center - Stuart, status: NOT_YET_RECRUITING, city: Stuart, state: Florida, zip: 34997, country: United States, geoPoint lat: 27.19755, lon: -80.25283, locations facility: K2 Medical Research - Tampa, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33607, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Charter Research - Lady Lake, status: RECRUITING, city: The Villages, state: Florida, zip: 32162, country: United States, contacts name: Brittany Ortiz, role: CONTACT, phone: 352-775-1000, email: brittany.ortiz@charterresearch.com, geoPoint lat: 28.93408, lon: -81.95994, locations facility: Alzheimers Research and Treatment Center - Wellington, status: NOT_YET_RECRUITING, city: Wellington, state: Florida, zip: 33414, country: United States, geoPoint lat: 26.65868, lon: -80.24144, locations facility: Conquest Research, status: RECRUITING, city: Winter Park, state: Florida, zip: 32789, country: United States, contacts name: Elizabeth Schneider, role: CONTACT, phone: 689-488-9113, email: elizabeth.schneider@ConquestResearch.com, geoPoint lat: 28.6, lon: -81.33924, locations facility: Charter Research - Winter Park, status: NOT_YET_RECRUITING, city: Winter Park, state: Florida, zip: 32792, country: United States, geoPoint lat: 28.6, lon: -81.33924, locations facility: Columbus Memory Center, status: NOT_YET_RECRUITING, city: Columbus, state: Georgia, zip: 31909, country: United States, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Accel Research- Neurostudies, status: NOT_YET_RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: CenExel - iResearch Atlanta, status: NOT_YET_RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: CenExel - iResearch Savannah, status: NOT_YET_RECRUITING, city: Savannah, state: Georgia, zip: 31405, country: United States, geoPoint lat: 32.08354, lon: -81.09983, locations facility: Office of Jeffrey S. Ross, MD, status: NOT_YET_RECRUITING, city: Northbrook, state: Illinois, zip: 60640, country: United States, geoPoint lat: 42.12753, lon: -87.82895, locations facility: KU Wichita Center for Clinical Research, status: NOT_YET_RECRUITING, city: Wichita, state: Kansas, zip: 67214, country: United States, geoPoint lat: 37.69224, lon: -97.33754, locations facility: ActivMed Practices and Research, status: NOT_YET_RECRUITING, city: Methuen, state: Massachusetts, zip: 03801, country: United States, geoPoint lat: 42.7262, lon: -71.19089, locations facility: Boston Center for Memory, status: NOT_YET_RECRUITING, city: Newton, state: Massachusetts, zip: 02459, country: United States, geoPoint lat: 42.33704, lon: -71.20922, locations facility: Donald S. Marks, MD. P.C., status: NOT_YET_RECRUITING, city: Plymouth, state: Massachusetts, zip: 02360, country: United States, geoPoint lat: 41.95844, lon: -70.66726, locations facility: Hattiesburg Clinic - Memory Center, status: NOT_YET_RECRUITING, city: Hattiesburg, state: Mississippi, zip: 39401-7246, country: United States, geoPoint lat: 31.32712, lon: -89.29034, locations facility: Las Vegas Medical Research Center, status: NOT_YET_RECRUITING, city: Las Vegas, state: Nevada, zip: 89113-2215, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Princeton Psychiatric Center, status: NOT_YET_RECRUITING, city: Princeton, state: New Jersey, zip: 08540-2859, country: United States, geoPoint lat: 40.34872, lon: -74.65905, locations facility: The Cognitive and Research Center of New Jersey, status: NOT_YET_RECRUITING, city: Springfield, state: New Jersey, zip: 07081, country: United States, geoPoint lat: 40.70491, lon: -74.31723, locations facility: CenExel - Advanced Memory Research Institute of NJ, status: RECRUITING, city: Toms River, state: New Jersey, zip: 08755, country: United States, contacts name: Anna Anna Brocco, role: CONTACT, phone: 732-341-9500, phoneExt: 3510, email: amri.recruitment@cenexel.com, geoPoint lat: 39.95373, lon: -74.19792, locations facility: IMA Clinical Research - Albuquerque, status: NOT_YET_RECRUITING, city: Albuquerque, state: New Mexico, zip: 87109, country: United States, geoPoint lat: 35.08449, lon: -106.65114, locations facility: Neurological Associates of Albany, status: NOT_YET_RECRUITING, city: Albany, state: New York, zip: 12208, country: United States, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Neurological Institute of New York, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: SUNY Upstate Medical University - Upstate University Hospital (SUNY Health Science Center), status: NOT_YET_RECRUITING, city: Syracuse, state: New York, zip: 13210-2342, country: United States, geoPoint lat: 43.04812, lon: -76.14742, locations facility: AMC Research, status: NOT_YET_RECRUITING, city: Matthews, state: North Carolina, zip: 28105, country: United States, geoPoint lat: 35.11681, lon: -80.72368, locations facility: Cleveland Clinic - Lou Ruvo Center for Brain Health (CCLRCBH), status: NOT_YET_RECRUITING, city: Lakewood, state: Ohio, zip: 44107, country: United States, geoPoint lat: 41.48199, lon: -81.79819, locations facility: Summit Research Network, status: NOT_YET_RECRUITING, city: Portland, state: Oregon, zip: 97210, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Abington Neurological Associates, status: NOT_YET_RECRUITING, city: Abington, state: Pennsylvania, zip: 19001, country: United States, geoPoint lat: 40.12067, lon: -75.11795, locations facility: Keystone Clinical Research, status: RECRUITING, city: Norristown, state: Pennsylvania, zip: 19462, country: United States, contacts name: Cherian Verghese, role: CONTACT, phone: 610-277-8073, email: CVerghese@flourishresearch.com, geoPoint lat: 40.1215, lon: -75.3399, locations facility: Rhode Island Mood and Memory, status: NOT_YET_RECRUITING, city: East Providence, state: Rhode Island, zip: 02914, country: United States, geoPoint lat: 41.81371, lon: -71.37005, locations facility: Neurology Clinic. P.C, status: NOT_YET_RECRUITING, city: Cordova, state: Tennessee, zip: 38018, country: United States, geoPoint lat: 35.15565, lon: -89.7762, locations facility: The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group), status: NOT_YET_RECRUITING, city: Knoxville, state: Tennessee, zip: 37920-1511, country: United States, geoPoint lat: 35.96064, lon: -83.92074, locations facility: Senior Adult Specialty Research, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78757, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Gadolin Research, LLC, status: NOT_YET_RECRUITING, city: Beaumont, state: Texas, zip: 77702, country: United States, geoPoint lat: 30.08605, lon: -94.10185, locations facility: Kerwin Medical Center, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Okanagan Clinical Trials, status: NOT_YET_RECRUITING, city: Kelowna, state: British Columbia, country: Canada, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Office of Alexandre Henri-Bhargava, MD, status: NOT_YET_RECRUITING, city: Victoria, state: British Columbia, country: Canada, geoPoint lat: 48.43294, lon: -123.3693, locations facility: Parkwood Institute, status: NOT_YET_RECRUITING, city: London, state: Ontario, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Hippocampe d/b/a Ottawa Memory Clinic, status: NOT_YET_RECRUITING, city: Ottawa, state: Ontario, country: Canada, geoPoint lat: 45.41117, lon: -75.69812, locations facility: The Kawartha Regional Memory Clinic (KRMC), status: NOT_YET_RECRUITING, city: Peterborough, state: Ontario, country: Canada, geoPoint lat: 44.30012, lon: -78.31623, locations facility: Baycrest - The Rotman Research Institute (RRI), status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Toronto Memory Program (TMP) (Neurology Research Inc.), status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: University Health Network (UHN) - Toronto Western Hospital (TWH) - Krembil Neuroscience Centre (KNC) - Memory Clinic, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: MoCA Research and Innovations, status: NOT_YET_RECRUITING, city: Greenfield Park, state: Quebec, country: Canada, geoPoint lat: 45.48649, lon: -73.46223, locations facility: Amiens university hospital, status: NOT_YET_RECRUITING, city: Amiens, country: France, geoPoint lat: 49.9, lon: 2.3, locations facility: Chu Pellegrin, status: NOT_YET_RECRUITING, city: Bordeaux, country: France, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Hopital Neurologique Pierre Wertheimer, status: NOT_YET_RECRUITING, city: Bron, country: France, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Hôpital de la Timone, status: NOT_YET_RECRUITING, city: Marseille Cedex 05, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Chu Montpellier, status: NOT_YET_RECRUITING, city: Montpellier, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Hopital Lariboisiere, status: NOT_YET_RECRUITING, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut de la Mémoire et de la Maladie d'Alzheimer -IM2A, status: NOT_YET_RECRUITING, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Rennes, CMRR, status: NOT_YET_RECRUITING, city: Rennes, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU de NANTES-Hôpital Nord Laennec, status: NOT_YET_RECRUITING, city: Saint-Herblain, country: France, geoPoint lat: 47.21765, lon: -1.64841, locations facility: Hôpitaux Universitaires de Strasbourg, status: NOT_YET_RECRUITING, city: Strasbourg, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Centre de Recherche du Gérontopôle - CHU de Toulouse Hôpital la Grave, status: NOT_YET_RECRUITING, city: Toulouse, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Charité - Universitaetsmedizin Berlin, status: NOT_YET_RECRUITING, city: Berlin, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Pharmakologisches Studienzentrum Chemnitz GmbH, status: NOT_YET_RECRUITING, city: Chemnitz, country: Germany, geoPoint lat: 50.8357, lon: 12.92922, locations facility: University Hospital of Cologne, status: NOT_YET_RECRUITING, city: Cologne, country: Germany, geoPoint lat: 50.93333, lon: 6.95, locations facility: Saarland University Hospital, status: NOT_YET_RECRUITING, city: Homburg, country: Germany, geoPoint lat: 49.32637, lon: 7.33867, locations facility: Zentralinstitut für seelische Gesundheit, status: NOT_YET_RECRUITING, city: Mannheim, country: Germany, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar, status: NOT_YET_RECRUITING, city: Munich, country: Germany, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Rostock University Medical Center, status: NOT_YET_RECRUITING, city: Rostock, country: Germany, geoPoint lat: 54.0887, lon: 12.14049, locations facility: Praxisgemeinschaft Dr. Springub/Schwarz, status: NOT_YET_RECRUITING, city: Westerstede, country: Germany, geoPoint lat: 53.25682, lon: 7.92737, locations facility: Fondazione Istituto G. Giglio di Cefalù, status: NOT_YET_RECRUITING, city: Cefalù, country: Italy, geoPoint lat: 38.03856, lon: 14.02285, locations facility: Policlinico San Martino, status: NOT_YET_RECRUITING, city: Genova, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, status: NOT_YET_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS San Gerardo dei Tintori, status: NOT_YET_RECRUITING, city: Monza, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, locations facility: Neurology Clinic, status: NOT_YET_RECRUITING, city: Perugia, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, locations facility: IRCCS Neuromed, status: NOT_YET_RECRUITING, city: Pozzilli, country: Italy, geoPoint lat: 41.51142, lon: 14.06252, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Sapienza Università di Roma - AOU Policlinico Umberto I, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: SSD Alzheimer's disease and related dementias, status: NOT_YET_RECRUITING, city: Torino, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: A.O. Piafondazione Card. G. Panico, status: NOT_YET_RECRUITING, city: Tricase, country: Italy, geoPoint lat: 39.93018, lon: 18.35421, locations facility: Centrum Medyczne Neuromed, status: NOT_YET_RECRUITING, city: Bydgoszcz, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Krakowska Akademia Neurologii Sp. z o.o., status: NOT_YET_RECRUITING, city: Krakow, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: NZOZ Syntonia, status: NOT_YET_RECRUITING, city: Pruszcz Gdanski, country: Poland, geoPoint lat: 54.26217, lon: 18.63625, locations facility: RCMed, status: NOT_YET_RECRUITING, city: Sochaczew, country: Poland, geoPoint lat: 52.22944, lon: 20.23838, locations facility: Centrum Medyczne Senior, status: NOT_YET_RECRUITING, city: Sopot, country: Poland, geoPoint lat: 54.4418, lon: 18.56003, locations facility: Centrum Medyczne NeuroProtect, status: NOT_YET_RECRUITING, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Hospital Universitari General de catalunya, status: NOT_YET_RECRUITING, city: Sant Cugat Del Vallès, state: Barcelona, country: Spain, geoPoint lat: 41.47063, lon: 2.08611, locations facility: Fundacion CITA alzheimer, status: NOT_YET_RECRUITING, city: San Sebastián, state: Gipuzkoa, country: Spain, geoPoint lat: 43.31283, lon: -1.97499, locations facility: Fundacion Neuropolis - Hospital Viamed Montecanal, status: NOT_YET_RECRUITING, city: Cuarte de Huerva, state: Zaragoza, country: Spain, geoPoint lat: 41.59466, lon: -0.93268, locations facility: Fundacio ACE, status: NOT_YET_RECRUITING, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Reina Sofia, status: NOT_YET_RECRUITING, city: Cordoba, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Cae Oroitu, status: NOT_YET_RECRUITING, city: Getxo, country: Spain, geoPoint lat: 43.35689, lon: -3.01146, locations facility: Hospital Ruber, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Policlínica Gipuzkoa, status: NOT_YET_RECRUITING, city: San Sebastian, country: Spain, geoPoint lat: 43.31283, lon: -1.97499, locations facility: Hospital Victoria Eugenia, status: NOT_YET_RECRUITING, city: Sevilla, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Hospital Universitari i Politècnic La Fe, status: NOT_YET_RECRUITING, city: Valencia, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Re:Cognition Health - Plymouth, status: NOT_YET_RECRUITING, city: Plymouth, state: Devon, country: United Kingdom, geoPoint lat: 50.37153, lon: -4.14305, locations facility: Panthera Biopartners - Enfield, status: NOT_YET_RECRUITING, city: Enfield Town, state: Greater London, country: United Kingdom, geoPoint lat: 51.65147, lon: -0.08497, locations facility: Re:Cognition Health - London, status: NOT_YET_RECRUITING, city: London, state: Greater London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: St. Pancras Clinical Research Ltd., status: NOT_YET_RECRUITING, city: London, state: Greater London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Panthera Bio-Partners - Rochdale, status: NOT_YET_RECRUITING, city: Rochdale, state: Greater Manchester, country: United Kingdom, geoPoint lat: 53.61766, lon: -2.1552, locations facility: Re:Cognition Health - Winchester, status: NOT_YET_RECRUITING, city: Winchester, state: Hampshire, country: United Kingdom, geoPoint lat: 51.06513, lon: -1.3187, locations facility: Neuroclin Glasgow, status: NOT_YET_RECRUITING, city: Motherwell, state: Lanarkshire, country: United Kingdom, geoPoint lat: 55.78924, lon: -3.99187, locations facility: Panthera Bio-Partners - Preston, status: NOT_YET_RECRUITING, city: Preston, state: Lancashire, country: United Kingdom, geoPoint lat: 53.76282, lon: -2.70452, locations facility: Re:Cognition Health - Guildford, status: NOT_YET_RECRUITING, city: Guildford, state: Surrey, country: United Kingdom, geoPoint lat: 51.23536, lon: -0.57427, locations facility: Re:Cognition Health - Birmingham, status: NOT_YET_RECRUITING, city: Birmingham, state: West Midlands, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Panthera Biopartners - Sheffield, status: NOT_YET_RECRUITING, city: Sheffield, state: Yorkshire, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, locations facility: Re:Cognition Health - Bristol, status: NOT_YET_RECRUITING, city: Bristol, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, hasResults: False
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protocolSection identificationModule nctId: NCT06335160, orgStudyIdInfo id: Mebendazole Ulcerative Colitis, briefTitle: Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine, conditionsModule conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Mebendazole, outcomesModule primaryOutcomes measure: change in disease activity, primaryOutcomes measure: change in Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity, secondaryOutcomes measure: Change in Hemoglobin Concentration, secondaryOutcomes measure: Change in Erythrocyte sedimentation rate (ESR), secondaryOutcomes measure: Change in Serum albumin, secondaryOutcomes measure: Change in Serum Interleukin -6 (IL-6), secondaryOutcomes measure: Change in Serum Nitric oxide (NO), secondaryOutcomes measure: Change in Serum Intra cellular adhesion molecule 1 (ICAM-1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06335147, orgStudyIdInfo id: HLX10IIT114, briefTitle: PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6 neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched pro-inflammatory pan macrophage subpopulations, conditionsModule conditions: Metastatic Colon Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab, mFOLFOX6, outcomesModule primaryOutcomes measure: pathologic complete response（pCR）, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: 2-year overall survival rate, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335134, orgStudyIdInfo id: SCW0502-1016, briefTitle: A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-14, primaryCompletionDateStruct date: 2024-01-08, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Hangzhou Sciwind Biosciences Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin, conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: XW003 injection, interventions name: Metformin, interventions name: Warfarin, interventions name: Rosuvastatin, interventions name: Digoxin, outcomesModule primaryOutcomes measure: Pharmacokinetics of metformin: AUC0-inf, primaryOutcomes measure: Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf, primaryOutcomes measure: Pharmacokinetics of rosuvastatin: AUC0-inf, primaryOutcomes measure: Pharmacokinetics of digoxin: AUC0-inf, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Second University Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Qin Yu, role: CONTACT, phone: 02885503960, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06335121, orgStudyIdInfo id: 21120602, secondaryIdInfos id: 1R01MH134264, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MH134264, briefTitle: Implementation of PrEP Care Among Women in Family Planning Clinics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Rush University Medical Center, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), collaborators name: University of Illinois at Chicago, collaborators name: Planned Parenthood of Illinois, descriptionModule briefSummary: This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers., conditionsModule conditions: PrEP Uptake, conditions: HIV, conditions: Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: POWER Up strategies -, outcomesModule primaryOutcomes measure: PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP., secondaryOutcomes measure: Receipt of PrEP refills among Black women accessing FP services at 6 months., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335108, orgStudyIdInfo id: SenoEx_TLA_Maligne, briefTitle: Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 ), statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-05, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery., conditionsModule conditions: Breast Carcinoma, conditions: Breast Carcinoma in Situ, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: General Anaesthesia, interventions name: Local tumescent anaesthesia, outcomesModule primaryOutcomes measure: Postoperative Pain, secondaryOutcomes measure: HRQoL/ Quality of life, secondaryOutcomes measure: Postoperative pain medication requirements, secondaryOutcomes measure: Complications, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Drainage delivery rate, secondaryOutcomes measure: Follow-up surgery for R1 situation, secondaryOutcomes measure: Preoperative fear of surgery and anaesthesia, secondaryOutcomes measure: Costs, secondaryOutcomes measure: Satisfaction of the surgeon with the course of the operation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Women's Hospital, status: RECRUITING, city: Tübingen, zip: 72076, country: Germany, contacts name: Bettina Böer, Dr., role: CONTACT, phone: +49 7071 29 82211, email: Bettina.Boeer@med.uni-tuebingen.de, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
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protocolSection identificationModule nctId: NCT06335095, orgStudyIdInfo id: a319, briefTitle: Gait Analysis and Degenerative Spine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Universidade Nova de Lisboa, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:* What are the biomechanical variables affected by the disease* How they evolve with disease progression and treatment, conditionsModule conditions: Spinal Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Kinematic sensors, outcomesModule primaryOutcomes measure: Change from baseline in gait parameter - speed (m/s) - at 3 months, primaryOutcomes measure: Change from baseline in gait parameter - speed (m/s) - at 6 months, primaryOutcomes measure: Change from baseline in gait parameter - speed (m/s) - at 12 months, primaryOutcomes measure: Change from baseline in gait parameter - step length (m) - at 3 months, primaryOutcomes measure: Change from baseline in gait parameter - step length (m) - at 6 months, primaryOutcomes measure: Change from baseline in gait parameter - step length (m) - at 12 months, primaryOutcomes measure: Change from baseline in gait parameter - step width (m) - at 3 months, primaryOutcomes measure: Change from baseline in gait parameter - step width (m) - at 6 months, primaryOutcomes measure: Change from baseline in gait parameter - step width (m) - at 12 months, secondaryOutcomes measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months, secondaryOutcomes measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months, secondaryOutcomes measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months, secondaryOutcomes measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months, secondaryOutcomes measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months, secondaryOutcomes measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months, secondaryOutcomes measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06335082, orgStudyIdInfo id: DISRUPT-AF, briefTitle: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF, acronym: DISRUPT-AF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Heart Rhythm Clinical and Research Solutions, LLC, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Pulsed Field Ablation, outcomesModule primaryOutcomes measure: Long term effectiveness, primaryOutcomes measure: Long-term safety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arrhythmia Institute at Grandview, city: Birmingham, state: Alabama, zip: 35243, country: United States, contacts name: Anil Rajendra, MD, role: CONTACT, phone: 205-971-7578, email: arajendra@alcardio.com, contacts name: Susan Thorington, role: CONTACT, phone: 205-971-7578, email: susan.thorington@grandviewhealth.com, contacts name: Anil Rajendra, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Community Memorial Health Systems, city: Ventura, state: California, zip: 93003, country: United States, contacts name: Jonathan Dukes, MD, role: CONTACT, phone: 805-653-0101, email: jonathan_dukes@mac.com, contacts name: Jennifer Freeland, role: CONTACT, phone: 805-948-8278, email: jfreeland@cmhshealth.org, contacts name: Jonathan Dukes, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.27834, lon: -119.29317, locations facility: Endeavor Health (Northshore), city: Glenview, state: Illinois, zip: 60026, country: United States, contacts name: Mark Metzl, MD, role: CONTACT, phone: 847-570-2640, email: mmetzl@northshore.org, contacts name: Marisa Durante, role: CONTACT, phone: 847-687-8527, email: mdurante@northshore.org, contacts name: Mark Metzl, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.06975, lon: -87.78784, locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Jorge Romero, MD, role: CONTACT, phone: 617-732-5241, email: jeromero@bwh.harvard.edu, contacts name: Fernando Moreno, role: CONTACT, phone: 617-732-5241, email: fmoreno2@bwh.harvard.edu, contacts name: Jorge Romero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Cardiovascular Associates of Delaware Valley, city: Haddon Heights, state: New Jersey, zip: 08035, country: United States, contacts name: George Mark, MD, role: CONTACT, phone: 856-546-3003, email: gmark4@yahoo.com, contacts name: Erin Siderio, role: CONTACT, phone: 856-582-2000, phoneExt: 5207, email: esiderio@hearthousenj.com, contacts name: George Mark, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.87734, lon: -75.06462, locations facility: Texas Cardiac Arrhythmia Research Foundation (St. Davids), city: Austin, state: Texas, zip: 78705, country: United States, contacts name: Andrea Natale, MD, role: CONTACT, phone: 512-522-9410, email: tcarfan@gmail.com, contacts name: Deb Cardinal, RN, role: CONTACT, phone: 512-431-4868, email: dscardinal@austinheartbeat.com, contacts name: Andrea Natale, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.26715, lon: -97.74306, hasResults: False
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protocolSection identificationModule nctId: NCT06335069, orgStudyIdInfo id: 2023-508066-15-00, briefTitle: 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients., conditionsModule conditions: Breast Cancer, conditions: Breast Neoplasms, conditions: Breast Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-group, single-center pilot study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI, outcomesModule primaryOutcomes measure: To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer., secondaryOutcomes measure: To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center+, city: Maastricht, zip: 5800, country: Netherlands, contacts name: Thiemo JA van Nijnatten, MD, PhD, role: CONTACT, email: thiemo.nijnatten@mumc.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
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protocolSection identificationModule nctId: NCT06335056, orgStudyIdInfo id: IRBAM-21-0702, secondaryIdInfos id: 1R15HD108765-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R15HD108765-01A1, briefTitle: Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools, acronym: ProudMe, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Louisiana State University and A&M College, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: Pennington Biomedical Research Center, collaborators name: Texas A&M University, collaborators name: University of Nevada, Las Vegas, descriptionModule briefSummary: This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost., conditionsModule conditions: Treatment (ProudMe), conditions: Waitlist Control, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: ProudMe, interventions name: Waitlist Control, outcomesModule primaryOutcomes measure: Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers, primaryOutcomes measure: Screen time, primaryOutcomes measure: Food environment, secondaryOutcomes measure: Body mass index z score, secondaryOutcomes measure: Waist circumference, otherOutcomes measure: Activity self-efficacy, otherOutcomes measure: Self-monitoring, otherOutcomes measure: Social support, otherOutcomes measure: School Wellness Policy, otherOutcomes measure: Cafeteria Nutrition, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: LSU Pedagogical Kinesiology Lab, city: Baton Rouge, state: Louisiana, zip: 70803, country: United States, geoPoint lat: 30.45075, lon: -91.15455, hasResults: False
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protocolSection identificationModule nctId: NCT06335043, orgStudyIdInfo id: 119245, briefTitle: Personalized Pharmacotherapy Using Pharmacogenetics in Veterans, acronym: PGx, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation., conditionsModule conditions: Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 155, type: ESTIMATED, armsInterventionsModule interventions name: Pharmacogenetics Testing, outcomesModule primaryOutcomes measure: PHQ-9 - Patient Health Questionnaire 9, primaryOutcomes measure: GAD-7 - General Anxiety Disorder-7, primaryOutcomes measure: PCL-5 - Posttraumatic Stress Disorder Checklist - 5, primaryOutcomes measure: OQ-45 - Outcome Questionnaire 45, primaryOutcomes measure: Pharmacological Side Effect Measure, primaryOutcomes measure: Electronic Medical Record Extraction Measure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06335030, orgStudyIdInfo id: 2.1_AUT-SP2_001_Tancredi, briefTitle: Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-03-29, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, collaborators name: Ospedale Borgo Trento - Verona, collaborators name: Università degli Studi di Trento, descriptionModule briefSummary: Brief Summary: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder (ASD), both on an individual level, both on family and social ones .Children (2-6 years) diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM5) criteria were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers. Regarding this sample, principal aims of the study are to describe characteristics of food selectivity, to evaluate its correlation with ASD symptoms, with cognitive and adaptive functioning of ASD preschoolers, to describe its impact on parental stress., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Child Oral and Motor Proficiency Scale (ChOMPS), primaryOutcomes measure: Brief Autism Mealtime Behavior Inventory (BAMBI), primaryOutcomes measure: Sensory Profile 2 (SP2), primaryOutcomes measure: Child Behavior Checklist (CBCL), primaryOutcomes measure: Parenting Stress Index (PSI), primaryOutcomes measure: Observation of child meal-time, primaryOutcomes measure: Food Diary, primaryOutcomes measure: Gastrointestinal severity symptom index (GSSI), primaryOutcomes measure: Mac Arthur, secondaryOutcomes measure: Autism Quotient (AQ), secondaryOutcomes measure: Autism Diagnostic Observation Schedule-2 (ADOS-2), secondaryOutcomes measure: Vineland-II scales (VABS II), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Stella Maris, status: RECRUITING, city: Pisa, state: PI, zip: 56128, country: Italy, contacts name: Raffaella Tancredi, role: CONTACT, phone: +39050886292, email: raffaella.tancredi@fsm.unipi.it, contacts name: Roberta Nencioli, role: CONTACT, phone: +39050886347, email: roberta.nencioli@fsm.unipi.it, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione, status: TERMINATED, city: Rovereto, zip: 38068, country: Italy, geoPoint lat: 45.8904, lon: 11.04053, locations facility: Azienda Ospedaliera Borgo Trento, status: TERMINATED, city: Verona, zip: 37126, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False
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protocolSection identificationModule nctId: NCT06335017, orgStudyIdInfo id: 294-2024-HFH, briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Holy Family Hospital, Nazareth, Israel, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in multiparous women.The main question it aims to answer are:Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline.In the control group, the catheter will be inserted into cervical canal without ingestion of castor oil., conditionsModule conditions: Induction of Labor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: Induction of labor, outcomesModule primaryOutcomes measure: time to delivery, secondaryOutcomes measure: balloon expulsion time, secondaryOutcomes measure: Bishop score at catheter expulsion, secondaryOutcomes measure: Number of women that will have non-vertex presentation after removal of the catheter, secondaryOutcomes measure: Duration of active phase, secondaryOutcomes measure: Duration of second stage, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Indications for cesarean or vacuum deliveries, secondaryOutcomes measure: Number of patients that will have intrapartum fever ≥ 38 °C, secondaryOutcomes measure: Number of patients that will require use of intrapartum use of antibiotic treatment, secondaryOutcomes measure: Number of Participants with that will develop clinical signs of chorioamnionitis., secondaryOutcomes measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations., secondaryOutcomes measure: Number of Participants with develop postpartum hemorrhage., secondaryOutcomes measure: Number of Participants with need blood transfusion., secondaryOutcomes measure: Number of women that will have side effects related to castor oil use, secondaryOutcomes measure: Oxytocin dosage, secondaryOutcomes measure: Number of participants with Umbilical Cord prolapse., secondaryOutcomes measure: Number of neonates that will have Apgar score (range 0 to 10) <7., secondaryOutcomes measure: number of women with cord artery pH <7.1, secondaryOutcomes measure: Neonatal birthweight, secondaryOutcomes measure: Number of neonates with Neonatal fever ≥ 38 °C, secondaryOutcomes measure: The number of neonates that will develop neonatal sepsis., secondaryOutcomes measure: The number of neonates that will require antibiotic treatment., secondaryOutcomes measure: number of neonates with any neonatal complications, secondaryOutcomes measure: The number of neonates that will Admit to neonatal intensive care unit (NICU), secondaryOutcomes measure: Length of stay in NICU., secondaryOutcomes measure: Number of neonatal death, secondaryOutcomes measure: Maternal hemoglobin level after delivery., secondaryOutcomes measure: Number of participants that will require postpartum hysterectomy., secondaryOutcomes measure: Number of participants that will require postpartum laparotomy., secondaryOutcomes measure: Number of women that will develop postpartum complications, secondaryOutcomes measure: The length of stay from birth to discharge home., secondaryOutcomes measure: Maternal satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Holy Family hospital, Nazareth, status: RECRUITING, city: Nazareth, country: Israel, contacts name: Wiaam Khatib, MD, role: CONTACT, phone: 0549192433, email: wiaam.khatib.95@gmail.com, contacts name: Raed Salim, MD, role: CONTACT, email: r.salim@hfhosp.org, contacts name: Wiaam Khatib, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.69925, lon: 35.30483, hasResults: False
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protocolSection identificationModule nctId: NCT06335004, orgStudyIdInfo id: 926, briefTitle: Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods., conditionsModule conditions: Glymphatic System, conditions: White Matter Disease, conditions: Pediatric Disorder, conditions: Perivascular Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance imaging, outcomesModule primaryOutcomes measure: Extent of white matter lesions, primaryOutcomes measure: Number of perivascular spaces, primaryOutcomes measure: Volume of parasagittal dural space, eligibilityModule sex: ALL, minimumAge: 9 Months, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Institute IRCCS Eugenio Medea, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, geoPoint lat: 45.80075, lon: 9.29, hasResults: False
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protocolSection identificationModule nctId: NCT06334991, orgStudyIdInfo id: QUILT-106, briefTitle: Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: ImmunityBio, Inc., class: INDUSTRY, descriptionModule briefSummary: Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL)., conditionsModule conditions: Non-Hodgkin Lymphoma Refractory/ Relapsed, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study is open label, for Refractory/ Relapsed Non-Hodgkin Lymphoma. Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: CD19 t-haNK, outcomesModule primaryOutcomes measure: Overall safety evaluation in combining CD19 t haNK as a single agent with rituximab, primaryOutcomes measure: Incidence of treatment-emergent AEs (TEAEs) and serious AEs (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 5.0.Clinically important changes in safety laboratory tests and vital signs., secondaryOutcomes measure: Best tumor response in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334978, orgStudyIdInfo id: 1-2024, briefTitle: The Effectiveness of Osteopathic Treatment in Cervical Whiplash., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-13, primaryCompletionDateStruct date: 2022-07-10, completionDateStruct date: 2022-08-10, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Hospital San Juan de Dios del Aljarafe de Sevilla, class: OTHER, collaborators name: Hospital Universitario Virgen Macarena, collaborators name: University of Seville, descriptionModule briefSummary: Introduction. Whiplash is common after road traffic accidents and affects millions of people worldwide; 50% develop chronic symptoms and 15% have their ability to work compromised. The aim of this study was to evaluate an osteopathic intervention in whiplash and determine whether pain, mobility and quality of life improve with respect to conventional treatment.Methodology. A randomised, controlled clinical trial between 13/01/2021_10/08/2022 conducted at Hospital San Juan de Dios del Aljarafe. The control group followed the hospital's protocol, and the experimental group also received an osteopathic intervention. Statistical analysis: Statistical Package for the Social Sciences (SPSS-vs27.0); intra-subject comparison: Student's t-test for dependent samples, Wilcoxon's test; inter-group comparisons: Student's t-test for independent samples, Mann-Whitney U, chi-squared., conditionsModule conditions: Whiplash Injury of Cervical Spine, conditions: Osteopathia, conditions: Quality of Life, conditions: Chronic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Randomised controlled clinical trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: The study was blinded: patients were unaware of the group to which they had been assigned. Patient evaluations at the start and end were performed by a physiotherapist different to the one performing the intervention, who was also unaware of the patient assignment. The same person performed all therapies for both the control and intervention groups and was unaware of the pre-intervention measurements. The statistician who analysed the data was also unaware of the group to which each patient belonged., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: Osteopathic intervention, outcomesModule primaryOutcomes measure: Cervical Pain, primaryOutcomes measure: Quality of life in Whiplash Disability, primaryOutcomes measure: Functionality-Neck Disability Index, secondaryOutcomes measure: Number of sites, secondaryOutcomes measure: Number of analgesics, otherOutcomes measure: Measuring mobility using inclinometry, otherOutcomes measure: Measurement of pressure pain using algometry, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: María Victoria RUIZ ROMERO, city: Bollullos de la Mitación, state: Sevilla, zip: 41110, country: Spain, geoPoint lat: 37.34014, lon: -6.13719, hasResults: False
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protocolSection identificationModule nctId: NCT06334965, orgStudyIdInfo id: APHP230279, briefTitle: Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort, acronym: OPERANDI-HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Radioembolization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Simultaneous 18F-Choline PET-MRI, outcomesModule primaryOutcomes measure: Clinical response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beaujon hospital, city: Clichy, country: France, contacts name: Mohamed BOUATTOUR, role: CONTACT, geoPoint lat: 48.90018, lon: 2.30952, locations facility: CHU Nantes, city: Nantes, country: France, contacts name: Yann TOUCHEFEU, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
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protocolSection identificationModule nctId: NCT06334952, orgStudyIdInfo id: RCAPHM23_0074, secondaryIdInfos id: ID-RCB, type: OTHER, domain: 2023-A02482-43, briefTitle: Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic, acronym: GALVANI GS-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique Hopitaux De Marseille, class: OTHER, collaborators name: CRMBM-CEMEREM, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France - LTSI, collaborators name: Neuroelectrics Corporation, descriptionModule briefSummary: The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are:* Changes in quality of life* Percent of newly reported side effects after the stimulation period* Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total)., conditionsModule conditions: Epilepsy, conditions: Drug Resistant Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: transcranial direct current stimulation, outcomesModule primaryOutcomes measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference., primaryOutcomes measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference., primaryOutcomes measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference., primaryOutcomes measure: To obtain a significant seizure frequency change at the end of tDCS sessions compared to the seizure frequency calculated in the pre-treatment period of reference., secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluation of the number of responders (defined as patient with >50% of seizure reduction), secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Evaluate the number of seizure-free patients, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Quality of life after stimulation sessions with the baseline period, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Evaluation of the change in seizure severity, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Changes in psychiatric comorbidities, secondaryOutcomes measure: Safety assessment and possible side effects, secondaryOutcomes measure: Safety assessment and possible side effects, secondaryOutcomes measure: Safety assessment and possible side effects, secondaryOutcomes measure: Safety assessment and possible side effects, otherOutcomes measure: Compare brain functional connectivity before and after tDCS treatment, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes (IESs), otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, otherOutcomes measure: Evaluation of the impact of tDCS on interictal epileptic spikes, eligibilityModule sex: ALL, minimumAge: 9 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Neurophysiologie Clinique de l'Enfant et de L'Adulte, Pôle de Neurosciences Cliniques, city: Bordeaux, zip: 33000, country: France, contacts name: Jerome Aupy, role: CONTACT, email: Jerome.aupy@chu-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Département Neurologie Fonctionnelle et Epilepsie, Hôpital neurologique - Hospices Civils de Lyon, city: Bron, zip: 69677, country: France, contacts name: Sylvain Rheims, role: CONTACT, email: Sylvain.rheims@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Service de Neurophysiologie clinique - Hôpital Roger Salengro, CHU Lille, city: Lille, zip: 59037, country: France, contacts name: Philippe Derambure, role: CONTACT, email: Philippe.Derambure@chru-lille.fr, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Service Epileptologie et Rythmologie Cérébrale, Hôpital La Timone, city: Marseille, zip: 13005, country: France, contacts name: Fabrice Bartolomei, role: CONTACT, email: Fabrice.bartolomei@ap-hm.fr, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Service de Neurophysiologie clinique - GHU Psychiatrie et Neurosciences Sainte-Anne, city: Paris, zip: 75014, country: France, contacts name: Martine Gavaret, role: CONTACT, email: m.gavaret@ghu-paris.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Service de Neurologie - CHU de Rennes - Hôpital Pontchaillou, city: Rennes, zip: 35033, country: France, contacts name: Anca Nica, role: CONTACT, email: Anca.nica@chu-rennes.fr, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Explorations neurophysiologiques - Pôle neurosciences, CHU de Toulouse, Hôpital Pierre Paul Riquet, city: Toulouse, zip: 31059, country: France, contacts name: Luc Valton, role: CONTACT, email: valton.l@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
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protocolSection identificationModule nctId: NCT06334939, orgStudyIdInfo id: KSH.2023-32, briefTitle: Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Ahmet Yuksek, class: OTHER_GOV, descriptionModule briefSummary: Emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. This situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. Recovery agitation may occur when the patient begins to recover and is usually a short-term condition. It resolves spontaneously. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient\&#39;s condition and relaxation. Rapid recovery from anesthesia in the clinic is also a risk factor for agitation.When the literature is examined, there are not enough studies on Bis suppression ratio and its relationship with recovery agitation is not yet known enough. For this purpose, our study aimed to question this relationship., conditionsModule conditions: Emergence Agitation, conditions: Anesthesia Recovery, conditions: Bispectral Index Monitor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Bispectal index Monitoring, outcomesModule primaryOutcomes measure: Relationship between BIS SR value and Emergence Agitation, secondaryOutcomes measure: Relationship between average and lowest BIS values and Emergence agitation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli City Hospital, status: RECRUITING, city: Kocaeli, state: Izmıt, zip: 41100, country: Turkey, contacts name: Mehmet Yilmaz, Associate Proffessor, role: CONTACT, phone: 505-217-4432, email: drmyilmaz33@gmail.com, contacts name: Ahmet Yuksek, Md, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False
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protocolSection identificationModule nctId: NCT06334926, orgStudyIdInfo id: EK 18-002-VK, briefTitle: BMI and Lymph Node Count in Colorectal Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-12-01, primaryCompletionDateStruct date: 2020-03-31, completionDateStruct date: 2020-03-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Klinikum Floridsdorf, class: OTHER, collaborators name: Medical University of Vienna, collaborators name: Klinik Favoriten, collaborators name: Salzkammergut Klinikum Vöcklabruck, descriptionModule briefSummary: Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS., conditionsModule conditions: The Aim of This Study is to Determine the Influence of BMI and Lymph Node Status on OS in CRC Patients in the Long Term, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1192, type: ACTUAL, armsInterventionsModule interventions name: no intervention, retrospective data analysis, outcomesModule primaryOutcomes measure: overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinik Floridsdorf, city: Wien, zip: 1210, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06334913, orgStudyIdInfo id: IRAS 332286, briefTitle: A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Guy's and St Thomas' NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The investigators will assess the use of a smart phone app to monitor patient reported outcomes and record biometric data in patients with myeloproliferative neoplasms., conditionsModule conditions: Myeloproliferative Neoplasm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Patient reported outcomes - Myeloproliferative Neoplasm-10 Total Symptom Score, secondaryOutcomes measure: Healthcare adherence, secondaryOutcomes measure: Biometric data analysis - activity index, secondaryOutcomes measure: Biometric data analysis - sleep score, secondaryOutcomes measure: Biometric data analysis - heart rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334900, orgStudyIdInfo id: 69HCL24_0297, briefTitle: Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia, acronym: Ata-GAD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms., conditionsModule conditions: GAD-receptor Antibodies-associated Encephalitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: GAD patients, outcomesModule primaryOutcomes measure: GAD Patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est, status: RECRUITING, city: Bron, zip: 69677, country: France, contacts name: Jérôme Honnorat, professor, role: CONTACT, phone: +33 4 72 35 78 06, email: jerome.honnorat@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False
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protocolSection identificationModule nctId: NCT06334887, orgStudyIdInfo id: PID2021-124409OB-I00_O3, briefTitle: esTOCma, an App Used by Teachers: an RCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, collaborators name: Ministry of Science and Innovation, descriptionModule briefSummary: The aim of the present study is to assess the efficacy of a mobile application called esTOCma in promoting mental health literacy, reducing stigmatizing attitudes related to the Obsessive-Compulsive Disorder (OCD) and improving teachers' confidence in dealing with students that might have OCD. A parallel, randomized controlled trial with two conditions (experimental and control group) will be carried out in a sample of teachers that work in primary and secondary education. Pre-post changes will be assessed. Experimental group will use the app until they finish it (within a set period of 10 days), whereas control group will do nothing for 10 days. Primarily, it is expected that after the use of the app, participants will show an improvement in OCD-related literacy, stigmatizing attitudes, desired social distance and their comfort, confidence and perceived ability in teaching and handling students with OCD. Secondarily, the investigators hypothesize that experimental group might show a reduction in obsessive-compulsive symptoms., conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A parallel randomized controlled trial (RCT) with two arms: experimental group (use of esTOCma) and control group (untreated) will be carried out.As participants enroll in the study, those that meet the inclusion criteria will be randomized into experimental or control group and into contamination or aggressive vignette (see Outcome Measures). Everyone will complete the baseline measures (T1). Then, those assigned to experimental group will use the app esTOCma until they finish it (they will be given a 10-days deadline), whereas control group will do nothing for 10 days. After that, all the participants will complete again the assessment instruments (T2)., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Use of esTOCma, outcomesModule primaryOutcomes measure: Change in general OCD literacy, primaryOutcomes measure: Change in OCD literacy associated with a vignette, primaryOutcomes measure: Change in stigmatizing attitudes related to OCD associated with a vignette, primaryOutcomes measure: Change in comfort in addressing OCD, primaryOutcomes measure: Change in desired social distance, secondaryOutcomes measure: Change in obsessive-compulsive symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Valencia/ Universitat de València, status: RECRUITING, city: Valencia, zip: 46010, country: Spain, contacts name: Gemma Garcia-Soriano, PhD, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06334874, orgStudyIdInfo id: REC-FPFUE-32/2023, briefTitle: Study of the Efficacy and Safety of Antioxidants Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Future University in Egypt, class: OTHER, descriptionModule briefSummary: Community acquired pneumonia (CAP) is one of the most common and morbid conditions encountered in clinical practice, which causes serious morbidity worldwide. In CAP, oxidative stress is linked to inflammation, demonstrated by increased production of interleukin (IL)-6 and tumor necrosis factor (TNF)-α, which attract inflammatory cells and increase oxidant production by these cells. Attenuation of oxidative stress via antioxidants would be expected to result in reduced pulmonary damage. Antioxidants have been found to be effective in alleviating lung injury and protecting against damage of other organs., conditionsModule conditions: Community-acquired Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Astaxanthin Oral Capsule, interventions name: Placebo, outcomesModule primaryOutcomes measure: change in IL-6 after treatment in the ASX group compared with those in the control group., primaryOutcomes measure: change in IL-10 after treatment in the ASX group compared with those in the control group., primaryOutcomes measure: change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group., secondaryOutcomes measure: difference in CURB 65 scores after treatment in the ASX group compared with the control group., secondaryOutcomes measure: o Adverse drug reactions related to ASX as increase bowel movement, stomach pain and increase PT and APTT will be assessed., secondaryOutcomes measure: Length of hospital and ICU stay., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elmatarya Teaching Hospital, status: RECRUITING, city: Cairo, zip: 4650201, country: Egypt, contacts name: fatma makram, role: CONTACT, phone: 01015000329, email: fatma.aboelhassan@fue.edu.eg, contacts name: eman elmokadam, role: CONTACT, email: Eman.abdellatif@fue.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06334861, orgStudyIdInfo id: 5001, briefTitle: Multidisciplinary Hospital-Territory Vaccine Center: a Model for Achieving the Herpes Zoster Vaccine Coverage, acronym: CeVOT-Her-Zo, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-23, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The National Vaccination Program, updated by the Ministry of Health in 2021, provides a new vaccination opportunity for frail patients against Herpes zoster virus (HZ). The new treatment option, on the other hand, is designed by combining VZV-specific antigen (gE) with an adjuvant system (AS01B) to induce antigen-specific cellular and humoral immune responses in individuals with preexisting immunity to VZV. Efficacy, assessed in people given two doses 2 months apart, is around 97% in those aged 50 years and 91% in those over 70 years. In the studies conducted, HZ-related hospitalizations were significantly reduced. The vaccine schedule calls for the administration of two doses 2 months apart. The current HZ Vaccination Program implemented at the regional level recommends its active and free offer in people from 18 years of age with congenital and/or acquired immunodepression, through a collaborative relationship involving, on the one hand, multispecialist and multiprofessional medical staff and, on the other hand, citizens called to play a role that is no longer passive but the subject of empowerment by consciously making their own health choices. The collaboration with ASL Roma1, in this sense, acquires value as guarantor of the supply of the adjuvanted recombinant anti-HZ vaccine and of the appropriate reporting of vaccination coverage, which to date is still far from the targets set by the PNPV'17-'19 in adults at risk for disease.The purpose of this study Single-center prospective longitudinal observational cohort study is to verify patients' compliance with the proposed vaccination, the effectiveness of counseling carried out by a multidisciplinary team in the hospital setting., conditionsModule conditions: Herpes Zoster, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Herpes Zoster adjuvanted recombinant vaccine, outcomesModule primaryOutcomes measure: Compliance to vaccination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli - UCSC, status: RECRUITING, city: Roma, state: RM, zip: 00168, country: Italy, contacts name: Patrizia Laurenti, MD PHD, role: CONTACT, email: patrizia.laurenti@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06334848, orgStudyIdInfo id: TOT versus mini sling, briefTitle: Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence., conditionsModule conditions: Stress Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: transobturator tape, outcomesModule primaryOutcomes measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications, primaryOutcomes measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain, secondaryOutcomes measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function, eligibilityModule sex: FEMALE, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334835, orgStudyIdInfo id: 1/23 OSS SDN, briefTitle: Long Non-coding RNAs and Their Role on Epigenome as Diagnostic Markers in Childhood Acute Lymphoblastic Leukemia of T Cells., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-30, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: IRCCS SYNLAB SDN, class: OTHER, collaborators name: Fondazione Santobono Pausilipon, descriptionModule briefSummary: Long non-coding RNAs (lncRNAs) are a class of biomarkers of crescent interest in the hematologic and oncologic field.They do not encode proteins and can alter gene expression by acting on different steps of regulation, including DNA methylation and chromatin structure. Recent data identified recurrent somatic alterations in genes involved in DNA methylation and post-translational histone modifications in T-ALL, suggesting that epigenetic homeostasis is critically required in restraining tumor development in the T-cell lineage. Further, recent studies showed that the expression levels of specific lncRNAs correlate with the prognosis of patients with Acute Lymphoblastic Leukemia of T-cells (T-ALL). The objectives of this research project are to identify T-ALL-specific lncRNAs to be used as new diagnostic and prognostic biomarkers of disease and to explore their role on chromatin reorganization and transcriptional regulation that may lead to the onset and progression of T-ALL., conditionsModule conditions: Acute Lymphoblastic Leukemia, Pediatric, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: lncRNA signature analyses, outcomesModule primaryOutcomes measure: Evaluation of the expression of selected lncRNAs in pediatric T-ALL patients and cellular models of T-ALL, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Irccs Synlab Sdn, status: RECRUITING, city: Naples, zip: 80143, country: Italy, contacts name: Giovanni Smaldone, PhD, role: CONTACT, phone: 3398768331, email: giovanni.smaldone@synlab.it, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
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protocolSection identificationModule nctId: NCT06334822, orgStudyIdInfo id: HFT-2024-01, briefTitle: Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK., acronym: HF-TRACK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Heartfelt Technologies, class: INDUSTRY, descriptionModule briefSummary: The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization.Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly.The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy.This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This 6-month study involves up to 210 patients using the Heartfelt device at home. It is a crossover trial with a 21-day break between two 69-day periods to prevent overlap effects. Patients will either receive standard care or standard care plus Heartfelt alerts. The Heartfelt group is further divided into three 23-day sub-studies to test different alert systems.Another 60 patients will have monthly measurements taken at the pharmacy without being part of the main randomisation., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Only outcomes assessors will be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Heartfelt Device installed, interventions name: Standard care, interventions name: Questionnaires, interventions name: Heartfelt Device in pharmacy, interventions name: Heartfelt device alerting system, outcomesModule primaryOutcomes measure: All-Cause Mortality Rate., primaryOutcomes measure: Heart Failure Hospitalisation Incidence., primaryOutcomes measure: Device-Related Complication Rate., secondaryOutcomes measure: Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices, secondaryOutcomes measure: Hospital Admission Duration, secondaryOutcomes measure: Cause of Hospitalization, secondaryOutcomes measure: Date of Changes in HF Medication Post-Discharge, secondaryOutcomes measure: Changes in dosage of HF Medication Post-Discharge, secondaryOutcomes measure: Cause of Death, secondaryOutcomes measure: Date of Death, secondaryOutcomes measure: Loss of Independence, secondaryOutcomes measure: Hospitalisation Admission Route, secondaryOutcomes measure: Scheduling of Care Events, secondaryOutcomes measure: Setting of Care Events, secondaryOutcomes measure: Timestamp of Health Alerts Generated by the Heartfelt Device, secondaryOutcomes measure: Frequency of Health Alerts Generated by the Heartfelt Device, secondaryOutcomes measure: Foot volume, secondaryOutcomes measure: Peripheral oedema grading, secondaryOutcomes measure: Weight, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr R Raut & Partnership (General Practice), city: Hull, state: East Riding Of Yorkshire, zip: HU7 5DD, country: United Kingdom, contacts name: Rajeev Raut, MD, role: CONTACT, phone: +441482 835880, email: HF-TRACK@hftech.org, contacts name: Rajeev Raut, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.7446, lon: -0.33525, hasResults: False
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protocolSection identificationModule nctId: NCT06334809, orgStudyIdInfo id: 028FPO22, briefTitle: INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations, acronym: INSIDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-09, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Fondazione del Piemonte per l'Oncologia, class: OTHER, descriptionModule briefSummary: 400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as \>cT3 or PSA \> 20 ng/mL or presence of ECE or SVI at mpMRI;Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC);Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number, type and frequency of DDR and MMR germline/somatic alterations, primaryOutcomes measure: Changes in PSA levels in the 3 cohorts, secondaryOutcomes measure: Number of patient-derived preclinical models, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, status: RECRUITING, city: Candiolo, state: Turin, zip: 10060, country: Italy, contacts name: Pasquale Rescigno, MD, role: CONTACT, email: pasquale.rescigno@ircc.it, contacts name: Ilaria Buondonno, PhD, role: CONTACT, phone: +390119933393, email: ilaria.buondonno@ircc.it, geoPoint lat: 44.95858, lon: 7.59812, locations facility: AOU San Luigi Gonzaga, status: RECRUITING, city: Orbassano, state: Turin, zip: 10060, country: Italy, contacts name: Francesco Porpiglia, MD, role: CONTACT, geoPoint lat: 45.00547, lon: 7.53813, hasResults: False
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protocolSection identificationModule nctId: NCT06334796, orgStudyIdInfo id: 10476, briefTitle: Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology, acronym: AIDEN, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia, class: OTHER, collaborators name: Entelai, descriptionModule briefSummary: This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. In a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. Neurologists first reviewed the AI's recommendations using clinical records and then assessed its performance directly with patients. The findings were as follows: neurologists agreed with the AI's decisions nearly all the time, and the AI outperformed earlier versions of Chat GPT in every tested aspect. Patients and doctors found the AI to be highly effective, rating it as excellent or very good in most cases. This suggests the AI could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used., conditionsModule conditions: Stroke, conditions: Guillain-Barre Syndrome, conditions: Facial Palsy, conditions: Migraine, conditions: Status Epilepticus, conditions: Vertigo Benign Positional, conditions: Delirium, conditions: Trigeminal Neuralgia, conditions: Meningitis, conditions: Subarachnoid Hemorrhage, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The model of this Phase 1 interventional study involves evaluating the diagnostic accuracy and utility of an AI-powered virtual assistant in the triage of emergency neurological conditions. Patients and healthcare professionals interacted with the assistant, providing real-world clinical scenarios to assess its effectiveness. The study's design aimed to demonstrate the assistant's potential to enhance emergency neurological care by comparing its performance with established diagnostic tools and patient outcomes., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Virtual Assistant, outcomesModule primaryOutcomes measure: Diagnostic performance, secondaryOutcomes measure: Appropriate medical conduct or recommendation, secondaryOutcomes measure: Assessment of Usability and Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fleni, city: Buenos Aires, zip: 1428, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, hasResults: False
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protocolSection identificationModule nctId: NCT06334783, orgStudyIdInfo id: HV-IIT, briefTitle: TIL for Patients With Advanced Solid Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Hervor Therapeutics, class: INDUSTRY, collaborators name: Jinling Hospital, China, collaborators name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, collaborators name: Women's Hospital School Of Medicine Zhejiang University, descriptionModule briefSummary: Background:Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients.TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.Objective:To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.Eligibility:Adults aging 18-75 with advanced solid tumor.Design:1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.2. Freshly resected patient tumors were dissected by the surgeon.3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.4. At last TIL cells will be re-infused into the patients., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Autologous tumor-infiltrating lymphocyte cells, outcomesModule primaryOutcomes measure: Safety of TIL, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, status: RECRUITING, city: Shenzhen, state: Guangdong, country: China, contacts name: Xiugui Sheng, PhD, role: CONTACT, email: hanxiuchen@yeah.net, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Nanjing Jinling Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Tangfeng Lv, PhD, role: CONTACT, phone: +86 25 8086 0114, email: bairoushui@163.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Wowen's hospital, School of medicine, Zhejiang University, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Hui Wang, PhD, role: CONTACT, email: 5198008@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06334770, orgStudyIdInfo id: FDASuRecD032136, briefTitle: Influence of Roxolid Implant Material on the Implant Stability Implant Stability, acronym: BLX, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-15, primaryCompletionDateStruct date: 2022-01-22, completionDateStruct date: 2023-12-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Fourteen completely edentulous patients were selected to participate in this study. From the outpatient clinic of Prosthodontic Department, Faculty of Dentistry, Ain Shams University.After fabrication of complete denture for all patients, patients were randomly divided to:Group A: Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX® implant were inserted opposed by mandibular complete denture.Group B: Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture.After implant placement using surgical guide, smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks, secondary stability was measured for both groups.After four months, the second stage started in which exposure of the implant fixtures took place and pick up was carried out.Patients were recalled frequently for post-insertion inspection and adjustment., conditionsModule conditions: Completely Edentulous Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Roxolid implants, interventions name: Titanium implants, outcomesModule primaryOutcomes measure: measuring primary at time of surgery, secondaryOutcomes measure: secondary implant stability after 6 weeks, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry of Dentistry Ainshams Univeristy, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06334757, orgStudyIdInfo id: HLX10IIT22, briefTitle: Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-08, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients., conditionsModule conditions: Non-Squamous Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab, interventions name: Bevacizumab Biosimilar HLX04, interventions name: Pemetrexed, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: ORR(Overall Response Rate), secondaryOutcomes measure: PFS(Progression Free Survival), secondaryOutcomes measure: OS(Overall Survival), secondaryOutcomes measure: AE(Adverse Event), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450003, country: China, contacts name: zhen he, role: CONTACT, phone: 13523530961, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
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protocolSection identificationModule nctId: NCT06334744, orgStudyIdInfo id: COVAR, briefTitle: Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-17, primaryCompletionDateStruct date: 2023-01-08, completionDateStruct date: 2023-06-08, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, descriptionModule briefSummary: To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine., conditionsModule conditions: Oncologic Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, outcomesModule primaryOutcomes measure: Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same., secondaryOutcomes measure: Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine, secondaryOutcomes measure: Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine., secondaryOutcomes measure: Evaluation of the incidence of local and systemic adverse reactions (ARs), directly or indirectly linked to the vaccine, in an observation period up to 4 weeks later the third dose of vaccine., secondaryOutcomes measure: Evaluation of the incidence of "New onset" immune-related adverse events (IRAEs), such as immune-related pruritus, rashes, hypophysitis, hepatitis, pneumonia, diarrhoea, colitis in patients undergoing immunotherapy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs San Matteo Pavia, city: Pavia, state: PV, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06334731, orgStudyIdInfo id: 045.PHA.2021.D, briefTitle: Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic., conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of third generation cephalosporin-resistant bacteria (3GCRB), secondaryOutcomes measure: Incidence of ESBLPE, secondaryOutcomes measure: Incidence of CRB, secondaryOutcomes measure: Incidence of other pathogens, secondaryOutcomes measure: Incidence of nosocomial infections, secondaryOutcomes measure: Incidence of clinical outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Dallas Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75203, country: United States, contacts name: Matthew Crotty, PharmD, role: CONTACT, phone: 214-941-2400, email: matthewcrotty@mhd.com, contacts name: Matthew Crotty, PharmD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06334718, orgStudyIdInfo id: 318417, secondaryIdInfos id: NIHR204382, type: OTHER_GRANT, domain: National Institute for Health and Care Research, briefTitle: Drone Delivered Defibrillators (The 3D Project)., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-08-22, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Warwick, class: OTHER, collaborators name: Welsh Ambulance Service NHS Trust, descriptionModule briefSummary: The goal of this observational study is to explore the optimisation and integration of a drone-delivered Automated External Defibrillator (AED) system into the pre-hospital response to out-of-hospital cardiac arrest. The study is being conducted by the University of Warwick and Welsh Ambulance Service National Health Service Trust (both in the UK)There are two separate packages of work. In work package 1 the investigators will interview people who have been involved in emergency (999) calls for cardiac arrest, asking them about their experiences with the call-handler and how they feel they might have responded if they had received an AED that had been delivered by a flying drone.In work package 2 the investigators will conduct simulated cardiac arrests. The participants in the study will make an emergency (999) call to a trained call-handler and, once the cardiac arrest is identified during the call, a drone will be activated from a distant location and fly up to 2km to the test site and deliver an AED. The investigators will record how long it takes to retrieve and attach the AED, and ask the participants for their views about the interaction with the call-handler, AED and drone., conditionsModule conditions: Cardiac Arrest, Out-Of-Hospital, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Interviews and simulation, outcomesModule primaryOutcomes measure: Time away from patient's side (SIMULATION), primaryOutcomes measure: Barriers and facilitators to drone-delivered AED use (INTERVIEW), secondaryOutcomes measure: Interventions to overcome barriers to drone delivered AED use (INTERVIEW), secondaryOutcomes measure: Hands off CPR time (SIMULATION), secondaryOutcomes measure: Total time from start of 999 call to AED application and first shock (SIMULATION), secondaryOutcomes measure: Total drone flight time (SIMULATION), secondaryOutcomes measure: Time from drone arrival to safe to approach (SIMULATION), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Warwick, status: RECRUITING, city: Coventry, country: United Kingdom, contacts name: Christopher M Smith, MBChB, PhD, role: CONTACT, phone: (+44)2476151083, geoPoint lat: 52.40656, lon: -1.51217, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-27, uploadDate: 2024-03-11T10:47, filename: Prot_000.pdf, size: 1072430, hasResults: False
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protocolSection identificationModule nctId: NCT06334705, orgStudyIdInfo id: C22-11, secondaryIdInfos id: 2022-A02312- 41, type: REGISTRY, domain: IDRCB, briefTitle: EGEA4 THE 30 YEAR FOLLOW UP OF THE EGEA STUDY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2027-02-15, completionDateStruct date: 2028-02-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Institut National de la Santé Et de la Recherche Médicale, France, class: OTHER_GOV, collaborators name: APHP, collaborators name: CHU LYON, collaborators name: APHM, collaborators name: University Hospital, Grenoble, collaborators name: University Hospital, Montpellier, descriptionModule briefSummary: Cardiovascular (CV) diseases affect 523 million people worldwide, and are the leading cause of death, accounting for over 18 million deaths (around 30% of all deaths) every year. CV diseases account for around 45% of all deaths in Europe, or around 140,000 deaths a year in France. Asthma is one of the main non-communicable diseases, with a significant societal and individual burden, particularly in subjects suffering from severe asthma. The prevalence of asthma worldwide has risen rapidly over the past five decades, and now affects 272 million people worldwide, representing a prevalence of around 3.6%.Asthma is often associated with multimorbidity. Allergic rhinitis, chronic sinusitis, sleep apnea syndrome, gastro-oesophageal reflux disease, obesity and hormonal disorders are among the most common conditions associated with asthma. More recently, other chronic conditions linked to asthma have been suggested, including CV diseases.Although data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events, the underlying mechanisms remain poorly understood. In particular, it is not known whether asthma and CV disease share common etiological processes, such as anthropometric parameters, lifestyle, social, environmental and/or genetic factors, or whether CV disease is a direct consequence of certain features of asthma, such as systemic inflammation or asthma treatments.Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma, which is supported by a growing body of scientific data.However, it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV health.We hypothesize that asthma, and more specifically adult and moderate-to-severe asthma, are associated with early markers of CV risk. Furthermore, by providing a better understanding of the mechanisms involved in this association, we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma., conditionsModule conditions: Healthy Volunteer EGEA4 Cohort, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: blood test, food collection, hair collection, calcium scan, etc., outcomesModule primaryOutcomes measure: Framingham score variability between asthmatics and non-asthmatics, secondaryOutcomes measure: Aortic pulse wave velocity, secondaryOutcomes measure: validated predictive biomarkers of CV disease (NTproBNP, Troponin(I) hs),, secondaryOutcomes measure: Soluble ST2, secondaryOutcomes measure: coronary calcium score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Universitaire Grenoble Alpes, status: RECRUITING, city: Grenoble, zip: 38043, country: France, contacts name: Bruno DEGANO, PhD, role: CONTACT, email: BDEGANO@chu-grenoble.fr, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Hopital de la Croix Rousse, status: RECRUITING, city: Lyon, zip: 69317, country: France, contacts name: Gilles Mr DEVOUASSOUX, MD, role: CONTACT, email: gilles.devouassoux@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, locations facility: APHM, status: RECRUITING, city: Marseille, zip: 13000, country: France, contacts name: Pascal CHANEZ, PhD, role: CONTACT, email: pascal.chanez@univ-amu.fr, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Hôpital Arnaud De Villeneuve, status: RECRUITING, city: Montpellier, zip: 34295, country: France, contacts name: Pascal Mr DEMOLY, PHD, role: CONTACT, email: pascal.demoly@inserm.fr, geoPoint lat: 43.61092, lon: 3.87723, locations facility: APHP - Hôpital Bichat Claude Bernard, status: RECRUITING, city: Paris, zip: 75018, country: France, contacts name: Camille TAILLE, PHD, role: CONTACT, email: camille.taille@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06334692, orgStudyIdInfo id: BLINDER, briefTitle: Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome, acronym: BLINDER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, descriptionModule briefSummary: This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN)., conditionsModule conditions: Nephrotic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa)., outcomesModule primaryOutcomes measure: Levels of circulating anti-nephrin autoantibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò, city: Ranica, state: BG, zip: 24020, country: Italy, contacts name: Federica Casiraghi, PhD, role: CONTACT, phone: +3903545351, email: federica.casiraghi@marionegri.it, geoPoint lat: 45.72328, lon: 9.71335, hasResults: False
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protocolSection identificationModule nctId: NCT06334679, orgStudyIdInfo id: zeynepersoz, briefTitle: The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not., conditionsModule conditions: Burns, conditions: Pruritus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It is a prospective interventional type two-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as clinical routine (liquid petroleum jelly) and cold gel pack, and Group-2 (Control) was designed as clinical routine (liquid petroleum jelly)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: When cold application studies in the literature are examined, cold gel packs are placed in a sheath and contacted with the skin of the patients. Therefore, due to the nature of the application method to be used, patients and the researcher will not be considered blind. The evaluator will be considered blind in the analysis of the study., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cold Gel Packet Application, outcomesModule primaryOutcomes measure: Itching severity, primaryOutcomes measure: Itching grade, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kartal Dr.Lütfi Kırdar City Hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Zeynep Ersoz, role: CONTACT, phone: 05553496718, email: zeynepersoz08@gmail.com, contacts name: Gaye Filinte, role: CONTACT, phone: 5339576333, email: gayetaylan@yahoo.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06334666, orgStudyIdInfo id: SI 172/2024, briefTitle: The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease (NAFLD), leading to metabolic-associated steatotic liver disease (MASLD). The prevalence of NAFLD was 19.7%, with higher rates in individuals with metabolic syndrome and diabetes. MASLD is associated with insulin resistance and genetic polymorphisms, particularly the patatin like phospholipase domain containing 3-rs738409 variant. Additionally, physical activity was inversely related to liver disease risk, with higher step counts associated with reduced incidence of NAFLD and liver-related mortality. The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks., conditionsModule conditions: Daily Step Count, conditions: MASLD, conditions: BMI, conditions: Metabolic Syndrome, conditions: NAFLD, conditions: Insulin Resistance, conditions: Genetic Polymorphism, conditions: Cardiovascular Disease (CVD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Encourage using pedometer, outcomesModule primaryOutcomes measure: To compare the changes in hepatic fat accumulation assessed by MRI-PDFF between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior., secondaryOutcomes measure: To compare changes in metabolic parameters between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior, along with dietary adjustments., secondaryOutcomes measure: To study the impact of genes on changes in hepatic fat accumulation between the MASLD patient group wearing pedometers to promote physical activity, compared to the MASLD patient group with normal daily walking behavior., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334653, orgStudyIdInfo id: H-23069670, briefTitle: Exercise-regulated Organ Crosstalk, Influence of IL-6, acronym: EVEX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Helga Ellingsgaard, class: OTHER, descriptionModule briefSummary: Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise., conditionsModule conditions: Healthy Volunteers Only, conditions: Energy Metabolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: exercise, outcomesModule primaryOutcomes measure: Whole body substrate kinetics., primaryOutcomes measure: Tissue specific utilization and production of substrates., primaryOutcomes measure: IL-6 regulation of protein synthesis and degradation., primaryOutcomes measure: Number of EVs from muscle, liver, and brain., primaryOutcomes measure: Size of EVs from muscle, liver, and brain., primaryOutcomes measure: EVs from muscle, liver, and brain., primaryOutcomes measure: Influence of exercise on EV number., primaryOutcomes measure: Influence of exercise on EV size, primaryOutcomes measure: Influence of exercise on EV content., primaryOutcomes measure: Tissue specific proteomic content of EVs., secondaryOutcomes measure: Lactate., secondaryOutcomes measure: Pyruvate., secondaryOutcomes measure: Keto acids., secondaryOutcomes measure: Ketone bodies., secondaryOutcomes measure: Influence of IL-6 on fatty acid oxidation rates., secondaryOutcomes measure: Influence of IL-6 on insulin., secondaryOutcomes measure: Influence of IL-6 on glucagon., secondaryOutcomes measure: Influence of IL-6 on epinephrine., secondaryOutcomes measure: Influence of IL-6 on norepinephrine., secondaryOutcomes measure: IL-6 levels., secondaryOutcomes measure: Influence of IL-6 on substrate usage., secondaryOutcomes measure: Influence of IL-6 on perceived exertion., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, state: Capital Region, zip: 2100, country: Denmark, contacts name: Helga Ellingsgaard, PhD, role: CONTACT, phone: +4535457544, email: helga.ellingsgaard@regionh.dk, contacts name: Peter S Plomgaard, MD PhD, role: CONTACT, phone: +4535457544, email: Peter.Plomgaard@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06334640, orgStudyIdInfo id: 37C302, briefTitle: Sleeping Quality and Chronic Ocular Diseases, acronym: SONNO-OCU, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-10-17, completionDateStruct date: 2025-10-17, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: To assess the impact of sleep quality on chronic eyes diseases, conditionsModule conditions: Sleep Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 186, type: ESTIMATED, armsInterventionsModule interventions name: Three questionaires, outcomesModule primaryOutcomes measure: Proportion of sleep disorders in patients and healthy volunteers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milan, zip: 20145, country: Italy, contacts name: Paolo Milani, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06334627, orgStudyIdInfo 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, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-05-03, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: London School of Hygiene and Tropical Medicine, class: OTHER, collaborators name: International Centre for Diarrhoeal Disease Research, Bangladesh, collaborators name: Golden Community, Nepal, collaborators name: Muhimbili University of Health and Allied Sciences, collaborators name: University of Glasgow, descriptionModule 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., conditionsModule conditions: Child Development, conditions: Child Development Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1651, type: ACTUAL, armsInterventionsModule interventions name: Pre-Primary Intervention, outcomesModule primaryOutcomes measure: Measuring Early Learning Quality and Outcomes (MELQO Tool), primaryOutcomes measure: The Pediatric Evaluation of Disability Inventory, secondaryOutcomes measure: Washington Group Questionnaire, secondaryOutcomes measure: The Wechsler Preschool & Primary Scale of Intelligence, secondaryOutcomes measure: Pre-school Register, secondaryOutcomes measure: Mental Health Questionnaire, secondaryOutcomes measure: Pediatric Quality of Life Inventory (PEDSQL Tool), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: International Centre for Diarrheal Disease Research, Bangladesh, city: Dhaka, country: Bangladesh, geoPoint lat: 23.7104, lon: 90.40744, locations facility: Golden Community, city: Lalitpur, country: Nepal, geoPoint lat: 27.67658, lon: 85.31417, locations facility: Muhimbili University of Health and Allied Sciences, city: Dar Es Salaam, country: Tanzania, geoPoint lat: -6.82349, lon: 39.26951, hasResults: False
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protocolSection identificationModule nctId: NCT06334614, orgStudyIdInfo id: IIT_iReach, briefTitle: iReach: a Rehabilitative Medical Device, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-08, primaryCompletionDateStruct date: 2025-05-08, completionDateStruct date: 2025-12-08, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Istituto Italiano di Tecnologia, class: OTHER, descriptionModule 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., conditionsModule conditions: Blindness, conditions: Visual Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participant masking because the clinical trial involves infants, whoMasked: PARTICIPANT, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: iReach, outcomesModule primaryOutcomes measure: Incidence of Device Adverse Events, secondaryOutcomes measure: Change in motor skills after training with iReach medical device, secondaryOutcomes measure: Perceptual responses to multisensory stimuli, secondaryOutcomes measure: Change in motor abilities following the rehabilitation with the iReach medical device, secondaryOutcomes measure: Variation in the power of the cortical activity following the rehabilitation with the iReach medical device, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 36 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334601, orgStudyIdInfo id: 09C333, briefTitle: Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness, acronym: Muscle-OSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule 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., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Tests of upper airway collapsibility and muscle responsiveness., outcomesModule primaryOutcomes measure: Upper airway collapsibility, primaryOutcomes measure: Upper airway muscle responsiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano,Ospedale San Luca, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Elisa Perger, MD, role: CONTACT, phone: +390261911, phoneExt: 2705, email: e.perger@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06334588, orgStudyIdInfo id: APHP240105, secondaryIdInfos id: 2023-A02668-37, type: REGISTRY, domain: ID-RCB, briefTitle: Understanding the Mechanisms of Autism : an MRI and Social Cognition Study, acronym: ECLAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule 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, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: MRI, interventions name: Eye-tracking, interventions name: Clinical Scales, interventions name: Research of genetic anomalies, outcomesModule primaryOutcomes measure: Rest cerebral blood flow (CBF), secondaryOutcomes measure: Measurements of white matter microstructure - fractional anisotropy, secondaryOutcomes measure: Measurements of white matter microstructure - mean diffusivity, secondaryOutcomes measure: Measurements of white matter microstructure - radial diffusivity, secondaryOutcomes measure: Measurements of white matter microstructure - axial diffusivity, secondaryOutcomes measure: Measurements of resting state functional connectivity, secondaryOutcomes measure: Correlation between social perception and multimodal brain imaging, secondaryOutcomes measure: Correlation between clinical severity and multimodal brain imaging, secondaryOutcomes measure: Imaging abnormalities associated with known genetic mutations, secondaryOutcomes measure: Social perception abnormalities associated with known genetic mutations, secondaryOutcomes measure: Anatomic changes over time - study of developmental trajectory, secondaryOutcomes measure: Social perception changes over time - study of developmental trajectory, secondaryOutcomes measure: Brain imaging in young children associated with ASD, secondaryOutcomes measure: Early data on social perception, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Necker Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Nathalie BODDAERT, MD, PhD, role: CONTACT, phone: +33 1.71.39.65.30, email: nathalie.boddaert@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06334575, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Maria Joyera Rodríguez, class: OTHER, descriptionModule 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, conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Budesonide, outcomesModule primaryOutcomes measure: Significant molecular changes in COPD stratified by their blood eosinophil counts., secondaryOutcomes measure: Significant molecular changes in COPD with different airflow limitation severities., eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Philips University of Marburg, city: Marburg, country: Germany, contacts name: Peter Alter, role: CONTACT, geoPoint lat: 50.80904, lon: 8.77069, locations facility: Academisch Ziekenhuis Groningen, city: Groningen, country: Netherlands, contacts name: Marteen van den Berge, role: CONTACT, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Clínic Barcelona, city: Barcelona, zip: 08036, country: Spain, contacts name: Alvar Agustí, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Son Espases, city: Palma De Mallorca, zip: 07120, country: Spain, contacts name: Francisco de Borja Cosio, role: CONTACT, geoPoint lat: 39.56939, lon: 2.65024, locations facility: University of Leicester, city: Leicester, country: United Kingdom, contacts name: Christopher Brightling, role: CONTACT, geoPoint lat: 52.6386, lon: -1.13169, locations facility: Imperial College London, city: London, country: United Kingdom, contacts name: Lydia J Finney, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06334562, orgStudyIdInfo id: KY-2023-112, briefTitle: The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule 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., conditionsModule conditions: Neuromuscular Blockade, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: SUGAMMADEX SODIUM 100 Mg in 1 mL, interventions name: Neostigmine, outcomesModule primaryOutcomes measure: Muscle relaxation recovery time, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334549, orgStudyIdInfo id: LSKY2023-107-01, briefTitle: A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12-05, completionDateStruct date: 2024-12-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Dalian Municipal Central Hospital, class: OTHER, descriptionModule 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., conditionsModule conditions: Hypotension Drug-Induced, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Ephedrine-P, interventions name: Phenylephrine-P, interventions name: Norepinephrine-P, interventions name: Ephedrine-S, interventions name: Phenylephrine-S, interventions name: Norepinephrine-S, outcomesModule primaryOutcomes measure: Continual changes in Cerebral Oxygen Saturation, secondaryOutcomes measure: Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), secondaryOutcomes measure: Continual changes in heart rate (HR), secondaryOutcomes measure: Continual changes in stroke volume (SV), secondaryOutcomes measure: Continual changes in cardiac output (CO), secondaryOutcomes measure: Continual changes in systemic vascular resistance (SVR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dalian Municipal Central Hospital, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116033, country: China, contacts name: Liping Han, M.D., role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, hasResults: False
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protocolSection identificationModule nctId: NCT06334536, orgStudyIdInfo id: 0832/66, briefTitle: Multi-country Survey on Violence Against Women Among Medical Staff, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, collaborators name: Asia and Oceania Federation of Obstetrics and Gynaecology, descriptionModule 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 countriesThe 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 countriesParticipants will be asked to complete the online self-administrated questionnaire., conditionsModule conditions: Violence Against Women, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: KAP towards VAW, primaryOutcomes measure: KAP towards support service of VAW, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334523, orgStudyIdInfo id: Volem, briefTitle: Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout, acronym: Volem, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Intercommunal Creteil, class: OTHER, descriptionModule 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., conditionsModule conditions: Extremely Low Birthweight Infant, conditions: Continuous Tracheal Gas Insufflation, conditions: Medical Device, conditions: Lung Protection, conditions: Ventilator-Induced Lung Injury, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: ventilation, outcomesModule primaryOutcomes measure: cumulative duration of non-invasive ventilation periods in living patients, secondaryOutcomes measure: The pressure gradient of the ventilation, secondaryOutcomes measure: The age at the definitive withdrawal of any ventilatory support (PPS), secondaryOutcomes measure: Definitive weaning age of invasive ventilation, secondaryOutcomes measure: Definitive O2 weaning age, secondaryOutcomes measure: the death rate, secondaryOutcomes measure: The rate of recourse to the HFO, secondaryOutcomes measure: The level of pneumothorax, secondaryOutcomes measure: The rate of bronchopulmonary dysplasia (BPD) diagnosed, secondaryOutcomes measure: Rate of postnatal systemic corticosteroid therapy, secondaryOutcomes measure: Duration of exposure to systemic sedatives, secondaryOutcomes measure: The cumulative day invasive ventilation, secondaryOutcomes measure: Non-programmed extubation rate, secondaryOutcomes measure: Rate of secondary blooddstream infection, secondaryOutcomes measure: neuroimaging complication, secondaryOutcomes measure: Neurodevelopmental monitoring, secondaryOutcomes measure: Pulmonary inflammation by cytokine dosage for intubated patients, secondaryOutcomes measure: Pulmonary inflammation by cytokine dosage for intubated patients, secondaryOutcomes measure: Pulmonary inflammation by cytokine dosage for intubated patients, secondaryOutcomes measure: rate of Retinopathy rank >1, secondaryOutcomes measure: severe hypoxemia, secondaryOutcomes measure: Additional dose of surfactant, eligibilityModule sex: ALL, minimumAge: 23 Weeks, maximumAge: 26 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334510, orgStudyIdInfo id: HL-SJLG-2021-Ⅳ-01, briefTitle: Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-17, primaryCompletionDateStruct date: 2023-01-20, completionDateStruct date: 2023-03-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Hualan Biological Bacterin Co. Ltd., class: INDUSTRY, descriptionModule 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‰., conditionsModule conditions: GCP, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4900, type: ACTUAL, armsInterventionsModule interventions name: One dose of quadrivalent influenza virus split vaccine was administered, outcomesModule primaryOutcomes 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‰., secondaryOutcomes measure: To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 74 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kou Zengqiang, city: Jinan, state: Shandong, zip: 250000, country: China, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06334497, orgStudyIdInfo id: APH220791, secondaryIdInfos id: 2023-506216-40-00, type: OTHER, domain: EU CT, briefTitle: Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections, acronym: LUCY-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule 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., conditionsModule conditions: Cytomegalovirus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Letermovir, interventions name: Valganciclovir, interventions name: Letermovir placebo, outcomesModule primaryOutcomes measure: Virological response to treatment on week-3, secondaryOutcomes measure: Eradication of CMV DNAemia (< 200 IU/ml) before Week-12, secondaryOutcomes measure: Number of days between baseline and first measure of CMV DNAemia < 200 IU/mL, secondaryOutcomes measure: Absence of CMV-related symptoms at baseline and each visit, secondaryOutcomes measure: Adverse event (AE) occurence, secondaryOutcomes measure: Sequencing of whole UL97, UL54, UL56, UL89 and UL51 genes, secondaryOutcomes measure: Ganciclovir plasma concentration, secondaryOutcomes measure: Letermovir plasma concentration, secondaryOutcomes measure: Measure of the CMV specific T-cell immunity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Necker Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Laurence BUSSIERES, PhD, role: CONTACT, phone: +33 6 62 08 19 58, email: laurence.bussieres@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06334484, orgStudyIdInfo id: 6413, briefTitle: Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics, acronym: TiTR_GR1DM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-09-26, completionDateStruct date: 2026-03-26, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule 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, conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Advanced hybrid closed loop systems, outcomesModule primaryOutcomes measure: change in time spent in tighter glucose range after 24 months of hybrid closed loop system, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, contacts name: DARIO PITOCCO, role: CONTACT, phone: +390630155701, email: dario.pitocco@policlinicogemelli.it, contacts name: DARIO PITOCCO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06334471, orgStudyIdInfo id: INCS_WGS_B-001, briefTitle: Whole Genome Sequencing in Breast Cancer, acronym: WGS SIT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-02, primaryCompletionDateStruct date: 2025-08-02, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Inocras Korea Inc., class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: no intervention needed, outcomesModule primaryOutcomes measure: Establishing individual genetic characteristics of breast cancer patients through WGS, secondaryOutcomes measure: Analysis of correlation between whole-genome sequencing results and genetic subtypes of breast cancer, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Yeon Hee Park, MD, role: CONTACT, contacts name: Yeon Hee Park, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06334458, orgStudyIdInfo id: IEO 1910, briefTitle: Epigenomic and Machine Learning Models to Predict Pancreatic Cancer, acronym: IMAGene, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-03, primaryCompletionDateStruct date: 2024-02-21, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule 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., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ACTUAL, armsInterventionsModule interventions name: Early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, outcomesModule primaryOutcomes measure: Observation of a two or three-fold enrichment in early detection of suspicious pancreatic lesion using the CRPA algorithm, primaryOutcomes 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, primaryOutcomes measure: Validation of igenetic biomarker testing in liquid biopsy followed by radiological exam as early cancer diagnostic tool, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Toulouse University Hospital, city: Toulouse, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: European Institute of Oncology, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Oncological Institute "Prof. Dr. Ion Chiricuta", city: Cluj-Napoca, country: Romania, geoPoint lat: 46.76667, lon: 23.6, locations facility: Catalan Institute of Oncology, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06334445, orgStudyIdInfo id: IEO 1874, briefTitle: CARDIOCARE Prospective Clinical Study, acronym: CARDIOCARE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule 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., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 736, type: ESTIMATED, armsInterventionsModule interventions name: Control group, interventions name: Intervention group, outcomesModule primaryOutcomes measure: Evaluation of the onset of cardiotoxicity, secondaryOutcomes measure: Intra-patient assessment of major adverse cardiac events (MACEs), secondaryOutcomes measure: Intra-patient assessment of plasma Troponin I, secondaryOutcomes measure: Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation, secondaryOutcomes measure: Percentage in the two arm of hospital admission, secondaryOutcomes measure: Number of Cardiovascular death in the two arms, secondaryOutcomes measure: Number of Non-cardiovascular death in the two arms, secondaryOutcomes measure: Evaluation of Health Related Quality of Life in the two arms, secondaryOutcomes measure: Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-adjusted life-years (QALYs) in the two arms, eligibilityModule sex: FEMALE, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Gabriella Pravettoni, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06334432, orgStudyIdInfo id: NUV-1511-01, briefTitle: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Nuvation Bio Inc., class: INDUSTRY, descriptionModule 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., conditionsModule 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), designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 466, type: ESTIMATED, armsInterventionsModule interventions name: NUV-1511, outcomesModule primaryOutcomes measure: Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors, primaryOutcomes measure: Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s)), primaryOutcomes measure: Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s), primaryOutcomes measure: Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development, primaryOutcomes measure: Phase 2: Confirm the optimal NUV-1511 target tumor types for further development, secondaryOutcomes measure: Phase 1: Explore preliminary efficacy of NUV-1511, secondaryOutcomes measure: Phase 1: Explore preliminary efficacy of NUV-1511, secondaryOutcomes measure: Phase 1: Explore preliminary efficacy of NUV-1511, secondaryOutcomes measure: Characterize the PK profile of NUV-1511, secondaryOutcomes measure: Characterize the PK profile of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity, otherOutcomes measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity, otherOutcomes measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity, otherOutcomes measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity, otherOutcomes measure: Evaluate drug exposure-response relationship, otherOutcomes measure: Evaluate drug exposure-response relationship, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Oncology, status: RECRUITING, city: Irving, state: Texas, zip: 75038, country: United States, contacts name: Naga Koteswari Cheedella, role: CONTACT, phone: 214-645-4673, email: ncheedella@nextoncology.com, geoPoint lat: 32.81402, lon: -96.94889, locations facility: START Mountain, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84124, country: United States, contacts name: William McKean, role: CONTACT, phone: 801-581-2121, email: William.McKean@hci.utah.edu, geoPoint lat: 40.76078, lon: -111.89105, locations facility: NEXT Oncology, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Alex Spira, role: CONTACT, phone: 210-580-9500, email: aspira@nextoncology.com, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False
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protocolSection identificationModule nctId: NCT06334419, orgStudyIdInfo id: 2023-0795, briefTitle: Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Craig Erickson, class: OTHER, collaborators name: Healx Limited, descriptionModule 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., conditionsModule conditions: Fragile X Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo 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, maskingInfo masking: NONE, maskingDescription: Quadruple masking (participant, care provider, investigator and outcomes assessor), enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Gaboxadol, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate target engagement of gaboxadol treatment on high density EEG recordings, secondaryOutcomes measure: To investigate the feasibility of home research visits and procedures in adult males with FXS, secondaryOutcomes measure: To investigate the feasibility of high density EEG recording at home in adult males with FXS, secondaryOutcomes measure: To potentially explore the pharmacokinetics of gaboxadol treatment in single-dose trial design, secondaryOutcomes measure: To investigate the effect of gaboxadol treatment on neuropsychological assessments, secondaryOutcomes measure: To investigate the effect of gaboxadol treatment on eye tracking assessments, secondaryOutcomes measure: To investigate the effect of gaboxadol treatment on clinician-rated measures, secondaryOutcomes measure: To determine whether FMRP levels predict treatment response, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cincinnati Children's Hospital Medical Center, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Ashley Dapore, role: CONTACT, phone: 513-517-1580, email: ashley.dapore@cchmc.org, contacts name: Hannah J Sachs, MPA, role: CONTACT, phone: 513-636-2592, email: hannah.sachs@cchmc.org, contacts name: Craig A Erickson, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kelli Dominick, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Meredith Nelson, PhD, role: SUB_INVESTIGATOR, contacts name: Ernest Pedapati, MD, role: SUB_INVESTIGATOR, contacts name: Debra Reisinger, PhD, role: SUB_INVESTIGATOR, contacts name: Lauren Schmitt, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, hasResults: False
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protocolSection identificationModule nctId: NCT06334406, orgStudyIdInfo id: 098 DRC 210 ER03 012, briefTitle: Antitumor T Cell Responses in Patients With Bladder Cancer, acronym: immunoBLAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2026-04-02, completionDateStruct date: 2026-04-02, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor., conditionsModule conditions: Bladder Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Biological samples, outcomesModule primaryOutcomes measure: Tumor antigen specific T-cell responses, secondaryOutcomes measure: Monitoring of T cells in the blood, secondaryOutcomes measure: Monitoring of immune cell death parameters in the blood, secondaryOutcomes measure: Monitoring of immune suppressive cells in the blood, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Local progression-free survival, secondaryOutcomes measure: Transcriptomic analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334393, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Valneva Austria GmbH, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Zika, conditions: Zika Virus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: VLA1601, interventions name: CpG 1018®, interventions name: 3M-052-AF, outcomesModule primaryOutcomes measure: Solicited Adverse Events, primaryOutcomes measure: Solicited Adverse Events, primaryOutcomes measure: Neutralizing antibodies against ZIKA virus (ZIKV), secondaryOutcomes measure: Solicited Adverse Events, secondaryOutcomes measure: Solicited Adverse Events, secondaryOutcomes measure: Unsolicited AEs, secondaryOutcomes measure: Unsolicited AEs, secondaryOutcomes measure: Vaccine-related unsolicited AEs, secondaryOutcomes measure: Vaccine-related unsolicited AEs, secondaryOutcomes measure: Any AEs, secondaryOutcomes measure: Any AEs, secondaryOutcomes measure: any vaccine-related AEs, secondaryOutcomes measure: Vaccine-related unsolicited AEs, secondaryOutcomes measure: Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Vaccine-related Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Vaccine-related Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Serious Adverse Events (SAE), secondaryOutcomes measure: Serious Adverse Events (SAE), secondaryOutcomes measure: Vaccine-related Serious Adverse Events (SAE), secondaryOutcomes measure: Vaccine-related Serious Adverse Events (SAE), secondaryOutcomes measure: ZIKV-specific neutralizing antibodies, secondaryOutcomes measure: Seroconversion rate (SCR), secondaryOutcomes measure: Geometric Mean Fold Increase (GMFI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Flourish Research, status: RECRUITING, city: Chicago, state: Illinois, zip: 60640, country: United States, contacts name: Rupal Trivedi, MD, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Velocity Clinical Research, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68134, country: United States, contacts name: Frederick Raiser, MD, role: CONTACT, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False
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protocolSection identificationModule nctId: NCT06334380, orgStudyIdInfo id: 73688, briefTitle: VR for Surgical Prehabilitation and Rehabilitation, acronym: VR-PREP, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule 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., conditionsModule conditions: Breast Cancer, conditions: Frailty, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: SINGLE, maskingDescription: Blinded assessor will conduct adherence calls., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Modules Only, interventions name: Virtual Reality Modules + Live Physical Therapist Support, outcomesModule primaryOutcomes measure: VR for remote Physical Therapy (PT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford Hospital and Clinics, city: Palo Alto, state: California, zip: 94305, country: United States, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False
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protocolSection identificationModule nctId: NCT06334367, orgStudyIdInfo id: SWYX:NO.2022-1028, briefTitle: Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2026-03-26, completionDateStruct date: 2026-03-26, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Wang Xin, class: OTHER_GOV, descriptionModule 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., conditionsModule conditions: GVHD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: CD25 treatment, interventions name: low-dose ATG, outcomesModule primaryOutcomes measure: The incidence of aGVHD, primaryOutcomes measure: The incidence of cGVHD, secondaryOutcomes measure: the time of immune reconstitution in haploidentical transplant, secondaryOutcomes measure: the time of infection occurrence, secondaryOutcomes measure: the time of donor cell engraftment, secondaryOutcomes measure: the time of disease relapse, secondaryOutcomes measure: the time of death of transplant patient, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, city: Jinan, state: Shandong, zip: 250021, country: China, contacts name: Xin Wang, MD, PHD, role: CONTACT, phone: 86-531-68778331, email: xinw007@126.com, contacts name: Xiaosheng Fang, MD, PHD, role: CONTACT, phone: 8615168889703, email: fxsh_1010@126.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06334354, orgStudyIdInfo id: 23-320, briefTitle: A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC), acronym: TRAC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule 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., conditionsModule conditions: Breast Cancer Survivors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Assessments, interventions name: Assessment (Survivors Only), interventions name: APOE and DNA Isolation, outcomesModule primaryOutcomes measure: examine cognitive effects, secondaryOutcomes measure: measure levels of smoking exposure, eligibilityModule sex: FEMALE, minimumAge: 65 Years, maximumAge: 80 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: James Root, PhD, role: CONTACT, phone: 646-888-0035, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (All protocol activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: James Root, PhD, role: CONTACT, phone: 646-888-0035, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (All Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: James Root, PhD, role: CONTACT, phone: 646-888-0035, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: James Root, PhD, role: CONTACT, phone: 646-888-0035, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (All Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: James Root, PhD, role: CONTACT, phone: 646-888-0035, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: James Root, PhD, role: CONTACT, phone: 646-888-0035, contacts name: Tim Ahles, PhD, role: CONTACT, phone: 646-888-0048, contacts name: James Root, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (All Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: James Root, PhD, role: CONTACT, phone: 646-888-0035, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False
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protocolSection identificationModule nctId: NCT06334341, orgStudyIdInfo 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, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Henry Ford Health System, class: OTHER, collaborators name: University of South Florida, collaborators name: New York University, descriptionModule 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., conditionsModule conditions: HIV Seropositivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1380, type: ESTIMATED, armsInterventionsModule interventions name: Computer-based simulation training for providers, interventions name: Best Practice Alert, interventions name: HIV Risk Assessment, interventions name: PrEP Informational Video, outcomesModule primaryOutcomes measure: Clinic-Level PrEP Prescription, secondaryOutcomes measure: PrEP Knowledge, secondaryOutcomes measure: PrEP awareness, secondaryOutcomes measure: PrEP prescribing comfort, secondaryOutcomes measure: PrEP prescribing intentions, secondaryOutcomes measure: Perceived HIV risk, secondaryOutcomes measure: Preferences for patient- provider communication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henry Ford Health, city: Detroit, state: Michigan, zip: 48202, country: United States, geoPoint lat: 42.33143, lon: -83.04575, hasResults: False
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protocolSection identificationModule nctId: NCT06334328, orgStudyIdInfo id: 2205009237, briefTitle: Virtual Reality-based Mindful Movement Therapy for Seniors, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-15, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Drexel University, class: OTHER, descriptionModule 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., conditionsModule conditions: Cognitive Decline, conditions: Physical Activity, conditions: Psychological Wellbeing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: Virtual reality based mindful movement therapy, outcomesModule primaryOutcomes measure: Treatment adherence, primaryOutcomes measure: Treatment acceptability, primaryOutcomes measure: Treatment satisfaction, primaryOutcomes measure: Qualitative feedback, primaryOutcomes measure: Safety, secondaryOutcomes measure: Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Trail making test, secondaryOutcomes measure: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), secondaryOutcomes measure: Physical Activity Scale for the Elderly (PASE), secondaryOutcomes measure: Physical Performance Battery (SPPB), secondaryOutcomes measure: General Self-Efficacy Scale, secondaryOutcomes measure: Positive Affect and Negative Affect Scale (PANAS), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Drexel Universitsy, city: Philadelphia, state: Pennsylvania, zip: 19102, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06334315, orgStudyIdInfo id: 2000037337, secondaryIdInfos id: R01HD111436, type: OTHER_GRANT, domain: NIH, briefTitle: Oral Contraceptive Pill (OCP) Pharmacogenomics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule 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), conditionsModule conditions: Contraception, conditions: Pharmacogenomic Drug Interaction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Desogestrel / Ethinyl Estradiol Pill, outcomesModule primaryOutcomes measure: Serum etonogestrel concentration, primaryOutcomes measure: Serum ethinyl estradiol concentration, secondaryOutcomes measure: Serum estradiol concentration, secondaryOutcomes measure: Serum progesterone concentration, secondaryOutcomes measure: Modified Hoogland score, secondaryOutcomes measure: Positive and Negative Affect Scheduled, secondaryOutcomes measure: Sex hormone binding globulin levels, secondaryOutcomes measure: Serum albumin concentration, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Yale, city: New Haven, state: Connecticut, zip: 06520, country: United States, geoPoint lat: 41.30815, lon: -72.92816, hasResults: False
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protocolSection identificationModule nctId: NCT06334302, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-25, completionDateStruct date: 2024-04-25, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Rabin Medical Center, class: OTHER, collaborators name: Omega 3 Galilee, descriptionModule 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)., conditionsModule conditions: Type1diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread", interventions name: Active Control-Nutella hazelnut cocoa spread, outcomesModule primaryOutcomes measure: Delta postprandial glucose level, secondaryOutcomes measure: Incremental area under the curve (iAUC), secondaryOutcomes measure: Peak postprandial glucose level, secondaryOutcomes measure: Time in range (TIR) of 70-180 mg/dl, secondaryOutcomes measure: Percentage of subjects who reached the desired glucose target, secondaryOutcomes measure: The percentage of time spent above 180 mg/dl, secondaryOutcomes measure: The percentage of time spent above 250 mg/dl, secondaryOutcomes measure: The percentage of time spent above 350 md/dl, secondaryOutcomes measure: Labeled Magnitude Scale (gLMS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Schneider Children Medical Center of Israel, status: RECRUITING, city: Petach-Tikva, country: Israel, contacts name: Alona Hamou, MSc, role: CONTACT, phone: 972-545-950-277, email: alonah@clalit.org.il, geoPoint lat: 32.08707, lon: 34.88747, hasResults: False
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protocolSection identificationModule nctId: NCT06334289, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Qianfoshan Hospital, class: OTHER, descriptionModule 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., conditionsModule conditions: Perioperative Neurocognitive Disorders, conditions: Frail Elderly, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 338, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Postoperative 7-day incidence of PND, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334276, orgStudyIdInfo id: DROWN_INHOS, briefTitle: Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016, acronym: DROWN_INHOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule 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., conditionsModule 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, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Drowning, outcomesModule primaryOutcomes measure: 30-day mortality, primaryOutcomes measure: Neurological outcome, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: Intensive care unit admission, secondaryOutcomes measure: Intensive care unit length of stay, secondaryOutcomes measure: Need for mechanical ventilation, secondaryOutcomes measure: Duration of mechanical ventilation, secondaryOutcomes measure: Survival to hospital discharge, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
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protocolSection identificationModule nctId: NCT06334263, orgStudyIdInfo id: 332302, briefTitle: Splenic Embolisation Decisions, acronym: SPEED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University Hospital Plymouth NHS Trust, class: OTHER, descriptionModule 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., conditionsModule conditions: Trauma, conditions: Spleen Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 8000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes 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., primaryOutcomes measure: To determine if variation in treatment affects SE outcomes in ATSI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06334250, orgStudyIdInfo id: IRAS:327077, briefTitle: Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial, acronym: PLANET-AF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Liverpool Heart and Chest Hospital NHS Foundation Trust, class: OTHER, descriptionModule 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., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Catheter ablation of atrial fibrillation using Pulsed Field Ablation, interventions name: Left atrial appendage occlusion, outcomesModule primaryOutcomes measure: Change in quality of lfie, secondaryOutcomes measure: Time to atrial fibrillation recurrence, secondaryOutcomes measure: Requirement for unplanned further ablation or cardioversion procedures, secondaryOutcomes measure: Procedural metrics, secondaryOutcomes measure: Procedural safety outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Liverpool Heart and Chest Hospital, city: Liverpool, state: Merseyside, zip: L14 3PE, country: United Kingdom, contacts name: Mark Mills, role: CONTACT, phone: +441516001616, email: mark.mills@lhch.nhs.uk, geoPoint lat: 53.41058, lon: -2.97794, hasResults: False
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protocolSection identificationModule nctId: NCT06334237, orgStudyIdInfo id: Y_113_0009, briefTitle: Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-21, completionDateStruct date: 2026-02-21, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Changhua Christian Hospital, class: OTHER, descriptionModule 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., conditionsModule conditions: Migraine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: personalized treatment, outcomesModule primaryOutcomes measure: Migraine attack frequency, primaryOutcomes measure: Migraine attack intensity, primaryOutcomes measure: Migraine attack duration, primaryOutcomes measure: Effectiveness of acute medication, secondaryOutcomes measure: Compliance rate of migraine diary, secondaryOutcomes measure: Compliance rate of lifestyle modification, secondaryOutcomes measure: depression, secondaryOutcomes measure: anxiety, secondaryOutcomes measure: well-being, secondaryOutcomes measure: Pain Resilience, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhua Christian Hospital, city: Chang Hua, zip: 500, country: Taiwan, contacts name: Yen-Yu Chen, MD, role: CONTACT, phone: +886-4-7238595, email: 107281@cch.org.tw, geoPoint lat: 24.07327, lon: 120.56276, hasResults: False
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protocolSection identificationModule nctId: NCT06334224, orgStudyIdInfo id: 2242/MODREC/23, briefTitle: Acute Physiological Responses to Twice Daily Blood Flow Restriction Training, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Defence Medical Rehabilitation Centre, UK, class: OTHER_GOV, collaborators name: University of Bath, descriptionModule 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., conditionsModule conditions: Muscle Weakness, conditions: Muscle Damage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two arm randomised control trial, primaryPurpose: BASIC_SCIENCE, maskingInfo 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., enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Low load resistance training with blood flow restriction, interventions name: Low load resistance training, outcomesModule primaryOutcomes measure: Maximum isometric voluntary contraction of knee extensor muscles, secondaryOutcomes measure: Vastus lateralis muscle thickness, secondaryOutcomes measure: Venous blood sampling for markers of exercise induced muscle damage, secondaryOutcomes measure: Delayed onset muscle soreness, secondaryOutcomes measure: Quadriceps discomfort, secondaryOutcomes measure: Discomfort caused by the BFR cuff, secondaryOutcomes measure: Rating of perceived exertion, secondaryOutcomes measure: Knee joint range of motion, secondaryOutcomes measure: Daily wellness questionnaire, secondaryOutcomes measure: Venous blood sampling for inflammatory markers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Defence Medical Rehabilitation Centre, status: RECRUITING, city: Loughborough, zip: LE12 5QW, country: United Kingdom, contacts name: Kieran M Lunt, MSc, role: CONTACT, phone: +44(0) 1509 251 500, phoneExt: 3401, email: kieran.lunt103@mod.gov.uk, contacts name: Peter Ladlow, PhD, role: CONTACT, phone: +44(0) 1509 251 500, phoneExt: 3407, email: peter.ladlow100@mod.gov.uk, contacts name: Kieran M Lunt, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.76667, lon: -1.2, hasResults: False
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protocolSection identificationModule nctId: NCT06334211, orgStudyIdInfo id: FP-020C-23-001, briefTitle: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Foresee Pharmaceuticals Co., Ltd., class: INDUSTRY, collaborators name: InClin, Inc., descriptionModule 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., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo 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, maskingInfo masking: TRIPLE, maskingDescription: Double-blind (placebo appears the same as active FP-020), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: FP-020, interventions name: placebo, outcomesModule primaryOutcomes measure: The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs)., primaryOutcomes measure: Clinically significant abnormalities., secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz, secondaryOutcomes measure: Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2, secondaryOutcomes measure: Evaluate the food effect on the PK profile of FP-020 - Cmax, secondaryOutcomes measure: Evaluate the food effect on the PK profile of FP-020 - Tmax, secondaryOutcomes measure: Evaluate the food effect on the PK profile of FP-020 - AUC, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax, secondaryOutcomes measure: Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Scientia Clinical Research Ltd, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: Christopher Argent, MD, role: CONTACT, geoPoint lat: -33.91439, lon: 151.24895, hasResults: False
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protocolSection identificationModule nctId: NCT06334198, orgStudyIdInfo id: Naldemedine_OIBD, secondaryIdInfos id: 2023-507744-36-00, type: CTIS, briefTitle: The Effect of Naldemedine on Opioid-induced Bowel Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Asbjørn Mohr Drewes, class: OTHER, descriptionModule 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, conditionsModule conditions: Opioid-Induced Bowel Dysfunction, conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Naldemedine, interventions name: Placebo, interventions name: Tramadol, outcomesModule primaryOutcomes measure: Total gastrointestinal transit time, primaryOutcomes measure: Colorectal transit time, secondaryOutcomes measure: Constipation symptoms, secondaryOutcomes measure: Bowel movement frequency, secondaryOutcomes measure: Stool consistency, secondaryOutcomes measure: Gastrointestinal symptoms, secondaryOutcomes measure: Opioid-induced constipation, secondaryOutcomes measure: Diagnostic evaluation of opioid-induced constipation, secondaryOutcomes measure: Colonic motility patterns, secondaryOutcomes measure: Opiate withdrawal symptoms, secondaryOutcomes measure: Colon volume, secondaryOutcomes measure: Colonic water content, secondaryOutcomes measure: Defecation assessment, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aalborg University Hospital, status: RECRUITING, city: Aalborg, zip: 9000, country: Denmark, contacts name: Asbjørn Mohr Drewes, role: CONTACT, geoPoint lat: 57.048, lon: 9.9187, hasResults: False
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protocolSection identificationModule nctId: NCT06334185, orgStudyIdInfo id: pVax, briefTitle: Evaluation of Vaccination for Streptococcus Pneumoniae in Adults With an Episode of Invasive Pneumococcal Infection., acronym: pVax, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera di Lecco, class: OTHER, collaborators name: IRCCS Ospedale San Raffaele, descriptionModule 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., conditionsModule conditions: Invasive Pneumococcal Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 320, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of antipneumococcal vaccination in hospitalized patients for invasive pneumococcal infection between 2015 and 2019., secondaryOutcomes measure: Rate of pneumococcal serotype that caused the invasive infection in patients vaccinated prior to the infectious event, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06334172, orgStudyIdInfo id: H-23071221, briefTitle: The Role of Oxytocin in Regulating Blood Glucose, acronym: GLOXY-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Gentofte, Copenhagen, class: OTHER, descriptionModule briefSummary: Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose., conditionsModule conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus), designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: DOUBLE, maskingDescription: The randomized order of infusions is blinded to both participant and investigator, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Oxytocin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Insulin secretion - c-peptide, secondaryOutcomes measure: Glucose, secondaryOutcomes measure: Insulin, secondaryOutcomes measure: Glucagon, secondaryOutcomes measure: GIP, secondaryOutcomes measure: GLP-1, secondaryOutcomes measure: Lipids, secondaryOutcomes measure: Cross-linked C-telopeptide of type I collagen( CTX), secondaryOutcomes measure: Procollagen type I N-terminal propeptide (P1NP), eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Clinical Metabolic Research, Gentofte Hospital, status: RECRUITING, city: Hellerup, state: Capital Region, zip: 2900, country: Denmark, contacts name: Filip K Knop, MD, PhD, role: CONTACT, phone: 004538674266, email: filip.krag.knop.01@regionh.dk, geoPoint lat: 55.73204, lon: 12.57093, hasResults: False
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