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Participants will fill out questionnaires and the researchers will measure their vision and hearing functions. conditions: Dual Sensory Impairment of Vision and Hearing studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 300 type: ESTIMATED measure: information access measure: mobility measure: communication measure: fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC, location VUmc city: Amsterdam state: Noord Holland zip: 1081 HV country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06362200 id: LYG20230083 briefTitle: The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-12-31 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: Central South University class: OTHER briefSummary: In this proposed study, tACS will be used to intervene in the autism spectrum disorders of children and adolescents, and the efficacy of this intervention method will be evaluated, as well as the internal mechanism of adolescents' autism spectrum disorders will be discussed. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 40 Hz tACS intervention measure: Autism assessment assessment index measure: EEG physiological detection index measure: Magnetic resonance detection index measure: Eye movement index measure: Emotion recognition index measure: Understanding of social interaction index measure: Understanding of thoughts and intentions index measure: Social Communication Changes index measure: Stereotyped behavior index measure: Sensory index measure: Abnormal behavior indicator measure: Sleep index measure: Plasma Metabolite Levels Assessment measure: Safety evaluation SAFTEE indicator sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06362187 id: STUDY00003238 briefTitle: VR Pilot for Pancreatitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Cedars-Sinai Medical Center class: OTHER briefSummary: The purpose of the research is to test the feasibility and preliminary impact of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pancreatitis (CP) and recurrent acute pancreatitis (RAP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP or RAP. conditions: Chronic Pancreatitis conditions: Recurrent Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, controlled primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Gut Directed VR name: Sham Control VR measure: Feasibility of home-based VR measure: Impact of home-based VR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marissa Podell city: Los Angeles state: California zip: 90048 country: United States lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06362174 id: SHEBA-22-9902-SBH-CTIL briefTitle: Capsule & Omics for pRedicting Exacerbation of Crohn's Disease acronym: CORE-CD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-07 date: 2025-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Sheba Medical Center class: OTHER_GOV briefSummary: The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohn's disease in remission, demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance enterography and inflammatory biomarkers. Subsequently, deep learning algorithms had developed to provide excellent accuracy for identification and grading of ulcers and intestinal strictures on capsule endoscopy still images. The investigators will advance this knowledge using a parallel two-parts approach. conditions: Crohn's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 62 type: ACTUAL measure: Crohn's Disease Activity Index score (CDAI) measure: Disease related complications measure: disease related hospitalization measure: Change of crohn's disease medications measure: opinion of the principle investigator (PI) or the treating physician measure: The rate of clinical flare accompanied by objective signs of mucosal inflammation. measure: The rate of inflammatory worsening with/without accompanying clinical symptoms sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sheba Medical Center city: Tel-Hashomer country: Israel lat: 32.04195 lon: 34.85623 hasResults: False
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<|newrecord|> nctId: NCT06362161 id: IRB-300011066 briefTitle: Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes. conditions: Functional Neurological Disorder conditions: Convulsion, Non-Epileptic conditions: Functional Seizure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1100 type: ESTIMATED measure: Patient Demographic Information measure: Hospital Anxiety and Depression Scale (HADS) measure: ASM 121 functional assessment definitions measure: SF-36 (subjective health and wellbeing) measure: Work and Social Adjustment Scale (WSAS) measure: Patient Health Questionnaire 15 measure: Dizziness Handicap Inventory measure: Dizziness Symptom Profile measure: Adult Tic Questionnaire (ATQ) measure: Child Self-Report Tic Questionnaire measure: Parent Tic Questionnaire (PTQ) measure: Seizure Questionnaire measure: Level 2-Somatic Symptom report measure: Revised Children's Anxiety and Depression Scale (RCADS) measure: Functional Disability Inventory (FDI) measure: Impact on the Family Scale measure: Pediatric Quality of Life (Peds-QL) measure: Healthcare Utility Questionnaire measure: Assessment of control over symptoms sex: ALL minimumAge: 8 Years maximumAge: 89 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Michelle Bumpers role: CONTACT lat: 33.52066 lon: -86.80249 hasResults: False
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<|newrecord|> nctId: NCT06362148 id: 1-10-72-134-23 briefTitle: Circulating Tumor DNA in Peripheral T-cell Lymphomas acronym: CIRCULATE overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2030-12 date: 2024-04-12 date: 2024-04-22 name: University of Aarhus class: OTHER name: Aarhus University Hospital briefSummary: The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL). conditions: Peripheral T-cell Lymphoma conditions: NK/T-Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay name: 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) measure: ctDNA occurrence measure: ctDNA quantification measure: Progression free survival measure: Overall survival measure: Radiographic assessment by PET/CT measure: Comparison of molecular and radiographic response measure: Spatial and temporal mutational homo- or heterogeneity measure: Fragment pattern analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Hematology, Aarhus University Hospital status: RECRUITING city: Aarhus state: Central Denmark Region zip: 8200 country: Denmark name: Patrick R Noerhave, MD role: CONTACT phone: +4551543715 email: [email protected] name: Francesco A d'Amore, MD, DMSc role: CONTACT phone: +4523708527 email: [email protected] name: Patrick R Noerhave, MD role: PRINCIPAL_INVESTIGATOR name: Martin B Pedersen, MD, PhD role: SUB_INVESTIGATOR name: Francesco A d'Amore, MD, DMSc role: SUB_INVESTIGATOR lat: 56.15674 lon: 10.21076 hasResults: False
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<|newrecord|> nctId: NCT06362135 id: 0733 briefTitle: Virtual Home Visits for Stroke Patients and Their Caregivers acronym: INHABASAEV overallStatus: RECRUITING date: 2023-08-01 date: 2024-12-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-15 name: The Scientific and Technological Research Council of Turkey class: OTHER briefSummary: The primary aim of this study is to evaluate the effectiveness of virtual home care for stroke patients and their caregivers. The secondary purpose is to evaluate the usability of the application by developing a mobile application for use in virtual home visits.
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The study will be carried out using the mixed research model, in which quantitative and qualitative methods are used together. The population of the research will consist of patients and caregivers with the diagnosis of hemorrhage, infarction, cerebrovascular accident and cerebral infarction, who applied to the Antalya Provincial Health Directorate Antalya Training and Research Hospital Home Health Unit, where the study is planned to be conducted. The sample of the study will consist of stroke patients and caregivers who meet the criteria for inclusion in the study. The first phase of the study was designed as a parallel group, single center and single blind randomized controlled trial to evaluate the effectiveness of virtual home visits in terms of time, cost and caregiver competence. The experimental group was the patient/patient relative group who made a virtual home visit, the control group will consist of 48 patients/patient relatives who have been visited face-to-face. In the second phase of the study, semi-structured interview method will be used to determine the views of patients/patient relatives about virtual home visits. In order to evaluate the usability of the developed application, a usability survey will be applied to the group that has visited the virtual home.
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With the results of this study, telemedicine applications in home care services will help to increase accessibility to home care services and reduce health care costs.considered to contribute. At the same time, it is expected that the results of the study will contribute to the scientific literature in the field of design and application of telemedicine services, which are developing and spreading conditions: Stroke conditions: Caregiver conditions: Virtual conditions: Home Visit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Virtual visit with stroke patient and their caregiver primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Telephone support or virtual meeting during the research process will be provided by an independent interviewer. whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Virtual Home Visit name: Control Group measure: Effect of Virtual and Face to face to home visit measure: Level of competence of stroke caregiver measure: Frequency of unplanned hospital readmission measure: Effect of the virtual home visit sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin Demi̇r Avci̇ status: RECRUITING city: Antalya zip: 07058 country: Turkey name: Yasemin Demir Avcı, PhD role: CONTACT phone: +905514028492 email: [email protected] lat: 36.90812 lon: 30.69556 hasResults: False
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<|newrecord|> nctId: NCT06362122 id: PREDICTO-POLYP briefTitle: Anatomo-clinico-biological Profiles in Severe Nasal Polyps overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-10-01 date: 2024-04-12 date: 2024-04-12 name: Poitiers University Hospital class: OTHER briefSummary: Nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population.
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Therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. Local corticosteroid therapy, using nasal sprays, is the background treatment. Surgical management is offered to patients in case of failure of medical treatment. Although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. Recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. There is currently no possibility of determining the probability of response to treatments in patients.
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It is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. Indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. This correlation will serve as a predictor of treatment response. conditions: NASAL POLYPS studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: identification anatomo-clinico-biological profiles measure: Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment. measure: Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale measure: Evaluation to quality of life by Sino-Nasal Outcome Test measure: Identify biological profiles for patients with nasal sinus polyposis measure: Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362109 id: Once tubefeeding briefTitle: The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Zhao Song Ling class: OTHER_GOV briefSummary: This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer:
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Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia.
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Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine rehabilitation name: Intermittent Oro-esophageal Tube Feeding measure: Nutritional status-prealbumin measure: Nutritional status-albumin measure: Nutritional status-hemoglobin sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362096 id: pyrotinib diarrhra briefTitle: A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Huihua Xiong class: OTHER briefSummary: To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 72 type: ESTIMATED name: Trastuzumab+pyrotinib+taxene measure: Incidence of ≥ grade 3 diarrhea sex: ALL minimumAge: 17 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362083 id: 34-317 ex 21/22 briefTitle: Urethral Stricture Database overallStatus: RECRUITING date: 2024-01-15 date: 2034-01-15 date: 2034-03-15 date: 2024-04-12 date: 2024-04-12 name: Medical University of Graz class: OTHER briefSummary: Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study. conditions: Urethral Stricture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Questionnaires and data collection measure: Success rate of urethral reconstructive surgeries measure: Complications of urethral reconstructive surgeries measure: Sexual function after urethral reconstructive surgeries measure: Health status after urethral reconstructive surgeries sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Röthl Martina Anna status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Marianne Leitsmann, Prof. Dr. role: CONTACT phone: +43 316 385 80550 email: [email protected] name: Marianne Leitsmann, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False
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<|newrecord|> nctId: NCT06362070 id: COMPAR-G briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy overallStatus: RECRUITING date: 2024-01-31 date: 2024-03-30 date: 2025-07-31 date: 2024-04-12 date: 2024-04-12 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER briefSummary: The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:
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* DaVinci;
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* Hugo;
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* Versius.
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This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.
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The questions it aims to answer are:
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* Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?
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* Are there any differences between the three platforms related to the learning curve for surgeons?
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Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:
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1. surgery with the daVinci platform;
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2. surgery with the Hugo platform;
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3. surgery with the Versius platform. conditions: Gastric Cancer conditions: Gastrointestinal Cancer conditions: Neoplasms conditions: Gastric Diffuse Adenocarcinoma conditions: Gastric Neoplasm conditions: Stomach Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: DaVinci® Surgical System name: Hugo™ RAS System name: Versius® Robotic Surgery System measure: Conversion rate to open or laparoscopic approach (Phase 1) measure: Number of participants with major intraoperative complications (Phase 1) measure: Evaluation of surgical times of the standardized procedures (Phase 2) measure: Analysis of video of surgical procedures (Phase 2) measure: Estimated Blood Loss measure: Overall duration of the surgery measure: Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps) measure: Number of participants with major postoperative complications measure: Compliance rate to ERAS protocol measure: Postoperative hospitalization measure: Postoperative pain measure: Re-admission rate to hospitalization measure: Damage due to positioning measure: Positive Surgical Margin measure: Lymph nodes resection measure: Quality of Life Evaluation measure: Time taken for platform-related technical steps measure: Possible malfunction of the platform measure: Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase. measure: Procedure-related costs sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General and Upper GI Unit status: RECRUITING city: Verona zip: 37126 country: Italy name: Simone SG Giacopuzzi, MD, Prof role: CONTACT phone: +39 0458127510 email: [email protected] name: Simone Giacopuzzi, MD, Prof role: PRINCIPAL_INVESTIGATOR name: Maria Bencivenga, MD, Prof role: SUB_INVESTIGATOR lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06362057 id: ADMNF-0020324 briefTitle: Biomechanical Effects of Digitally Constructed Subperiosteal Implants overallStatus: RECRUITING date: 2024-04-04 date: 2024-06-20 date: 2024-07-27 date: 2024-04-12 date: 2024-04-12 name: Menoufia University class: OTHER briefSummary: Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy. conditions: Bone Loss studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 9 type: ESTIMATED name: Subperiosteal implant framework measure: bone loss under the implants sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohammed A. El-Sawy status: RECRUITING city: Mansoura zip: 12345 country: Egypt name: Mohammed A. El-Sawy, PhD role: CONTACT phone: 161314522 email: [email protected] name: PhD role: CONTACT lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06362044 id: P24-120 briefTitle: A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan overallStatus: RECRUITING date: 2023-06-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: AbbVie class: INDUSTRY briefSummary: Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.
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Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.
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Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.
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There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice. conditions: Chronic Lymphocytic Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 89 type: ESTIMATED measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center Hospital East /ID# 265970 status: RECRUITING city: Kashiwa state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 hasResults: False
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<|newrecord|> nctId: NCT06362031 id: H18.Oncology.12-SR1812 briefTitle: A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review overallStatus: WITHDRAWN date: 2023-06-01 date: 2024-04-30 date: 2024-04-30 date: 2024-04-12 date: 2024-04-12 name: AbbVie class: INDUSTRY briefSummary: Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.
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Data from up to 700 participants will be collected. No participants will be enrolled in this study.
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Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.
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There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 0 type: ACTUAL measure: Overall Survival (OS) measure: Event-free survival (EFS) measure: Percentage of Participants Achieving Best Overall Response measure: Duration of Response (DoR) measure: Percentage of Participants with Transfusion Independence (TI) measure: Number of Participants with Healthcare Resource Utilization (HRU) sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06362018 id: MHC/CT/23-24/055 id: MHC/CT/23-24/055, Version No.: type: OTHER domain: Mprex Healthcare Pvt. Ltd. briefTitle: Bioavailability of Three Mitopure Formulations overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-05-31 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: Amazentis SA class: INDUSTRY name: Mprex Healthcare Pvt. Ltd. briefSummary: This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of three Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.
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Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness. conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 36 type: ESTIMATED name: Mitopure (Urolithin A) measure: Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax) measure: Exposure to Urolithin A over time measured as area under the curve (AUC) measure: Number of adverse events and serious adverse events throughout the study. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Lokmanya Medical Research Centre and Hospital city: Pune zip: 411033 country: India name: Dr Ramshyam Agarwal, MD role: CONTACT lat: 18.51957 lon: 73.85535 hasResults: False
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<|newrecord|> nctId: NCT06362005 id: AUAREC2023011-1 briefTitle: The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus acronym: RCT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-10-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-23 name: Al-Azhar University class: OTHER name: Sphinx university briefSummary: evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus. conditions: Lichen Planus, Oral studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Triamcinolone Acetonide 0.1% Oint name: Tacrollimus Topical name: Selenium name: Selenium & Triamcinolone Acetonide 0.1% Oint name: Selenium& Tacrollimus topical measure: to assess a visual analog scale (VAS)of the oral lichen planus lesion measure: to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis measure: Biochemical evaluation of salivary Glutathione level using (ELISA) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Alazhar university ,faculty of Dental Medicine city: Assiut zip: 0000 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06361992 id: BC_SERBIA_2022 briefTitle: Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children overallStatus: COMPLETED date: 2022-03-15 date: 2023-09-15 date: 2024-02-13 date: 2024-04-12 date: 2024-04-15 name: Catalysis SL class: INDUSTRY briefSummary: To verify the efficacy and tolerability of Activated Piroctone Olamine (Blue Cap Foam, label volume 100 ml) by CATALYSIS, S. L. Madrid, applied in the management of all types of dermatitis (atopic, seborrheic, eczema) in patients with significant manifestations of the disease in varying areas of the body of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients aged 3 to 18 years. conditions: Atopic Dermatitis conditions: Atopic Dermatitis and Related Conditions conditions: Atopic Dermatitis Eczema conditions: Atopic Dermatitis \(AD\) studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ACTUAL name: Blue Cap Foam measure: Grade of Patient Tolerability to the investigation product measure: Clinical Improvement of Patients with Dermatitis measure: Clinical assessment of symptoms and sings associated with Dermatitis measure: Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis. measure: Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš city: Niš state: Nišava zip: 18108 country: Serbia lat: 43.32472 lon: 21.90333 facility: City Institute for Skin and Venereal Diseases Belgrade city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: University of Belgrade Faculty of Medicine, University Clinical Center of Serbia city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False
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<|newrecord|> nctId: NCT06361979 id: A1811 briefTitle: SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Huihua Xiong class: OTHER briefSummary: This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases conditions: Breasr Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: SHR-A1811 name: Bevacizumab measure: CNS-ORR measure: PFS measure: ORR measure: AE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06361966 id: 2021/00638 briefTitle: Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets overallStatus: COMPLETED date: 2022-01-11 date: 2023-01-09 date: 2023-01-09 date: 2024-04-12 date: 2024-04-12 name: Tan Tock Seng Hospital class: OTHER name: Prosfit Technologies JSC name: Centre for Allied Health and Pharmacy Excellence (CAPE) briefSummary: The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.
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The main question\[s\] it aims to answer are:
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1. To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.
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2. To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method.
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3. To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.
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Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.
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Participants will attend 6 visits across a total duration of 11 weeks during the course of the study. conditions: Amputation conditions: Prosthesis User studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: 3d printed prosthetic socket measure: Prosthesis Evaluation Questionnaire measure: Socket Comfort Score sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tan Tock Seng Hospital city: Singapore zip: 308433 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06361953 id: IR.SBMU.MSP.REC. 1401. 161 briefTitle: Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder overallStatus: COMPLETED date: 2022-06-01 date: 2023-07-01 date: 2023-07-01 date: 2024-04-12 date: 2024-04-12 name: Shahid Beheshti University of Medical Sciences class: OTHER briefSummary: Generalized anxiety disorder (GAD) is one of the most prevalent mental disorders in adults, marked by excessive and uncontrollable worry about various events or activities. It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms.
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In addition, a critical and up-to-date comparison of different treatments for GAD is crucial due to their high costs and unsatisfactory outcomes. EEG neurofeedback training has not reached the same level of evidence as more extensively validated non-pharmacological treatments, such as cognitive behavioral therapy.This study aimed to compare the efficacy of two protocols: one targeting alpha-theta amplitude increase and the other concentrating on SMR. conditions: Generalized Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: EEG Neurofeedback measure: The Beck Anxiety Inventory measure: The Perceived Stress Questionnaire measure: Spielberger's state-trait anxiety test sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shahid Beheshti University of Medical Science city: Tehran zip: 4739-19395 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False
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<|newrecord|> nctId: NCT06361940 id: IIT-CHAUDHARY-ENDOCRINE2-OPP briefTitle: Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2028-12 date: 2029-12 date: 2024-04-12 date: 2024-04-15 name: Medical College of Wisconsin class: OTHER briefSummary: This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks). conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Aromatase inhibitors or tamoxifen measure: Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-2 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-3 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-4 receptor tyrosine kinases protein expression in tumors. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Froedtert Hospital and the Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Lubna N Chaudhary, MD role: CONTACT email: [email protected] lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06361927 id: SSGJ-707-NSCLC-II-01 briefTitle: A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients overallStatus: RECRUITING date: 2024-05 date: 2025-06 date: 2025-07 date: 2024-04-12 date: 2024-04-12 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: SSGJ-707 measure: ORR measure: Safety and tolerability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Lin Wu, MD,Ph.D role: CONTACT phone: 0731-89762302 email: [email protected] lat: 28.19874 lon: 112.97087 hasResults: False
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<|newrecord|> nctId: NCT06361914 id: 2314393 briefTitle: Digital CBT-I for Patients With Chronic Pain and Insomnia acronym: Back2Sleep overallStatus: RECRUITING date: 2024-04-12 date: 2026-03-01 date: 2026-09-01 date: 2024-04-12 date: 2024-04-18 name: Odense University Hospital class: OTHER name: Aarhus University Hospital name: University of Southern Denmark name: University of Aarhus name: Odense Patient Data Explorative Network name: T&W Engineering A/S briefSummary: Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who are sleeping well. Sleep disturbances are often considered a consequence to chronic pain. This means that insomnia is often overlooked or ineffectively managed with hypnotics or advice on sleep hygiene. Therefore, efficacious, easily accessible, and safe alternatives to the current pharmacological treatments for patients with chronic pain and insomnia are needed. Cognitive behavioral therapy for insomnia (CBT-I) is a cost-effective and safe treatment for insomnia and is recommended as first-line treatment. While highly efficacious, the challenge is to deliver CBT-I to those in need. The main barriers of face-to-face delivered CBT-I are availability of trained therapists, costs, as well as physical and geographical constraints.
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The primary aim of this randomized controlled clinical superiority trial is to investigate whether digitally-delivered CBT-I has a greater effect on insomnia and pain than digitally-delivered sleep hygiene education in patients with chronic pain and comorbid insomnia.
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Secondary objectives are to a) explore whether the pain-relieving effect is mediated by a change in physiological markers of sleep quality, b) whether health care cost and use of medications at 12 months are reduced after digital CBT-I, and c) to explore the effectiveness of digital CBT-I compared with sleep hygiene education on:
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1. Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients).
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2. Self-reported sleep quality.
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3. Quality of life.
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4. Physical and mental health.
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5. Thoughts and beliefs about sleep and pain. conditions: Chronic Pain conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Digital CBT-I name: Digital Sleep hygiene education measure: Insomnia severity measure: Average pain intensity during the last 7 days measure: The trajectory of ISI severity scores measure: 30% ISI responders measure: 50% ISI responders measure: Weekly pain intensity score trajectory measure: 30% pain intensity responders measure: 50% pain intensity responders measure: Global Perceived Effect (GPE) for sleep measure: Global Perceived Effect (GPE) for pain measure: Sleep Quality measure: Physical and Mental Health measure: Sleep diary measure: Thoughts about sleep and pain measure: Thoughts about sleep measure: Treatment compliance measure: Health-related quality of life - mobility measure: Health-related quality of life - self care measure: Health-related quality of life - usual activities measure: Health-related quality of life - pain/discomfort measure: Health-related quality of life - anxiety/depression measure: Health-related quality of life - global measure: Age measure: Sex measure: Chronic pain measure: Ethnicity measure: Height measure: Weight measure: Marital status measure: Level of education measure: Pain distribution measure: Medical history and concomitant illnesses measure: Concomitant medication measure: Health-related quality of life - mobility measure: Health-related quality of life - self care measure: Health-related quality of life - usual activities measure: Health-related quality of life - pain/discomfort measure: Health-related quality of life - anxiety/depression measure: Health-related quality of life - global measure: Insomnia Severity measure: Average pain intensity during the last 7 days measure: Medication use measure: Economical evaluation measure: Time from sleep onset until final awakening (TST) from Ear EEG in subgroup of 60 patients measure: Sleep efficiency (SE) from Ear EEG in subgroup of 60 patients measure: Sleep onset latency (SOL) from Ear EEG in subgroup of 60 patients measure: Wake after sleep onset (WASO) from Ear EEG in subgroup of 60 patients measure: REM sleep latency from Ear EEG in subgroup of 60 patients measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG measure: Number of awakenings within TST from Ear EEG measure: Arousal index which is number of arousals per hour from Ear EEG measure: Ease-of-use and Comfort with ear EEG measure: Ear EEG adverse device effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense status: RECRUITING city: Odense zip: 5000 country: Denmark name: Henrik B Vaegter, PhD role: CONTACT phone: 004565413869 email: [email protected] name: Louise S Olsen, MSc role: CONTACT phone: 004565413869 email: [email protected] name: Henrik B Vægter, PhD role: PRINCIPAL_INVESTIGATOR name: Louise S Olsen, MSc role: SUB_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False
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<|newrecord|> nctId: NCT06361901 id: 2023GR0452 briefTitle: Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia overallStatus: RECRUITING date: 2023-11-17 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Korea University Guro Hospital class: OTHER briefSummary: Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.
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Clinical evaluation tools will be performed before and after the treatment for all patients
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* K-Western Aphasia Battery for aphasia assessment tools
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* Cerebral blood flow changes with near-infrared spectroscopy conditions: Stroke conditions: Aphasia conditions: Speech Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Zenicog;language rehabilitation program name: Conventional language rehabilitation measure: Aphasic quatient measure: Change of cerebral blood flow sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, Korea University Guro Hospital status: RECRUITING city: Seoul zip: 08308 country: Korea, Republic of name: Seung Nam Yang, MD, PhD role: CONTACT phone: 82-2-2626-1500 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06361888 id: 2023-012-00CH1 briefTitle: A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-08-31 date: 2027-08-31 date: 2024-04-12 date: 2024-04-12 name: Hutchmed class: INDUSTRY briefSummary: To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer conditions: Metastatic Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 482 type: ESTIMATED name: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine name: Nab-paclitaxel Plus Gemcitabine name: Surufatinib with Nab-paclitaxel, and Gemcitabine measure: Overall Survival (OS) measure: Progression-free Survival (PFS) (RECIST1.1) measure: Objective response rate (ORR)(RECIST1.1) measure: Duration of response (DoR)(RECIST1.1) measure: Disease control rate (DCR)(RECIST1.1) measure: Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measure: Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Tianyinshan Hospital city: Nanjing state: Jiang Su zip: 210000 country: China name: Shukui Qin, Prof. role: CONTACT lat: 32.06167 lon: 118.77778 facility: Tianjin Cancer Hospital city: Tianjin state: Tianjin zip: 300000 country: China name: Jihui Hao, Prof. role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06361875 id: VAV00045 id: U1111-1295-2852 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above overallStatus: RECRUITING date: 2024-04-01 date: 2025-05-22 date: 2025-05-22 date: 2024-04-12 date: 2024-04-12 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) compared to an active control (QIV- standard dose (SD), QIV- high dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older. conditions: Influenza Immunization studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel with dose escalation for sentinel cohort primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Modified double-blind (Participants; Sites except for those preparing/administering study intervention; Sponsor's except Sponsor unblinded internal safety review committee) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1002 type: ESTIMATED name: Quadrivalent Influenza mRNA Vaccine MRT5421 name: Quadrivalent Influenza mRNA Vaccine MRT5424 name: Quadrivalent Influenza mRNA Vaccine MRT5429 name: Quadrivalent Influenza Standard Dose Vaccine name: Quadrivalent Influenza High-Dose Vaccine name: Quadrivalent Recombinant Influenza Vaccine measure: Number of participants with immediate unsolicited systemic adverse events (AEs) measure: Number of participants with solicited injection site reactions measure: Number of participants with solicited systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with medically attended adverse events (MAAEs) measure: Number of participants with serious adverse events (SAEs) measure: AESIs reported throughout the study measure: Number of participants with adverse events of special interests (AESIs) measure: Number of participants with out-of-range biological test results measure: Geometric Mean Titer (GMT) measure: Geometric Mean of individual Titer Ratio (GMTR) measure: Seroconversion measure: HAI Ab titer ≥ 40 (1/dil) measure: Neutralizing Ab titers at D01 and D29 measure: Individual neutralizing antibodies titer ratio measure: 2-fold and 4-fold increase in neutralizing titers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research Site Number : 8400048 status: RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: California Research Foundation Site Number : 8400038 status: RECRUITING city: San Diego state: California zip: 92123-1881 country: United States lat: 32.71533 lon: -117.15726 facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001 status: RECRUITING city: DeLand state: Florida zip: 32720-0834 country: United States lat: 29.02832 lon: -81.30312 facility: Indago Research and Health Center Site Number : 8400032 status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Research Centers of America Site Number : 8400037 status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Suncoast Research Group, LLC Site Number : 8400015 status: RECRUITING city: Miami state: Florida zip: 33135 country: United States lat: 25.77427 lon: -80.19366 facility: Brengle Family Medicine Site Number : 8400045 status: RECRUITING city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: AMR Lexington Site Number : 8400042 status: RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States lat: 37.98869 lon: -84.47772 facility: Velocity Clinical Research Site Number : 8400053 status: RECRUITING city: Metairie state: Louisiana zip: 70006 country: United States lat: 29.98409 lon: -90.15285 facility: Optimal Research, LLC Rockville Site Number : 8400025 status: RECRUITING city: Rockville state: Maryland zip: 20850 country: United States lat: 39.084 lon: -77.15276 facility: The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034 status: RECRUITING city: Kansas City state: Missouri zip: 64114 country: United States lat: 39.09973 lon: -94.57857 facility: Velocity Clinical Research Norfolk Site Number : 8400046 status: RECRUITING city: Norfolk state: Nebraska zip: 68701 country: United States lat: 42.02834 lon: -97.417 facility: Velocity Clinical Research, Omaha Site Number : 8400008 status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States lat: 41.25626 lon: -95.94043 facility: Rochester Clinical Research. Inc. Site Number : 8400005 status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Aventiv Research Columbus Site Number : 8400020 status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States lat: 39.96118 lon: -82.99879 facility: Coastal Carolina Research Center Site Number : 8400014 status: RECRUITING city: North Charleston state: South Carolina zip: 29405 country: United States lat: 32.85462 lon: -79.97481 facility: AMR Knoxville Site Number : 8400043 status: RECRUITING city: Knoxville state: Tennessee zip: 37909 country: United States lat: 35.96064 lon: -83.92074 facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029 status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056 status: RECRUITING city: Tomball state: Texas zip: 77375 country: United States lat: 30.09716 lon: -95.61605 facility: JBR Clinical Research Site Number : 8400051 status: RECRUITING city: Salt Lake City state: Utah zip: 84107 country: United States lat: 40.76078 lon: -111.89105 facility: Investigational Site Number : 6300002 status: RECRUITING city: Barrio Sabana zip: 00694 country: Puerto Rico hasResults: False
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<|newrecord|> nctId: NCT06361862 id: WARD - Overtreatment briefTitle: Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? acronym: WARD-OT overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-12 date: 2024-04-12 name: Rigshospitalet, Denmark class: OTHER name: Bispebjerg Hospital briefSummary: This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group. conditions: Cancer conditions: Chronic Obstructive Pulmonary Disease conditions: Surgery-Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 700 type: ESTIMATED name: Active alarms from WARD software measure: Frequency of patients having at least one of the following tests/treatments: measure: The frequency of individual treatments and diagnostics: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eske Kvanner Aasvang status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Eske K Aasvang, M.D., DMSci role: CONTACT phone: +4526232076 email: [email protected] lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06361849 id: 55013 briefTitle: TauTona Pneumoperitoneum Assist Device (TPAD) acronym: TPAD overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-12-31 date: 2025-06-01 date: 2024-04-12 date: 2024-04-24 name: Stanford University class: OTHER name: TauTona Group briefSummary: The purpose of this study is to assess the safety and ease of use of a trocar placement access device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery. conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Trocar Placement Assist Device (TPAD) measure: Surgeon satisfaction survey measure: Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Hospital & Clinics city: Palo Alto state: California zip: 94305 country: United States lat: 37.44188 lon: -122.14302 hasResults: False
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