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protocolSection identificationModule nctId: NCT06284733, orgStudyIdInfo id: P.T.REC/012/004874, briefTitle: Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-05, primaryCompletionDateStruct date: 2024-04-08, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: MTI University, class: OTHER, descriptionModule briefSummary: This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital.All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data., conditionsModule conditions: Amputation; Traumatic, Leg, Lower, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: They will be assigned into three equal groups:, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double blinded, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 115, type: ACTUAL, armsInterventionsModule interventions name: Whole-body vibration plus conservative care, interventions name: conservative care, outcomesModule primaryOutcomes measure: Prosthetic leg stability test, secondaryOutcomes measure: Sway Index, secondaryOutcomes measure: Limits of Stability Test, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ahmed Mohamed Ahmed Abdelhady, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06284720, orgStudyIdInfo id: Project number 144, briefTitle: Transcranial Alternating Current Stimulation for the Improvement of Episodic Memory in Healthy Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Universidade Católica Portuguesa, class: OTHER, collaborators name: Clínica NeuroVida (Portugal), descriptionModule briefSummary: Memory complaints are a common symptom among Subjective Cognitive Decline, Mild Cognitive Impairment and Alzheimer disease. Indeed, episodic memory and Alzheimer disease are highly sensitive to aging. Many brain areas become active when we remember an event from the past. The precuneus, part of the posterior system of default mode network, has been identified as a central node of episodic memory retrieval and a central node in various psychiatric and neurological disorders, such as Alzheimer disease. Age-related changes have been consistently found in the default mode network connectivity, occurring within its posterior areas and with the reduction of connectivity between anterior and posterior subnetwork. It has also been found that aging is associated with decreased functional connectivity in the precuneus and posterior cingulate of the default mode network. Furthermore, γ-Aminobutyric acid (GABA), which plays an essential role in regulating brain activity and modulating the default mode network, shows a decrease throughout the normal course of aging, in Mild Cognitive Impairment and Alzheimer disease. It was also verified a link between cognitive decline and the dysfunction of the inhibitory activity of GABAergic interneurons, particularly parvalbumin-positive interneurons, that play a role in control local circuitry, brain networks and memory processing. Parvalbumin interneurons are the fast-spiking interneurons that generate and maintain gamma frequency. Gamma band has been associated with the encoding and retrieval of episodic memory. Impairments of gamma oscillations have been observed in healthy aging, Mild Cognitive Impairment and Alzheimer disease.By identifying these functional connectivity changes, non-invasive neuromodulation techniques may offer a new strategy for improving cognitive functions. Transcranial Alternating Current Stimulation (tACS) is a form of non-invasive brain stimulation that modulates cortical activity by applying weak, oscillating electrical currents to the cortex via two or more scalp electrodes. By using alternating currents, it is possible to simulate the rhythmic pattern of electrophysiological activity of the brain. tACS can interact with neural firing at behaviorally relevant frequencies linked to memory.In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether stimulation with gamma tACS on the precuneus can improve episodic memory in healthy older adults., conditionsModule conditions: Healthy Older Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Gamma tACS (40 Hz) over the precuneus, interventions name: Sham tACS over the precuneus, outcomesModule primaryOutcomes measure: Changes in immediate and delayed free recall Auditory Verbal Learning Test scores, primaryOutcomes measure: Changes in immediate free recall and delayed recognition Face-Name Memory Test scores, secondaryOutcomes measure: Change in functional connectivity, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Filipa Ribeiro, city: Lisbon, country: Portugal, contacts name: Filipa Ribeiro, PhD, role: CONTACT, phone: +351 217214147, email: [email protected], contacts name: Joana Macedo, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Filipa Ribeiro, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False |
protocolSection identificationModule nctId: NCT06284707, orgStudyIdInfo id: Rhythmic_PAU_2024, briefTitle: Effect of Rhythmic Gymnastics Training in Children With Down Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-08, completionDateStruct date: 2024-05-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Castilla-La Mancha, class: OTHER, descriptionModule briefSummary: Some of the clinical characteristics of people with Down syndrome (DS) are orthopedic, cardiovascular, neuromuscular, visual, cognitive and perceptual disorders, which directly affect the quality of their movements. Children with DS often have a sedentary lifestyle or low levels of physical activity which exacerbates problems related to obesity and overall physical health. Therefore, the practice of physical exercise in this type of population is essential to improve their health-related physical fitness. The aim of this study was to analyze the influence of an adapted rhythmic gymnastics training program on body composition, tendon architecture and stiffness, and physical capacity in children with DS., conditionsModule conditions: Physical Conditioning, Human, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: The care provider will be responsible for administering the training program. Two different people will develop swimming training and rhythmic gymnastics training. Each participant will be assigned a code. The researcher will process the data with the code of each participant., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: swimming training, interventions name: rhythmic gymnastics training, outcomesModule primaryOutcomes measure: Body composition, primaryOutcomes measure: Tendon thickness, primaryOutcomes measure: Stiffness tendon, primaryOutcomes measure: Hamstrings flexibility, primaryOutcomes measure: body mass index, primaryOutcomes measure: visceral fat area, primaryOutcomes measure: metabolism, primaryOutcomes measure: tendon elastography, primaryOutcomes measure: balance, primaryOutcomes measure: functional capacity, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universidad de Castilla La Mancha, status: RECRUITING, city: Toledo, zip: 45071, country: Spain, contacts name: Paula Esteban-García, PhD, role: CONTACT, phone: 925 26 88 00, email: [email protected], geoPoint lat: 39.8581, lon: -4.02263, hasResults: False |
protocolSection identificationModule nctId: NCT06284694, orgStudyIdInfo id: REB23-0120, briefTitle: Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI)., conditionsModule conditions: Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will receive active rTMS treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Repetitive Transcranial Magnetic Stimulation (rTMS), outcomesModule primaryOutcomes measure: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) v3.0, primaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a, secondaryOutcomes measure: Quality of Life Index Spinal Cord Injury version (QLI-SCI), secondaryOutcomes measure: Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: World Health Organization Disability Assessment Schedule (WHODAS) 2.0, secondaryOutcomes measure: Generalized Anxiety Disorder scale-7 (GAD-7), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foothills Medical Centre, city: Calgary, state: Alberta, zip: T2N 2T9, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False |
protocolSection identificationModule nctId: NCT06284681, orgStudyIdInfo id: IRB-300012557, secondaryIdInfos id: 3P50MD017338-03S1, type: NIH, link: https://reporter.nih.gov/quickSearch/3P50MD017338-03S1, briefTitle: Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults, acronym: WISE Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit)., conditionsModule conditions: Obesity, conditions: Prehypertension, conditions: Hypertension, conditions: PreDiabetes, conditions: Type 2 Diabetes, conditions: Dyslipidemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Weight-focused health coaching, interventions name: Weight-neutral health coaching, interventions name: Intensify lifestyle approach, interventions name: Augment with enhanced medical management, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Response/Non-response rate to initial interventions, primaryOutcomes measure: Attendance to health coaching sessions, primaryOutcomes measure: Treatment Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Treatment Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Treatment Preference, primaryOutcomes measure: Treatment Preference, primaryOutcomes measure: Family medicine clinic capacity for research, primaryOutcomes measure: Study visit duration, primaryOutcomes measure: Time required for surveys completion, primaryOutcomes measure: Response to weight-focused health coaching, primaryOutcomes measure: Response to weight-neutral health coaching measurement, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in glucose, secondaryOutcomes measure: Change in insulin, secondaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in total cholesterol, secondaryOutcomes measure: Change in LDL-cholesterol, secondaryOutcomes measure: Change in HDL-cholesterol, secondaryOutcomes measure: Change in triglycerides, secondaryOutcomes measure: Change in Metabolic Syndrome Severity Score, otherOutcomes measure: Change in blood pressure, otherOutcomes measure: Change in glucose, otherOutcomes measure: Change in insulin, otherOutcomes measure: Change in HbA1c, otherOutcomes measure: Change in total cholesterol, otherOutcomes measure: Change in LDL-cholesterol, otherOutcomes measure: Change in HDL-cholesterol, otherOutcomes measure: Change in triglycerides, otherOutcomes measure: Change in body weight, otherOutcomes measure: Change in physical activity, otherOutcomes measure: Change in fat mass, otherOutcomes measure: Change in fat mass, otherOutcomes measure: Change in lean mass, otherOutcomes measure: Change in lean mass, otherOutcomes measure: Change in waist circumference, otherOutcomes measure: Change in waist circumference, otherOutcomes measure: Dietary intake measurement, otherOutcomes measure: Dietary intake measurement, otherOutcomes measure: Change in insulin sensitivity, otherOutcomes measure: Change in Metabolic Syndrome Severity Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284668, orgStudyIdInfo id: GWang027, briefTitle: Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University General Hospital, class: OTHER, descriptionModule briefSummary: To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval, conditionsModule conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: normal Saline, interventions name: Esketamine, interventions name: Remimazolam, outcomesModule primaryOutcomes measure: The incidence of postoperative sleep disturbance on the first night after surgery, secondaryOutcomes measure: The incidence of sleep disturbance one day before surgery, secondaryOutcomes measure: The incidence of postoperative sleep disturbance on the second and third postoperative nights, secondaryOutcomes measure: Postoperative anxiety, secondaryOutcomes measure: Postoperative depression, secondaryOutcomes measure: Pain Score (NRS), secondaryOutcomes measure: Mean intraoperative blood pressure, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Somatokinetic reaction, secondaryOutcomes measure: Operation time, secondaryOutcomes measure: Duration of anesthesia, secondaryOutcomes measure: Time to walking down, secondaryOutcomes measure: Adverse event, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Tianjin Medical University General Hospital, status: RECRUITING, city: Tianjin, zip: 300052, country: China, contacts name: Guolin Wang, role: CONTACT, phone: +8618604755166, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06284655, orgStudyIdInfo id: 635362 a, briefTitle: The Effect of a Brief Educational Intervention for Adults With ADHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: St. Olavs Hospital, class: OTHER, collaborators name: Norwegian University of Science and Technology, descriptionModule briefSummary: This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel two-arms randomized control trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Blinded statistician, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: group-based combined with innovative technology education, interventions name: Standard treatment, outcomesModule primaryOutcomes measure: Change in client satisfaction using CSQ, primaryOutcomes measure: Change in general self-efficacy using GSE-6, primaryOutcomes measure: Change in satisfaction with the information, primaryOutcomes measure: Knowledge and treatment preferences, secondaryOutcomes measure: Change in patient activation using PAM, secondaryOutcomes measure: Change in ADHD-related symptoms using ASRS, secondaryOutcomes measure: Change in ADHD-related symptoms using SCL-9, secondaryOutcomes measure: Change in depression and anxiety symptoms using PHQ-4, secondaryOutcomes measure: Change in patient enablement using PEN-13, secondaryOutcomes measure: Change in stress level using PSS-4, secondaryOutcomes measure: Change in level of functioning using WSAS, secondaryOutcomes measure: Change in ADHD Quality of life using AAQoL, secondaryOutcomes measure: Change in Health-related Quality of life using EQ-5D-5L, otherOutcomes measure: Cost, otherOutcomes measure: Health care usage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Olav's Hospital, city: Trondheim, country: Norway, contacts name: Mariela Loreto Lara-Cabrera, PhD, role: CONTACT, email: [email protected], geoPoint lat: 63.43049, lon: 10.39506, hasResults: False |
protocolSection identificationModule nctId: NCT06284642, orgStudyIdInfo id: LD-ITUK-2024-001, briefTitle: Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Nanchang University, class: OTHER, collaborators name: Changhai Hospital, descriptionModule briefSummary: The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group. Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase, once a day for 3 consecutive days. Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo (0.9%NaCl) injection. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 2 on the modified Rankin Scale (mRS), at 6 months after aneurysmal SAH. Primary outcome will be determined by a member of the Independent Committee on Terminal events., conditionsModule conditions: Aneurysmal Subarachnoid Hemorrhage, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 424, type: ESTIMATED, armsInterventionsModule interventions name: Urokinase, interventions name: Placebo, outcomesModule primaryOutcomes measure: Modified Rankin Scale (mRS), secondaryOutcomes measure: Modified Rankin Scale (mRS), secondaryOutcomes measure: Relative Modified Rankin Scale (mRS), secondaryOutcomes measure: Modified Rankin Scale (mRS) distribution, secondaryOutcomes measure: Glasgow Outcome Scale (GOS）, secondaryOutcomes measure: Questionnaire EuroQol Five Dimensions Questionnaire (EQ-5D), secondaryOutcomes measure: Barthel Index for Activities of Daily Living (BI), secondaryOutcomes measure: Total hospitalized time, secondaryOutcomes measure: Total hospitalized costs, secondaryOutcomes measure: Cerebral vasospasm (CV), secondaryOutcomes measure: Delayed cerebral ischemia (DCI), secondaryOutcomes measure: Death, secondaryOutcomes measure: Hydrocephalus, secondaryOutcomes measure: Rebleeding, otherOutcomes measure: Subarachnoid hemorrhage volume clearance, otherOutcomes measure: Correlationship between cerebralspinal fluid pressure with subarachnoid hemorrhage volume, otherOutcomes measure: Correlationship between clinical grades and subarachnoid hemorrhage volume, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Nanchang University, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Xingen Zhu, MS, role: CONTACT, email: [email protected], geoPoint lat: 28.68396, lon: 115.85306, hasResults: False |
protocolSection identificationModule nctId: NCT06284629, orgStudyIdInfo id: PD-DigiCare, briefTitle: Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes., acronym: PD-DigiCare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Odense University Hospital, collaborators name: Zealand University Hospital, descriptionModule briefSummary: The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Participants and physicians will be blinded to device and app data in the control group. Blinding of the group allocation is not possible due to the investigated device., enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Neptune, interventions name: Standard clinical care, outcomesModule primaryOutcomes measure: Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale), secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., secondaryOutcomes measure: Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet Glostrup, city: Glostrup, zip: 2600, country: Denmark, contacts name: Nikolaj la Cour Karottki, MD, role: CONTACT, phone: 40432773, email: [email protected], geoPoint lat: 55.6666, lon: 12.40377, locations facility: Odense University Hospital, city: Odense, country: Denmark, contacts name: Morten Blaabjerg, MD, role: CONTACT, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Zealand University Hospital, Roskilde, city: Roskilde, country: Denmark, contacts name: Helle Thagesen, MD, role: CONTACT, geoPoint lat: 55.64152, lon: 12.08035, hasResults: False |
protocolSection identificationModule nctId: NCT06284616, orgStudyIdInfo id: K2019-0392, briefTitle: JASP-1 for Children Recently Diagnosed and Their Parents, acronym: JASP-1, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-08-15, primaryCompletionDateStruct date: 2023-04-15, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, descriptionModule briefSummary: To implement and evaluate a patient-and family-centered Juvenile Arthritis Support Program during one year (JASP-1) for children recently diagnosed with JIA and their parents and after 12 months compare satistaction with care and health outcomes with a control group receiving standard care., conditionsModule conditions: JIA, conditions: Support Program, conditions: Patient Satisfaction, conditions: Patient Outcome Assessment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a non-randomized intervention study with 2 groups receiving either a Support program (JASP-1) or standard care, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: All patient receiving a JIA diagnose was offered to participate in JASP-1. The controls had received diagnose before the start of the study., enrollmentInfo count: 82, type: ACTUAL, armsInterventionsModule interventions name: JASP-1, outcomesModule primaryOutcomes measure: Rate of Patient Reported Experienced Measures (PREM), secondaryOutcomes measure: Rate of Overall perceived health, secondaryOutcomes measure: Rate of Child Health Activity Questionnaire (CHAQ), secondaryOutcomes measure: Number of active joints, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Astrid Lindgren Children´s Hospital, city: Stockholm, state: Region Stockholm, zip: 17176, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06284603, orgStudyIdInfo id: AWF_LA_HBOT, briefTitle: Effectiveness of Hyperbaric Oxygen Therapy in Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-12-20, completionDateStruct date: 2023-12-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.The main questions it aims to answer are:1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two study groups (dependent on frequency of HBOT treatments) and control group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Hyperbaric Oxygen Therapy - HBOT, outcomesModule primaryOutcomes measure: Volume of oxygen and carbon dioxide, primaryOutcomes measure: Heart rate, primaryOutcomes measure: Vascular circulation measures, secondaryOutcomes measure: Body composition (body mass, fat mass, lean body mass, muscle mass), secondaryOutcomes measure: Inflammatory cytokine profile, secondaryOutcomes measure: Oxidative stress indicators, secondaryOutcomes measure: F2-Isoprostanes (F2-IsoP), secondaryOutcomes measure: Brain-derived neurotrophic factor concentration (BDNF), secondaryOutcomes measure: Nicotinamide (NAD) metabolites, secondaryOutcomes measure: Gut microbiome and metabolome, secondaryOutcomes measure: Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA), secondaryOutcomes measure: endothelial nitric oxide synthase (eNOS), secondaryOutcomes measure: Vascular endothelial growth factor (VEGF), secondaryOutcomes measure: Hypoxia inducible factor-1 (HIF-1alfa), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Poznan University of Physical Education, city: Poznan, state: Wielkopolska, zip: 61-871, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False |
protocolSection identificationModule nctId: NCT06284590, orgStudyIdInfo id: PH-ICKPD1-02/21, secondaryIdInfos id: MK-3475-F20, type: OTHER, domain: Merck Sharp & Dohme LLC, secondaryIdInfos id: KEYNOTE-F20, type: OTHER, domain: missing, briefTitle: Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients, acronym: INTACT/MeRCI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2028-07, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Philogen S.p.A., class: INDUSTRY, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma., conditionsModule conditions: Melanoma Stage III, conditions: Melanoma Stage IV, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 162 patients. Patients enrolled will be randomized in a 1:1:1 ratio. i) systemic pembrolizumab in combination with intralesional L19IL2 (Arm 1): 54 patients.ii) systemic pembrolizumab in combination with intralesional L19TNF (Arm 2): 54 patients iii) systemic pembrolizumab in combination with intralesional L19IL2/L19TNF (Arm 3): 54 patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: L19IL2, interventions name: L19TNF, interventions name: L19IL2/L19TNF, interventions name: KEYTRUDA®, outcomesModule primaryOutcomes measure: Confirmed Objective Response Rate (ORR), secondaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Pathological response, secondaryOutcomes measure: Confirmed ORR, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Serious Adverse Event (SAEs), secondaryOutcomes measure: Drug-Induced Liver Injury (DILI), secondaryOutcomes measure: Number of patients with Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Number of patients with Immune-Related Adverse Events (IRAEs), secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal hematology laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal serum chemistry laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal coagulation laboratory tests results, secondaryOutcomes measure: Number of participants with abnormal body temperature, secondaryOutcomes measure: Number of participants with abnormal blood pressure, secondaryOutcomes measure: Number of participants with abnormal Electrocardiogram (ECG) readings, secondaryOutcomes measure: Number of participants with abnormal Echocardiogram (ECHO) readings, secondaryOutcomes measure: Number of participants with abnormal physical examination results, secondaryOutcomes measure: Concomitant medication usage, secondaryOutcomes measure: Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering Cancer Center, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06284577, orgStudyIdInfo id: 677186, briefTitle: Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, descriptionModule briefSummary: The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients., conditionsModule conditions: Cystic Fibrosis in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Multistrain Probiotic, interventions name: Placebo - maltodextrin, outcomesModule primaryOutcomes measure: Changes in GI related QoL using the questionnaire PedsQL GI, secondaryOutcomes measure: Changes in microbiota, secondaryOutcomes measure: Changes in intestinal inflammation, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, country: Norway, contacts name: Magnhild P Kolsgaard, PhD, role: CONTACT, phone: 0047 41514045, email: [email protected], contacts name: Camilla Styffe Sæland, Master, role: CONTACT, phone: 004793257798, email: [email protected], contacts name: Magnhild P Kolsgaard, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Camilla Styffe Sæland, Master, role: SUB_INVESTIGATOR, contacts name: Linh Dieu Ngo, Master, role: SUB_INVESTIGATOR, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False |
protocolSection identificationModule nctId: NCT06284564, orgStudyIdInfo id: 2023-0538, secondaryIdInfos id: NCI-2024-03604, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Bristol-Myers Squibb, collaborators name: Cancer Prevention Research Institute of Texas, collaborators name: United States Department of Defense, descriptionModule briefSummary: To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied., conditionsModule conditions: Metastatic Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Evolocumab, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Eric Jonasch, MD, role: CONTACT, phone: 713-563-7232, email: [email protected], contacts name: Eric Jonasch, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06284551, orgStudyIdInfo id: 202111069RINB, briefTitle: The Relationship Between Internet-use Behavior and Mental Health in Youth, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-02-08, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2025-01-27, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Introduction: WHO defines youth as 15-24 years age group. At this stage, the brain is still under development, with high impulsiveness, being fond of stimulation and yearning for peer life. Compared with traditional interpersonal interaction, modern youths use the Internet as a main interpersonal interaction platform and conduct lots of leisure activities on the Internet. Poor cognitive emotion regulation strategies and personal traits may extend to new types of mental health issues; and are associated with depression, anxiety, suicidal/self-injurious behaviors, and cyberbullying.Objectives: (1) To investigate whether emotion regulation strategies while facing stressful events are highly related to with cyberbullying, social media, and internet gaming disorder. (2) To investigate the relation between cyberbullying and depression, anxiety, suicide/self-injury among Taiwanese youths. (3) To investigate the probability of cyberbullying, social media addiction, and internet gaming disorder occurring at the same time.Method: This cross-sectional study recruits cases of youths from 15 to 24 years old and collects data through questionnaires survey. In addition to collection of basic data, Internet using habits, and medical history, self-rated questionnaires include Suicide/Self-Injury Ideation Questionnaire, The Beck Depression Inventory 2nd Edition, Multidimensional Anxiety Scale for Children-Taiwan version, Cognitive Emotion Regulation Questionnaire, Cyberbullying Questionnaire, and Internet Gaming Disorder Scale-Short Form., conditionsModule conditions: Mental Health Issue, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Cyberbullying Questionnaire, secondaryOutcomes measure: Beck's Depression Inventory (BDI-II), eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06284538, orgStudyIdInfo id: NA-01-23, briefTitle: Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds, acronym: WOUND-H, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Nova Argentia S.r.l., class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events., conditionsModule conditions: Wound Healing Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: NOVA.EMOSTOP RE-EPITHELIZING, outcomesModule primaryOutcomes measure: improvement in Clinical Healing score at visit 3, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Casa di cura riabilitativa Villa Sofia, status: RECRUITING, city: Acireale, state: Catania, zip: 95024, country: Italy, contacts name: Marco Daniele, PI, role: CONTACT, phone: 0957631997, email: [email protected], contacts name: Salvatore Balsamo, role: SUB_INVESTIGATOR, geoPoint lat: 37.60886, lon: 15.16577, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-06-26, uploadDate: 2024-02-13T04:55, filename: Prot_SAP_000.pdf, size: 2091803, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-04-02, uploadDate: 2024-02-21T04:35, filename: ICF_001.pdf, size: 95177, hasResults: False |
protocolSection identificationModule nctId: NCT06284525, orgStudyIdInfo id: 2137420, briefTitle: Ankle Assistance and Resistance in Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Northern Arizona University, class: OTHER, descriptionModule briefSummary: The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Ankle resistance and biofeedback, outcomesModule primaryOutcomes measure: 6MWT, primaryOutcomes measure: Metabolic power, primaryOutcomes measure: Plantar flexor strength, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Arizona University, status: RECRUITING, city: Flagstaff, state: Arizona, zip: 86011, country: United States, contacts name: Zach Lerner, PhD, role: CONTACT, phone: 928-523-1787, email: [email protected], geoPoint lat: 35.19807, lon: -111.65127, hasResults: False |
protocolSection identificationModule nctId: NCT06284512, orgStudyIdInfo id: Uveal Melanoma 1942/2022, briefTitle: Uveal Melanoma - Comparative Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography., conditionsModule conditions: Uveal Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Sonography, color fundus photography, outcomesModule primaryOutcomes measure: Largest Basal Diameter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, Department of Ophthalmology and Optometry, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Judith Kreminger, MD, role: CONTACT, phone: +4314040048470, email: [email protected], contacts name: Reinhard Told, MD, PhD, Priv.-Doz., role: CONTACT, phone: +434040079690, email: [email protected], contacts name: Adrian Reumueller, MD, Priv.-Doz, role: SUB_INVESTIGATOR, contacts name: Roman Dunavölgyi, Assoc.-Prof. Priv.-Doz. Dr., role: SUB_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False |
protocolSection identificationModule nctId: NCT06284499, orgStudyIdInfo id: 26308819120, briefTitle: Effect of Different Fixed Lingual Retainers on Tooth Stability, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2020-01-16, primaryCompletionDateStruct date: 2023-01-15, completionDateStruct date: 2023-10-13, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Mustafa Kemal University, class: OTHER, descriptionModule briefSummary: Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests., conditionsModule conditions: Effect of Lingual Retainers on Tooth Stability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: measuring tooth stability after orthodontic treatment using a Periotest® device., outcomesModule primaryOutcomes measure: Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hatay Mustafa Kemal University, Faculty of Dentistry, city: Hatay, zip: 31060, country: Turkey, geoPoint lat: 38.40227, lon: 27.10486, hasResults: False |
protocolSection identificationModule nctId: NCT06284486, orgStudyIdInfo id: 2023-0794, secondaryIdInfos id: NCI-2024-01721, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Syndax Pharmaceuticals, collaborators name: Break Through Cancer, collaborators name: AbbVie, descriptionModule briefSummary: To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Venetoclax, interventions name: Revumenib, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Ghayas Issa, MD, role: CONTACT, phone: 713-745-6798, email: [email protected], contacts name: Ghayas Issa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06284473, orgStudyIdInfo id: 212154, briefTitle: Ketamine as a Supplement to Local Anesthesia for Minor Procedures, acronym: INK-MP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-25, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Loyola University, class: OTHER, descriptionModule briefSummary: This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS).Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research, conditionsModule conditions: Pain, Procedural, conditions: Minor Laceration, conditions: Abscess, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients presenting to the emergency department at Loyola University Medical Center for a minor medical procedure requiring local anesthesia will be randomly assigned to receive either standard local anesthesia with 0.7 mg/kg intranasal ketamine before the procedure or to standard local anesthesia with volume-based dose saline before the procedure using a 1:1 random block allocation., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All participants and study personnel are blinded except for the clinical pharmacist who prepares the intervention., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine, interventions name: Saline, outcomesModule primaryOutcomes measure: Immediate pain, primaryOutcomes measure: Acute pain, primaryOutcomes measure: Delayed pain, secondaryOutcomes measure: Immediate agitation, secondaryOutcomes measure: Acute agitation, secondaryOutcomes measure: Delayed agitation, secondaryOutcomes measure: Immediate alertness, secondaryOutcomes measure: Acute alertness, secondaryOutcomes measure: Delayed alertness, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loyola University Medical Center, status: RECRUITING, city: Maywood, state: Illinois, zip: 60153, country: United States, contacts name: Shannon Lovett, MD, role: CONTACT, phone: 847-951-2936, email: [email protected], contacts name: Trent Reed, DO, role: CONTACT, phone: 708-216-4117, email: [email protected], geoPoint lat: 41.8792, lon: -87.84312, hasResults: False |
protocolSection identificationModule nctId: NCT06284460, orgStudyIdInfo id: 2022-0622, secondaryIdInfos id: NCI-2024-01692, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase I/II Study of a Combination of Decitabine and Cedazuridine (ASTX727) and ASTX029, an ERK Inhibitor, for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: The goal of Part 1 of this clinical research study is to find the highest tolerable dose of ASTX029 that can be given in combination with ASTX727 to participants who have RAS-mutant MDS or MDS/MPN. The goal of Part 2 of this clinical research study is to learn if the dose of ASTX029 found in Part 1 can help to control the disease when used in combination with ASTX727., conditionsModule conditions: Pathway Mutant Myelodysplastic Syndromes, conditions: Myelodysplastic Neoplasm, conditions: Myeloproliferative Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ASTX029, interventions name: ASTX727, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Cente, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Guillermo Montalban Bravo, MD, role: CONTACT, phone: 713-794-3604, email: [email protected], contacts name: Guillermo Montalban Bravo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06284447, orgStudyIdInfo id: 22-004500, secondaryIdInfos id: NCI-2024-00181, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 22-004500, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Barriers to Cervical Cancer Screening, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-23, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study evaluates barriers to cervical cancer screening among non-compliant women., conditionsModule conditions: Cervical Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200000, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Identify barriers to cervical cancer screening, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Brittany A. Strelow, DSMc, PA-C, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06284434, orgStudyIdInfo id: CHI2311, briefTitle: Liposomal Bupivacaine Use in Alveolar Bone Graft Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Kerry O'Rourke, class: OTHER, collaborators name: Shriners Hospitals for Children, descriptionModule briefSummary: The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:* pain scores at hip and jaw sites* opioid use in amount and frequency* scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine., conditionsModule conditions: Cleft Lip and Palate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The design of this study is a randomized control trial, double-blinded. Patients who meet criteria and consent will be randomized to receive LB or standard bupivacaine., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Surgeons and patients will be unaware of which cohort the subject will be randomized to be part of. The pharmacist, anesthesiologist, and research coordinator may all be aware of which drug is administered., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Liposomal Bupivacaine, interventions name: Bupivacain, interventions name: Epinephrine, outcomesModule primaryOutcomes measure: Visual Analog Pain Scores, primaryOutcomes measure: Opioid Use, primaryOutcomes measure: PROMIS Pediatric Mobility Questionnaire, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284421, orgStudyIdInfo id: IRB23-1068, briefTitle: Durometer for Measuring Uterine Tone, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery., conditionsModule conditions: Uterine Tone Disorders, conditions: Cesarean Section Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Shore durometer, outcomesModule primaryOutcomes measure: feasibility of a durometer, secondaryOutcomes measure: durometer reading, secondaryOutcomes measure: durometer reading, secondaryOutcomes measure: durometer reading, secondaryOutcomes measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone"), secondaryOutcomes measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone"), secondaryOutcomes measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone"), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Naida M Cole, MD, role: CONTACT, phone: 773-702-6700, email: [email protected], contacts name: Somayeh Mohammadi, role: CONTACT, phone: 17738343274, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06284408, orgStudyIdInfo id: 2024-15683, briefTitle: Centralized Screening Unit (CSU) at Montefiore-Einstein, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Albert Einstein College of Medicine, class: OTHER, collaborators name: American Cancer Society, Inc., descriptionModule briefSummary: This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Systems-level intervention which using a mixed study design including stepped-wedge with a cluster randomized arm within the stepped-wedge. The implementation and evaluation of the CSU will be accomplished using cluster randomization to select 24 sites to be phased-into the CSU intervention according to a stepped-wedge design. Randomization will take place at the clinic level. The clinic clusters will be brought 'online' in a graded manner over the study period. 24 of the 35 NYC RING sites will be selected to enter the experimental (CSU) condition in three waves: Month 6, Month 12, or Month 18 after the start of the study. The remaining 11 sites will receive CSU support after completion of the third randomized group of clinics, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 9460, type: ESTIMATED, armsInterventionsModule interventions name: Centralized Screening Unit Implementation, outcomesModule primaryOutcomes measure: Participant Referrals, primaryOutcomes measure: Proportion of participants with early stage lung cancer (LCa), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 77 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING), city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Yocheved Halberstam, MPH, role: CONTACT, phone: 917-833-1070, email: [email protected], contacts name: H. Dean Hosgood, PhD, role: CONTACT, phone: 203-215-3275, email: [email protected], geoPoint lat: 40.84985, lon: -73.86641, hasResults: False |
protocolSection identificationModule nctId: NCT06284395, orgStudyIdInfo id: HGM1471-002/24, briefTitle: Two Schemes Response in Multiple Myeloma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hospital General de Mexico, class: OTHER_GOV, descriptionModule briefSummary: Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination., conditionsModule conditions: Response, Acute Phase, conditions: Survivorship, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 83, type: ESTIMATED, armsInterventionsModule interventions name: Bortezomib, outcomesModule primaryOutcomes measure: Favorable Response, primaryOutcomes measure: Time to next treatment, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital General de Mexico Dr. Eduardo Liceaga, status: RECRUITING, city: Mexico City, state: Cdmx, zip: 06720, country: Mexico, contacts name: Christian O Ramos Peñafiel, PhD, role: CONTACT, phone: 5523351588, email: [email protected], contacts name: Adan G Gallardo Rodriguez, role: CONTACT, phone: +525584005072, email: [email protected], contacts name: Juan M Cano Calderón, MD, role: SUB_INVESTIGATOR, contacts name: Juan F Zazueta Pozos, MD, role: SUB_INVESTIGATOR, contacts name: Adán G Gallardo Rodriguez, PhD, role: SUB_INVESTIGATOR, contacts name: Carlos Martínez Murillo, PhD, role: SUB_INVESTIGATOR, contacts name: Irma Olarte Carrillo, PhD, role: SUB_INVESTIGATOR, contacts name: Adolfo Martínez Tovar, PhD, role: SUB_INVESTIGATOR, contacts name: Christian O Ramos Peñafiel, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, hasResults: False |
protocolSection identificationModule nctId: NCT06284382, orgStudyIdInfo id: 2022-A02736-37, briefTitle: Interaction Between Early Trauma and Odor-induced Dopamine Release, acronym: T-ODOR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hôpital le Vinatier, class: OTHER, descriptionModule briefSummary: This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors., conditionsModule conditions: Trauma, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, single-center, double-blind, parallel-group controlled trial with two arms., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: High score at Childhood Trauma Questionnaire., interventions name: Low score at Childhood Trauma Questionnaire., outcomesModule primaryOutcomes measure: Dopamine transmission measured with positron emission tomography, secondaryOutcomes measure: Odor hedonic appreciation., secondaryOutcomes measure: Functional brain connectivity., secondaryOutcomes measure: Effective brain connectivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284369, orgStudyIdInfo id: Mongolia, briefTitle: Video Messages for Smoking Cessation Campaign, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Loma Linda University, class: OTHER, descriptionModule briefSummary: 240 adult smokers will be recruited. Subjects will be asked to view video messages that encourage smoking cessation. The effect of these videos will be assessed., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants don't know which video each subject is randomized to, whoMasked: PARTICIPANT, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Developing, Evaluating and Testing Video Messages for a Smoking Cessation Campaign, interventions name: Health Message Framing, outcomesModule primaryOutcomes measure: Message Engagement, secondaryOutcomes measure: Readiness to Quit Smoking, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284356, orgStudyIdInfo id: IRB Session 2022/14 Protocol 6, briefTitle: Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, collaborators name: Elazig Special Eastern Anatolian Hospital, descriptionModule briefSummary: Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG).While postoperative complications are divided into early and late complications, complications that develop during surgery and in the postoperative period before discharge are defined as perioperative complications. Early surgical complications after LSG include complications such as staple line bleeding, leaks, pulmonary thromboembolism, and torsion of the remnant stomach. It is important to detect these complications, which can be controlled with early intervention in the perioperative period.Monitoring blood parameters and monitoring inflammation are methods that are easily accessible and provide rapid evaluation. Platelet lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), which are used in the evaluation and detection of postoperative complications, have shed light on studies in this direction. Pan immune inflammation value (PIV) is calculated from blood parameters and has been used to evaluate prognosis and chemotherapy results in colorectal cancer.In this study, the diagnostic importance of changes in NLR, PLR, and PIV values in the preoperative and postoperative periods will be investigated in detecting complications that develop in the perioperative period before discharge in patients who underwent LSG., conditionsModule conditions: Morbid Obesity, conditions: Laparoscopic Sleeve Gastrectomy, conditions: Post Operative Complicaiton, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 159, type: ACTUAL, armsInterventionsModule interventions name: Laparoscopic Sleeve Gastrectomy, outcomesModule primaryOutcomes measure: Complication prediction after LSG with complete blood cell parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kahramanmaras SIU, city: Kahramanmaraş, zip: 46000, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, hasResults: False |
protocolSection identificationModule nctId: NCT06284343, orgStudyIdInfo id: 6414, briefTitle: Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study, acronym: GynCAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, collaborators name: Fondazione Umberto Veronesi, descriptionModule briefSummary: Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk.GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded.The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population.The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine \& Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes.In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population., conditionsModule conditions: Cancer-associated Thrombosis, conditions: Venous Thromboembolism, conditions: Gynecologic Cancer, conditions: Ovarian Cancer, conditions: Cervix Cancer, conditions: Endometrial Cancer, conditions: Vaginal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1800, type: ESTIMATED, armsInterventionsModule interventions name: Anticoagulant, outcomesModule primaryOutcomes measure: Venous thromboembolism, secondaryOutcomes measure: Bleeding, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Rome, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06284330, orgStudyIdInfo id: STU-2023-0881, briefTitle: CHARGE Study: CHoice ARchitecture Genetic tEsting, acronym: CHARGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, descriptionModule briefSummary: CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care., conditionsModule conditions: Hereditary Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Enhanced cascade testing, outcomesModule primaryOutcomes measure: Rate of cascade genetic testing, secondaryOutcomes measure: Change in probands' family communication about genetic test results as measured by Proband survey, secondaryOutcomes measure: Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months, secondaryOutcomes measure: Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale, secondaryOutcomes measure: Proband's reaction to intervention materials as measured by proband survey., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UT Southwestern Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Sukh Makhnoon, PhD, MS, role: CONTACT, phone: 214-648-3242, email: [email protected], contacts name: Sukh Makhnoon, PhD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06284317, orgStudyIdInfo id: ETOP 25-23, briefTitle: A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer., acronym: ADOPT-lung, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2029-10, completionDateStruct date: 2030-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: ETOP IBCSG Partners Foundation, class: NETWORK, collaborators name: AstraZeneca AG Switzerland, descriptionModule briefSummary: ADOPT-LUNG is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: Adjuvant durvalumab, outcomesModule primaryOutcomes measure: Disease-free survival (DFS), secondaryOutcomes measure: Response rate as per investigator assessment., secondaryOutcomes measure: Proportion of patients undergoing surgery, secondaryOutcomes measure: Proportion of patients with surgical outcome R0 and R1, secondaryOutcomes measure: pCR rate, secondaryOutcomes measure: Proportion of patients eligible for randomisation, secondaryOutcomes measure: Proportion of patients effectively randomised, secondaryOutcomes measure: Toxicity according to CTCAE v5.0, secondaryOutcomes measure: DFS in patients with pCR, secondaryOutcomes measure: Overall survival (OS) in patients with/without pCR, secondaryOutcomes measure: DFS in patients with/without ctDNA clearance, secondaryOutcomes measure: Time to recurrence (TTR) in patients with/without pCR, secondaryOutcomes measure: Time to treatment discontinuation (TTD) in patients with/without pCR, secondaryOutcomes measure: Toxicity according to CTCAE v5.0, otherOutcomes measure: Correlation between ctDNA clearance and pathological response, otherOutcomes measure: Correlation between ctDNA clearance and DFS, otherOutcomes measure: Correlation between ctDNA clearance and OS, otherOutcomes measure: Correlation between ctDNA clearance and initial PD-L1 assessment, otherOutcomes measure: Outcome (OS), otherOutcomes measure: Outcome (event-free survival), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284304, orgStudyIdInfo id: N22DES, briefTitle: A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL, acronym: DESTINATION, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, descriptionModule briefSummary: Trial design: A single centre phase II non-randomised studyTrial population: Men with intermediate risk localised prostate cancerRecruitment target: 20 patients in totalTrial objectives:* Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects* Secondary * To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2 yearsTrial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: De-escalated radiotherapy, outcomesModule primaryOutcomes measure: Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac, secondaryOutcomes measure: Acute GU toxicity, secondaryOutcomes measure: Acute GI toxicity, secondaryOutcomes measure: Late GU toxicity, secondaryOutcomes measure: Late GI toxicity, secondaryOutcomes measure: PROMs, secondaryOutcomes measure: Biochemical free survival, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Netherlands Cancer Institute, status: RECRUITING, city: Amsterdam, zip: 1066CX, country: Netherlands, contacts name: Floris Pos, MD PhD, role: CONTACT, phone: +31 20 512 9111, email: [email protected], geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06284291, orgStudyIdInfo id: TMSpath, secondaryIdInfos id: RF-2021-12372804, type: OTHER_GRANT, domain: Italian Ministry of Health, briefTitle: Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-22, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments., conditionsModule conditions: Epilepsy, conditions: Genetic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: transcranial magnetic stimulation (TMS), outcomesModule primaryOutcomes measure: Resting motor threshold, primaryOutcomes measure: SICI, primaryOutcomes measure: ICF, primaryOutcomes measure: LICI, primaryOutcomes measure: TEP amplitude, primaryOutcomes measure: TEP latency, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Firenze, country: Italy, contacts name: Simona Balestrini, MD, role: CONTACT, email: [email protected], geoPoint lat: 43.77925, lon: 11.24626, hasResults: False |
protocolSection identificationModule nctId: NCT06284278, orgStudyIdInfo id: NCKU_PPGP_diaphragm, briefTitle: Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: YI-JU TSAI, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain., conditionsModule conditions: Postpartum, conditions: Pregnancy Related, conditions: Pelvic Girdle Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Diaphragmatic breathing retraining, interventions name: Pelvic stabilization exercise, interventions name: pelvic anatomy education, outcomesModule primaryOutcomes measure: Muscle function measures of lumbopelvic muscles, primaryOutcomes measure: Diaphragm thickness, primaryOutcomes measure: Diaphragm mobility, primaryOutcomes measure: Diaphragm strength, primaryOutcomes measure: Mechanical Property of Thoracolumbar Fascia, primaryOutcomes measure: Functional performance of ASLR fatigue task, primaryOutcomes measure: Functional performance of timed up and go test, primaryOutcomes measure: Functional performance of 6m timed walk test, primaryOutcomes measure: pain intensity measure of Numeric Rating Scale (NRS), primaryOutcomes measure: Disability Level: measure of pelvic girdle questionnaire(PGQ), primaryOutcomes measure: Health-related Quality of Life: Short Form-36 (SF36), primaryOutcomes measure: Fear Avoidance Belief: Tampa Scale of Kinesiophobia, primaryOutcomes measure: Self-Efficacy: Pain Self-efficacy Questionnaire, primaryOutcomes measure: Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF), primaryOutcomes measure: Self-perceived Change: Global Rating of Change Scale (GROC), eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cheng Kung University, status: RECRUITING, city: Tainan, zip: 701, country: Taiwan, contacts name: Tsai Yi-Ju, role: CONTACT, phone: 06-2353535, phoneExt: 5930, email: [email protected], geoPoint lat: 22.99083, lon: 120.21333, hasResults: False |
protocolSection identificationModule nctId: NCT06284265, orgStudyIdInfo id: MMH-407-007, briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Materia Medica Holding, class: INDUSTRY, descriptionModule briefSummary: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis, conditionsModule conditions: Cystitis Chronic, conditions: Cystitis Bacterial, conditions: Recurrence of Chronic Bacterial Cystitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 632, type: ESTIMATED, armsInterventionsModule interventions name: Raphamin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to the first recurrence of chronic bacterial cystitis, secondaryOutcomes measure: Percentage of patients with a reduction of recurrences of chronic bacterial cystitis, otherOutcomes measure: Average duration of episodes of recurrences of chronic bacterial cystitis, otherOutcomes measure: Average number of recurrences of chronic bacterial cystitis, otherOutcomes measure: Severity of chronic bacterial cystitis recurrences, otherOutcomes measure: Change in the severity of chronic bacterial cystitis recurrences, otherOutcomes measure: VAS score at the end of the follow-up period, otherOutcomes measure: The Presence of Adverse Events (AEs)., otherOutcomes measure: Changes in Vital Signs (Blood Pressure measured in mm Hg), otherOutcomes measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute), otherOutcomes measure: Changes in Vital Signs (Respiration Rate (Breathing Rate) measured in breaths per minute), otherOutcomes measure: Proportion of patients with clinically significant laboratory abnormalities, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department, status: RECRUITING, city: Irkutsk, zip: 664003, country: Russian Federation, contacts name: Larisa Suturina, Prof., role: CONTACT, contacts name: Larisa Suturina, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.29778, lon: 104.29639, locations facility: Kazan State Medical University/Professor's clinic, status: NOT_YET_RECRUITING, city: Kazan, zip: 420012, country: Russian Federation, contacts name: Ruslan Fatykhov, MD, PhD, role: CONTACT, contacts name: Ruslan Fatykhov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.78874, lon: 49.12214, locations facility: LLC "Fenareta" Women's and Men's Health Clinic", status: RECRUITING, city: Kemerovo, zip: 650000, country: Russian Federation, contacts name: Natalia Artymuk, Prof., role: CONTACT, contacts name: Natalia Artymuk, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.33333, lon: 86.08333, locations facility: City Clinical Hospital #15 named after O.M. Filatov Department of Health of Moscow, status: RECRUITING, city: Moscow, zip: 111539, country: Russian Federation, contacts name: Vladimir Kuzmin, Prof., role: CONTACT, contacts name: Vladimir Kuzmin, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: City Clinical Hospital # 13/Gynecology Department # 1, status: RECRUITING, city: Moscow, zip: 115280, country: Russian Federation, contacts name: Felix Grigoryan, PhD, role: CONTACT, contacts name: Felix Grigoryan, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Clinical Hospital # 85 of the Federal Medical and Biological Agency/Central polyclinic, status: RECRUITING, city: Moscow, zip: 115409, country: Russian Federation, contacts name: Sergey Levakov, Prof., role: CONTACT, contacts name: Sergey Levakov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Research Institute of Rheumatology named after V.A. Nasonova, status: RECRUITING, city: Moscow, zip: 115522, country: Russian Federation, contacts name: Victoria Gelashvili, MD, role: CONTACT, contacts name: Victoria Gelashvili, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V.I. Kulakov/Department of Aesthetic Gynecology and Rehabilitation, status: RECRUITING, city: Moscow, zip: 117198, country: Russian Federation, contacts name: Inna Apolikhina, Prof., role: CONTACT, contacts name: Inna Apolikhina, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Peoples' Friendship University of Russia/Department of Obstetrics and Gynecology with a course in perinatology, status: WITHDRAWN, city: Moscow, zip: 117198, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Russian National Research Medical University named after N.I. Pirogov/Department of Obstetrics and Gynecology, Faculty of Medicine, status: RECRUITING, city: Moscow, zip: 117997, country: Russian Federation, contacts name: Yulia Dobrokhotova, Prof., role: CONTACT, contacts name: Yulia Dobrokhotova, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: City Clinical Hospital # 1 named after. N.I. Pirogov of the Moscow City Health Department, status: RECRUITING, city: Moscow, zip: 119049, country: Russian Federation, contacts name: Sergey Kotov, PhD, MD, role: CONTACT, contacts name: Sergey Kotov, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: United hospital with clinic of the Administration of the President of the Russian Federation, status: NOT_YET_RECRUITING, city: Moscow, zip: 119285, country: Russian Federation, contacts name: Nikolay Keshishev, MD, PhD, role: CONTACT, contacts name: Nikolay Keshishev, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: City Clinical Hospital # 67 named after L.A. Vorokhobov, status: NOT_YET_RECRUITING, city: Moscow, zip: 121423, country: Russian Federation, contacts name: Olga Perevozkina, MD, PhD, role: CONTACT, contacts name: Olga Perevozkina, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: JSC "MEDSI Group of Companies", status: WITHDRAWN, city: Moscow, zip: 123056, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Moscow State Medical and Dental University named after A.I. Evdokimov/Department of Urologya, status: RECRUITING, city: Moscow, zip: 127473, country: Russian Federation, contacts name: Dmitry Pushkar, Prof., role: CONTACT, contacts name: Dmitry Pushkar, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Privolzhsky District Medical Center, status: RECRUITING, city: Nizhny Novgorod, zip: 603001, country: Russian Federation, contacts name: Vagif Atduev, Prof., role: CONTACT, contacts name: Vagif Atduev Vagif, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.32867, lon: 44.00205, locations facility: National Medical Research Center for Radiology/Research Institute of Urology and Interventional Radiology named after. N.A. Lopatkin, status: NOT_YET_RECRUITING, city: Obninsk, zip: 105425, country: Russian Federation, contacts name: Tatyana Perepanova, Prof., role: CONTACT, contacts name: Tatyana Perepanova, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.09681, lon: 36.61006, locations facility: City Clinical Hospital, status: NOT_YET_RECRUITING, city: Pyatigorsk, zip: 357500, country: Russian Federation, contacts name: Alexander Bardin, MD, role: CONTACT, contacts name: Alexander Bardin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.04861, lon: 43.05944, locations facility: Clinical and Diagnostic Center "Health" in Rostov-on-Don, status: RECRUITING, city: Rostov-on-Don, zip: 344011, country: Russian Federation, contacts name: Igor Aboyan, Prof., role: CONTACT, contacts name: Igor Aboyan, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Rostov State Medical University/Department of Urology and Human Reproductive Health with a course of pediatric urology-andrology, status: RECRUITING, city: Rostov-on-Don, zip: 344022, country: Russian Federation, contacts name: Mikhail Kogan, Prof., role: CONTACT, contacts name: Mikhail Kogan, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Rostov Central District Hospital, status: NOT_YET_RECRUITING, city: Rostov, zip: 152155, country: Russian Federation, contacts name: Ariz Gyulmamedov, MD, role: CONTACT, contacts name: Ariz Gyulmamedov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.1914, lon: 39.41394, locations facility: JSC "Polyclinic Complex", status: WITHDRAWN, city: Saint Petersburg, zip: 190013, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Medical Center Capital-Polis", status: NOT_YET_RECRUITING, city: Saint Petersburg, zip: 190013, country: Russian Federation, contacts name: Dmitry Gorelov, MD, role: CONTACT, contacts name: Dmitry Gorelov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "BioTechService", status: RECRUITING, city: Saint Petersburg, zip: 190121, country: Russian Federation, contacts name: Alexander Parshin, PhD, role: CONTACT, contacts name: Alexander Parshin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City clinic # 44, status: NOT_YET_RECRUITING, city: Saint Petersburg, zip: 192071, country: Russian Federation, contacts name: Farzali Farzaliev, MD, role: CONTACT, contacts name: Farzali Farzaliev, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov/Urology department, status: RECRUITING, city: Saint Petersburg, zip: 194044, country: Russian Federation, contacts name: Vladislav Grigoriev, PhD, role: CONTACT, contacts name: Vladislav Grigoriev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Luke's Clinical Hospital, status: RECRUITING, city: Saint Petersburg, zip: 194044, country: Russian Federation, contacts name: Orlov Igor, PhD, role: CONTACT, contacts name: Orlov Igor, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Multidisciplinary Hospital # 2/Urology department, status: WITHDRAWN, city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Llc "Medical Clinic", status: RECRUITING, city: Saint Petersburg, zip: 194356, country: Russian Federation, contacts name: Maxim Bushara, MD, role: CONTACT, contacts name: Maxim Bushara, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical and sanitary unit No. 70 - branch of the St. Petersburg State Unitary Enterprise of Passenger Road Transport, status: RECRUITING, city: Saint Petersburg, zip: 195197, country: Russian Federation, contacts name: Vadim Zubarev, PhD, MD, role: CONTACT, contacts name: Vadim Zubarev, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: LLC "Research Center Eco-Safety", status: TERMINATED, city: Saint Petersburg, zip: 196143, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Jsc "Northwestern Center of Evidence-Based Medicine", status: WITHDRAWN, city: Saint Petersburg, zip: 196158, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Hospital # 15, status: NOT_YET_RECRUITING, city: Saint Petersburg, zip: 198205, country: Russian Federation, contacts name: Konstantin Dunets, MD, role: CONTACT, contacts name: Konstantin Dunets, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott/Department of Gynecology and Endocrinology, status: RECRUITING, city: Saint Petersburg, zip: 199034, country: Russian Federation, contacts name: Maria Yarmolinskaya, Prof., role: CONTACT, contacts name: Maria Yarmolinskaya, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: City Pokrovskaya Hospital/Department of Urology, status: RECRUITING, city: Saint Petersburg, zip: 199106, country: Russian Federation, contacts name: Andrey Gorelov, Prof., role: CONTACT, contacts name: Andrey Gorelov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Sertolovo City Hospital, status: NOT_YET_RECRUITING, city: Sertolovo, zip: 188650, country: Russian Federation, contacts name: Alexander Shvets, MD, role: CONTACT, contacts name: Alexander Shvets, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 60.1444, lon: 30.20165, locations facility: Siberian State Medical University/Faculty clinics of Siberian State Medical University, status: NOT_YET_RECRUITING, city: Tomsk, zip: 634050, country: Russian Federation, contacts name: Victor Latypov, MD, PhD, role: CONTACT, contacts name: Victor Latypov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.49771, lon: 84.97437, locations facility: Bashkir State Medical University/Department of Obstetrics and Gynecology # 1, status: WITHDRAWN, city: Ufa, zip: 450008, country: Russian Federation, geoPoint lat: 54.74306, lon: 55.96779, locations facility: Voronezh State Medical University named after N.N. Burdenko/Department of Urology, status: RECRUITING, city: Voronezh, zip: 394036, country: Russian Federation, contacts name: Andrey Kuzmenko, Prof., role: CONTACT, contacts name: Andrey Kuzmenko, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.67204, lon: 39.1843, locations facility: Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery, status: RECRUITING, city: Vsevolozhsk, zip: 188643, country: Russian Federation, contacts name: Nikolay Kanareikin, MD, role: CONTACT, contacts name: Nikolay Kanareikin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 60.01512, lon: 30.67314, locations facility: Yaroslavl State Medical University/Department of Urology and Nephrology, status: NOT_YET_RECRUITING, city: Yaroslavl, zip: 150000, country: Russian Federation, contacts name: Igor Shormanov, Prof., role: CONTACT, contacts name: Igor Shormanov, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, locations facility: LLC "Clinic of Modern Medicine Dr. Bogorodskaya", status: NOT_YET_RECRUITING, city: Yaroslavl, zip: 150001, country: Russian Federation, contacts name: Andrey Soloviev, MD, PhD, role: CONTACT, contacts name: Andrey Soloviev, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, locations facility: LLC "Medical Center for Diagnosis and Prevention Plus", status: RECRUITING, city: Yaroslavl, zip: 150040, country: Russian Federation, contacts name: Svetlana Isakova, MD, role: CONTACT, contacts name: Svetlana Isakova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, locations facility: Regional Clinical Hospital/Urology department, status: RECRUITING, city: Yaroslavl, zip: 150062, country: Russian Federation, contacts name: Dmitry Komlev, PhD, role: CONTACT, contacts name: Dmitry Komlev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False |
protocolSection identificationModule nctId: NCT06284252, orgStudyIdInfo id: TÜBİTAK-323S135, briefTitle: Virtual Game Simulation on Nursing Students' Physical Examination Skills, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-15, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, collaborators name: TÜBİTAK, descriptionModule briefSummary: The project is unique in that it will use virtual game simulation, a new learning method, and it will address the physical examination skills of nursing students, an area that has not been researched before. In the project, a randomized controlled research design with a pretest-posttest control group will be used. The population will consist of 200 second-year students enrolled in the Physical Examination in Nursing course at Necmettin Erbakan University, Faculty of Nursing, Department of Nursing, in the 2024-2025 Fall Semester. 120 students from the population who meet the research inclusion criteria will be randomly assigned to control (n=60) and experimental (n=60) groups according to their general academic success score. In collecting data; Introductory characteristics form, skill checklist for physical examination of the heart, skill checklist for physical examination of the abdomen, skill checklist for physical examination of the respiratory system and an evaluation form for the effect of virtual game simulation on skill practice for physical examination will be used. In the project, three different virtual game simulations will be developed for physical examinations of the heart, abdomen and respiratory system. During the fall semester, theoretical and laboratory demonstration applications will be carried out by the project team. A pre-test will be administered to all students, and then virtual game simulations will be made available to students in the experimental group for three weeks. Then, the virtual games will be closed to the students and a post-test will be administered to the experimental and control group students. After the final test application, virtual game simulations will be made available to students in the control group. In pre- and post-test applications, students will practice physical examination skills on simulated patients at three different stations (heart, abdomen and respiratory system) and will be evaluated by the project team according to skill checklists. After the skill evaluations, the students in the experimental group will be given a form to evaluate the effect of the virtual game simulation for physical examination on skill practice and will be asked to fill it out., conditionsModule conditions: Simulation of Physical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Control group and intervention group, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Participant blinding: In order to ensure participant blinding, all students will register to the site where virtual game simulations will be hosted.Statistics blinding: In order to blind the statistics expert, at the end of data collection, the website expert will share the collected data with the statistics expert as group A and B data. The statistician will perform statistical analyzes without knowing which group is the control and which group is the experiment.Researcher blinding: In order to ensure researcher blinding, the expert who designed the web page for virtual game simulations selected the students who registered on the website, using the "A" and "B" codes, according to the list he received from the statistics expert, on the website with a random group as control and one group as experiment. will assign it to the site., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Gaming Simulation, outcomesModule primaryOutcomes measure: Skill assessment for physical examination of the abdomen (Pretest), primaryOutcomes measure: Skill assessment for physical examination of the heart(Pretest), primaryOutcomes measure: Evaluation of physical examination skills of the respiratory system(Pretest), secondaryOutcomes measure: Skill assessment for physical examination of the abdomen (Posttest), secondaryOutcomes measure: Skill assessment for physical examination of the heart(Posttest), secondaryOutcomes measure: Evaluation of physical examination skills of the respiratory system(Posttest), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 25 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06284239, orgStudyIdInfo id: Tell Me Game, briefTitle: Using Games in Teaching Nursing History, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, descriptionModule briefSummary: Innovative learning methods can be used in teaching nursing history. One of the most preferred among these methods is learning through games. It is known that today's Generation Z students prefer active learning methods and want to learn by having fun instead of learning by rote. It is reported that learning through games improves students' knowledge and skills and increases retention. One of the methods of learning through games is the "tell me" game. The "Tell Me" game involves the narrator explaining the words prepared specifically for the subject to a group of students without using prohibited words. Other students in the group try to know the word explained. Thus, both the student narrator and the student trying to know actively use their critical thinking and decision-making skills. This research aims to determine the effect of the tell-all game used in teaching nursing history on students' learning and opinions., conditionsModule conditions: Education Nursing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It refers to the intervention group in which the "Tell Me" game will be played., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Participants will be informed about the research. However, participants will not know which group they belong to. At the same time, the statistical analysis of the research will be carried out by an independent statistician. Thus, blinding of both the participant and the outcome assessor will be ensured., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Tell me about the game., outcomesModule primaryOutcomes measure: Nursing History Knowledge Test, secondaryOutcomes measure: Nursing History Teaching Evaluation Form, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 24 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06284226, orgStudyIdInfo id: CCT-ANK-11, briefTitle: An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor Patients, acronym: CCT-ANK-11, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2022-03-25, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Beijing Kejing Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients, conditionsModule conditions: Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer), designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Allogeneic NK（CCT-ANK-11), outcomesModule primaryOutcomes measure: To evaluate the safety and the efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06284213, orgStudyIdInfo id: 5U24NS100591, type: NIH, link: https://reporter.nih.gov/quickSearch/5U24NS100591, briefTitle: Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium, acronym: MarkVCID, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-29, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Duke University, collaborators name: Johns Hopkins University, collaborators name: University of New Mexico, collaborators name: University of Southern California, collaborators name: University of Kentucky, collaborators name: Rush University Medical Center, collaborators name: University of Maryland, Baltimore, collaborators name: University of California, San Francisco, collaborators name: University of California, Los Angeles, collaborators name: University of California, Davis, collaborators name: University of Texas, collaborators name: The University of Texas Health Science Center at San Antonio, collaborators name: The University of Texas Health Science Center, Houston, collaborators name: Mayo Clinic, collaborators name: University of Mississippi Medical Center, collaborators name: Washington University School of Medicine, collaborators name: Olive View-UCLA Education & Research Institute, descriptionModule briefSummary: Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking and memory problems. Alzheimer's disease and other dementias leave signatures on brain scans or in the blood called biomarkers. The MarkVCID study will measure a panel of candidate biomarkers in 1800 participants and watch them closely to see what they tell us about changes in brain function and risk of memory loss.Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally. Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes. However, research and patient care can be held back by limited biomarkers that identify who should be treated.The MarkVCID Consortium includes 17 US medical centers, a Coordinating Center, an External Advisory Committee, and NIH leadership. Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories, so that researchers can use this information to study brain function., conditionsModule conditions: Cognitive Impairment, conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1800, type: ESTIMATED, armsInterventionsModule interventions name: No interventions, outcomesModule primaryOutcomes measure: SVD progression as measured by decline in global cognition, secondaryOutcomes measure: SVD progression as measured by decline in executive function, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Southern California, status: RECRUITING, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Danny JJ Wang, PhD, MSCE, role: CONTACT, phone: 323-442-7246, email: [email protected], geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of California Los Angeles, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Jason Hinman, MD, PhD, role: CONTACT, phone: 310-794-1195, email: [email protected], geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of California Davis, status: RECRUITING, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Pauline Maillard, PhD, role: CONTACT, phone: 916-734-3588, email: [email protected], geoPoint lat: 38.58157, lon: -121.4944, locations facility: University of California San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94158, country: United States, contacts name: Joel Kramer, PsyD, role: CONTACT, phone: 415-476-5572, email: [email protected], geoPoint lat: 37.77493, lon: -122.41942, locations facility: Olive View - UCLA Medical Center, status: RECRUITING, city: Sylmar, state: California, zip: 91342, country: United States, contacts name: Keith Vossel, MD, role: CONTACT, phone: 310-794-1195, email: [email protected], geoPoint lat: 34.30778, lon: -118.44925, locations facility: Mayo Clinic Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224, country: United States, contacts name: Gregory Day, role: CONTACT, phone: 904-953-0856, email: [email protected], geoPoint lat: 30.33218, lon: -81.65565, locations facility: Rush University Medical Center & Illinois Institute of Technology, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Konstantinos Arfanakis, PhD, role: CONTACT, phone: 312-567-3864, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, locations facility: University of Kentucky, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40536, country: United States, contacts name: Gregory Jicha, MD, PhD, role: CONTACT, phone: 859-257-1000, email: [email protected], geoPoint lat: 37.98869, lon: -84.47772, locations facility: University of Maryland, Baltimore, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Peiying Liu, PhD, role: CONTACT, phone: 410-706-2441, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, locations facility: Johns Hopkins University, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Hanzhang Lu, PhD, role: CONTACT, phone: 410-955-1431, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, locations facility: Mayo Clinic Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55901, country: United States, contacts name: Ronald Petersen, MD, PhD, role: CONTACT, phone: 507-284-1588, email: [email protected], geoPoint lat: 44.02163, lon: -92.4699, locations facility: University of Mississippi Medical Center, status: RECRUITING, city: Jackson, state: Mississippi, zip: 39216, country: United States, contacts name: Gwen Windham, MD, role: CONTACT, phone: 601-984-5610, email: [email protected], geoPoint lat: 32.29876, lon: -90.18481, locations facility: Washington University in St. Louis, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Jin-Moo Lee, MD, PhD, role: CONTACT, phone: 314-362-7382, email: [email protected], geoPoint lat: 38.62727, lon: -90.19789, locations facility: University of New Mexico, status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87131, country: United States, contacts name: Gary Rosenberg, MD, role: CONTACT, phone: 505-272-3315, email: [email protected], geoPoint lat: 35.08449, lon: -106.65114, locations facility: University of Texas Southwestern, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Rong Zhang, PhD, role: CONTACT, phone: 214-345-4619, email: [email protected], geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Texas Health Science Center Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Sean Savitz, MD, role: CONTACT, phone: 713-500-7083, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, locations facility: University of Texas Health Science Center San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Claudia Satizabal, PhD, role: CONTACT, phone: 210-450-8417, email: [email protected], geoPoint lat: 29.42412, lon: -98.49363, hasResults: False |
protocolSection identificationModule nctId: NCT06284200, orgStudyIdInfo id: sarcopenia eRA, briefTitle: Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-23, primaryCompletionDateStruct date: 2024-03-23, completionDateStruct date: 2024-06-23, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, descriptionModule briefSummary: introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared.Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study., conditionsModule conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 48, type: ESTIMATED, outcomesModule primaryOutcomes measure: Evaluation of Muscle Mass, primaryOutcomes measure: Evaluation of Muscle Strength, primaryOutcomes measure: Evaluation of Muscle Performance, secondaryOutcomes measure: Rheumatoid Arthritis Quality of Life Scale, secondaryOutcomes measure: Health Assessment Questionnaire (HAQ), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Sciences University, Kayseri Medicine Faculty, status: RECRUITING, city: Kocasinan, state: Kayseri, zip: 38125, country: Turkey, contacts name: MEHMET KÖKSAL, M.D., role: CONTACT, phone: +905514043114, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06284187, orgStudyIdInfo id: KhonKaenH, briefTitle: Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Khon Kaen Hospital, class: OTHER_GOV, descriptionModule briefSummary: BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture., conditionsModule conditions: Tuberculosis, conditions: Pulmonary, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, outcomesModule primaryOutcomes measure: Number of participants with pulmonary TB by Allplex™ MTB/MDRe, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thananit Sangkomkamhang, city: Khon Kaen, zip: 40000, country: Thailand, geoPoint lat: 16.44671, lon: 102.833, hasResults: False |
protocolSection identificationModule nctId: NCT06284174, orgStudyIdInfo id: B-BR-109-054-T, briefTitle: Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking., statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, descriptionModule briefSummary: This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery, and to determine which solution is more effective. Additionally, we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation., conditionsModule conditions: Spine Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This research will include patients diagnosed with lumbar spinal stenosis causing nerve compression, who are scheduled for open spinal decompression and fusion surgery. Patients will be randomly assigned to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics. Before wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline. Samples from deep and superficial tissues and implants will be taken for bacterial culture and molecular biochip analysis., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Patients will be randomly assigned by computer to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics.All patients understood the experimental process and signed the consent form. The patients did not know the group they were assigned to during the whole process. The bacterial culturers, examiners and clinical outcome assessors did not know the patient group., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Povidone-iodine solution; chlorhexidine gluconate, outcomesModule primaryOutcomes measure: Bacteria culture and Polymerase chain reaction exam, secondaryOutcomes measure: Post operative infection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cheng Kung University Hospital, status: RECRUITING, city: Tainan, zip: 704, country: Taiwan, contacts name: Wei-Ren Su, M.D., M.Sc., role: CONTACT, phone: 886-6-2766689, email: [email protected], geoPoint lat: 22.99083, lon: 120.21333, hasResults: False |
protocolSection identificationModule nctId: NCT06284161, orgStudyIdInfo id: RBHP 2020 GUY, secondaryIdInfos id: 2020-A02765-34, type: OTHER, domain: ANSM, briefTitle: QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up, acronym: PEM-SLA, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-28, primaryCompletionDateStruct date: 2025-06-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Quadriceps Combined Test, outcomesModule primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), primaryOutcomes measure: Parameters from the QCT (Quadriceps Combined Test), secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, secondaryOutcomes measure: Clinical and paraclinical likely course data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Clermont-Ferrand, status: RECRUITING, city: Clermont-Ferrand, zip: 63000, country: France, contacts name: Lise Laclautre, role: CONTACT, phone: +33473754963, email: [email protected], contacts name: Nathalie Guy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False |
protocolSection identificationModule nctId: NCT06284148, orgStudyIdInfo id: Pro00093964, secondaryIdInfos id: 5R18HS025654-03, type: AHRQ, link: https://reporter.nih.gov/quickSearch/5R18HS025654-03, briefTitle: Confidential IPV Screening Tool, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-10-06, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, collaborators name: Agency for Healthcare Research and Quality (AHRQ), descriptionModule briefSummary: Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care., conditionsModule conditions: Violence, Domestic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 19655, type: ACTUAL, armsInterventionsModule interventions name: Screening for intimate partner violence, interventions name: Assessment and referral, outcomesModule primaryOutcomes measure: IPV positive (Yes/No), primaryOutcomes measure: Screening completed (Yes/No), secondaryOutcomes measure: Severity of risk, secondaryOutcomes measure: Physician compliance with IPV management tools, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Biomedical Informatics Center, city: Charleston, state: South Carolina, zip: 29403, country: United States, geoPoint lat: 32.77657, lon: -79.93092, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-01, uploadDate: 2024-02-20T12:06, filename: Prot_SAP_000.pdf, size: 179261, hasResults: False |
protocolSection identificationModule nctId: NCT06284135, orgStudyIdInfo id: 2017-PS-03, secondaryIdInfos id: PV6099, type: OTHER, domain: Martini-Klinik, briefTitle: MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-06-19, primaryCompletionDateStruct date: 2019-10-16, completionDateStruct date: 2021-05-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Martini-Klinik am UKE GmbH, class: OTHER, descriptionModule briefSummary: A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention., conditionsModule conditions: Lymphocele After Surgical Procedure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1080, type: ACTUAL, armsInterventionsModule interventions name: Michl-stitch, outcomesModule primaryOutcomes measure: rate of lymphoceles requiring intervention after RARP, secondaryOutcomes measure: total lymphocele rate after RARP, secondaryOutcomes measure: other complications ≥ grade IIIa according to Clavien-Dindo after RARP, secondaryOutcomes measure: continence rates after RARP, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Martini-Klinik am UKE GmbH, city: Hamburg, zip: 20246, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False |
protocolSection identificationModule nctId: NCT06284122, orgStudyIdInfo id: MorningLyte, briefTitle: Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5, acronym: MorningLyte, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-11, completionDateStruct date: 2034-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: The Lymphoma Academic Research Organisation, class: OTHER, collaborators name: Lymphoma Study Association, collaborators name: Swiss Group for Clinical Cancer Research, collaborators name: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, descriptionModule briefSummary: This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma., conditionsModule conditions: Follicular Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 790, type: ESTIMATED, armsInterventionsModule interventions name: Mosunetuzumab, interventions name: Lenalidomide, interventions name: Rituximab, interventions name: Obinutuzumab, interventions name: Cyclophosphamide, interventions name: Doxorubicin, interventions name: Vincristin, interventions name: Prednisone, interventions name: Rituximab, interventions name: Obinutuzumab, interventions name: Bendamustin, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS), primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Response (OR), secondaryOutcomes measure: Complete Metabolic Rate (CMR), secondaryOutcomes measure: Overall Response (OR), secondaryOutcomes measure: Complete Metabolic Rate (CMR), secondaryOutcomes measure: Best Overall Response (CMR + PMR) rate, secondaryOutcomes measure: Best Overall Response (CMR + PMR) rate, secondaryOutcomes measure: Progression of disease within 2 years (POD24), secondaryOutcomes measure: PFS, secondaryOutcomes measure: PFS, secondaryOutcomes measure: Event Free Survival (EFS) by Lugano 2014, secondaryOutcomes measure: Event Free Survival (EFS) by Lugano 2014, secondaryOutcomes measure: Time to Next Anti-Lymphoma Treatment (TTNLT), secondaryOutcomes measure: Time to Next Anti-Lymphoma Treatment (TTNLT), secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Overall Response (OR), secondaryOutcomes measure: Complete Metabolic Rate (CMR), secondaryOutcomes measure: Duration of complete response, secondaryOutcomes measure: Duration of complete response, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs), secondaryOutcomes measure: Incidence and severity of AEs including SAEs and AESIs, secondaryOutcomes measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation, secondaryOutcomes measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation, secondaryOutcomes measure: Incidence of Second Primary Malignancies (SPM), secondaryOutcomes measure: Incidence of Second Primary Malignancies (SPM), secondaryOutcomes measure: anti-drug antibodies (ADA) to mosunetuzumab, secondaryOutcomes measure: Time to deterioration in physical functioning, secondaryOutcomes measure: Time to deterioration in lymphoma symptoms, secondaryOutcomes measure: Maximum serum concentration of mosunetuzumab - Cmax, secondaryOutcomes measure: Minimum serum concentration of mosunetuzumab - Cmin, secondaryOutcomes measure: Area under the curve of serum concentration of mosunetuzumab - AUC, secondaryOutcomes measure: Maximum serum concentration of lenalidomide - Cmax, secondaryOutcomes measure: Minimum serum concentration of lenalidomide - Cmin, secondaryOutcomes measure: Area under the curve of serum concentration of lenalidomide - AUC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie, city: Brugge, zip: 8000, country: Belgium, contacts name: Sylvia SNAUWAERT, Pr, role: CONTACT, geoPoint lat: 51.20892, lon: 3.22424, locations facility: INSTITUT JULES BORDET - Service Hématologie, city: Bruxelles, zip: 1070, country: Belgium, contacts name: Marie MAEREVOET, MD, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie, city: Bruxelles, zip: 1200, country: Belgium, contacts name: Eric VAN DEN NESTE, Pr, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: GRAND HOPITAL DE CHARLEROI - Service Hématologie, city: Charleroi, zip: 6000, country: Belgium, contacts name: Delphine PRANGER, MD, role: CONTACT, geoPoint lat: 50.41136, lon: 4.44448, locations facility: UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie, city: Gent, zip: 9000, country: Belgium, contacts name: Ciel DE WRIENDT, MD, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: CHU DE LIEGE - Service Hématologie, city: Liège, zip: 4000, country: Belgium, contacts name: Christophe BONNET, Pr, role: CONTACT, geoPoint lat: 50.63373, lon: 5.56749, locations facility: CHR VERVIERS - LA TOURELLE - Service Hématologie, city: Verviers, zip: 4800, country: Belgium, contacts name: Gaetan VANSTRAELEN, MD, role: CONTACT, geoPoint lat: 50.58907, lon: 5.86241, locations facility: CHU UCL NAMUR - SITE GODINNE - Service Hématologie, city: Yvoir, zip: 5530, country: Belgium, contacts name: Gilles CROCHET, MD, role: CONTACT, geoPoint lat: 50.3279, lon: 4.88059, locations facility: CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie, city: Avignon, zip: 84000, country: France, contacts name: Hacène ZERAZHI, MD, role: CONTACT, geoPoint lat: 43.94834, lon: 4.80892, locations facility: CH DE LA COTE BASQUE - Service Hématologie, city: Bayonne, zip: 64100, country: France, contacts name: Sophie BERNARD, MD, role: CONTACT, geoPoint lat: 43.48333, lon: -1.48333, locations facility: CHU JEAN MINJOZ - Service Hématologie, city: Besançon, zip: 25030, country: France, contacts name: Adrien CHAUCHET, MD, role: CONTACT, geoPoint lat: 47.24878, lon: 6.01815, locations facility: INSTITUT BERGONIE - Service d'Oncologie Médicale, city: Bordeaux, zip: 33076, country: France, contacts name: Fontanet BIJOU, MD, role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie, city: Cahors, zip: 46005, country: France, contacts name: Martin GAUTHIER, MD, role: CONTACT, geoPoint lat: 44.4491, lon: 1.43663, locations facility: CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie, city: Chambéry, zip: 73011, country: France, contacts name: Arthur DONY, MD, role: CONTACT, geoPoint lat: 45.56667, lon: 5.93333, locations facility: CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique, city: Clermont-Ferrand, zip: 63003, country: France, contacts name: Romain GUIEZE, Pr, role: CONTACT, geoPoint lat: 45.77966, lon: 3.08628, locations facility: HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes, city: Créteil, zip: 94010, country: France, contacts name: François LEMONNIER, MD, role: CONTACT, geoPoint lat: 48.78333, lon: 2.46667, locations facility: CHU DIJON BOURGOGNE - Service Hématologie Clinique, city: Dijon, zip: 21000, country: France, contacts name: Amandine DURAND, MD, role: CONTACT, geoPoint lat: 47.31667, lon: 5.01667, locations facility: CHD DE VENDEE - Service Hématologie, city: La Roche-sur-Yon, zip: 85925, country: France, contacts name: Nadine MORINEAU, MD, role: CONTACT, geoPoint lat: 46.66667, lon: -1.43333, locations facility: CHU DE GRENOBLE - Service Hématologie, city: La Tronche, zip: 38700, country: France, contacts name: Sylvain CARRAS, MD, role: CONTACT, geoPoint lat: 45.20429, lon: 5.73645, locations facility: HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie, city: Lille, zip: 59020, country: France, contacts name: Sandy AMORIM, MD, role: CONTACT, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie, city: Lille, zip: 59037, country: France, contacts name: Franck MORSCHHAUSER, Pr, role: CONTACT, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire, city: Limoges, zip: 87042, country: France, contacts name: Julie ABRAHAM, MD, role: CONTACT, geoPoint lat: 45.83153, lon: 1.25781, locations facility: INSTITUT PAOLI CALMETTES - Service Hématologie, city: Marseille, zip: 13273, country: France, contacts name: Gabriel BRISOU, MD, role: CONTACT, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU DE MONTPELLIER - Département d'Hématologie Clinique, city: Montpellier, zip: 34090, country: France, contacts name: Guillaume CARTRON, Pr, role: CONTACT, geoPoint lat: 43.61092, lon: 3.87723, locations facility: GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie, city: Mulhouse, zip: 68100, country: France, contacts name: Bernard DRENOU, MD, role: CONTACT, geoPoint lat: 47.75, lon: 7.33333, locations facility: CHU DE NANTES - Service Hématologie, city: Nantes, zip: 44093, country: France, contacts name: Thomas GASTINNE, MD, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CENTRE HOSPITALIER DE NIORT - Médecine interne, city: Niort, zip: 79021, country: France, contacts name: Gaëlle OLIVIER, MD, role: CONTACT, geoPoint lat: 46.32313, lon: -0.45877, locations facility: HOPITAL SAINT-LOUIS - Service Hématologie, city: Paris, zip: 75475, country: France, contacts name: Catherine THIEBLEMONT, Pr, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire, city: Pessac, zip: 33604, country: France, contacts name: François-Xavier GROS, MD, role: CONTACT, geoPoint lat: 44.81011, lon: -0.64129, locations facility: CHU LYON-SUD - Hématologie, city: Pierre-Bénite, zip: 69495, country: France, geoPoint lat: 45.7009, lon: 4.82511, locations facility: CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie, city: Poissy, zip: 78303, country: France, contacts name: Mohammed BOUDERBALA, MD, role: CONTACT, geoPoint lat: 48.92902, lon: 2.04952, locations facility: CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire, city: Poitiers, zip: 86021, country: France, contacts name: Stéphanie GUIDEZ, MD, role: CONTACT, geoPoint lat: 46.58333, lon: 0.33333, locations facility: CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie, city: Pringy, zip: 74374, country: France, contacts name: Hannah MOATTI, MD, role: CONTACT, geoPoint lat: 45.94622, lon: 6.12608, locations facility: CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie, city: Reims, zip: 57092, country: France, contacts name: Eric DUROT, MD, role: CONTACT, geoPoint lat: 49.25, lon: 4.03333, locations facility: CHU PONTCHAILLOU - Hématologie Clinique, city: Rennes, zip: 35033, country: France, contacts name: Roch HOUOT, Pr, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CENTRE HENRI BECQUEREL - Service Hématologie, city: Rouen, zip: 76038, country: France, geoPoint lat: 49.44313, lon: 1.09932, locations facility: INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie, city: Saint-Cloud, zip: 92210, country: France, contacts name: Clémentine SARKOZY, MD, role: CONTACT, geoPoint lat: 48.84598, lon: 2.20289, locations facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie, city: Saint-Priest-en-Jarez, zip: 42270, country: France, contacts name: Ludovic FOUILLET, MD, role: CONTACT, geoPoint lat: 45.47501, lon: 4.37614, locations facility: INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique, city: Strasbourg, zip: 67033, country: France, contacts name: Luc-Matthieu FORNECKER, Pr, role: CONTACT, geoPoint lat: 48.58392, lon: 7.74553, locations facility: IUCT ONCOPOLE - Service Hématologie, city: Toulouse, zip: 31059, country: France, contacts name: Loïc YSEBAERT, MD, role: CONTACT, geoPoint lat: 43.60426, lon: 1.44367, locations facility: CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire, city: Tours, zip: 37044, country: France, contacts name: Laurianne DRIEU LA ROCHELLE, MD, role: CONTACT, geoPoint lat: 47.38333, lon: 0.68333, locations facility: CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie, city: Valenciennes, zip: 59322, country: France, contacts name: Sabine TRICOT, MD, role: CONTACT, geoPoint lat: 50.35, lon: 3.53333, locations facility: CHU BRABOIS - Service Hématologie, city: Vandœuvre-lès-Nancy, zip: 54511, country: France, contacts name: Pierre FEUGIER, Pr, role: CONTACT, geoPoint lat: 48.65, lon: 6.18333, locations facility: CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie, city: Vannes, zip: 56017, country: France, contacts name: Antoine BONNET, MD, role: CONTACT, geoPoint lat: 47.66667, lon: -2.75, locations facility: GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique, city: Villejuif, zip: 94085, country: France, contacts name: Vincent RIBRAG, MD, role: CONTACT, geoPoint lat: 48.7939, lon: 2.35992, locations facility: UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III, city: Regensburg, zip: 93053, country: Germany, contacts name: Stephanie MAYER, MD, role: CONTACT, geoPoint lat: 49.01513, lon: 12.10161, locations facility: UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie, city: Ulm, zip: 89081, country: Germany, contacts name: Christian BUSKE, Pr, role: CONTACT, geoPoint lat: 48.39841, lon: 9.99155, locations facility: INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia, city: Lisboa, zip: 1099, country: Portugal, contacts name: Maria GOMES DA SILVA, Pr, role: CONTACT, geoPoint lat: 38.71667, lon: -9.13333, locations facility: HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia, city: Salamanca, zip: 37007, country: Spain, contacts name: Alejandro MARTIN GARCIA-SANCHO, MD, role: CONTACT, geoPoint lat: 40.96882, lon: -5.66388, hasResults: False |
protocolSection identificationModule nctId: NCT06284109, orgStudyIdInfo id: 23-1036, briefTitle: Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, collaborators name: Pacira Pharmaceuticals, Inc, descriptionModule briefSummary: Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pre-Operative Patients will receive cryoanalgesia or sham cryoanalgesia before amputation., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: All participants will receive nerve blocks with Local anesthetic. Participants will be Randomized on a 1:1 fashion to cryoanalgesia or sham cryoanalgesia, based on computer-generated codes and use random-sized blocks. Patients will not be told which group they are in., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Cryoanalgesia, interventions name: Sham Cryoanalgesia, outcomesModule primaryOutcomes measure: Phantom limb pain score, secondaryOutcomes measure: Mobility, secondaryOutcomes measure: General physical and emotional disability, secondaryOutcomes measure: Opioid consumption, otherOutcomes measure: Residual limb pain, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06284096, orgStudyIdInfo id: 2023/391, briefTitle: The Personal Recovery Based Psychoeducation For Schizophrenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively. The program's effectiveness will be evaluated through a randomized controlled research design. The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation. In this context, the following hypotheses have been formulated.Research Question:1) Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission?Hypotheses:H0a: Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission.H0b: Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission.H0c: Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission.H1a: Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission.H1b: Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission.H1c: Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission., conditionsModule conditions: Mental Health Recovery, conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Personal Recovery levels of individuals diagnosed with schizophrenia, secondaryOutcomes measure: Psychological resilience levels of individuals diagnosed with schizophrenia, secondaryOutcomes measure: Hope levels of individuals diagnosed with schizophrenia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Umraniye Community Mental Health Center affiliated with the Ministry of Health., city: Istanbul, state: Umraniye, zip: 34760, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06284083, orgStudyIdInfo id: Cumhuriyet University Hospital, briefTitle: Measuring Various Variables in Obstructive Sleep Apnea, acronym: OUAS, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-18, primaryCompletionDateStruct date: 2021-01-15, completionDateStruct date: 2022-02-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cumhuriyet University, class: OTHER, descriptionModule briefSummary: This study included 90 volunteer Obstructive Sleep Apnea Syndrome patients. Only 7 mL blood samples collected from patients. Some biochemicals parameters analyzed in blood serum/plasma., conditionsModule conditions: Obstructive Sleep Apnea-hypopnea Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study group consisted of 90 newly diagnosed OSAS patients who were admitted to the Clinic for Chest Diseases of the Research and Practice Hospital of Sivas Cumhuriyet University Faculty of Medicine. For the definitive diagnosis of OSAS, the patients were hospitalized overnight in the Sleep Center and polysomnography test was performed. OSAS patients, who were randomly selected without discrimination in terms of age and gender, were connected to the PSG device for one night and various measurements were taken and the values were recorded. The apnea/hypopnea index (AHI) was defined as the sum of the apnea and hypopnea number per hour of sleep. Volunteer patients were grouped into three based on apnea-hypopnea index (AHI) scores: mild OSAS (n=30; 5 ≤ AHI ≤ 13.70), moderate (n=30; 15.80 ≤ AHI ≤ 26.60) and severe (n=30; 34.10 ≤ AHI ≤ 86.30). The mean SpO2 percentages of the PSG device were measured from the fingertip with a system-defined pulse oximeter., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: taking a blood sample, outcomesModule primaryOutcomes measure: Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity., secondaryOutcomes measure: Polysomnographic measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sivas Cumhuriyet University, city: Sivas, state: Centre, zip: 58140, country: Turkey, geoPoint lat: 39.74833, lon: 37.01611, hasResults: False |
protocolSection identificationModule nctId: NCT06284070, orgStudyIdInfo id: 202433, briefTitle: Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, class: OTHER, descriptionModule briefSummary: Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations., conditionsModule conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Diagnostic efficacy, secondaryOutcomes measure: SUV, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400010, country: China, contacts name: Xiao Chen, Ph.D, role: CONTACT, phone: 15922970174, email: [email protected], contacts name: Xiao Chen, Ph.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Jinju Sun, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06284057, orgStudyIdInfo id: CopperHealthCentre3, briefTitle: Lower Silesia Culotte Bifurcation Registry (LSCBR)., acronym: LSCBR, statusModule overallStatus: RECRUITING, startDateStruct date: 2013-04-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Regional Cardiology Center, The Copper Health Centre (MCZ),, class: OTHER, collaborators name: Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland., descriptionModule briefSummary: The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis., conditionsModule conditions: Safety Issues, conditions: Efficacy, Self, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte, outcomesModule primaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: MACE, otherOutcomes measure: Stent thrombosis, otherOutcomes measure: Stent restenosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, Provincial Specialized Hospital in Legnica,, status: RECRUITING, city: Legnica, state: Lower Silesia, zip: 59-220, country: Poland, contacts name: Mateusz Barycki, M.D, role: CONTACT, phone: +48767211446, email: [email protected], contacts name: Piotr Rola, M.D. Ph.D, role: CONTACT, phone: +48767211446, email: [email protected], contacts name: Mateusz Barycki, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Piotr Rola, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 51.21006, lon: 16.1619, locations facility: Department of Cardiology, The Copper Health Centre (MCZ), status: RECRUITING, city: Lubin, state: Lower Silesia, zip: 59-300, country: Poland, contacts name: Adrian Włodarczak, Assoc Prof., role: CONTACT, phone: +48768460300, email: [email protected], contacts name: Szymon Włodarczak, MD, role: CONTACT, phone: +4876 846 03 00, email: [email protected], contacts name: Adrian Włodarczak, Assoc Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Szymon Włodarczak, MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.40089, lon: 16.20149, hasResults: False |
protocolSection identificationModule nctId: NCT06284044, orgStudyIdInfo id: NIHR204885, briefTitle: Facilitating Safe Transition to Home for Preterm Infants - a National Database Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University Hospitals of Derby and Burton NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: Preterm infants (i.e. born before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Readiness for discharge home typically requires a level of physiological maturity, such that an infant is: 1) able to breathe spontaneously without additional support; 2) able to maintain body temperature; 3) able to take all nutritional requirements orally; 4) weighs ≥1700 grams and is consistently gaining weight.Staying in the hospital longer than necessary can be detrimental to infants, stressful for families, and costly to the NHS. Reducing the length of stay by just one day would be meaningful to parents and could save the UK National Health Service (NHS) almost £25million per year. Currently little is known about whether, how long and why preterm infants stay in hospital beyond the point at which they are physiologically ready for discharge.This study will use data from babies' medical records from the whole of England and Wales to identify the age and postmenstrual age when preterm infants reach each of the physiological barriers to discharge and identify which physiological discharge barrier requires preterm infants to remain in hospital the longest. The study will quantify the difference between the time preterm infants become physiologically ready for discharge and actual discharge home and describe factors associated with extended stays., conditionsModule conditions: Premature Birth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 250000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Age and postmenstrual age when each of three physiological barriers are reached, primaryOutcomes measure: Final barrier to discharge home, secondaryOutcomes measure: Number of days in hospital after surpassing all physiological discharge barriers, eligibilityModule sex: ALL, minimumAge: 22 Weeks, maximumAge: 36 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: University Hospitals of Derby and Burton, status: RECRUITING, city: Derby, state: Derbyshire, zip: DE22 3DT, country: United Kingdom, contacts name: Janine Abramson, BSc Hon, role: CONTACT, phone: 01332 724690, email: [email protected], geoPoint lat: 52.92277, lon: -1.47663, hasResults: False |
protocolSection identificationModule nctId: NCT06284031, orgStudyIdInfo id: Brachy Study, briefTitle: Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-26, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National University Hospital, Singapore, class: OTHER, descriptionModule briefSummary: Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient settingPrimary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5, conditionsModule conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: 3 fractions HDR brachytherapy, outcomesModule primaryOutcomes measure: Local control rate, primaryOutcomes measure: Loco-regional control rate, primaryOutcomes measure: Progression-free survival (PFS), primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Long term toxicities, eligibilityModule sex: FEMALE, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University Hospital, status: RECRUITING, city: Singapore, zip: 119074, country: Singapore, contacts name: Fatin Aliyah, BSc, role: CONTACT, phone: +6581005851, email: [email protected], contacts name: Syadwa Abdul Shukor, MD, role: SUB_INVESTIGATOR, contacts name: Yiat Horng Leong, MD, role: SUB_INVESTIGATOR, contacts name: Shing Fung Lee, MD, role: SUB_INVESTIGATOR, contacts name: Michelle Tseng, MD, role: SUB_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06284018, orgStudyIdInfo id: postnatal low back pain, briefTitle: Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain, conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: intervention The design of the study was randomized controlled study. The patients were divided randomly into two equal groups (A\&B). Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Progressive Muscle Relaxation Exercises, interventions name: Pilates Exercises, outcomesModule primaryOutcomes measure: Pressure Algometer, secondaryOutcomes measure: Oswestry Disability Index, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of physical therapy: Cairo university, city: Giza, zip: 12662, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06284005, orgStudyIdInfo id: MOTU ATP - Studio clinico, briefTitle: Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb at the Transfemoral Level, acronym: MOTU-ATP, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-27, primaryCompletionDateStruct date: 2022-11-10, completionDateStruct date: 2022-12-22, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Don Carlo Gnocchi Onlus, class: OTHER, descriptionModule briefSummary: The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.The main question it aims to answer are:* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.Participants will perform:* walking tests inside parallel bars on flat and/or inclined terrain;* walking tests on treadmill;* stair climbing/descent tests., conditionsModule conditions: Amputation, conditions: Amputation; Traumatic, Leg, Lower, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ACTUAL, armsInterventionsModule interventions name: WRL ATP, outcomesModule primaryOutcomes measure: ad hoc check-list Adverse Event, primaryOutcomes measure: ad hoc check-list Adverse Event, primaryOutcomes measure: ad hoc check-list Adverse Event, primaryOutcomes measure: ad hoc check-list Adverse Event, primaryOutcomes measure: ad hoc check-list Adverse Event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Don Carlo Gnocchi, city: Firenze, state: FI, zip: 50143, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False |
protocolSection identificationModule nctId: NCT06283992, orgStudyIdInfo id: 2024p000095, secondaryIdInfos id: K23MD016439, type: NIH, link: https://reporter.nih.gov/quickSearch/K23MD016439, briefTitle: Digital Health Navigation for Latino Patients With Type II Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Researchers will compare effectiveness between two arms: 1) patient education using a digital navigator on using digital tools after discharge and 2) usual care (educational sheet)., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Digital Navigation, outcomesModule primaryOutcomes measure: Proportion of Participants Who Login to the Portal, secondaryOutcomes measure: Proportion of Participants that Perform Distinct Portal Functions, secondaryOutcomes measure: Proportion of participants that complete a telehealth, secondaryOutcomes measure: Proportion of participants that are re-admitted, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02120, country: United States, contacts name: Jorge A Rodriguez, MD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06283979, orgStudyIdInfo id: 199723, briefTitle: A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers., acronym: BLADE OPU2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Biocomposites Ltd, class: INDUSTRY, collaborators name: MCRA, descriptionModule briefSummary: The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers., conditionsModule conditions: Pressure Ulcer, Stage IV, conditions: Osteomyelitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: STIMULAN VG, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Individual patient success and findings at the 8 week follow-up visit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283966, orgStudyIdInfo id: D5989C00001, briefTitle: A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease, acronym: THARROS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2028-03-06, completionDateStruct date: 2028-03-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk., conditionsModule conditions: COPD (Chronic Obstructive Pulmonary Disease), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: BGF MDI 320/14.4/9.6 μg, interventions name: GFF MDI 14.4/9.6 μg, outcomesModule primaryOutcomes measure: Time to first severe cardiac or COPD event, secondaryOutcomes measure: Time to first severe COPD exacerbation event, secondaryOutcomes measure: Time to first severe cardiac event, secondaryOutcomes measure: Time to cardiopulmonary death, secondaryOutcomes measure: Moderate/severe COPD exacerbation rate, secondaryOutcomes measure: Time to Myocardial Infarction (MI) hospitalization or cardiac death, secondaryOutcomes measure: Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death, otherOutcomes measure: Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Athens, state: Alabama, zip: 35611, country: United States, geoPoint lat: 34.80243, lon: -86.97219, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cullman, state: Alabama, zip: 35058, country: United States, geoPoint lat: 34.17482, lon: -86.84361, locations facility: Research Site, status: RECRUITING, city: Fairhope, state: Alabama, zip: 36532, country: United States, geoPoint lat: 30.52297, lon: -87.90333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Huntsville, state: Alabama, zip: 35801, country: United States, geoPoint lat: 34.7304, lon: -86.58594, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mobile, state: Alabama, zip: 36608, country: United States, geoPoint lat: 30.69436, lon: -88.04305, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sheffield, state: Alabama, zip: 35660, country: United States, geoPoint lat: 34.76509, lon: -87.69864, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gilbert, state: Arizona, zip: 85296, country: United States, geoPoint lat: 33.35283, lon: -111.78903, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Glendale, state: Arizona, zip: 85308, country: United States, geoPoint lat: 33.53865, lon: -112.18599, locations facility: Research Site, status: RECRUITING, city: Mesa, state: Arizona, zip: 85206, country: United States, geoPoint lat: 33.42227, lon: -111.82264, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mesa, state: Arizona, zip: 85213, country: United States, geoPoint lat: 33.42227, lon: -111.82264, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85006, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tempe, state: Arizona, zip: 85281, country: United States, geoPoint lat: 33.41477, lon: -111.90931, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tempe, state: Arizona, zip: 85283, country: United States, geoPoint lat: 33.41477, lon: -111.90931, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tucson, state: Arizona, zip: 85710, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Apple Valley, state: California, zip: 92307, country: United States, geoPoint lat: 34.50083, lon: -117.18588, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Banning, state: California, zip: 92220, country: United States, geoPoint lat: 33.92557, lon: -116.87641, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Canoga Park, state: California, zip: 91303, country: United States, geoPoint lat: 34.20112, lon: -118.59814, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Garden Grove, state: California, zip: 92844, country: United States, geoPoint lat: 33.77391, lon: -117.94145, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gardena, state: California, zip: 90247, country: United States, geoPoint lat: 33.88835, lon: -118.30896, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Inglewood, state: California, zip: 90301, country: United States, geoPoint lat: 33.96168, lon: -118.35313, locations facility: Research Site, status: NOT_YET_RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, geoPoint lat: 32.76783, lon: -117.02308, locations facility: Research Site, status: NOT_YET_RECRUITING, city: La Palma, state: California, zip: 90623, country: United States, geoPoint lat: 33.8464, lon: -118.04673, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lomita, state: California, zip: 90717, country: United States, geoPoint lat: 33.79224, lon: -118.31507, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Newport Beach, state: California, zip: 92660, country: United States, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Research Site, status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Research Site, status: NOT_YET_RECRUITING, city: North Hollywood, state: California, zip: 91602, country: United States, geoPoint lat: 34.17223, lon: -118.37897, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Panorama City, state: California, zip: 91402, country: United States, geoPoint lat: 34.22473, lon: -118.44981, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pomona, state: California, zip: 91768, country: United States, geoPoint lat: 34.05529, lon: -117.75228, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sacramento, state: California, zip: 95823, country: United States, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sacramento, state: California, zip: 95831, country: United States, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Salinas, state: California, zip: 93901, country: United States, geoPoint lat: 36.67774, lon: -121.6555, locations facility: Research Site, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92111, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Research Site, status: NOT_YET_RECRUITING, city: San Dimas, state: California, zip: 91773, country: United States, geoPoint lat: 34.10668, lon: -117.80673, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Santa Ana, state: California, zip: 92704, country: United States, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tarzana, state: California, zip: 91356, country: United States, geoPoint lat: 34.17334, lon: -118.55397, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Thousand Oaks, state: California, zip: 91360, country: United States, geoPoint lat: 34.17056, lon: -118.83759, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vista, state: California, zip: 92081, country: United States, geoPoint lat: 33.20004, lon: -117.24254, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Westminster, state: California, zip: 92683, country: United States, geoPoint lat: 33.75918, lon: -118.00673, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aurora, state: Colorado, zip: 80012, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80224, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80228, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Washington, state: District of Columbia, zip: 20016, country: United States, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Boynton Beach, state: Florida, zip: 33435, country: United States, geoPoint lat: 26.52535, lon: -80.06643, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bradenton, state: Florida, zip: 34208, country: United States, geoPoint lat: 27.49893, lon: -82.57482, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cape Coral, state: Florida, zip: 33990, country: United States, geoPoint lat: 26.56285, lon: -81.94953, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Clearwater, state: Florida, zip: 33756, country: United States, geoPoint lat: 27.96585, lon: -82.8001, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Clearwater, state: Florida, zip: 33765, country: United States, geoPoint lat: 27.96585, lon: -82.8001, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Crystal River, state: Florida, zip: 34429, country: United States, geoPoint lat: 28.90248, lon: -82.5926, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cutler Bay, state: Florida, zip: 33189, country: United States, geoPoint lat: 25.5783, lon: -80.3377, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Edgewater, state: Florida, zip: 32132, country: United States, geoPoint lat: 28.98888, lon: -80.90228, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fort Lauderdale, state: Florida, zip: 33308, country: United States, geoPoint lat: 26.12231, lon: -80.14338, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fort Myers, state: Florida, zip: 33912, country: United States, geoPoint lat: 26.62168, lon: -81.84059, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hialeah, state: Florida, zip: 33013, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kissimmee, state: Florida, zip: 34741, country: United States, geoPoint lat: 28.30468, lon: -81.41667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kissimmee, state: Florida, zip: 34746, country: United States, geoPoint lat: 28.30468, lon: -81.41667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lake City, state: Florida, zip: 32055, country: United States, geoPoint lat: 30.18968, lon: -82.63929, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lake Worth, state: Florida, zip: 33467, country: United States, geoPoint lat: 26.61708, lon: -80.07231, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lakeland, state: Florida, zip: 33813, country: United States, geoPoint lat: 28.03947, lon: -81.9498, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Loxahatchee Groves, state: Florida, zip: 33470, country: United States, geoPoint lat: 26.68368, lon: -80.27977, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Miami Lakes, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33155, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Research Site, status: RECRUITING, city: Miami, state: Florida, zip: 33175, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33256, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Naples, state: Florida, zip: 34102, country: United States, geoPoint lat: 26.14234, lon: -81.79596, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ocala, state: Florida, zip: 34470, country: United States, geoPoint lat: 29.1872, lon: -82.14009, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32807, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32819, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32825, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ormond Beach, state: Florida, zip: 32174, country: United States, geoPoint lat: 29.28581, lon: -81.05589, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pembroke Pines, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.00315, lon: -80.22394, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Plantation, state: Florida, zip: 33324, country: United States, geoPoint lat: 26.13421, lon: -80.23184, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Saint Petersburg, state: Florida, zip: 33713, country: United States, geoPoint lat: 27.77086, lon: -82.67927, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sun City Center, state: Florida, zip: 33573, country: United States, geoPoint lat: 27.71809, lon: -82.35176, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tamarac, state: Florida, zip: 33321, country: United States, geoPoint lat: 26.21286, lon: -80.24977, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33606, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33607, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33625, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30349, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Buford, state: Georgia, zip: 30519, country: United States, geoPoint lat: 34.12066, lon: -84.00435, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Peachtree Corners, state: Georgia, zip: 30092, country: United States, geoPoint lat: 33.9701, lon: -84.22159, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Savannah, state: Georgia, zip: 31406, country: United States, geoPoint lat: 32.08354, lon: -81.09983, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Boise, state: Idaho, zip: 83706, country: United States, geoPoint lat: 43.6135, lon: -116.20345, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60607, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Winfield, state: Illinois, zip: 60190, country: United States, geoPoint lat: 41.8617, lon: -88.1609, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Valparaiso, state: Indiana, zip: 46383, country: United States, geoPoint lat: 41.47309, lon: -87.06114, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Newton, state: Kansas, zip: 67114, country: United States, geoPoint lat: 38.04668, lon: -97.34504, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wichita, state: Kansas, zip: 67218, country: United States, geoPoint lat: 37.69224, lon: -97.33754, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lexington, state: Kentucky, zip: 40503, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Paducah, state: Kentucky, zip: 42001, country: United States, geoPoint lat: 37.08339, lon: -88.60005, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lafayette, state: Louisiana, zip: 70508, country: United States, geoPoint lat: 30.22409, lon: -92.01984, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Monroe, state: Louisiana, zip: 71201, country: United States, geoPoint lat: 32.50931, lon: -92.1193, locations facility: Research Site, status: RECRUITING, city: Shreveport, state: Louisiana, zip: 71105, country: United States, geoPoint lat: 32.52515, lon: -93.75018, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zachary, state: Louisiana, zip: 70791, country: United States, geoPoint lat: 30.64852, lon: -91.1565, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Oxon Hill, state: Maryland, zip: 20745, country: United States, geoPoint lat: 38.80345, lon: -76.9897, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Potomac, state: Maryland, zip: 20854, country: United States, geoPoint lat: 39.01817, lon: -77.20859, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Flint, state: Michigan, zip: 48504, country: United States, geoPoint lat: 43.01253, lon: -83.68746, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lathrup Village, state: Michigan, zip: 48076, country: United States, geoPoint lat: 42.49642, lon: -83.22271, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Southfield, state: Michigan, zip: 48034, country: United States, geoPoint lat: 42.47337, lon: -83.22187, locations facility: Research Site, status: RECRUITING, city: Gulfport, state: Mississippi, zip: 39503, country: United States, geoPoint lat: 30.36742, lon: -89.09282, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Olive Branch, state: Mississippi, zip: 38654, country: United States, geoPoint lat: 34.96176, lon: -89.82953, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kansas City, state: Missouri, zip: 64116, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Liberty, state: Missouri, zip: 64068, country: United States, geoPoint lat: 39.24611, lon: -94.41912, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Saint Louis, state: Missouri, zip: 63136, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Research Site, status: RECRUITING, city: Missoula, state: 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lon: -83.12852, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toledo, state: Ohio, zip: 43617, country: United States, geoPoint lat: 41.66394, lon: -83.55521, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Norman, state: Oklahoma, zip: 73071, country: United States, geoPoint lat: 35.22257, lon: -97.43948, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73134, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tulsa, state: Oklahoma, zip: 74133, country: United States, geoPoint lat: 36.15398, lon: -95.99277, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Grants Pass, state: Oregon, zip: 97527, country: United States, geoPoint lat: 42.43933, lon: -123.33067, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Medford, state: Oregon, zip: 97504, country: United States, 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South Carolina, zip: 29414, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Columbia, state: South Carolina, zip: 29201, country: United States, geoPoint lat: 34.00071, lon: -81.03481, locations facility: Research Site, status: RECRUITING, city: Gaffney, state: South Carolina, zip: 29340, country: United States, geoPoint lat: 35.07179, lon: -81.64982, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Spartanburg, state: South Carolina, zip: 29303, country: United States, geoPoint lat: 34.94957, lon: -81.93205, locations facility: Research Site, status: RECRUITING, city: Union, state: South Carolina, zip: 29379, country: United States, geoPoint lat: 34.71541, lon: -81.62371, locations facility: Research Site, status: NOT_YET_RECRUITING, city: North Sioux City, state: South Dakota, zip: 57049, country: United States, geoPoint lat: 42.52722, lon: -96.48309, locations facility: Research 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lon: -86.20943, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Abilene, state: Texas, zip: 79606, country: United States, geoPoint lat: 32.44874, lon: -99.73314, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Amarillo, state: Texas, zip: 79106, country: United States, geoPoint lat: 35.222, lon: -101.8313, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78704, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brownsville, state: Texas, zip: 78520, country: United States, geoPoint lat: 25.90175, lon: -97.49748, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75225, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75235, country: United States, geoPoint lat: 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city: Morgantown, state: West Virginia, zip: 26505, country: United States, geoPoint lat: 39.62953, lon: -79.9559, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cudahy, state: Wisconsin, zip: 53110, country: United States, geoPoint lat: 42.95974, lon: -87.86147, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Milwaukee, state: Wisconsin, zip: 53228, country: United States, geoPoint lat: 43.0389, lon: -87.90647, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Milwaukee, state: Wisconsin, zip: 53295, country: United States, geoPoint lat: 43.0389, lon: -87.90647, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Buenos Aires, zip: C1012AAR, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Buenos Aires, zip: C1414AIF, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, status: 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Natal, zip: 59020-035, country: Brazil, geoPoint lat: -5.795, lon: -35.20944, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Niterói, zip: 24020-096, country: Brazil, geoPoint lat: -22.88333, lon: -43.10361, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Porto Alegre, zip: 90035-903, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Porto Alegre, zip: 90035074, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Porto Alegre, zip: 9061-000, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Porto Alegre, zip: 91350-280, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Recife, zip: 50740-465, country: Brazil, geoPoint lat: -8.05389, lon: -34.88111, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rio de Janeiro, zip: 20551-030, country: Brazil, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rio de Janeiro, zip: 22281-100, country: Brazil, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Salvador, zip: 40170-130, country: Brazil, geoPoint lat: -12.97111, lon: -38.51083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Santo Andre, zip: 09080-110, country: Brazil, geoPoint lat: -23.66389, lon: -46.53833, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sao Bernardo do Campo, zip: 09750-420, country: Brazil, geoPoint lat: -23.69389, lon: -46.565, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sao Jose Do Rio Preto, zip: 15090-000, country: Brazil, geoPoint lat: -20.81972, lon: -49.37944, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Serra, zip: 29160-750, country: Brazil, geoPoint lat: -20.12861, lon: -40.30778, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sorocaba, zip: 18040-425, country: Brazil, geoPoint lat: -23.50167, lon: -47.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: São Paulo, zip: 04012-180, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Volta Redonda, zip: 27258-000, country: Brazil, geoPoint lat: -22.52306, lon: -44.10417, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Votuporanga, zip: 15501-405, country: Brazil, geoPoint lat: -20.42278, lon: -49.97278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Burgas, zip: 8000, country: Bulgaria, geoPoint lat: 42.50606, lon: 27.46781, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dupnitsa, zip: 2600, country: Bulgaria, geoPoint lat: 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country: Bulgaria, geoPoint lat: 42.15, lon: 24.75, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Plovdiv, zip: 4003, country: Bulgaria, geoPoint lat: 42.15, lon: 24.75, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Plovdiv, zip: 4004, country: Bulgaria, geoPoint lat: 42.15, lon: 24.75, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ruse, zip: 7002, country: Bulgaria, geoPoint lat: 43.85639, lon: 25.97083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sandanski, zip: 2800, country: Bulgaria, geoPoint lat: 41.56667, lon: 23.28333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sliven, zip: 8800, country: Bulgaria, geoPoint lat: 42.68583, lon: 26.32917, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sofia, zip: 1000, country: Bulgaria, geoPoint lat: 42.69751, lon: 23.32415, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vratsa, zip: 3000, country: Bulgaria, geoPoint lat: 43.21, lon: 23.5625, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yambol, zip: 8600, country: Bulgaria, geoPoint lat: 42.48333, lon: 26.5, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sherwood Park, state: Alberta, zip: T8L 0N2, country: Canada, geoPoint lat: 53.51684, lon: -113.3187, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 2H4, country: Canada, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sydney, state: Nova Scotia, zip: B1M 0A1, country: Canada, geoPoint lat: 46.13511, lon: -60.1831, locations facility: Research Site, status: RECRUITING, city: Ajax, state: Ontario, zip: L1S 2J5, country: Canada, geoPoint lat: 43.85012, lon: -79.03288, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guelph, state: Ontario, zip: N1H 1B1, country: Canada, geoPoint lat: 43.54594, lon: -80.25599, locations facility: Research Site, status: RECRUITING, city: Hamilton, state: Ontario, zip: L8M 1K7, country: Canada, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Thunder Bay, state: Ontario, zip: P7B 5N3, country: Canada, geoPoint lat: 48.38202, lon: -89.25018, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M5T 3A9, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, status: NOT_YET_RECRUITING, city: St Charles Borromee, state: Quebec, zip: J6E 2B4, country: Canada, geoPoint lat: 46.05007, lon: -73.46586, locations facility: Research Site, status: RECRUITING, city: Trois-Rivières, state: Quebec, zip: G8T 7A1, country: Canada, geoPoint lat: 46.34515, lon: -72.5477, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Trois-Rivières, state: Quebec, zip: G9A 4P3, country: Canada, geoPoint lat: 46.34515, lon: -72.5477, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Saskatoon, state: Saskatchewan, zip: S7N 0W8, country: Canada, geoPoint lat: 52.13238, lon: -106.66892, locations facility: Research Site, status: RECRUITING, city: Quebec, zip: G1G 3Y8, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quebec, zip: G1V 4G5, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quebec, zip: G1W 4R4, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quebec, zip: G3K 2P8, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Curico, zip: 3341643, country: Chile, geoPoint lat: -34.98279, lon: -71.23943, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quillota, zip: 2260000, country: Chile, geoPoint lat: -32.88341, lon: -71.24882, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Santiago, zip: 7500691, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Santiago, zip: 7750495, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Talca, zip: 3465584, country: Chile, geoPoint lat: -35.4264, lon: -71.65542, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Temuco, zip: 4810345, country: Chile, geoPoint lat: -38.73965, lon: -72.59842, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Victoria, zip: 4720097, country: Chile, geoPoint lat: -38.23291, lon: -72.33292, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vitacura, zip: 7630226, country: Chile, geoPoint lat: -33.39227, lon: -70.58275, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Viña del Mar, zip: 2540488, country: Chile, geoPoint lat: -33.02457, lon: -71.55183, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Anhui, zip: 230061, country: China, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Baotou, zip: 14010, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Baotou, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changsha, zip: 410004, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changsha, zip: 410015, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changzhi, zip: 46000, country: China, geoPoint lat: 35.20889, lon: 111.73861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610031, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610072, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 611130, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chifeng, zip: 024000, country: China, geoPoint lat: 42.26833, lon: 118.96361, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chongqing, zip: 401320, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510000, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510145, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hangzhou, zip: 310006, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Heze, zip: 274099, country: China, geoPoint lat: 35.23929, lon: 115.47358, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hohhot, zip: 010017, country: China, geoPoint lat: 40.81056, lon: 111.65222, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hohhot, zip: 750306, country: China, geoPoint lat: 40.81056, lon: 111.65222, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Huizhou, zip: 516001, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Huizhou, zip: 516002, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Jinhua, zip: 321099, country: China, geoPoint lat: 29.10678, lon: 119.64421, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Jining, zip: 272029, country: China, geoPoint lat: 35.405, lon: 116.58139, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kaifeng, zip: 475000, country: China, geoPoint lat: 34.7986, lon: 114.30742, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanchang, zip: 330006, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanjing, zip: 210009, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pingxiang, zip: 337055, country: China, geoPoint lat: 27.61672, lon: 113.85353, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Qingdao, zip: 266011, country: China, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200240, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 201199, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shenyang, zip: 110022, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shenyang, zip: 110083, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shijiazhuang, zip: 50051, country: China, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Siping, zip: 136000, country: China, geoPoint lat: 43.16143, lon: 124.37785, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taicang, zip: 215400, country: China, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taiyuan, zip: 030001, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taiyuan, zip: 030012, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taiyuan, zip: 030032, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taizhou, zip: 318000, country: China, geoPoint lat: 32.49069, lon: 119.90812, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Urumqi, zip: 831118, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wenzhou, zip: 325027, country: China, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xi'an, zip: 710006, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xinxiang, zip: 453002, country: China, geoPoint lat: 35.19033, lon: 113.80151, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xuzhou, zip: 221000, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xuzhou, zip: 221009, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yangzhou, zip: 225000, country: China, geoPoint lat: 32.39722, lon: 119.43583, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yangzhou, zip: 225001, country: China, geoPoint lat: 32.39722, lon: 119.43583, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yinchuan, zip: 750001, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yinchuan, zip: 750004, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zhengzhou, zip: 450006, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Barranquilla, zip: 080020, country: Colombia, geoPoint lat: 10.96854, lon: -74.78132, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bogota, zip: 111411, country: Colombia, geoPoint lat: 4.60971, lon: -74.08175, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Medellin, zip: 050025, country: Colombia, geoPoint lat: 6.25184, lon: -75.56359, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Medellin, zip: 050030, country: Colombia, geoPoint lat: 6.25184, lon: -75.56359, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rionegro, zip: 054047, country: Colombia, geoPoint lat: 6.15515, lon: -75.37371, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brandys nad Labem, zip: 250 01, country: Czechia, geoPoint lat: 50.18356, lon: 14.67244, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Olomouc, zip: 772 00, country: Czechia, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ostrava, zip: 702 00, country: Czechia, geoPoint lat: 49.83465, lon: 18.28204, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Praha 1, zip: 110 00, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rokycany, zip: 337 22, country: Czechia, geoPoint lat: 49.7427, lon: 13.59459, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aalborg, zip: 9000, country: Denmark, geoPoint lat: 57.048, lon: 9.9187, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, geoPoint lat: 55.47028, lon: 8.45187, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hvidovre, zip: 2650, country: Denmark, geoPoint lat: 55.65719, lon: 12.47364, locations facility: Research Site, status: NOT_YET_RECRUITING, city: København NV, zip: 2400, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Næstved, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vejle, zip: 7100, country: Denmark, geoPoint lat: 55.70927, lon: 9.5357, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Helsinki, zip: 00180, country: Finland, geoPoint lat: 60.16952, lon: 24.93545, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Helsinki, zip: 00980, country: Finland, geoPoint lat: 60.16952, lon: 24.93545, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kuopio, zip: 70100, country: Finland, geoPoint lat: 62.89238, lon: 27.67703, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Turku, zip: 20100, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aix en Provence, zip: 13616, country: France, geoPoint lat: 43.5283, lon: 5.44973, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aurillac Cedex, zip: 15002, country: France, geoPoint lat: 44.91667, lon: 2.45, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bayonne, zip: 64100, country: France, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Biarritz, zip: 64200, country: France, geoPoint lat: 43.48012, lon: -1.55558, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brest Cedex, zip: 29609, country: France, geoPoint lat: 48.3903, lon: -4.48628, locations 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France, geoPoint lat: 48.72381, lon: -3.98709, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vandoeuvre-Les-Nancy Cedex, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: VANNES cedex, zip: 56017, country: France, geoPoint lat: 47.66667, lon: -2.75, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Augsburg, zip: 86150, country: Germany, geoPoint lat: 48.37154, lon: 10.89851, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 10625, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 10787, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 10969, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 12157, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 12159, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 12203, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 12627, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 13187, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bremen, zip: 28215, country: Germany, geoPoint lat: 53.07516, lon: 8.80777, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bremen, zip: 28259, country: Germany, geoPoint lat: 53.07516, lon: 8.80777, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cottbus, zip: 03050, country: Germany, geoPoint lat: 51.75769, lon: 14.32888, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dachau, zip: 85221, country: Germany, geoPoint lat: 48.26, lon: 11.43402, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Darmstadt, zip: 64283, country: Germany, geoPoint lat: 49.87167, lon: 8.65027, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Deggingen, zip: 73326, country: Germany, geoPoint lat: 48.5971, lon: 9.71891, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dresden, zip: 01069, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Essen, zip: 45127, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Essen, zip: 45355, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Frankfurt/Main, zip: 60389, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Frankfurt, zip: 60596, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Großhansdorf, zip: 22927, country: Germany, geoPoint lat: 53.66667, lon: 10.28333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hamburg, zip: 22335, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hamburg, zip: 22459, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hannover, zip: 30449, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hannover, zip: D-30173, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Heidelberg, zip: 69115, country: Germany, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ibbenbüren, zip: 49477, country: Germany, geoPoint lat: 52.27964, lon: 7.71457, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Karlsruhe, zip: 76137, country: Germany, geoPoint lat: 49.00937, lon: 8.40444, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leipzig, zip: 04103, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leipzig, zip: 04157, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leipzig, zip: 04299, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lübeck, zip: 23552, country: Germany, geoPoint lat: 53.86893, lon: 10.68729, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mainz, zip: 55128, country: Germany, geoPoint lat: 49.98419, lon: 8.2791, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Moers, zip: 47441, country: Germany, geoPoint lat: 51.45342, lon: 6.6326, locations facility: Research Site, status: NOT_YET_RECRUITING, city: München, zip: 80336, country: Germany, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Offenbach am Main, zip: 63069, country: Germany, geoPoint lat: 50.10061, lon: 8.76647, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rheine, zip: 48431, country: Germany, geoPoint lat: 52.28509, lon: 7.44055, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Riesa, zip: 01587, country: Germany, geoPoint lat: 51.30777, lon: 13.29168, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Solingen, zip: 42699, country: Germany, geoPoint lat: 51.17343, lon: 7.0845, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wallerfing, zip: 94574, country: Germany, geoPoint lat: 48.68416, lon: 12.88035, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Weißenburg, zip: 91781, country: Germany, geoPoint lat: 49.03095, lon: 10.97221, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wermsdorf, zip: 04779, country: Germany, geoPoint lat: 51.28333, lon: 12.95, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wiesbaden, zip: 65189, country: Germany, geoPoint lat: 50.08258, lon: 8.24932, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Witten, zip: 58452, country: Germany, geoPoint lat: 51.44362, lon: 7.35258, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Athens, zip: 11521, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Athens, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Athens, zip: 12462, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Athens, zip: 17562, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Athens, zip: 18547, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Exohi Thessaloniki, zip: 57010, country: Greece, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ioannina, zip: 45500, country: Greece, geoPoint lat: 39.66486, lon: 20.85189, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Patras, zip: 26500, country: Greece, geoPoint lat: 38.24444, lon: 21.73444, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Thessaloniki, zip: 57010, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Budapest, zip: 1121, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Budapest, zip: 1194, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Edelény, zip: 3780, country: Hungary, geoPoint lat: 48.3, lon: 20.73333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gyöngyös - Mátraháza, zip: 3200, country: Hungary, locations facility: Research Site, status: SUSPENDED, city: Gödöllő, zip: 2100, country: Hungary, geoPoint lat: 47.59657, lon: 19.35515, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hajdúnánás, zip: 4080, country: Hungary, geoPoint lat: 47.85, lon: 21.43333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kalocsa, zip: 6300, country: Hungary, geoPoint lat: 46.52639, lon: 18.98583, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Komádi, zip: 4138, country: Hungary, geoPoint lat: 47.0, lon: 21.5, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Monor, zip: 2200, country: Hungary, geoPoint lat: 47.35133, lon: 19.44733, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pécs, zip: 7626, country: Hungary, geoPoint lat: 46.08333, lon: 18.23333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Püspökladány, zip: 4150, country: Hungary, geoPoint lat: 47.31667, lon: 21.11667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Szolnok, zip: 5000, country: Hungary, geoPoint lat: 47.18333, lon: 20.2, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Százhalombatta, zip: 2440, country: Hungary, geoPoint lat: 47.32579, lon: 18.92141, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Székesfehérvár, zip: 8000, country: Hungary, geoPoint lat: 47.18995, lon: 18.41034, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tapolca, zip: 8300, country: Hungary, geoPoint lat: 46.88152, lon: 17.44117, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aligarh, zip: 202002, country: India, geoPoint lat: 27.88145, lon: 78.07464, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Belagavi, zip: 590010, country: India, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dehradun, zip: 248001, country: India, geoPoint lat: 30.32295, lon: 78.03168, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Delhi, zip: 110029, country: India, geoPoint lat: 28.65195, lon: 77.23149, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hyderabad, zip: 500068, country: India, geoPoint lat: 17.38405, lon: 78.45636, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mangalore, zip: 575003, country: India, geoPoint lat: 12.91723, lon: 74.85603, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ancona, zip: 60100, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Firenze, zip: 50134, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Genoa, zip: 16132, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mestre, zip: 30174, country: Italy, geoPoint lat: 45.49167, lon: 12.24538, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Milano, zip: 20123, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Modena, zip: 41124, country: Italy, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Napoli, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pavia, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Perugia, zip: 06126, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Roma, zip: 00128, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Roma, zip: 00133, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Roma, zip: 161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rome, zip: 00189, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Siena, zip: 53100, country: Italy, geoPoint lat: 43.31822, lon: 11.33064, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Varese, zip: 21100, country: Italy, geoPoint lat: 45.82058, lon: 8.82511, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fujieda-shi, zip: 426-8677, country: Japan, geoPoint lat: 34.86667, lon: 138.26667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kitakyusyu, zip: 802-0052, country: Japan, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kobe-shi, zip: 651-0072, country: Japan, geoPoint lat: 34.6913, lon: 135.183, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kure-shi, zip: 737-0193, country: Japan, geoPoint lat: 34.23222, lon: 132.56658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kyoto-shi, zip: 607-8062, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mizunami-shi, zip: 509-6134, country: Japan, geoPoint lat: 35.36667, lon: 137.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Osaka-shi, zip: 530-0012, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shinjuku-ku, zip: 162-8655, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Takamatsu-shi, zip: 761-8073, country: Japan, geoPoint lat: 34.33333, lon: 134.05, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yamagata-shi, zip: 990-8533, country: Japan, geoPoint lat: 38.23333, lon: 140.36667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yanagawa-shi, zip: 832-0059, country: Japan, geoPoint lat: 33.16667, lon: 130.4, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yokohama-shi, zip: 234-0054, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Daegu, zip: 42415, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guri-si, zip: 11923, country: Korea, Republic of, geoPoint lat: 37.5986, lon: 127.1394, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Jeonju, zip: 54907, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seoul, zip: 03312, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seoul, zip: 04763, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seoul, zip: 06591, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ulsan, zip: 44033, country: Korea, Republic of, geoPoint lat: 35.53722, lon: 129.31667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Alor Setar, zip: 05460, country: Malaysia, geoPoint lat: 6.12104, lon: 100.36014, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kajang, zip: 43000, country: Malaysia, geoPoint lat: 2.99424, lon: 101.78875, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kuala Lumpur, zip: 50586, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kuala Pilah, zip: 72000, country: Malaysia, geoPoint lat: 2.7389, lon: 102.2487, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sandakan, zip: 90000, country: Malaysia, geoPoint lat: 5.8402, lon: 118.1179, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sarawak Miri, zip: 98000, country: Malaysia, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seremban, zip: 70300, country: Malaysia, geoPoint lat: 2.7297, lon: 101.9381, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sibu, zip: 96000, country: Malaysia, geoPoint lat: 2.29998, lon: 111.81667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Benito Juarez, zip: 03650, country: Mexico, geoPoint lat: 19.3984, lon: -99.15766, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chihuahua, zip: 31000, country: Mexico, geoPoint lat: 28.63528, lon: -106.08889, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cuernavaca, zip: 62290, country: Mexico, geoPoint lat: 18.9261, lon: -99.23075, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Culiacan, zip: 80020, country: Mexico, geoPoint lat: 24.79032, lon: -107.38782, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guadalajara, zip: 44200, country: Mexico, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guadalajara, zip: 44670, country: Mexico, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Juriquilla, zip: 76320, country: Mexico, geoPoint lat: 20.71277, lon: -100.45568, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Merida, zip: 97130, country: Mexico, geoPoint lat: 20.97537, lon: -89.61696, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Metepec, zip: 52170, country: Mexico, geoPoint lat: 19.25934, lon: -99.60175, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mexico City, zip: 03310, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Monterrey, zip: 64310, country: Mexico, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Monterrey, zip: 64460, country: Mexico, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Oaxaca, zip: 68020, country: Mexico, geoPoint lat: 17.06542, lon: -96.72365, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tijuana, zip: 22010, country: Mexico, geoPoint lat: 32.5027, lon: -117.00371, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Veracruz, zip: 91910, country: Mexico, geoPoint lat: 19.18095, lon: -96.1429, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xalapa, zip: 91193, country: Mexico, geoPoint lat: 19.53124, lon: -96.91589, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zapopan, zip: 45138, country: Mexico, geoPoint lat: 20.72356, lon: -103.38479, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kongsberg, zip: 3612, country: Norway, geoPoint lat: 59.66858, lon: 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protocolSection identificationModule nctId: NCT06283953, orgStudyIdInfo id: 2023P001695, secondaryIdInfos id: IHS-2022C1-26100, type: OTHER_GRANT, domain: Patient Centered Outcomes Research Institute (PCORI), briefTitle: Boosting Resources for Tracheostomy Care at Home, acronym: BREATHE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Children's Hospital Medical Center, Cincinnati, collaborators name: Children's Hospital of Philadelphia, collaborators name: Children's Hospitals and Clinics of Minnesota, collaborators name: Children's National Research Institute, collaborators name: Rady Children's Hospital, San Diego, collaborators name: Patient-Centered Outcomes Research Institute, descriptionModule briefSummary: The goal of this trial is to advance our understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:* How can we support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?* How can we leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm., conditionsModule conditions: Tracheostomy, conditions: Caregiver Burden, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Blinding of care team delivering the interventions and of caregiver participants receiving the interventions is not possible for this study.The outcome assessors collecting the readmission data and statistician conducting analyses will be blinded to the assignment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Trach@Home, interventions name: Trach Me Home, outcomesModule primaryOutcomes measure: Caregiver Burden, secondaryOutcomes measure: Medical Complications Associated with Tracheostomy, secondaryOutcomes measure: 6-month Readmission Rate, secondaryOutcomes measure: Frequency of pediatrician communication, secondaryOutcomes measure: Primary care pediatrician satisfaction, otherOutcomes measure: Medical Complications Associated with Tracheostomy, otherOutcomes measure: Caregiver Burden, otherOutcomes measure: Number of readmissions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of San Diego Rady Children's Hospital, city: La Jolla, state: California, zip: 92093, country: United States, contacts name: Matthew Brigger, MD, role: CONTACT, email: [email protected], contacts name: Matthew Brigger, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Children's National Medical Center, Children's Research Institute, city: Silver Spring, state: Maryland, zip: 20910, country: United States, contacts name: Habib Zalzal, MD, role: CONTACT, email: [email protected], contacts name: Habib Zalzal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.99067, lon: -77.02609, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Karen Sepucha, PhD, role: CONTACT, email: [email protected], contacts name: Christopher Hartnick, MD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Children's Hospitals and Clinics of Minnesota, city: Minneapolis, state: Minnesota, zip: 55404, country: United States, contacts name: Asitha Jayawardena, MD, role: CONTACT, email: [email protected], contacts name: Asitha Jayawardena, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Matthew Smith, MD, role: CONTACT, email: [email protected], contacts name: Matthew Smith, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19146, country: United States, contacts name: Luv Javia, MD, role: CONTACT, email: [email protected], contacts name: Luv Javia, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06283940, orgStudyIdInfo id: 281694, briefTitle: Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation, acronym: TAVI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS.Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI.Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life., conditionsModule conditions: Aortic Valve Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention group and matched controls based on age, gender and exercise capacity in watt., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Data collection will be conducted by a physiotherapist not involved in the intervention., enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapist-led exercise based cardiac rehabilitation (PT-X), outcomesModule primaryOutcomes measure: Exercise capacity in watt, primaryOutcomes measure: Rating of perceived exertion Borg RPE scale 6-20, primaryOutcomes measure: Exercise capacity in Watt, primaryOutcomes measure: Rating of perceived exertion Borg RPE scale 6-20, primaryOutcomes measure: Muscular endurance test, shoulder flexion, primaryOutcomes measure: Muscular endurance test, shoulder flexion, primaryOutcomes measure: Muscle endurance test, shoulder abduction, primaryOutcomes measure: Muscle endurance test, shoulder abduction, primaryOutcomes measure: Muscle endurance test, unilateral heel-lift, primaryOutcomes measure: Muscle endurance test, unilateral heel-lift, primaryOutcomes measure: Lower extremity function, primaryOutcomes measure: Lower extremity function, primaryOutcomes measure: Physical activity, primaryOutcomes measure: Physical activity, primaryOutcomes measure: Self-assessed level of physical activity, primaryOutcomes measure: Self-assessed level of physical activity, primaryOutcomes measure: Health Related Quality of Life, primaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Hospital admission, secondaryOutcomes measure: Hospital admission, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283927, orgStudyIdInfo id: MEC-2020-0812-5, briefTitle: The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302), acronym: RECSUR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Jasper Gerritsen, class: OTHER, collaborators name: Haaglanden Medical Centre, collaborators name: Universitaire Ziekenhuizen KU Leuven, collaborators name: University Hospital Heidelberg, collaborators name: Technical University of Munich, collaborators name: Insel Gruppe AG, University Hospital Bern, collaborators name: Massachusetts General Hospital, collaborators name: University of California, San Francisco, descriptionModule briefSummary: Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media., conditionsModule conditions: Glioblastoma, conditions: Glioblastoma Multiforme, conditions: Glioblastoma, IDH-wildtype, conditions: Glioblastoma Multiforme of Brain, conditions: Glioblastoma Multiforme, Adult, conditions: Recurrent Glioblastoma, conditions: Astrocytoma, Malignant, conditions: Astrocytoma of Brain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 464, type: ESTIMATED, armsInterventionsModule interventions name: Re-resection, interventions name: Temozolomide, interventions name: Lomustine, interventions name: Re-irradiation, interventions name: Experimental therapy, interventions name: Best supportive care, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Neurological morbidity at 6 weeks, secondaryOutcomes measure: Neurological morbidity at 3 months, secondaryOutcomes measure: Neurological morbidity at 6 months, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Residual tumor volume, secondaryOutcomes measure: Quality of life at 6 weeks (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 3 months (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 6 months (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 6 weeks (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 3 months (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 6 months (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 6 weeks (EQ-5D), secondaryOutcomes measure: Quality of life at 3 months (EQ-5D), secondaryOutcomes measure: Quality of life at 6 months (EQ-5D), secondaryOutcomes measure: Serious Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Mitchel Berger, MD PhD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Brian Nahed, MD PhD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University Hospital Leuven, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Steven De Vleeschouwer, MD PhD, role: CONTACT, geoPoint lat: 50.87959, lon: 4.70093, locations facility: University Hospital Heidelberg, status: RECRUITING, city: Heidelberg, country: Germany, contacts name: Christine Jungk, Dr. med., role: CONTACT, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Technical University Munich, status: NOT_YET_RECRUITING, city: Munich, country: Germany, contacts name: Arthur Wagner, MD, role: CONTACT, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015 CE, country: Netherlands, contacts name: Arnaud Vincent, MD PhD, role: CONTACT, phone: +31639428949, email: [email protected], contacts name: Jasper Gerritsen, MD, role: CONTACT, phone: +31629119553, email: [email protected], geoPoint lat: 51.9225, lon: 4.47917, locations facility: Medical Center Haaglanden, status: RECRUITING, city: The Hague, state: Zuid-Holland, zip: 2261 CP, country: Netherlands, contacts name: Marike Broekman, MD PhD, role: CONTACT, phone: +31639758253, email: [email protected], geoPoint lat: 52.07667, lon: 4.29861, locations facility: Inselspital Universitätsspital Bern, status: NOT_YET_RECRUITING, city: Bern, country: Switzerland, contacts name: Philippe Schucht, MD PhD, role: CONTACT, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False |
protocolSection identificationModule nctId: NCT06283914, orgStudyIdInfo id: BIO-2024-0011, briefTitle: Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: American University of Beirut Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this is prospective cohort study is to to study the relationship between PaO2 and SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims include studying the relationship between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for patients undergoing general anesthesia in the OT.The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age \>18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded., conditionsModule conditions: Oxygen Saturation, conditions: Respiratory Distress Syndrome, conditions: Anesthesia, General, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: PaO2, otherOutcomes measure: SpO2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283901, orgStudyIdInfo id: NL82013.018.22, briefTitle: Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness, acronym: IMPROVE-DOC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome., conditionsModule conditions: Traumatic Brain Injury, conditions: Intracranial Hemorrhages, conditions: Subarachnoid Hemorrhage, conditions: Meningitis, conditions: Encephalitis, conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, outcomesModule primaryOutcomes measure: Glasgow Outcome Scale Extended, secondaryOutcomes measure: Glasgow Outcome Scale Extended, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud UMC, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525 GA, country: Netherlands, contacts name: Astrid Hoedemaekers, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105 AZ, country: Netherlands, contacts name: Wolmet Haksteen, MD, role: CONTACT, phone: +31 020 - 566 9111, email: [email protected], geoPoint lat: 52.37403, lon: 4.88969, locations facility: Haaglanden MC, locatie Westeinde, status: RECRUITING, city: Den Haag, state: Zuid-Holland, zip: 2512 VA, country: Netherlands, contacts name: Sefanja Achterberg, role: CONTACT, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Erasmus MC, status: NOT_YET_RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015 GD, country: Netherlands, contacts name: Mathieu van der Jagt, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, locations facility: UMC Groningen, status: NOT_YET_RECRUITING, city: Groningen, zip: 9713 GZ, country: Netherlands, contacts name: Joukje van der Naalt, role: CONTACT, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06283888, orgStudyIdInfo id: PRECISE-PCI, briefTitle: CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Zunyi Medical College, class: OTHER, descriptionModule briefSummary: In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice., conditionsModule conditions: ACS - Acute Coronary Syndrome, conditions: CYP2C19 Polymorphism, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: CYP2C19 Genotype Guided DAPT, interventions name: Conventional DAPT, outcomesModule primaryOutcomes measure: NACE (net adverse clinical event), secondaryOutcomes measure: Incidence of clinically significant bleeding, secondaryOutcomes measure: Incidence of MACCE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Zunyi Medical University, status: RECRUITING, city: Zunyi, state: Guizhou, zip: 563003, country: China, contacts name: Cai De Jin, MD, role: CONTACT, phone: 86+173-8576-9997, email: [email protected], contacts name: Yan Yan Jin, MD, PhD, role: CONTACT, phone: 86+157-7229-0925, email: [email protected], contacts name: Cai De Jin, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ran Zun Zhao, MD, role: SUB_INVESTIGATOR, geoPoint lat: 27.68667, lon: 106.90722, hasResults: False |
protocolSection identificationModule nctId: NCT06283875, orgStudyIdInfo id: PROMISEPLUS-301, briefTitle: The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2029-01-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Geneplus-Beijing Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS., conditionsModule conditions: Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: DFS of enrolled patients for 2 years, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, zip: 215006, country: China, contacts name: Jinhua Zhou, role: CONTACT, phone: +86 13914024750, email: [email protected], contacts name: Songbing Qin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False |
protocolSection identificationModule nctId: NCT06283862, orgStudyIdInfo id: HUM00231159b, secondaryIdInfos id: VMR2022-03, type: OTHER_GRANT, domain: Michigan, State of, Licensing and Regulatory Affairs, Department of 573000, briefTitle: MIVetsCan: Can-Coach Trial (Phase 2), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Michigan, State of, Licensing and Regulatory Affairs, descriptionModule briefSummary: The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to immediately receive 4 sessions of tailored guidance or to receive it after 12 weeks, as a waitlist control condition., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 468, type: ESTIMATED, armsInterventionsModule interventions name: Educational Session, outcomesModule primaryOutcomes measure: Patient Global Impression of Change (PGIC) score, secondaryOutcomes measure: Self-report of pain (intensity or severity) from a numerical rating scale of 0-10, secondaryOutcomes measure: Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1, secondaryOutcomes measure: Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1, secondaryOutcomes measure: Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1, secondaryOutcomes measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation, secondaryOutcomes measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48105, country: United States, contacts name: Vivian Kurtz, role: CONTACT, phone: 734-998-7156, email: [email protected], contacts name: Kevin Boehnke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False |
protocolSection identificationModule nctId: NCT06283849, orgStudyIdInfo id: SON-2024-32671, briefTitle: Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The disparate burden of Type 2 Diabetes (T2D) faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated cardiovascular (CV) complications, essential.Similar to differences in cardiovascular disease (CVD) rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in physical activity PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.The disparate burden of T2D faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated CV complications, essential.Similar to differences in CVD rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.The goal is to develop a deeper understanding of individuals' experiences of sedentary behavior (SB) and collaborate to design strategies to reduce SB. Using the Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM) conceptual model, social-ecological framework, and COM-B model, the study will seek to understand the relationship between SB and individual, relationship, community, and societal factors. The study will also examine the context of SB and strategies that participants have used and could or would consider using to break up the time they spend sitting., conditionsModule conditions: Cardiovascular Diseases, conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: strategies to break up SB, outcomesModule primaryOutcomes measure: sedentary time, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Mary O Whipple, PhD, RN, PHN, role: CONTACT, phone: 612-625-4470, email: [email protected], geoPoint lat: 44.97997, lon: -93.26384, hasResults: False |
protocolSection identificationModule nctId: NCT06283836, orgStudyIdInfo id: Dexrem ATI 4-6, briefTitle: Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Iuliu Hatieganu University of Medicine and Pharmacy, class: OTHER, descriptionModule briefSummary: Dexmedetomidine continuous intravenous infusion vs. remifentanil target-controlled infusion conscious sedation for stapedotomy/stapedectomy- a prospective, single-center, double-masked randomized trialThe goal of this clinical trial is to compare monitored anesthesia care with continuous intravenous dexmedetomidine vs. remifentanil target-controlled infusion in patients undergoing stapedotomy or stapedectomy for otosclerosis. The aims of this research are:* to assess the patient's satisfaction with each sedation regimen* the surgeon will also grade their satisfaction regarding the surgical field The investigators will monitor and analyze the vitals during and after the intervention and document any intra- and postoperative complications.Participants will be randomly assigned to receive either dexmedetomidine or remifentanil, and the patient, the surgeon, and the investigator will not be aware of the treatment administered., conditionsModule conditions: Otosclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Remifentanil, outcomesModule primaryOutcomes measure: Patient satisfaction, primaryOutcomes measure: Surgeon satisfaction, secondaryOutcomes measure: mean arterial pressure, secondaryOutcomes measure: Heart Rate, otherOutcomes measure: the need for adjuncts during intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cluj County Clinical Emergency Hospital, city: Cluj Napoca, state: Cluj, zip: 400006, country: Romania, contacts name: Caius Mihai Breazu, MD, PhD, role: CONTACT, phone: +40743010012, email: [email protected], contacts name: ioan florin marchis, MD, PhD, role: CONTACT, phone: +40757065205, email: [email protected], geoPoint lat: 46.76667, lon: 23.6, hasResults: False |
protocolSection identificationModule nctId: NCT06283823, orgStudyIdInfo id: 41821, briefTitle: Morphological Changes of Removable Orthodontic Retainers During the Use, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-21, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-21, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of L'Aquila, class: OTHER, descriptionModule briefSummary: The retention is one of the stages of orthodontic treatment that aims to keep the teeth in the correct positions after orthodontic treatment. Without a retention phase, there is a tendency for the teeth to return to their initial position (relapse). To prevent relapse, at the end of orthodontic therapy the use of retaining devices to keep the teeth in their ideal position is required. The aim of the study is to analyse whether intraoral aging of removable retention devices can lead to morphological or dimensional changes, and whether or not these changes are related to orthodontic relapse, expressed as a change in the Peer Assessment Rating (PAR) index. The PAR index is an index that allows us to evaluate the relapse after orthodontic treatment. In this study the PAR index will be measured at the start of the retention period (T0), at the three-months follow-up (T1) and at the six months follow-up (T2). In particular, two types of thermoformed retainers with different cutouts will be evaluated to determine whether the presence of higher margins in a type of retainers allows to maintain greater stability over time and, therefore, to confer a mechanical and clinical advantage., conditionsModule conditions: Orthodontic Retainer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Thermoformed orthodontic retainer, outcomesModule primaryOutcomes measure: Peer Assessment Rating (PAR) index, primaryOutcomes measure: Volumetric superimposition of digital models, secondaryOutcomes measure: Thickness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of L'Aquila, status: RECRUITING, city: L'Aquila, zip: 67100, country: Italy, contacts name: Michele Tepedino, DDS, role: CONTACT, phone: +39 340 276 1456, email: [email protected], geoPoint lat: 42.35055, lon: 13.39954, hasResults: False |
protocolSection identificationModule nctId: NCT06283810, orgStudyIdInfo id: 2023/168, briefTitle: The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Midwives, who have an important place in the health system, are expected to be equipped to meet the health care needs of women (Fışkın \& Doğan, 2020). Therefore, midwifery students, who are known to play a role in promoting women's health, should have good interpersonal relationships, good problem-solving skills, and high self-reflection and insight, which are assumed to be effective in both, in order to fulfill these responsibilities.Translated with DeepL.com (free version), conditionsModule conditions: Midwifery Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: psychotherapy of interpersonal relationships, interventions name: laughter therapy, interventions name: Plasebo, outcomesModule primaryOutcomes measure: self-reflection skills, primaryOutcomes measure: problem solving skills, primaryOutcomes measure: interpersonal relationship skills, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul University-Cerrahpasa, status: RECRUITING, city: Istanbul, zip: 34320, country: Turkey, contacts name: Betül Uncu, role: CONTACT, phone: +095078421227, email: [email protected], contacts name: Nurten Kaya, role: SUB_INVESTIGATOR, contacts name: Betül Uncu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06283797, orgStudyIdInfo id: RECHMPL22_0346, secondaryIdInfos id: 2023-A01661-44, type: OTHER, domain: ANSM, briefTitle: Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes, acronym: APATDIAGNOSIS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: Hopital Universitaire Robert-Debre, collaborators name: University Hospital, Tours, collaborators name: University Hospital, Angers, collaborators name: University of Virginia, descriptionModule briefSummary: The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized control study in parallel groups, followed by a non randomized extension, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: OmniPod 5, interventions name: Dexcom G6, interventions name: PAID questionnaires, outcomesModule primaryOutcomes measure: Glycated hemoglobin (HbA1c) level, secondaryOutcomes measure: Percent of time spent in the 70-180 mg/dl glucose range, secondaryOutcomes measure: Percent of time spent in the 70-140 mg/dl glucose range, secondaryOutcomes measure: Mean glucose level, secondaryOutcomes measure: Percent of time spent with glucose level below 70 mg/dl, secondaryOutcomes measure: Percent of time spent with glucose level below 54 mg/dl, secondaryOutcomes measure: Percent of time spent with glucose level above 180 mg/dl, secondaryOutcomes measure: Percent of time spent with glucose level above 250 mg/dl, secondaryOutcomes measure: Coefficient of glucose variability, secondaryOutcomes measure: Score of PAID questionnaire for parents, secondaryOutcomes measure: Score of PAID questionnaire for children, secondaryOutcomes measure: Stimulated plasma C-peptide level 10-min after 1mg IV glucagon, secondaryOutcomes measure: Number of needed interventions by the parents/guardians or care providers, otherOutcomes measure: Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent in the 70-180 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent in the 70-140 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of mean glucose level between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level below 70 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level below 54 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level above 180 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of percent of time spent with glucose level above 250 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of coefficient of glucose variability between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of score of PAID questionnaire for parents between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of score of PAID questionnaire for children between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of stimulated plasma C-peptide level 10-min after 1mg IV glucagon between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Change of number of needed interventions by the parents/guardians or care providers between 1st and 2nd year of use in the group who started HCL early after diagnosis, otherOutcomes measure: Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent in the 70-180 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent in the 70-140 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level below 70 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level below 54 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level above 180 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the percent of time spent with glucose level above 250 mg/dl between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the coefficient of glucose variability between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the score of PAID questionnaire for parents between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the score of PAID questionnaire for children between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the stimulated plasma C-peptide level 10-min after 1mg IV glucagon between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Difference in the number of needed interventions by the parents/guardians or care providers between the 2 initially randomized groups at the end of the extension period, otherOutcomes measure: Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs, otherOutcomes measure: Relatedness of treatment-emergent SUSARs, SAEs, ARs and AEs, otherOutcomes measure: Severity of treatment-emergent SUSARs, SAEs, ARs and AEs, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University Hospital, Angers, city: Angers, country: France, contacts name: Régis Coutant, MD, role: CONTACT, phone: 02 41 35 56 55, phoneExt: +33, email: [email protected], geoPoint lat: 47.46667, lon: -0.55, locations facility: University Hospital, Montpellier, city: Montpellier, country: France, contacts name: Eric Renard, MD, role: CONTACT, phone: 04 67 33 83 82, phoneExt: +33, email: [email protected], geoPoint lat: 43.61092, lon: 3.87723, locations facility: Robert Debré Hospital, AP-HP, city: Paris, country: France, contacts name: Elise Bismuth Reisman, MD, role: CONTACT, phone: 01 40 03 20 67, phoneExt: +33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: University Hospital, Tours, city: Tours, country: France, contacts name: Yannis Chartier, MD, role: CONTACT, phone: 06 85 67 93 35, phoneExt: +33, email: [email protected], geoPoint lat: 47.38333, lon: 0.68333, hasResults: False |
protocolSection identificationModule nctId: NCT06283784, orgStudyIdInfo id: YOVIS Capsules, briefTitle: Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-05, primaryCompletionDateStruct date: 2021-11-02, completionDateStruct date: 2022-05-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Biofarma, class: INDUSTRY, collaborators name: Hippocrates Research, descriptionModule briefSummary: This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days.The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days), conditionsModule conditions: Diarrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a double blind, randomized, placebo-controlled study., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics. Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste. Product test and placebo capsules will be indistinguishable.Investigational food supplement products will be packed in an individual way for each subject included in the investigation., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Yovis Capsules, interventions name: Placebo, outcomesModule primaryOutcomes measure: Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy, secondaryOutcomes measure: Severity and duration of AAD, secondaryOutcomes measure: Severity and duration of AAD, secondaryOutcomes measure: Evaluation of duration and severity of gastrointestinal symptoms, secondaryOutcomes measure: Evaluation of duration and severity of gastrointestinal symptoms, secondaryOutcomes measure: Evaluation of duration and severity of gastrointestinal symptoms, secondaryOutcomes measure: Impact of bowel habits on QoL, secondaryOutcomes measure: Effects of YOVIS, versus placebo, at each visit on the overall health status, secondaryOutcomes measure: Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo, secondaryOutcomes measure: Global Patient's self-reported acceptance at the end of study, secondaryOutcomes measure: Global acceptability (investigator) at the end of study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Practitioner Ambulatory, city: Sanremo, state: Italy/Imperia, zip: 18038, country: Italy, geoPoint lat: 43.81725, lon: 7.7772, hasResults: False |
protocolSection identificationModule nctId: NCT06283771, orgStudyIdInfo id: TU-BOZKUL-007, briefTitle: The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, collaborators name: Mersin University, descriptionModule briefSummary: In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\*Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analysis as further analy, conditionsModule conditions: Wearable Technology, conditions: Hypothermia, conditions: Shivering, conditions: Thermal Comfort Perception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: An independent biostatistician, who is not involved in the study, will select 70 individuals from the list of students enrolled between 1-250 by computer-generated randomization. The information that the volunteers included in the research sample were assigned to group A (experimental) and B (control) according to the randomization table will be kept by the researcher and the socks with the same appearance, with and without heating feature will be numbered from 1 to 70 according to the randomization table and given to the researcher. Thus, the practitioner will be blinded as he/she does not know which sock has a heating feature and which one does not. Healthy volunteers will be blinded because they do not know which group they are in. The data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will also be blinded to group assignment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Heated socks to be developed with wearable technology, outcomesModule primaryOutcomes measure: Body temperature, primaryOutcomes measure: Shivering level, primaryOutcomes measure: Thermal comfort perception, primaryOutcomes measure: Descriptive Characteristics, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283758, orgStudyIdInfo id: PARADISE HTN-III, briefTitle: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Suzhou Municipal Hospital, class: OTHER, collaborators name: The Affiliated Jiangning Hospital of Nanjing Medical University, collaborators name: The First Affiliated Hospital with Nanjing Medical University, collaborators name: Affiliated Hospital of Nantong University, descriptionModule briefSummary: This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control., conditionsModule conditions: Hypertension, conditions: Blood Pressure, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: focused power ultrasound mediate inferior perirenal adipose tissue modification, interventions name: Sham-control group, outcomesModule primaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Office Systolic Blood Pressure, secondaryOutcomes measure: Office Systolic Blood Pressure, secondaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Home Blood Pressure, secondaryOutcomes measure: Home Blood Pressure, secondaryOutcomes measure: Blood pressure control rate, secondaryOutcomes measure: Antihypertensive drug load index, otherOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Affiliated Jiangning Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Yuqing Zhang, role: CONTACT, phone: 13851672168, contacts name: Qin Tao, role: CONTACT, phone: 1585062208, contacts name: Yuqing Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The first Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Fang Zhou, role: CONTACT, phone: 13815401066, email: [email protected], contacts name: Wei Sun, role: CONTACT, phone: 13815860536, email: [email protected], contacts name: Fang Zhou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Affiliated Hospital of Nantong University, city: Nantong, state: Jiangsu, zip: 210000, country: China, contacts name: Hongzhuan Sheng, role: CONTACT, phone: 13515203348, contacts name: Jian Zhuo, role: CONTACT, phone: 18206297131, contacts name: Hongzhuan Sheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.03028, lon: 120.87472, locations facility: Suzhou Municipal Hospital, city: Suzhou, state: Jiangsu, zip: 210000, country: China, contacts name: Yanhui Sheng, role: CONTACT, phone: 13851647530, email: [email protected], contacts name: Yang Hua, role: CONTACT, phone: 13851624359, email: [email protected], contacts name: Yanhui Sheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False |
protocolSection identificationModule nctId: NCT06283745, orgStudyIdInfo id: 73225, briefTitle: Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-23, primaryCompletionDateStruct date: 2027-03-22, completionDateStruct date: 2027-03-22, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia., conditionsModule conditions: Paraosmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PRP injections will be given to one arm while sham saline injections will be given to the other arm., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Platelet-rich Plasma (PRP), interventions name: Saline, outcomesModule primaryOutcomes measure: Change in Sniffin Sticks Parosmia Test (SSParoT), primaryOutcomes measure: Change in questionnaire of olfactory disorders (QOD) scale score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford Sinus Center / Stanford University School of Medicine, city: Palo Alto, state: California, zip: 94304, country: United States, contacts name: Homer Abaya, BS, role: CONTACT, phone: 650-725-6500, email: [email protected], contacts name: Maxime Fieux, MD, PhD, role: CONTACT, phone: +33621611643, email: [email protected], contacts name: Zara Patel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False |
protocolSection identificationModule nctId: NCT06283732, orgStudyIdInfo id: 20392, briefTitle: A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Amway Corp, class: INDUSTRY, collaborators name: Citruslabs, descriptionModule briefSummary: The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires., conditionsModule conditions: Digestive System Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Greens powder, outcomesModule primaryOutcomes measure: Digestive Health Improvement, secondaryOutcomes measure: Quality of Life and Well-being Enhancement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Citruslabs, city: Santa Monica, state: California, zip: 90404, country: United States, geoPoint lat: 34.01945, lon: -118.49119, hasResults: False |
protocolSection identificationModule nctId: NCT06283719, orgStudyIdInfo id: ZG006-002, briefTitle: Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, open-label phase I/II study, divided into 2 parts:Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer., conditionsModule conditions: Small Cell Lung Cancer, conditions: Neuroendocrine Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: ZG006, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Disease control rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, city: Shanghai, state: Shanghai, country: China, contacts name: Shun Lu, role: CONTACT, contacts name: Shun Lu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06283706, orgStudyIdInfo id: 1000081113, briefTitle: The Tryptophan Requirement in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: The Hospital for Sick Children, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need., conditionsModule conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Tryptophan, outcomesModule primaryOutcomes measure: Determination of tryptophan requirement in adults >60 years of age., eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283693, orgStudyIdInfo id: RojdaBAYARYILDIRIM, briefTitle: The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-05-10, completionDateStruct date: 2025-06-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol.Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines., conditionsModule conditions: Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels, conditions: Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled classical experimental study, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Computer-assisted randomization will be used in the study, and participants will be randomized to an intervention or control list control group in a 1:1 ratio by entering the number of samples to be reached through the program whose URL address is https://www.randomizer.org. Women who apply to the infertility outpatient clinic by the researcher and volunteer for the study who meet the sample selection criteria will be given numbers according to the order of outpatient clinic registration. A randomization sequence will be created according to these numbers and women will be assigned to the intervention and control groups by computer-assisted randomization. Since the study is a thesis, blinding will not be possible due to its nature., whoMasked: PARTICIPANT, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: mindfulness-based stress reduction, outcomesModule primaryOutcomes measure: Informed Voluntary Consent Form (Annex 1), primaryOutcomes measure: Identifying Characteristics Information Form (Annex 2), primaryOutcomes measure: Perceived Stress Scale (Appendix 3):, primaryOutcomes measure: Depression-Anxiety-Stress Scale (Appendix 4), primaryOutcomes measure: Collection and study of salivary cortisol samples, secondaryOutcomes measure: Perceived Stress Scale (Appendix 3):, secondaryOutcomes measure: Depression-Anxiety-Stress Scale (Appendix 4), secondaryOutcomes measure: Collection and study of salivary cortisol samples, otherOutcomes measure: Perceived Stress Scale (Appendix 3):, otherOutcomes measure: Depression-Anxiety-Stress Scale (Appendix 4), otherOutcomes measure: Collection and study of salivary cortisol samples, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Saglık Bilimleri Universitesi, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06283680, orgStudyIdInfo id: 2024, briefTitle: The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-28, primaryCompletionDateStruct date: 2024-04-28, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Aylin Seylam Küşümler, class: OTHER, collaborators name: Koşuyolu Yüksek İhtisas Training and Research Hospital, descriptionModule briefSummary: The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list., conditionsModule conditions: Lung Transplant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 213, type: ESTIMATED, armsInterventionsModule interventions name: Lung transplantation, outcomesModule primaryOutcomes measure: BMI, secondaryOutcomes measure: Nutrition risk index, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OkanU, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06283667, orgStudyIdInfo id: NN9536-4872, secondaryIdInfos id: U1111-1266-3863, type: OTHER, domain: World Health Organization (WHO), briefTitle: Special Use - Results Surveillance on Long-term Use With Wegovy®, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks)., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide, outcomesModule primaryOutcomes measure: Number of Adverse Reactions (ARs), secondaryOutcomes measure: Number of Adverse Events (AEs), secondaryOutcomes measure: Number of serious adverse events (SAEs), secondaryOutcomes measure: Number of Serious Adverse Reactions (SARs), secondaryOutcomes measure: Change in body weight (Percent (%)), secondaryOutcomes measure: Change in body weight (Kilograms (Kg)), secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in BMI (Body Mass Index), secondaryOutcomes measure: Change in body weight after treatment discontinuation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novo Nordisk Investigational Site, city: Tokyo, state: Chiyoda City, zip: 100-0005, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False |
protocolSection identificationModule nctId: NCT06283654, orgStudyIdInfo id: VUmc 2018.539, briefTitle: Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation, acronym: relievED, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-09-30, primaryCompletionDateStruct date: 2021-09-30, completionDateStruct date: 2023-01-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, descriptionModule briefSummary: In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device, which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 204, type: ACTUAL, armsInterventionsModule interventions name: 1-lead ECG, outcomesModule primaryOutcomes measure: number of ED visits, secondaryOutcomes measure: ratio of the number of cardioversions emergency vs planned, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC -vumc, city: Amsterdam, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06283641, orgStudyIdInfo id: NN8022-7780, secondaryIdInfos id: U1111-1289-9747, type: OTHER, domain: World Health Organization (WHO), briefTitle: Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.The study will last for about 26 weeks., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Liraglutide, outcomesModule primaryOutcomes measure: Incidence of adverse events (AEs) by preferred term (PT), secondaryOutcomes measure: Number of adverse drug reaction (ADRs), secondaryOutcomes measure: Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs), secondaryOutcomes measure: Number of unexpected AEs and unexpected ADRs, secondaryOutcomes measure: Number of unexpected SAEs and unexpected SADRs, secondaryOutcomes measure: Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label, secondaryOutcomes measure: Body weight loss Percent (%) (Adult), secondaryOutcomes measure: Body weight loss (%) (Adult), secondaryOutcomes measure: Body weight loss Kilogram(Kg) (Adult), secondaryOutcomes measure: Body weight loss (kg) (Adult), secondaryOutcomes measure: The proportion of adult subjects losing at least 5% of baseline body weight, secondaryOutcomes measure: The proportion of adult subjects losing at least 5% of baseline body weight, secondaryOutcomes measure: The proportion of adult subjects losing more than 10% of baseline body weight, secondaryOutcomes measure: The proportion of adult subjects losing more than 10% of baseline body weight, secondaryOutcomes measure: The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda®, secondaryOutcomes measure: Change in body mass index (BMI) (kg/m^2) (Adolescent), secondaryOutcomes measure: Change in body mass index (BMI) (kg/m^2) (Adolescent), secondaryOutcomes measure: Change in body mass index (BMI) (%) (Adolescent), secondaryOutcomes measure: Change in body mass index (BMI) (%) (Adolescent), secondaryOutcomes measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent), secondaryOutcomes measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent), secondaryOutcomes measure: Body weight loss (%) (Adolescent), secondaryOutcomes measure: Body weight loss (%) (Adolescent), secondaryOutcomes measure: Body weight loss (kg) (Adolescent), secondaryOutcomes measure: Body weight loss (kg) (Adolescent), secondaryOutcomes measure: The proportion of adolescent subjects losing at least 4% of baseline BMI, secondaryOutcomes measure: The proportion of adolescent subjects losing at least 4% of baseline BMI, secondaryOutcomes measure: The proportion of adolescent subjects losing at least 10% of baseline BMI, secondaryOutcomes measure: The proportion of adolescent subjects losing at least 10% of baseline BMI, secondaryOutcomes measure: The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda®, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei City, zip: 100229, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: National Taiwan University Hospital, city: Taipei City, zip: 100, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06283628, orgStudyIdInfo id: STUDY00023737, briefTitle: Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves, acronym: LMB-RFA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation., conditionsModule conditions: Lumbar Spondylosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The subjects with bilateral low back pain will undergo radiofrequency ablation of the lumbar medial branch nerves using one approach (traditional) on one side and different approach (parasagittal) on the other side. One arm will use the traditional approach on the left and the parasagittal approach on the right. The other arm will use parasagittal approach on the left and the traditional approach on the right,, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: We will do computer randomization for the sides for each approach for all the subjects. The subjects will be assigned numbers, and the particular procedural approach for each side will be concealed in the numbered envelopes. The numbers on the envelopes will correspond to the numbers assigned to the patients. The envelopes will be opened by a treating physician in the procedure room. The patient and the assessor (who will not be the treating physician) will not know which procedural approach was used for the sides., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Radiofrequency ablation of lumbar medial branch nerves., outcomesModule primaryOutcomes measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)., primaryOutcomes measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)., primaryOutcomes measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)., secondaryOutcomes measure: Oswestry Disability index (ODI), secondaryOutcomes measure: Oswestry Disability index (ODI), secondaryOutcomes measure: Oswestry Disability index (ODI), otherOutcomes measure: Number of subjects who ceased requiring analgesia, otherOutcomes measure: Number of subjects who ceased requiring analgesia, otherOutcomes measure: Number of subjects who ceased requiring analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Penn State Hershey College of Medicine, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, contacts name: Nancy Ruth Jarbadan, BS, role: CONTACT, phone: 717-531-6135, email: [email protected], geoPoint lat: 40.28592, lon: -76.65025, hasResults: False |
protocolSection identificationModule nctId: NCT06283615, orgStudyIdInfo id: 2024-01-01, briefTitle: Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Jinling Hospital, China, class: OTHER, descriptionModule briefSummary: Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.The primary and secondary outcomes will be collected., conditionsModule conditions: Intestinal Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin D, outcomesModule primaryOutcomes measure: Quality of life score, primaryOutcomes measure: Muscle function status, secondaryOutcomes measure: Serum vitamin D levels, secondaryOutcomes measure: Hepatic and renal function, secondaryOutcomes measure: Bone mineral density, secondaryOutcomes measure: Thyroid and parathyroid-related hormones, secondaryOutcomes measure: Nutritional status indicators, secondaryOutcomes measure: Number of participants with treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinying Wang, status: RECRUITING, city: Nanning, state: Jiangsu, zip: 210002, country: China, contacts name: Xinying Wang, MD, role: CONTACT, phone: +86 13913028866, email: [email protected], contacts name: Xuejin Gao, MD, role: CONTACT, phone: +86 18251937684, email: [email protected], contacts name: Xinying Wang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Xuejin Gao, MD, role: SUB_INVESTIGATOR, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False |
protocolSection identificationModule nctId: NCT06283602, orgStudyIdInfo id: 2020/17, briefTitle: Oral Health in Children and Adolescents With Obesity and Normal Weight, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2021-03-05, completionDateStruct date: 2021-04-29, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, descriptionModule briefSummary: We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD)., conditionsModule conditions: Pediatric Obesity, conditions: Pediatric Dentistry, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ACTUAL, armsInterventionsModule interventions name: oral health status, outcomesModule primaryOutcomes measure: the results of DMFT, plaque and gingival indies, primaryOutcomes measure: the results of dmft, BEWE, ICDAS-II, probing dept, primaryOutcomes measure: Comparison of demographic attributes between obese and normal weights, secondaryOutcomes measure: biochemical parameters of obese individuals, secondaryOutcomes measure: other biochemical parameters of obese individuals, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Aslı Soğukpınar Önsüren, city: Mersin, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False |
protocolSection identificationModule nctId: NCT06283589, orgStudyIdInfo id: INZ701-401, briefTitle: The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-07-19, completionDateStruct date: 2024-08-19, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Inozyme Pharma, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine if multiple doses of INZ-701, given once per week over 4 weeks are safe and increase pyrophosphate (PPi) levels in hemodialysis-dependent (HD) end stage kidney disease (ESKD) study participants who have low PPi levels. In addition, the effect of hemodialysis on the PK of INZ-701 and PPi levels will be evaluated., conditionsModule conditions: Calciphylaxis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The SEAPORT 1 (INZ701-401) study is a Phase 1, open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of INZ-701, given once per week over 4 weeks, in study participants with end-stage kidney disease undergoing hemodialysis., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: INZ-701, outcomesModule primaryOutcomes measure: Determine if INZ-701 increases PPi levels, secondaryOutcomes measure: Assess the Time to Maximum Serum Concentration (Tmax), secondaryOutcomes measure: Assess the Maximum Serum Concentration (Cmax) of INZ-701, secondaryOutcomes measure: Assess the Area under the concentration-time curve over the dosing interval (AUCtau), secondaryOutcomes measure: Assess the Clearance after extravascular administration of drug (CL/F), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Florida Nephrology Research, status: RECRUITING, city: Coral Springs, state: Florida, zip: 33071, country: United States, contacts name: Ashgar Chaudhry, MD, role: CONTACT, phone: 954-510-7620, email: [email protected], geoPoint lat: 26.27119, lon: -80.2706, locations facility: Elixia Health, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, contacts name: Steven Zeig, role: CONTACT, phone: 954-900-1101, email: [email protected], geoPoint lat: 26.0112, lon: -80.14949, hasResults: False |
protocolSection identificationModule nctId: NCT06283576, orgStudyIdInfo id: PANCAID-00-08, briefTitle: Pancreatic Cancer Initial Detection Via Liquid Biopsy, acronym: PANCAID, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Karolinska University Hospital, class: OTHER, collaborators name: Umeå University, descriptionModule briefSummary: The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas \[N0M0\]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM)., conditionsModule conditions: Pancreatic Cancer, conditions: IPMN, Pancreatic, conditions: Individuals at Risk, conditions: Chronic Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Liquid biopsy, outcomesModule primaryOutcomes measure: Cancer detection, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gastrocentrum, KarolinskaUniversity Hospital, city: Stockholm, zip: 14186, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06283563, orgStudyIdInfo id: 2023/5474, briefTitle: Online Physical Activity Tracking in Patients With Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity tracking, interventions name: No physical activity tracking, outcomesModule primaryOutcomes measure: Smartphone pedometer, primaryOutcomes measure: Smartphone pedometer, primaryOutcomes measure: International Physical Activity Questionnaire - Short Form, primaryOutcomes measure: International Physical Activity Questionnaire - Short Form, secondaryOutcomes measure: Beck Depression Inventory II, secondaryOutcomes measure: Beck Depression Inventory II, secondaryOutcomes measure: Beck Anxiety Inventory, secondaryOutcomes measure: Beck Anxiety Inventory, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Multiple Sclerosis Quality of Life-54, secondaryOutcomes measure: Multiple Sclerosis Quality of Life-54, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283550, orgStudyIdInfo id: INNO-6052, briefTitle: Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Innovaderm Research Inc., class: OTHER, descriptionModule briefSummary: This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping., conditionsModule conditions: Chronic Hand Eczema, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Abrocitinib 200 mg, interventions name: Abrocitinib 100 mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS), secondaryOutcomes measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS), secondaryOutcomes measure: Reduction from baseline in hand Physician's Global Assessment (PGA), secondaryOutcomes measure: Change from baseline in Hand Eczema Severity Index (HECSI), secondaryOutcomes measure: Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE), secondaryOutcomes measure: Patient Global Assessment (PaGA) measurements, secondaryOutcomes measure: Change from baseline in hand Dermatology Life Quality Index (DLQI), secondaryOutcomes measure: Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ), secondaryOutcomes measure: Change from baseline in pain Numerical Rating Scale (NRS), secondaryOutcomes measure: Change from baseline in itch Numerical Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Innovaderm Research Inc., city: Montréal, state: Quebec, zip: H2X 2V1, country: Canada, contacts name: Rosanna Ottoni, BSc, role: CONTACT, phone: 514-521-4285, phoneExt: 107, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06283537, orgStudyIdInfo id: KÜBAP-01/2023-39, briefTitle: Online Episiotomy Simulation Training for Midwifery Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Kastamonu University, class: OTHER, descriptionModule briefSummary: Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data., conditionsModule conditions: Training Group, Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A comparative randomized controlled trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: After all students in the face-to-face education and online education groups complete their applications, the students will practice on the material one by one in the school environment and will be evaluated through the Episiotomy Skill Evaluation Form. In the evaluation, a blinding technique will be used to prevent the person conducting the study interventions from making an evaluation in favor of the intervention group. For this purpose, the faculty member conducting the research initiatives will not take part in the evaluation, instead the evaluation will be made by two different field experts. The experts to be consulted for the evaluation will consist of people working as academicians in the field of obstetrics, nursing and midwifery. After the evaluation, students will have to fill out the survey (Student Information Form) and scale (Student Satisfaction and Self-Confidence in Learning Scale)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Effect of training method, outcomesModule primaryOutcomes measure: episiotomy skill performances, secondaryOutcomes measure: Satisfaction with education, otherOutcomes measure: Self-confidence in learning, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283524, orgStudyIdInfo id: ETNA-TrainMS, briefTitle: Eye-tracking Investigation of Clinical Measures in Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-10-18, completionDateStruct date: 2026-03-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Innodem Neurosciences, class: INDUSTRY, descriptionModule briefSummary: The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in MS patients to train machine learning algorithms that will support the development and performance assessment of a sensitive and non-invasive eye-tracking software application. The training of our machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Eye-Tracking, outcomesModule primaryOutcomes measure: Predictive power of eye-movement biomarkers (EMBs) for MS severity in relationship to Expanded Disability Status Scale (EDSS), secondaryOutcomes measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS)., secondaryOutcomes measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Rey Auditory Verbal Learning Test (RAVLT) as part of the Brief International Cognitive Assessment for MS (BICAMS)., secondaryOutcomes measure: Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS)., secondaryOutcomes measure: Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC)., secondaryOutcomes measure: Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Genge Partners, Inc., city: Montréal, state: Quebec, zip: H4A 3T4, country: Canada, contacts name: Yousri Benchaar, role: CONTACT, phone: 514-906-3876, phoneExt: 6026, email: [email protected], contacts name: Alexander Saveriano, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06283511, orgStudyIdInfo id: IJB-RESTART, briefTitle: Evaluation of the RESTART Survival Programme, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Jules Bordet Institute, class: OTHER, descriptionModule briefSummary: The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme., conditionsModule conditions: Invasive Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: educational workshops, outcomesModule primaryOutcomes measure: Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions., secondaryOutcomes measure: assessment of quality of life, secondaryOutcomes measure: assessemnt of health literacy via HLQ questionnaire, secondaryOutcomes measure: assessment of professional status, secondaryOutcomes measure: assessment of level of physical activity, secondaryOutcomes measure: assessment of emotionnal distress, secondaryOutcomes measure: assessment of the intensity of residual fatigue, secondaryOutcomes measure: assessment of sleep quality, secondaryOutcomes measure: Measuring the rate of participation in the programme, secondaryOutcomes measure: assessment of quality of life, secondaryOutcomes measure: assessment of emotionnal distress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06283498, orgStudyIdInfo id: DO612574A, briefTitle: Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: InMode MD Ltd., class: INDUSTRY, descriptionModule briefSummary: The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladderThe main questions it aims to answer are:•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\]Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment., conditionsModule conditions: Overactive Bladder Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Device Morpheus8V, outcomesModule primaryOutcomes measure: Change in urgency incontinence episodes after 3 month, secondaryOutcomes measure: Change in urgency incontinence episodes after 1 month, secondaryOutcomes measure: Change in urgency incontinence episodes, secondaryOutcomes measure: Change in urgency incontinence episodes, secondaryOutcomes measure: Analysis to assess the urinary frequency, secondaryOutcomes measure: Analysis to assess urinary frequency, secondaryOutcomes measure: Analysis to assess the urinary frequency., secondaryOutcomes measure: Analysis to assess the urinary frequency., secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Patient-reported Pain assessment, secondaryOutcomes measure: Patient-reported outcome measure, secondaryOutcomes measure: Patient-reported outcome measure, secondaryOutcomes measure: Patient-reported outcome measure, secondaryOutcomes measure: Patient-reported outcome measure, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mickey Karram MD, city: Corona Del Mar, state: California, zip: 92625, country: United States, geoPoint lat: 33.59808, lon: -117.87311, locations facility: Institute for Female Pelvic Medicine, city: Knoxville, state: Tennessee, zip: 37932, country: United States, geoPoint lat: 35.96064, lon: -83.92074, hasResults: False |
protocolSection identificationModule nctId: NCT06283485, orgStudyIdInfo id: Study Artificial intelligence, briefTitle: Real-time Anatomy Recognition Tool Accuracy Research for Ultrasound-guided PENG and Suprainguinal Fascia Iliaca Blocks, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Konya City Hospital, class: OTHER, collaborators name: Betül Afşar, descriptionModule briefSummary: Background and rationale: Ultrasound-guided regional anesthesia is a widely used pain control method today. A critical aspect of the procedure is accurate visualization of anatomical structures on ultrasound to precisely define target areas. Distinguishing surrounding tissues with an imaging model that automatically recognizes sonoanatomy in ultrasound images will reduce unintended intraneural injections or injury to other anatomical structures in close proximity and increase patient safety.Research question; How can we improve the ultrasound images we frequently use in regional blocks by integrating them with artificial intelligence to reduce complications and improve applications? And what is the accuracy of the developed artificial intelligence support during imaging?Research purpose; This work; We aim to further increase the safety of different regional block positions, minimize the risk of complications, and improve ultrasound visualization by developing an artificial intelligence model (AI Model-Artificial Intelligence) that automatically identifies and segments anatomical landmarks, provides visual guidance for inexperienced colleagues, and improves the performance of the developed model during application. aims to demonstrate its accuracy.Hypothesis; Numerous studies have shown that the use of ultrasound and neurostimulators in practice increases the success, onset and quality of nerve blocks, but due to the low incidence of major complications and the absence of comparable randomized studies, no definitive statement can be made as to whether ultrasound reduces the overall rate of nerve damage. An imaging model that automatically marks sonoanatomy with artificial intelligence in ultrasound images can reduce unintended intraneural injections or injury to other anatomical structures in close proximity and improve patient safety., conditionsModule conditions: Artificial Intelligent, conditions: Ultrasound Therapy; Complications, conditions: Nerve Block, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: ultrasound examination, outcomesModule primaryOutcomes measure: Artificial intelligence Program size, primaryOutcomes measure: Score of assessment the pictures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasin Tire, status: RECRUITING, city: Konya, state: Meram, zip: 42140, country: Turkey, contacts name: Yasin Tire, role: CONTACT, phone: +905055367970, email: [email protected], contacts name: Betül Afşar, role: CONTACT, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False |
protocolSection identificationModule nctId: NCT06283472, orgStudyIdInfo id: 1805574553; Aims 14-16, secondaryIdInfos id: 2P60AA007611-403343, type: OTHER_GRANT, domain: National Institute on Alcohol Abuse and Alcoholism, secondaryIdInfos id: 2P60AA007611, type: NIH, link: https://reporter.nih.gov/quickSearch/2P60AA007611, briefTitle: Enhancing Prospective Thinking in Early Recovery (BEAM), acronym: BEAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:* Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues?* Will high-intensity EFT cues effect greater treatment-seeking interest?* Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity)* Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS?* Will the novel behavioral SS decision-making task activate the nucleus accumbens?Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups., whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: High-Intensity Cue, interventions name: Low-Intensity Cue, outcomesModule primaryOutcomes measure: Increase Prospective Thinking, primaryOutcomes measure: Delayed Rewards, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06283459, orgStudyIdInfo id: 301-23-101, briefTitle: Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Imunon, class: INDUSTRY, descriptionModule briefSummary: This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365)., conditionsModule conditions: SARS CoV 2 Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: IMNN-101, outcomesModule primaryOutcomes measure: Number of participants with local and systemic reactogenicity adverse events and all adverse events, primaryOutcomes measure: Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain., secondaryOutcomes measure: Number of participants with GMT of serum spike binding IgG antibodies, secondaryOutcomes measure: Number of participants with a magnitude and phenotype of cytokine producing S protein-specific T cells, as measured by flow cytometry and/or ELISpot., secondaryOutcomes measure: Number of participants with seroresponse rate (SRR)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beth Israel Deaconess Medical Center, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Elizabeth Oginni, role: CONTACT, email: [email protected], contacts name: Ai-Ris Y Collier, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: DM Clinical Research, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Kyle Bramble, role: CONTACT, email: [email protected], contacts name: Kem Yenal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06283446, orgStudyIdInfo id: 1805574553; Aims 11-13, secondaryIdInfos id: 1R21AA029760-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21AA029760-01, briefTitle: Enhancing Prospective Thinking in Early Recovery, acronym: NERF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues? Will high-intensity EFT cues effect greater treatment-seeking interest? Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS? Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups., whoMasked: PARTICIPANT, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: High-Intensity Cue, interventions name: Low-Intensity Cue, outcomesModule primaryOutcomes measure: Increase Prospective Thinking, primaryOutcomes measure: Delayed Rewards, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Indiana University School of Medicine - Goodman Hall, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Sarah Turo, BA, role: CONTACT, phone: 317-963-7220, email: [email protected], contacts name: Colton Lind, BS, role: CONTACT, phone: 317-963-2554, email: [email protected], contacts name: Brandon G Oberlin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False |
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