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{ "armsInterventionsModule": { "interventions": [ { "name": "Whole-body vibration plus conservative care" }, { "name": "conservative care" } ] }, "conditionsModule": { "conditions": [ "Amputation; Traumatic, Leg, Lower" ] }, "contactsLocationsModule": { "locations": [ { "city": "Cairo", "contacts": null, "country": "Egypt", "facility": "Ahmed Mohamed Ahmed Abdelhady", "geoPoint": { "lat": 30.06263, "lon": 31.24967 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "They will be assigned into three equal groups:", "maskingInfo": { "masking": "DOUBLE", "maskingDescription": "Double blinded", "whoMasked": [ "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 115, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "55 Years", "minimumAge": "40 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees", "nctId": "NCT06284733", "orgStudyIdInfo": { "id": "P.T.REC/012/004874", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Prosthetic leg stability test" } ], "secondaryOutcomes": [ { "measure": "Sway Index" }, { "measure": "Limits of Stability Test" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "MTI University" } }, "statusModule": { "completionDateStruct": { "date": "2024-04-20" }, "lastUpdatePostDateStruct": { "date": "2024-04-23" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2024-04-08" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-11-05" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
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{ "armsInterventionsModule": { "interventions": [ { "name": "Gamma tACS (40 Hz) over the precuneus" }, { "name": "Sham tACS over the precuneus" } ] }, "conditionsModule": { "conditions": [ "Healthy Older Adults" ] }, "contactsLocationsModule": { "locations": [ { "city": "Lisbon", "contacts": [ { "email": "[email protected]", "name": "Filipa Ribeiro, PhD", "phone": "+351 217214147", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Joana Macedo, MSc", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Filipa Ribeiro, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Portugal", "facility": "Filipa Ribeiro", "geoPoint": { "lat": 38.71667, "lon": -9.13333 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 16, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "65 Years", "sex": "ALL", "stdAges": [ "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Transcranial Alternating Current Stimulation for the Improvement of Episodic Memory in Healthy Older Adults", "nctId": "NCT06284720", "orgStudyIdInfo": { "id": "Project number 144", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Changes in immediate and delayed free recall Auditory Verbal Learning Test scores" }, { "measure": "Changes in immediate free recall and delayed recognition Face-Name Memory Test scores" } ], "secondaryOutcomes": [ { "measure": "Change in functional connectivity" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Clínica NeuroVida (Portugal)" } ], "leadSponsor": { "class": "OTHER", "name": "Universidade Católica Portuguesa" } }, "statusModule": { "completionDateStruct": { "date": "2024-10-31" }, "lastUpdatePostDateStruct": { "date": "2024-03-12" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-10-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-01" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
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{ "armsInterventionsModule": { "interventions": [ { "name": "swimming training" }, { "name": "rhythmic gymnastics training" } ] }, "conditionsModule": { "conditions": [ "Physical Conditioning, Human" ] }, "contactsLocationsModule": { "locations": [ { "city": "Toledo", "contacts": [ { "email": "[email protected]", "name": "Paula Esteban-García, PhD", "phone": "925 26 88 00", "phoneExt": null, "role": "CONTACT" } ], "country": "Spain", "facility": "Universidad de Castilla La Mancha", "geoPoint": { "lat": 39.8581, "lon": -4.02263 }, "state": null, "status": "RECRUITING", "zip": "45071" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "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", "CARE_PROVIDER", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 20, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "20 Years", "minimumAge": "6 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effect of Rhythmic Gymnastics Training in Children With Down Syndrome", "nctId": "NCT06284707", "orgStudyIdInfo": { "id": "Rhythmic_PAU_2024", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Body composition" }, { "measure": "Tendon thickness" }, { "measure": "Stiffness tendon" }, { "measure": "Hamstrings flexibility" }, { "measure": "body mass index" }, { "measure": "visceral fat area" }, { "measure": "metabolism" }, { "measure": "tendon elastography" }, { "measure": "balance" }, { "measure": "functional capacity" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "University of Castilla-La Mancha" } }, "statusModule": { "completionDateStruct": { "date": "2024-05-05" }, "lastUpdatePostDateStruct": { "date": "2024-03-08" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-03-08" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-01" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
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{ "armsInterventionsModule": { "interventions": [ { "name": "Repetitive Transcranial Magnetic Stimulation (rTMS)" } ] }, "conditionsModule": { "conditions": [ "Neuropathic Pain" ] }, "contactsLocationsModule": { "locations": [ { "city": "Calgary", "contacts": null, "country": "Canada", "facility": "Foothills Medical Centre", "geoPoint": { "lat": 51.05011, "lon": -114.08529 }, "state": "Alberta", "status": null, "zip": "T2N 2T9" } ] }, "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)." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "All participants will receive active rTMS treatment.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 10, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "75 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach", "nctId": "NCT06284694", "orgStudyIdInfo": { "id": "REB23-0120", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) v3.0" }, { "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)" }, { "measure": "Pain Catastrophizing Scale (PCS)" }, { "measure": "World Health Organization Disability Assessment Schedule (WHODAS) 2.0" }, { "measure": "Generalized Anxiety Disorder scale-7 (GAD-7)" }, { "measure": "Patient Health Questionnaire-9 (PHQ-9)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "University of Calgary" } }, "statusModule": { "completionDateStruct": { "date": "2025-06-30" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-06-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-01" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
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{ "armsInterventionsModule": { "interventions": [ { "name": "Weight-focused health coaching" }, { "name": "Weight-neutral health coaching" }, { "name": "Intensify lifestyle approach" }, { "name": "Augment with enhanced medical management" } ] }, "conditionsModule": { "conditions": [ "Obesity", "Prehypertension", "Hypertension", "PreDiabetes", "Type 2 Diabetes", "Dyslipidemia" ] }, "contactsLocationsModule": { "locations": null }, "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)." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "WISE Health", "briefTitle": "Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults", "nctId": "NCT06284681", "orgStudyIdInfo": { "id": "IRB-300012557", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": null, "id": "3P50MD017338-03S1", "link": "https://reporter.nih.gov/quickSearch/3P50MD017338-03S1", "type": "NIH" } ] }, "outcomesModule": { "otherOutcomes": [ { "measure": "Change in blood pressure" }, { "measure": "Change in glucose" }, { "measure": "Change in insulin" }, { "measure": "Change in HbA1c" }, { "measure": "Change in total cholesterol" }, { "measure": "Change in LDL-cholesterol" }, { "measure": "Change in HDL-cholesterol" }, { "measure": "Change in triglycerides" }, { "measure": "Change in body weight" }, { "measure": "Change in physical activity" }, { "measure": "Change in fat mass" }, { "measure": "Change in fat mass" }, { "measure": "Change in lean mass" }, { "measure": "Change in lean mass" }, { "measure": "Change in waist circumference" }, { "measure": "Change in waist circumference" }, { "measure": "Dietary intake measurement" }, { "measure": "Dietary intake measurement" }, { "measure": "Change in insulin sensitivity" }, { "measure": "Change in Metabolic Syndrome Severity Score" } ], "primaryOutcomes": [ { "measure": "Recruitment rate" }, { "measure": "Retention rate" }, { "measure": "Response/Non-response rate to initial interventions" }, { "measure": "Attendance to health coaching sessions" }, { "measure": "Treatment Credibility and Expectancy Questionnaire (CEQ)" }, { "measure": "Treatment Credibility and Expectancy Questionnaire (CEQ)" }, { "measure": "Treatment Preference" }, { "measure": "Treatment Preference" }, { "measure": "Family medicine clinic capacity for research" }, { "measure": "Study visit duration" }, { "measure": "Time required for surveys completion" }, { "measure": "Response to weight-focused health coaching" }, { "measure": "Response to weight-neutral health coaching measurement" } ], "secondaryOutcomes": [ { "measure": "Change in blood pressure" }, { "measure": "Change in glucose" }, { "measure": "Change in insulin" }, { "measure": "Change in insulin sensitivity" }, { "measure": "Change in HbA1c" }, { "measure": "Change in total cholesterol" }, { "measure": "Change in LDL-cholesterol" }, { "measure": "Change in HDL-cholesterol" }, { "measure": "Change in triglycerides" }, { "measure": "Change in Metabolic Syndrome Severity Score" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "National Institute on Minority Health and Health Disparities (NIMHD)" } ], "leadSponsor": { "class": "OTHER", "name": "University of Alabama at Birmingham" } }, "statusModule": { "completionDateStruct": { "date": "2025-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-03-21" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-01" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
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{ "armsInterventionsModule": { "interventions": [ { "name": "normal Saline" }, { "name": "Esketamine" }, { "name": "Remimazolam" } ] }, "conditionsModule": { "conditions": [ "Sleep Disturbance" ] }, "contactsLocationsModule": { "locations": [ { "city": "Tianjin", "contacts": [ { "email": "[email protected]", "name": "Guolin Wang", "phone": "+8618604755166", "phoneExt": null, "role": "CONTACT" } ], "country": "China", "facility": "Tianjin Medical University General Hospital", "geoPoint": { "lat": 39.14222, "lon": 117.17667 }, "state": null, "status": "RECRUITING", "zip": "300052" } ] }, "descriptionModule": { "briefSummary": "To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval" }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 300, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "45 Years", "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety", "nctId": "NCT06284668", "orgStudyIdInfo": { "id": "GWang027", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "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" }, { "measure": "The incidence of postoperative sleep disturbance on the second and third postoperative nights" }, { "measure": "Postoperative anxiety" }, { "measure": "Postoperative depression" }, { "measure": "Pain Score (NRS)" }, { "measure": "Mean intraoperative blood pressure" }, { "measure": "Oxygen saturation" }, { "measure": "Somatokinetic reaction" }, { "measure": "Operation time" }, { "measure": "Duration of anesthesia" }, { "measure": "Time to walking down" }, { "measure": "Adverse event" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Tianjin Medical University General Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2024-07-10" }, "lastUpdatePostDateStruct": { "date": "2024-03-05" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-06-20" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-04" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
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{ "armsInterventionsModule": { "interventions": [ { "name": "group-based combined with innovative technology education" }, { "name": "Standard treatment" } ] }, "conditionsModule": { "conditions": [ "ADHD" ] }, "contactsLocationsModule": { "locations": [ { "city": "Trondheim", "contacts": [ { "email": "[email protected]", "name": "Mariela Loreto Lara-Cabrera, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Norway", "facility": "St Olav's Hospital", "geoPoint": { "lat": 63.43049, "lon": 10.39506 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Parallel two-arms randomized control trial", "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Blinded statistician", "whoMasked": [ "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Effect of a Brief Educational Intervention for Adults With ADHD", "nctId": "NCT06284655", "orgStudyIdInfo": { "id": "635362 a", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Cost" }, { "measure": "Health care usage" } ], "primaryOutcomes": [ { "measure": "Change in client satisfaction using CSQ" }, { "measure": "Change in general self-efficacy using GSE-6" }, { "measure": "Change in satisfaction with the information" }, { "measure": "Knowledge and treatment preferences" } ], "secondaryOutcomes": [ { "measure": "Change in patient activation using PAM" }, { "measure": "Change in ADHD-related symptoms using ASRS" }, { "measure": "Change in ADHD-related symptoms using SCL-9" }, { "measure": "Change in depression and anxiety symptoms using PHQ-4" }, { "measure": "Change in patient enablement using PEN-13" }, { "measure": "Change in stress level using PSS-4" }, { "measure": "Change in level of functioning using WSAS" }, { "measure": "Change in ADHD Quality of life using AAQoL" }, { "measure": "Change in Health-related Quality of life using EQ-5D-5L" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Norwegian University of Science and Technology" } ], "leadSponsor": { "class": "OTHER", "name": "St. Olavs Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2030-12" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2027-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Urokinase" }, { "name": "Placebo" } ] }, "conditionsModule": { "conditions": [ "Aneurysmal Subarachnoid Hemorrhage" ] }, "contactsLocationsModule": { "locations": [ { "city": "Nanchang", "contacts": [ { "email": "[email protected]", "name": "Xingen Zhu, MS", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "China", "facility": "The Second Affiliated Hospital of Nanchang University", "geoPoint": { "lat": 28.68396, "lon": 115.85306 }, "state": "Jiangxi", "status": "RECRUITING", "zip": "330006" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 424, "type": "ESTIMATED" }, "phases": [ "PHASE4" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK)", "nctId": "NCT06284642", "orgStudyIdInfo": { "id": "LD-ITUK-2024-001", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Subarachnoid hemorrhage volume clearance" }, { "measure": "Correlationship between cerebralspinal fluid pressure with subarachnoid hemorrhage volume" }, { "measure": "Correlationship between clinical grades and subarachnoid hemorrhage volume" } ], "primaryOutcomes": [ { "measure": "Modified Rankin Scale (mRS)" } ], "secondaryOutcomes": [ { "measure": "Modified Rankin Scale (mRS)" }, { "measure": "Relative Modified Rankin Scale (mRS)" }, { "measure": "Modified Rankin Scale (mRS) distribution" }, { "measure": "Glasgow Outcome Scale (GOS)" }, { "measure": "Questionnaire EuroQol Five Dimensions Questionnaire (EQ-5D)" }, { "measure": "Barthel Index for Activities of Daily Living (BI)" }, { "measure": "Total hospitalized time" }, { "measure": "Total hospitalized costs" }, { "measure": "Cerebral vasospasm (CV)" }, { "measure": "Delayed cerebral ischemia (DCI)" }, { "measure": "Death" }, { "measure": "Hydrocephalus" }, { "measure": "Rebleeding" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Changhai Hospital" } ], "leadSponsor": { "class": "OTHER", "name": "Second Affiliated Hospital of Nanchang University" } }, "statusModule": { "completionDateStruct": { "date": "2026-06-30" }, "lastUpdatePostDateStruct": { "date": "2024-04-15" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2026-01-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-28" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Neptune" }, { "name": "Standard clinical care" } ] }, "conditionsModule": { "conditions": [ "Parkinson Disease" ] }, "contactsLocationsModule": { "locations": [ { "city": "Glostrup", "contacts": [ { "email": "[email protected]", "name": "Nikolaj la Cour Karottki, MD", "phone": "40432773", "phoneExt": null, "role": "CONTACT" } ], "country": "Denmark", "facility": "Rigshospitalet Glostrup", "geoPoint": { "lat": 55.6666, "lon": 12.40377 }, "state": null, "status": null, "zip": "2600" }, { "city": "Odense", "contacts": [ { "email": null, "name": "Morten Blaabjerg, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Denmark", "facility": "Odense University Hospital", "geoPoint": { "lat": 55.39594, "lon": 10.38831 }, "state": null, "status": null, "zip": null }, { "city": "Roskilde", "contacts": [ { "email": null, "name": "Helle Thagesen, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Denmark", "facility": "Zealand University Hospital, Roskilde", "geoPoint": { "lat": 55.64152, "lon": 12.08035 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "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.", "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 90, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "PD-DigiCare", "briefTitle": "Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes.", "nctId": "NCT06284629", "orgStudyIdInfo": { "id": "PD-DigiCare", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "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." }, { "measure": "Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention." }, { "measure": "Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale)" }, { "measure": "Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention." }, { "measure": "Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention." }, { "measure": "Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention." }, { "measure": "Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention." } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Odense University Hospital" }, { "name": "Zealand University Hospital" } ], "leadSponsor": { "class": "OTHER", "name": "Rigshospitalet, Denmark" } }, "statusModule": { "completionDateStruct": { "date": "2026-09-01" }, "lastUpdatePostDateStruct": { "date": "2024-04-22" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-09-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-09-01" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "JASP-1" } ] }, "conditionsModule": { "conditions": [ "JIA", "Support Program", "Patient Satisfaction", "Patient Outcome Assessment" ] }, "contactsLocationsModule": { "locations": [ { "city": "Stockholm", "contacts": null, "country": "Sweden", "facility": "Astrid Lindgren Children´s Hospital", "geoPoint": { "lat": 59.33258, "lon": 18.0649 }, "state": "Region Stockholm", "status": null, "zip": "17176" } ] }, "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." }, "designModule": { "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", "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.", "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }, "enrollmentInfo": { "count": 82, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "16 Years", "minimumAge": "1 Year", "sex": "ALL", "stdAges": [ "CHILD" ] }, "identificationModule": { "acronym": "JASP-1", "briefTitle": "JASP-1 for Children Recently Diagnosed and Their Parents", "nctId": "NCT06284616", "orgStudyIdInfo": { "id": "K2019-0392", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Rate of Patient Reported Experienced Measures (PREM)" } ], "secondaryOutcomes": [ { "measure": "Rate of Overall perceived health" }, { "measure": "Rate of Child Health Activity Questionnaire (CHAQ)" }, { "measure": "Number of active joints" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER_GOV", "name": "Region Stockholm" } }, "statusModule": { "completionDateStruct": { "date": "2023-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-03-06" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2023-04-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2019-08-15" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Hyperbaric Oxygen Therapy - HBOT" } ] }, "conditionsModule": { "conditions": [ "Healthy" ] }, "contactsLocationsModule": { "locations": [ { "city": "Poznan", "contacts": null, "country": "Poland", "facility": "Poznan University of Physical Education", "geoPoint": { "lat": 52.40692, "lon": 16.92993 }, "state": "Wielkopolska", "status": null, "zip": "61-871" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Two study groups (dependent on frequency of HBOT treatments) and control group", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 80, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "35 Years", "minimumAge": "18 Years", "sex": "MALE", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effectiveness of Hyperbaric Oxygen Therapy in Adults", "nctId": "NCT06284603", "orgStudyIdInfo": { "id": "AWF_LA_HBOT", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Volume of oxygen and carbon dioxide" }, { "measure": "Heart rate" }, { "measure": "Vascular circulation measures" } ], "secondaryOutcomes": [ { "measure": "Body composition (body mass, fat mass, lean body mass, muscle mass)" }, { "measure": "Inflammatory cytokine profile" }, { "measure": "Oxidative stress indicators" }, { "measure": "F2-Isoprostanes (F2-IsoP)" }, { "measure": "Brain-derived neurotrophic factor concentration (BDNF)" }, { "measure": "Nicotinamide (NAD) metabolites" }, { "measure": "Gut microbiome and metabolome" }, { "measure": "Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA)" }, { "measure": "endothelial nitric oxide synthase (eNOS)" }, { "measure": "Vascular endothelial growth factor (VEGF)" }, { "measure": "Hypoxia inducible factor-1 (HIF-1alfa)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Poznan University of Physical Education" } }, "statusModule": { "completionDateStruct": { "date": "2023-12-20" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2023-12-20" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2022-03-01" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "L19IL2" }, { "name": "L19TNF" }, { "name": "L19IL2/L19TNF" }, { "name": "KEYTRUDA®" } ] }, "conditionsModule": { "conditions": [ "Melanoma Stage III", "Melanoma Stage IV" ] }, "contactsLocationsModule": { "locations": [ { "city": "New York", "contacts": null, "country": "United States", "facility": "Memorial Sloan Kettering Cancer Center", "geoPoint": { "lat": 40.71427, "lon": -74.00597 }, "state": "New York", "status": null, "zip": "10065" } ] }, "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." }, "designModule": { "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", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 162, "type": "ESTIMATED" }, "phases": [ "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "INTACT/MeRCI", "briefTitle": "Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients", "nctId": "NCT06284590", "orgStudyIdInfo": { "id": "PH-ICKPD1-02/21", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "Merck Sharp & Dohme LLC", "id": "MK-3475-F20", "link": null, "type": "OTHER" }, { "domain": "missing", "id": "KEYNOTE-F20", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Confirmed Objective Response Rate (ORR)" } ], "secondaryOutcomes": [ { "measure": "Best overall response (BOR)" }, { "measure": "Duration of Response (DoR)" }, { "measure": "Pathological response" }, { "measure": "Confirmed ORR" }, { "measure": "Progression-free survival (PFS)" }, { "measure": "Overall survival (OS)" }, { "measure": "Serious Adverse Event (SAEs)" }, { "measure": "Drug-Induced Liver Injury (DILI)" }, { "measure": "Number of patients with Adverse Events of Special Interest (AESI)" }, { "measure": "Number of patients with Immune-Related Adverse Events (IRAEs)" }, { "measure": "Number of participants with abnormal hematology laboratory tests results" }, { "measure": "Number of participants with abnormal hematology laboratory tests results" }, { "measure": "Number of participants with abnormal hematology laboratory tests results" }, { "measure": "Number of participants with abnormal hematology laboratory tests results" }, { "measure": "Number of participants with abnormal serum chemistry laboratory tests results" }, { "measure": "Number of participants with abnormal serum chemistry laboratory tests results" }, { "measure": "Number of participants with abnormal serum chemistry laboratory tests results" }, { "measure": "Number of participants with abnormal serum chemistry laboratory tests results" }, { "measure": "Number of participants with abnormal serum chemistry laboratory tests results" }, { "measure": "Number of participants with abnormal coagulation laboratory tests results" }, { "measure": "Number of participants with abnormal body temperature" }, { "measure": "Number of participants with abnormal blood pressure" }, { "measure": "Number of participants with abnormal Electrocardiogram (ECG) readings" }, { "measure": "Number of participants with abnormal Echocardiogram (ECHO) readings" }, { "measure": "Number of participants with abnormal physical examination results" }, { "measure": "Concomitant medication usage" }, { "measure": "Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Merck Sharp & Dohme LLC" } ], "leadSponsor": { "class": "INDUSTRY", "name": "Philogen S.p.A." } }, "statusModule": { "completionDateStruct": { "date": "2028-07" }, "lastUpdatePostDateStruct": { "date": "2024-04-08" }, "overallStatus": "ACTIVE_NOT_RECRUITING", "primaryCompletionDateStruct": { "date": "2028-07" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-12-19" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Multistrain Probiotic" }, { "name": "Placebo - maltodextrin" } ] }, "conditionsModule": { "conditions": [ "Cystic Fibrosis in Children" ] }, "contactsLocationsModule": { "locations": [ { "city": "Oslo", "contacts": [ { "email": "[email protected]", "name": "Magnhild P Kolsgaard, PhD", "phone": "0047 41514045", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Camilla Styffe Sæland, Master", "phone": "004793257798", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Magnhild P Kolsgaard, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Camilla Styffe Sæland, Master", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Linh Dieu Ngo, Master", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "Norway", "facility": "Oslo University Hospital", "geoPoint": { "lat": 59.91273, "lon": 10.74609 }, "state": null, "status": "RECRUITING", "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 40, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "18 Years", "minimumAge": "2 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis", "nctId": "NCT06284577", "orgStudyIdInfo": { "id": "677186", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Changes in GI related QoL using the questionnaire PedsQL GI" } ], "secondaryOutcomes": [ { "measure": "Changes in microbiota" }, { "measure": "Changes in intestinal inflammation" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Oslo University Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2027-07-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2027-06-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-01-02" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Evolocumab" }, { "name": "Nivolumab" } ] }, "conditionsModule": { "conditions": [ "Metastatic Renal Cell Carcinoma" ] }, "contactsLocationsModule": { "locations": [ { "city": "Houston", "contacts": [ { "email": "[email protected]", "name": "Eric Jonasch, MD", "phone": "713-563-7232", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Eric Jonasch, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "MD Anderson Cancer Center", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas", "status": null, "zip": "77030" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 10, "type": "ESTIMATED" }, "phases": [ "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)", "nctId": "NCT06284564", "orgStudyIdInfo": { "id": "2023-0538", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "NCI-CTRP Clinical Registry", "id": "NCI-2024-03604", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Safety and adverse events (AEs)" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Bristol-Myers Squibb" }, { "name": "Cancer Prevention Research Institute of Texas" }, { "name": "United States Department of Defense" } ], "leadSponsor": { "class": "OTHER", "name": "M.D. Anderson Cancer Center" } }, "statusModule": { "completionDateStruct": { "date": "2026-10-01" }, "lastUpdatePostDateStruct": { "date": "2024-04-26" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-10-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-09-30" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": null }, "conditionsModule": { "conditions": [ "Mental Health Issue" ] }, "contactsLocationsModule": { "locations": [ { "city": "Taipei", "contacts": null, "country": "Taiwan", "facility": "National Taiwan University Hospital", "geoPoint": { "lat": 25.04776, "lon": 121.53185 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CONTROL", "primaryPurpose": null, "timePerspective": "CROSS_SECTIONAL" }, "enrollmentInfo": { "count": 50, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "24 Years", "minimumAge": "15 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Relationship Between Internet-use Behavior and Mental Health in Youth", "nctId": "NCT06284551", "orgStudyIdInfo": { "id": "202111069RINB", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Cyberbullying Questionnaire" } ], "secondaryOutcomes": [ { "measure": "Beck's Depression Inventory (BDI-II)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "National Taiwan University Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2025-01-27" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "ENROLLING_BY_INVITATION", "primaryCompletionDateStruct": { "date": "2024-02-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2022-02-08" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "NOVA.EMOSTOP RE-EPITHELIZING" } ] }, "conditionsModule": { "conditions": [ "Wound Healing Disorder" ] }, "contactsLocationsModule": { "locations": [ { "city": "Acireale", "contacts": [ { "email": "[email protected]", "name": "Marco Daniele, PI", "phone": "0957631997", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Salvatore Balsamo", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "Italy", "facility": "Casa di cura riabilitativa Villa Sofia", "geoPoint": { "lat": 37.60886, "lon": 15.16577 }, "state": "Catania", "status": "RECRUITING", "zip": "95024" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 112, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "WOUND-H", "briefTitle": "Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds", "nctId": "NCT06284538", "orgStudyIdInfo": { "id": "NA-01-23", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "improvement in Clinical Healing score at visit 3" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Nova Argentia S.r.l." } }, "statusModule": { "completionDateStruct": { "date": "2024-09-30" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-07-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-01-15" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
{ "largeDocumentModule": { "largeDocs": [ { "date": "2023-06-26", "filename": "Prot_SAP_000.pdf", "hasIcf": false, "hasProtocol": true, "hasSap": true, "label": "Study Protocol and Statistical Analysis Plan", "size": 2091803, "typeAbbrev": "Prot_SAP", "uploadDate": "2024-02-13T04:55" }, { "date": "2023-04-02", "filename": "ICF_001.pdf", "hasIcf": true, "hasProtocol": false, "hasSap": false, "label": "Informed Consent Form", "size": 95177, "typeAbbrev": "ICF", "uploadDate": "2024-02-21T04:35" } ] } }
{ "armsInterventionsModule": { "interventions": [ { "name": "Ankle resistance and biofeedback" } ] }, "conditionsModule": { "conditions": [ "Sarcopenia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Flagstaff", "contacts": [ { "email": "[email protected]", "name": "Zach Lerner, PhD", "phone": "928-523-1787", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Northern Arizona University", "geoPoint": { "lat": 35.19807, "lon": -111.65127 }, "state": "Arizona", "status": "RECRUITING", "zip": "86011" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 8, "type": "ESTIMATED" }, "phases": [ "EARLY_PHASE1" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "85 Years", "minimumAge": "65 Years", "sex": "ALL", "stdAges": [ "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Ankle Assistance and Resistance in Older Adults", "nctId": "NCT06284525", "orgStudyIdInfo": { "id": "2137420", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "6MWT" }, { "measure": "Metabolic power" }, { "measure": "Plantar flexor strength" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Northern Arizona University" } }, "statusModule": { "completionDateStruct": { "date": "2025-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-02-01" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Sonography, color fundus photography" } ] }, "conditionsModule": { "conditions": [ "Uveal Melanoma" ] }, "contactsLocationsModule": { "locations": [ { "city": "Vienna", "contacts": [ { "email": "[email protected]", "name": "Judith Kreminger, MD", "phone": "+4314040048470", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Reinhard Told, MD, PhD, Priv.-Doz.", "phone": "+434040079690", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Adrian Reumueller, MD, Priv.-Doz", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Roman Dunavölgyi, Assoc.-Prof. Priv.-Doz. Dr.", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "Austria", "facility": "Medical University of Vienna, Department of Ophthalmology and Optometry", "geoPoint": { "lat": 48.20849, "lon": 16.37208 }, "state": null, "status": "RECRUITING", "zip": "1090" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 50, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "99 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Uveal Melanoma - Comparative Study", "nctId": "NCT06284512", "orgStudyIdInfo": { "id": "Uveal Melanoma 1942/2022", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Largest Basal Diameter" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Medical University of Vienna" } }, "statusModule": { "completionDateStruct": { "date": "2024-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-10-15" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "measuring tooth stability after orthodontic treatment using a Periotest® device." } ] }, "conditionsModule": { "conditions": [ "Effect of Lingual Retainers on Tooth Stability" ] }, "contactsLocationsModule": { "locations": [ { "city": "Hatay", "contacts": null, "country": "Turkey", "facility": "Hatay Mustafa Kemal University, Faculty of Dentistry", "geoPoint": { "lat": 38.40227, "lon": 27.10486 }, "state": null, "status": null, "zip": "31060" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CROSSOVER", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 0, "type": "ACTUAL" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "20 Years", "minimumAge": "14 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effect of Different Fixed Lingual Retainers on Tooth Stability", "nctId": "NCT06284499", "orgStudyIdInfo": { "id": "26308819120", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Mustafa Kemal University" } }, "statusModule": { "completionDateStruct": { "date": "2023-10-13" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "WITHDRAWN", "primaryCompletionDateStruct": { "date": "2023-01-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2020-01-16" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Venetoclax" }, { "name": "Revumenib" } ] }, "conditionsModule": { "conditions": [ "Acute Myeloid Leukemia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Houston", "contacts": [ { "email": "[email protected]", "name": "Ghayas Issa, MD", "phone": "713-745-6798", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Ghayas Issa, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "MD Anderson Cancer Center", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas", "status": null, "zip": "77030" } ] }, "descriptionModule": { "briefSummary": "To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 8, "type": "ESTIMATED" }, "phases": [ "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "12 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "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", "nctId": "NCT06284486", "orgStudyIdInfo": { "id": "2023-0794", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "NCI-CTRP Clinical Registry", "id": "NCI-2024-01721", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Safety and adverse events (AEs)" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Syndax Pharmaceuticals" }, { "name": "Break Through Cancer" }, { "name": "AbbVie" } ], "leadSponsor": { "class": "OTHER", "name": "M.D. Anderson Cancer Center" } }, "statusModule": { "completionDateStruct": { "date": "2028-12-30" }, "lastUpdatePostDateStruct": { "date": "2024-03-27" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-12-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-07-31" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Ketamine" }, { "name": "Saline" } ] }, "conditionsModule": { "conditions": [ "Pain, Procedural", "Minor Laceration", "Abscess" ] }, "contactsLocationsModule": { "locations": [ { "city": "Maywood", "contacts": [ { "email": "[email protected]", "name": "Shannon Lovett, MD", "phone": "847-951-2936", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Trent Reed, DO", "phone": "708-216-4117", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Loyola University Medical Center", "geoPoint": { "lat": 41.8792, "lon": -87.84312 }, "state": "Illinois", "status": "RECRUITING", "zip": "60153" } ] }, "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" }, "designModule": { "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.", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "All participants and study personnel are blinded except for the clinical pharmacist who prepares the intervention.", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 108, "type": "ESTIMATED" }, "phases": [ "PHASE4" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "70 Years", "minimumAge": "7 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "INK-MP", "briefTitle": "Ketamine as a Supplement to Local Anesthesia for Minor Procedures", "nctId": "NCT06284473", "orgStudyIdInfo": { "id": "212154", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Immediate pain" }, { "measure": "Acute pain" }, { "measure": "Delayed pain" } ], "secondaryOutcomes": [ { "measure": "Immediate agitation" }, { "measure": "Acute agitation" }, { "measure": "Delayed agitation" }, { "measure": "Immediate alertness" }, { "measure": "Acute alertness" }, { "measure": "Delayed alertness" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Loyola University" } }, "statusModule": { "completionDateStruct": { "date": "2025-05-31" }, "lastUpdatePostDateStruct": { "date": "2024-03-15" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-05-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2022-05-25" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "ASTX029" }, { "name": "ASTX727" } ] }, "conditionsModule": { "conditions": [ "Pathway Mutant Myelodysplastic Syndromes", "Myelodysplastic Neoplasm", "Myeloproliferative Neoplasm" ] }, "contactsLocationsModule": { "locations": [ { "city": "Houston", "contacts": [ { "email": "[email protected]", "name": "Guillermo Montalban Bravo, MD", "phone": "713-794-3604", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Guillermo Montalban Bravo, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "MD Anderson Cancer Cente", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas", "status": null, "zip": "77030" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 36, "type": "ESTIMATED" }, "phases": [ "PHASE1", "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "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", "nctId": "NCT06284460", "orgStudyIdInfo": { "id": "2022-0622", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "NCI-CTRP Clinical Registry", "id": "NCI-2024-01692", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Safety and adverse events (AEs)" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "M.D. Anderson Cancer Center" } }, "statusModule": { "completionDateStruct": { "date": "2027-12-01" }, "lastUpdatePostDateStruct": { "date": "2024-04-03" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-12-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-07-31" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Non-Interventional Study" } ] }, "conditionsModule": { "conditions": [ "Cervical Carcinoma" ] }, "contactsLocationsModule": { "locations": [ { "city": "Rochester", "contacts": [ { "email": "[email protected]", "name": "Clinical Trials Referral Office", "phone": "855-776-0015", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Brittany A. Strelow, DSMc, PA-C", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Mayo Clinic in Rochester", "geoPoint": { "lat": 44.02163, "lon": -92.4699 }, "state": "Minnesota", "status": "RECRUITING", "zip": "55905" } ] }, "descriptionModule": { "briefSummary": "This study evaluates barriers to cervical cancer screening among non-compliant women." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "CROSS_SECTIONAL" }, "enrollmentInfo": { "count": 200000, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "21 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Barriers to Cervical Cancer Screening", "nctId": "NCT06284447", "orgStudyIdInfo": { "id": "22-004500", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "CTRP (Clinical Trial Reporting Program)", "id": "NCI-2024-00181", "link": null, "type": "REGISTRY" }, { "domain": "Mayo Clinic Institutional Review Board", "id": "22-004500", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Identify barriers to cervical cancer screening" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Mayo Clinic" } }, "statusModule": { "completionDateStruct": { "date": "2025-03-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-03-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-03-23" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Liposomal Bupivacaine" }, { "name": "Bupivacain" }, { "name": "Epinephrine" } ] }, "conditionsModule": { "conditions": [ "Cleft Lip and Palate" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "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.", "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", "CARE_PROVIDER", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "6 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Liposomal Bupivacaine Use in Alveolar Bone Graft Patients", "nctId": "NCT06284434", "orgStudyIdInfo": { "id": "CHI2311", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Visual Analog Pain Scores" }, { "measure": "Opioid Use" }, { "measure": "PROMIS Pediatric Mobility Questionnaire" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Shriners Hospitals for Children" } ], "leadSponsor": { "class": "OTHER", "name": "Kerry O'Rourke" } }, "statusModule": { "completionDateStruct": { "date": "2026-03" }, "lastUpdatePostDateStruct": { "date": "2024-03-04" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-03" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Shore durometer" } ] }, "conditionsModule": { "conditions": [ "Uterine Tone Disorders", "Cesarean Section Complications" ] }, "contactsLocationsModule": { "locations": [ { "city": "Chicago", "contacts": [ { "email": "[email protected]", "name": "Naida M Cole, MD", "phone": "773-702-6700", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Somayeh Mohammadi", "phone": "17738343274", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Chicago", "geoPoint": { "lat": 41.85003, "lon": -87.65005 }, "state": "Illinois", "status": "RECRUITING", "zip": "60637" } ] }, "descriptionModule": { "briefSummary": "This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DEVICE_FEASIBILITY", "timePerspective": null }, "enrollmentInfo": { "count": 20, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "50 Years", "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Durometer for Measuring Uterine Tone", "nctId": "NCT06284421", "orgStudyIdInfo": { "id": "IRB23-1068", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "feasibility of a durometer" } ], "secondaryOutcomes": [ { "measure": "durometer reading" }, { "measure": "durometer reading" }, { "measure": "durometer reading" }, { "measure": "correlation of durometer reading with a 0-10 uterine tone rating score (0= \"no tone\"; 10= \"excellent tone\")" }, { "measure": "correlation of durometer reading with a 0-10 uterine tone rating score (0= \"no tone\"; 10= \"excellent tone\")" }, { "measure": "correlation of durometer reading with a 0-10 uterine tone rating score (0= \"no tone\"; 10= \"excellent tone\")" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "University of Chicago" } }, "statusModule": { "completionDateStruct": { "date": "2024-09-30" }, "lastUpdatePostDateStruct": { "date": "2024-03-01" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-06-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-08" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
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{ "armsInterventionsModule": { "interventions": [ { "name": "Centralized Screening Unit Implementation" } ] }, "conditionsModule": { "conditions": [ "Lung Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Bronx", "contacts": [ { "email": "[email protected]", "name": "Yocheved Halberstam, MPH", "phone": "917-833-1070", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "H. Dean Hosgood, PhD", "phone": "203-215-3275", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING)", "geoPoint": { "lat": 40.84985, "lon": -73.86641 }, "state": "New York", "status": null, "zip": "10467" } ] }, "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." }, "designModule": { "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", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "HEALTH_SERVICES_RESEARCH", "timePerspective": null }, "enrollmentInfo": { "count": 9460, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "77 Years", "minimumAge": "50 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Centralized Screening Unit (CSU) at Montefiore-Einstein", "nctId": "NCT06284408", "orgStudyIdInfo": { "id": "2024-15683", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Participant Referrals" }, { "measure": "Proportion of participants with early stage lung cancer (LCa)" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "American Cancer Society, Inc." } ], "leadSponsor": { "class": "OTHER", "name": "Albert Einstein College of Medicine" } }, "statusModule": { "completionDateStruct": { "date": "2028-12" }, "lastUpdatePostDateStruct": { "date": "2024-03-04" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2028-12" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04" }, "studyFirstPostDateStruct": { "date": "2024-02-29" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Bortezomib" } ] }, "conditionsModule": { "conditions": [ "Response, Acute Phase", "Survivorship" ] }, "contactsLocationsModule": { "locations": [ { "city": "Mexico City", "contacts": [ { "email": "[email protected]", "name": "Christian O Ramos Peñafiel, PhD", "phone": "5523351588", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Adan G Gallardo Rodriguez", "phone": "+525584005072", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Juan M Cano Calderón, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Juan F Zazueta Pozos, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Adán G Gallardo Rodriguez, PhD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Carlos Martínez Murillo, PhD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Irma Olarte Carrillo, PhD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Adolfo Martínez Tovar, PhD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Christian O Ramos Peñafiel, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Mexico", "facility": "Hospital General de Mexico Dr. Eduardo Liceaga", "geoPoint": { "lat": 19.42847, "lon": -99.12766 }, "state": "Cdmx", "status": "RECRUITING", "zip": "06720" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }, "enrollmentInfo": { "count": 83, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "90 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Two Schemes Response in Multiple Myeloma", "nctId": "NCT06284395", "orgStudyIdInfo": { "id": "HGM1471-002/24", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Favorable Response" }, { "measure": "Time to next treatment" } ], "secondaryOutcomes": [ { "measure": "Overall survival" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER_GOV", "name": "Hospital General de Mexico" } }, "statusModule": { "completionDateStruct": { "date": "2024-03-30" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-03-20" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-11-20" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "High score at Childhood Trauma Questionnaire." }, { "name": "Low score at Childhood Trauma Questionnaire." } ] }, "conditionsModule": { "conditions": [ "Trauma, Psychological" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "This is a prospective, single-center, double-blind, parallel-group controlled trial with two arms.", "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "BASIC_SCIENCE", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "30 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": "T-ODOR", "briefTitle": "Interaction Between Early Trauma and Odor-induced Dopamine Release", "nctId": "NCT06284382", "orgStudyIdInfo": { "id": "2022-A02736-37", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Dopamine transmission measured with positron emission tomography" } ], "secondaryOutcomes": [ { "measure": "Odor hedonic appreciation." }, { "measure": "Functional brain connectivity." }, { "measure": "Effective brain connectivity" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Hôpital le Vinatier" } }, "statusModule": { "completionDateStruct": { "date": "2027-06-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-06-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-06-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Developing, Evaluating and Testing Video Messages for a Smoking Cessation Campaign" }, { "name": "Health Message Framing" } ] }, "conditionsModule": { "conditions": [ "Smoking Cessation" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Participants don't know which video each subject is randomized to", "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 240, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "64 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Video Messages for Smoking Cessation Campaign", "nctId": "NCT06284369", "orgStudyIdInfo": { "id": "Mongolia", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Message Engagement" } ], "secondaryOutcomes": [ { "measure": "Readiness to Quit Smoking" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Loma Linda University" } }, "statusModule": { "completionDateStruct": { "date": "2025-04" }, "lastUpdatePostDateStruct": { "date": "2024-03-04" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-03" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
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{ "armsInterventionsModule": { "interventions": [ { "name": "Laparoscopic Sleeve Gastrectomy" } ] }, "conditionsModule": { "conditions": [ "Morbid Obesity", "Laparoscopic Sleeve Gastrectomy", "Post Operative Complicaiton" ] }, "contactsLocationsModule": { "locations": [ { "city": "Kahramanmaraş", "contacts": null, "country": "Turkey", "facility": "Kahramanmaras SIU", "geoPoint": { "lat": 37.5847, "lon": 36.92641 }, "state": null, "status": null, "zip": "46000" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 159, "type": "ACTUAL" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy", "nctId": "NCT06284356", "orgStudyIdInfo": { "id": "IRB Session 2022/14 Protocol 6", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Complication prediction after LSG with complete blood cell parameters" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Elazig Special Eastern Anatolian Hospital" } ], "leadSponsor": { "class": "OTHER", "name": "Kahramanmaras Sutcu Imam University" } }, "statusModule": { "completionDateStruct": { "date": "2023-05-01" }, "lastUpdatePostDateStruct": { "date": "2024-03-01" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2023-05-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2022-05-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Anticoagulant" } ] }, "conditionsModule": { "conditions": [ "Cancer-associated Thrombosis", "Venous Thromboembolism", "Gynecologic Cancer", "Ovarian Cancer", "Cervix Cancer", "Endometrial Cancer", "Vaginal Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Rome", "contacts": null, "country": "Italy", "facility": "Fondazione Policlinico Universitario A. Gemelli IRCCS", "geoPoint": { "lat": 41.89193, "lon": 12.51133 }, "state": null, "status": null, "zip": "00168" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 1800, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "GynCAT", "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", "nctId": "NCT06284343", "orgStudyIdInfo": { "id": "6414", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Venous thromboembolism" } ], "secondaryOutcomes": [ { "measure": "Bleeding" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Fondazione Umberto Veronesi" } ], "leadSponsor": { "class": "OTHER", "name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS" } }, "statusModule": { "completionDateStruct": { "date": "2026-09-30" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-09-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Enhanced cascade testing" } ] }, "conditionsModule": { "conditions": [ "Hereditary Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Dallas", "contacts": [ { "email": "[email protected]", "name": "Sukh Makhnoon, PhD, MS", "phone": "214-648-3242", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Sukh Makhnoon, PhD, MS", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "UT Southwestern Medical Center", "geoPoint": { "lat": 32.78306, "lon": -96.80667 }, "state": "Texas", "status": "RECRUITING", "zip": "75390" } ] }, "descriptionModule": { "briefSummary": "CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "HEALTH_SERVICES_RESEARCH", "timePerspective": null }, "enrollmentInfo": { "count": 260, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "CHARGE", "briefTitle": "CHARGE Study: CHoice ARchitecture Genetic tEsting", "nctId": "NCT06284330", "orgStudyIdInfo": { "id": "STU-2023-0881", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Rate of cascade genetic testing" } ], "secondaryOutcomes": [ { "measure": "Change in probands' family communication about genetic test results as measured by Proband survey" }, { "measure": "Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months" }, { "measure": "Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale" }, { "measure": "Proband's reaction to intervention materials as measured by proband survey." } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "University of Texas Southwestern Medical Center" } }, "statusModule": { "completionDateStruct": { "date": "2025-08" }, "lastUpdatePostDateStruct": { "date": "2024-04-05" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-03" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-16" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Adjuvant durvalumab" } ] }, "conditionsModule": { "conditions": [ "Non Small Cell Lung Cancer" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 290, "type": "ESTIMATED" }, "phases": [ "PHASE3" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "ADOPT-lung", "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.", "nctId": "NCT06284317", "orgStudyIdInfo": { "id": "ETOP 25-23", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Correlation between ctDNA clearance and pathological response" }, { "measure": "Correlation between ctDNA clearance and DFS" }, { "measure": "Correlation between ctDNA clearance and OS" }, { "measure": "Correlation between ctDNA clearance and initial PD-L1 assessment" }, { "measure": "Outcome (OS)" }, { "measure": "Outcome (event-free survival)" } ], "primaryOutcomes": [ { "measure": "Disease-free survival (DFS)" } ], "secondaryOutcomes": [ { "measure": "Response rate as per investigator assessment." }, { "measure": "Proportion of patients undergoing surgery" }, { "measure": "Proportion of patients with surgical outcome R0 and R1" }, { "measure": "pCR rate" }, { "measure": "Proportion of patients eligible for randomisation" }, { "measure": "Proportion of patients effectively randomised" }, { "measure": "Toxicity according to CTCAE v5.0" }, { "measure": "DFS in patients with pCR" }, { "measure": "Overall survival (OS) in patients with/without pCR" }, { "measure": "DFS in patients with/without ctDNA clearance" }, { "measure": "Time to recurrence (TTR) in patients with/without pCR" }, { "measure": "Time to treatment discontinuation (TTD) in patients with/without pCR" }, { "measure": "Toxicity according to CTCAE v5.0" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "AstraZeneca AG Switzerland" } ], "leadSponsor": { "class": "NETWORK", "name": "ETOP IBCSG Partners Foundation" } }, "statusModule": { "completionDateStruct": { "date": "2030-03" }, "lastUpdatePostDateStruct": { "date": "2024-04-05" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2029-10" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-10" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "De-escalated radiotherapy" } ] }, "conditionsModule": { "conditions": [ "Prostate Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Amsterdam", "contacts": [ { "email": "[email protected]", "name": "Floris Pos, MD PhD", "phone": "+31 20 512 9111", "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "Netherlands Cancer Institute", "geoPoint": { "lat": 52.37403, "lon": 4.88969 }, "state": null, "status": "RECRUITING", "zip": "1066CX" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 20, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "MALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "DESTINATION", "briefTitle": "A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL", "nctId": "NCT06284304", "orgStudyIdInfo": { "id": "N22DES", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac" } ], "secondaryOutcomes": [ { "measure": "Acute GU toxicity" }, { "measure": "Acute GI toxicity" }, { "measure": "Late GU toxicity" }, { "measure": "Late GI toxicity" }, { "measure": "PROMs" }, { "measure": "Biochemical free survival" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "The Netherlands Cancer Institute" } }, "statusModule": { "completionDateStruct": { "date": "2027-04-01" }, "lastUpdatePostDateStruct": { "date": "2024-03-05" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-04-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-29" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "transcranial magnetic stimulation (TMS)" } ] }, "conditionsModule": { "conditions": [ "Epilepsy", "Genetic Disease" ] }, "contactsLocationsModule": { "locations": [ { "city": "Firenze", "contacts": [ { "email": "[email protected]", "name": "Simona Balestrini, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Italy", "facility": "Meyer Children's Hospital IRCCS", "geoPoint": { "lat": 43.77925, "lon": 11.24626 }, "state": null, "status": "RECRUITING", "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }, "enrollmentInfo": { "count": 150, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "70 Years", "minimumAge": "3 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies", "nctId": "NCT06284291", "orgStudyIdInfo": { "id": "TMSpath", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "Italian Ministry of Health", "id": "RF-2021-12372804", "link": null, "type": "OTHER_GRANT" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Resting motor threshold" }, { "measure": "SICI" }, { "measure": "ICF" }, { "measure": "LICI" }, { "measure": "TEP amplitude" }, { "measure": "TEP latency" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Meyer Children's Hospital IRCCS" } }, "statusModule": { "completionDateStruct": { "date": "2026-03-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-11-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-11-22" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Diaphragmatic breathing retraining" }, { "name": "Pelvic stabilization exercise" }, { "name": "pelvic anatomy education" } ] }, "conditionsModule": { "conditions": [ "Postpartum", "Pregnancy Related", "Pelvic Girdle Pain" ] }, "contactsLocationsModule": { "locations": [ { "city": "Tainan", "contacts": [ { "email": "[email protected]", "name": "Tsai Yi-Ju", "phone": "06-2353535", "phoneExt": "5930", "role": "CONTACT" } ], "country": "Taiwan", "facility": "National Cheng Kung University", "geoPoint": { "lat": 22.99083, "lon": 120.21333 }, "state": null, "status": "RECRUITING", "zip": "701" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "20 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain", "nctId": "NCT06284278", "orgStudyIdInfo": { "id": "NCKU_PPGP_diaphragm", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Muscle function measures of lumbopelvic muscles" }, { "measure": "Diaphragm thickness" }, { "measure": "Diaphragm mobility" }, { "measure": "Diaphragm strength" }, { "measure": "Mechanical Property of Thoracolumbar Fascia" }, { "measure": "Functional performance of ASLR fatigue task" }, { "measure": "Functional performance of timed up and go test" }, { "measure": "Functional performance of 6m timed walk test" }, { "measure": "pain intensity measure of Numeric Rating Scale (NRS)" }, { "measure": "Disability Level: measure of pelvic girdle questionnaire(PGQ)" }, { "measure": "Health-related Quality of Life: Short Form-36 (SF36)" }, { "measure": "Fear Avoidance Belief: Tampa Scale of Kinesiophobia" }, { "measure": "Self-Efficacy: Pain Self-efficacy Questionnaire" }, { "measure": "Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF)" }, { "measure": "Self-perceived Change: Global Rating of Change Scale (GROC)" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "YI-JU TSAI" } }, "statusModule": { "completionDateStruct": { "date": "2024-07-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-05-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-10-20" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Raphamin" }, { "name": "Placebo" } ] }, "conditionsModule": { "conditions": [ "Cystitis Chronic", "Cystitis Bacterial", "Recurrence of Chronic Bacterial Cystitis" ] }, "contactsLocationsModule": { "locations": [ { "city": "Irkutsk", "contacts": [ { "email": null, "name": "Larisa Suturina, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Larisa Suturina, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department", "geoPoint": { "lat": 52.29778, "lon": 104.29639 }, "state": null, "status": "RECRUITING", "zip": "664003" }, { "city": "Kazan", "contacts": [ { "email": null, "name": "Ruslan Fatykhov, MD, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Ruslan Fatykhov, MD, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Kazan State Medical University/Professor's clinic", "geoPoint": { "lat": 55.78874, "lon": 49.12214 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "420012" }, { "city": "Kemerovo", "contacts": [ { "email": null, "name": "Natalia Artymuk, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Natalia Artymuk, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "LLC \"Fenareta\" Women's and Men's Health Clinic\"", "geoPoint": { "lat": 55.33333, "lon": 86.08333 }, "state": null, "status": "RECRUITING", "zip": "650000" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Vladimir Kuzmin, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Vladimir Kuzmin, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City Clinical Hospital #15 named after O.M. Filatov Department of Health of Moscow", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "111539" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Felix Grigoryan, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Felix Grigoryan, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City Clinical Hospital # 13/Gynecology Department # 1", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "115280" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Sergey Levakov, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Sergey Levakov, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Clinical Hospital # 85 of the Federal Medical and Biological Agency/Central polyclinic", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "115409" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Victoria Gelashvili, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Victoria Gelashvili, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Research Institute of Rheumatology named after V.A. Nasonova", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "115522" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Inna Apolikhina, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Inna Apolikhina, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V.I. Kulakov/Department of Aesthetic Gynecology and Rehabilitation", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "117198" }, { "city": "Moscow", "contacts": null, "country": "Russian Federation", "facility": "Peoples' Friendship University of Russia/Department of Obstetrics and Gynecology with a course in perinatology", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "WITHDRAWN", "zip": "117198" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Yulia Dobrokhotova, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Yulia Dobrokhotova, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Russian National Research Medical University named after N.I. Pirogov/Department of Obstetrics and Gynecology, Faculty of Medicine", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "117997" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Sergey Kotov, PhD, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Sergey Kotov, PhD, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City Clinical Hospital # 1 named after. N.I. Pirogov of the Moscow City Health Department", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "119049" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Nikolay Keshishev, MD, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Nikolay Keshishev, MD, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "United hospital with clinic of the Administration of the President of the Russian Federation", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "119285" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Olga Perevozkina, MD, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Olga Perevozkina, MD, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City Clinical Hospital # 67 named after L.A. Vorokhobov", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "121423" }, { "city": "Moscow", "contacts": null, "country": "Russian Federation", "facility": "JSC \"MEDSI Group of Companies\"", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "WITHDRAWN", "zip": "123056" }, { "city": "Moscow", "contacts": [ { "email": null, "name": "Dmitry Pushkar, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Dmitry Pushkar, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Moscow State Medical and Dental University named after A.I. Evdokimov/Department of Urologya", "geoPoint": { "lat": 55.75222, "lon": 37.61556 }, "state": null, "status": "RECRUITING", "zip": "127473" }, { "city": "Nizhny Novgorod", "contacts": [ { "email": null, "name": "Vagif Atduev, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Vagif Atduev Vagif, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Privolzhsky District Medical Center", "geoPoint": { "lat": 56.32867, "lon": 44.00205 }, "state": null, "status": "RECRUITING", "zip": "603001" }, { "city": "Obninsk", "contacts": [ { "email": null, "name": "Tatyana Perepanova, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Tatyana Perepanova, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "National Medical Research Center for Radiology/Research Institute of Urology and Interventional Radiology named after. N.A. Lopatkin", "geoPoint": { "lat": 55.09681, "lon": 36.61006 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "105425" }, { "city": "Pyatigorsk", "contacts": [ { "email": null, "name": "Alexander Bardin, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Alexander Bardin, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City Clinical Hospital", "geoPoint": { "lat": 44.04861, "lon": 43.05944 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "357500" }, { "city": "Rostov-on-Don", "contacts": [ { "email": null, "name": "Igor Aboyan, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Igor Aboyan, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Clinical and Diagnostic Center \"Health\" in Rostov-on-Don", "geoPoint": { "lat": 47.23135, "lon": 39.72328 }, "state": null, "status": "RECRUITING", "zip": "344011" }, { "city": "Rostov-on-Don", "contacts": [ { "email": null, "name": "Mikhail Kogan, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Mikhail Kogan, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Rostov State Medical University/Department of Urology and Human Reproductive Health with a course of pediatric urology-andrology", "geoPoint": { "lat": 47.23135, "lon": 39.72328 }, "state": null, "status": "RECRUITING", "zip": "344022" }, { "city": "Rostov", "contacts": [ { "email": null, "name": "Ariz Gyulmamedov, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Ariz Gyulmamedov, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Rostov Central District Hospital", "geoPoint": { "lat": 57.1914, "lon": 39.41394 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "152155" }, { "city": "Saint Petersburg", "contacts": null, "country": "Russian Federation", "facility": "JSC \"Polyclinic Complex\"", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "WITHDRAWN", "zip": "190013" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Dmitry Gorelov, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Dmitry Gorelov, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "LLC \"Medical Center Capital-Polis\"", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "190013" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Alexander Parshin, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Alexander Parshin, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "LLC \"BioTechService\"", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "RECRUITING", "zip": "190121" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Farzali Farzaliev, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Farzali Farzaliev, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City clinic # 44", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "192071" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Vladislav Grigoriev, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Vladislav Grigoriev, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov/Urology department", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "RECRUITING", "zip": "194044" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Orlov Igor, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Orlov Igor, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "St. Luke's Clinical Hospital", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "RECRUITING", "zip": "194044" }, { "city": "Saint Petersburg", "contacts": null, "country": "Russian Federation", "facility": "City Multidisciplinary Hospital # 2/Urology department", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "WITHDRAWN", "zip": "194354" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Maxim Bushara, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Maxim Bushara, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Llc \"Medical Clinic\"", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "RECRUITING", "zip": "194356" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Vadim Zubarev, PhD, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Vadim Zubarev, PhD, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Medical and sanitary unit No. 70 - branch of the St. Petersburg State Unitary Enterprise of Passenger Road Transport", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "RECRUITING", "zip": "195197" }, { "city": "Saint Petersburg", "contacts": null, "country": "Russian Federation", "facility": "LLC \"Research Center Eco-Safety\"", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "TERMINATED", "zip": "196143" }, { "city": "Saint Petersburg", "contacts": null, "country": "Russian Federation", "facility": "Jsc \"Northwestern Center of Evidence-Based Medicine\"", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "WITHDRAWN", "zip": "196158" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Konstantin Dunets, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Konstantin Dunets, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City Hospital # 15", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "198205" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Maria Yarmolinskaya, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Maria Yarmolinskaya, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott/Department of Gynecology and Endocrinology", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "RECRUITING", "zip": "199034" }, { "city": "Saint Petersburg", "contacts": [ { "email": null, "name": "Andrey Gorelov, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Andrey Gorelov, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "City Pokrovskaya Hospital/Department of Urology", "geoPoint": { "lat": 59.93863, "lon": 30.31413 }, "state": null, "status": "RECRUITING", "zip": "199106" }, { "city": "Sertolovo", "contacts": [ { "email": null, "name": "Alexander Shvets, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Alexander Shvets, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Sertolovo City Hospital", "geoPoint": { "lat": 60.1444, "lon": 30.20165 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "188650" }, { "city": "Tomsk", "contacts": [ { "email": null, "name": "Victor Latypov, MD, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Victor Latypov, MD, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Siberian State Medical University/Faculty clinics of Siberian State Medical University", "geoPoint": { "lat": 56.49771, "lon": 84.97437 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "634050" }, { "city": "Ufa", "contacts": null, "country": "Russian Federation", "facility": "Bashkir State Medical University/Department of Obstetrics and Gynecology # 1", "geoPoint": { "lat": 54.74306, "lon": 55.96779 }, "state": null, "status": "WITHDRAWN", "zip": "450008" }, { "city": "Voronezh", "contacts": [ { "email": null, "name": "Andrey Kuzmenko, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Andrey Kuzmenko, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Voronezh State Medical University named after N.N. Burdenko/Department of Urology", "geoPoint": { "lat": 51.67204, "lon": 39.1843 }, "state": null, "status": "RECRUITING", "zip": "394036" }, { "city": "Vsevolozhsk", "contacts": [ { "email": null, "name": "Nikolay Kanareikin, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Nikolay Kanareikin, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery", "geoPoint": { "lat": 60.01512, "lon": 30.67314 }, "state": null, "status": "RECRUITING", "zip": "188643" }, { "city": "Yaroslavl", "contacts": [ { "email": null, "name": "Igor Shormanov, Prof.", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Igor Shormanov, Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Yaroslavl State Medical University/Department of Urology and Nephrology", "geoPoint": { "lat": 57.62987, "lon": 39.87368 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "150000" }, { "city": "Yaroslavl", "contacts": [ { "email": null, "name": "Andrey Soloviev, MD, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Andrey Soloviev, MD, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "LLC \"Clinic of Modern Medicine Dr. Bogorodskaya\"", "geoPoint": { "lat": 57.62987, "lon": 39.87368 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "150001" }, { "city": "Yaroslavl", "contacts": [ { "email": null, "name": "Svetlana Isakova, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Svetlana Isakova, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "LLC \"Medical Center for Diagnosis and Prevention Plus\"", "geoPoint": { "lat": 57.62987, "lon": 39.87368 }, "state": null, "status": "RECRUITING", "zip": "150040" }, { "city": "Yaroslavl", "contacts": [ { "email": null, "name": "Dmitry Komlev, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Dmitry Komlev, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Russian Federation", "facility": "Regional Clinical Hospital/Urology department", "geoPoint": { "lat": 57.62987, "lon": 39.87368 }, "state": null, "status": "RECRUITING", "zip": "150062" } ] }, "descriptionModule": { "briefSummary": "Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis" }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 632, "type": "ESTIMATED" }, "phases": [ "PHASE3" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis", "nctId": "NCT06284265", "orgStudyIdInfo": { "id": "MMH-407-007", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Average duration of episodes of recurrences of chronic bacterial cystitis" }, { "measure": "Average number of recurrences of chronic bacterial cystitis" }, { "measure": "Severity of chronic bacterial cystitis recurrences" }, { "measure": "Change in the severity of chronic bacterial cystitis recurrences" }, { "measure": "VAS score at the end of the follow-up period" }, { "measure": "The Presence of Adverse Events (AEs)." }, { "measure": "Changes in Vital Signs (Blood Pressure measured in mm Hg)" }, { "measure": "Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute)" }, { "measure": "Changes in Vital Signs (Respiration Rate (Breathing Rate) measured in breaths per minute)" }, { "measure": "Proportion of patients with clinically significant laboratory abnormalities" } ], "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" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Materia Medica Holding" } }, "statusModule": { "completionDateStruct": { "date": "2026-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-19" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2026-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-10-16" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Virtual Gaming Simulation" } ] }, "conditionsModule": { "conditions": [ "Simulation of Physical Illness" ] }, "contactsLocationsModule": null, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Control group and intervention group", "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", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 120, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "25 Years", "minimumAge": "19 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Virtual Game Simulation on Nursing Students' Physical Examination Skills", "nctId": "NCT06284252", "orgStudyIdInfo": { "id": "TÜBİTAK-323S135", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Skill assessment for physical examination of the abdomen (Pretest)" }, { "measure": "Skill assessment for physical examination of the heart(Pretest)" }, { "measure": "Evaluation of physical examination skills of the respiratory system(Pretest)" } ], "secondaryOutcomes": [ { "measure": "Skill assessment for physical examination of the abdomen (Posttest)" }, { "measure": "Skill assessment for physical examination of the heart(Posttest)" }, { "measure": "Evaluation of physical examination skills of the respiratory system(Posttest)" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "TÜBİTAK" } ], "leadSponsor": { "class": "OTHER", "name": "Necmettin Erbakan University" } }, "statusModule": { "completionDateStruct": { "date": "2025-02-15" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-01-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-09-15" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Tell me about the game." } ] }, "conditionsModule": { "conditions": [ "Education Nursing" ] }, "contactsLocationsModule": null, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "It refers to the intervention group in which the \"Tell Me\" game will be played.", "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", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 66, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "24 Years", "minimumAge": "20 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Using Games in Teaching Nursing History", "nctId": "NCT06284239", "orgStudyIdInfo": { "id": "Tell Me Game", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Nursing History Knowledge Test" } ], "secondaryOutcomes": [ { "measure": "Nursing History Teaching Evaluation Form" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Necmettin Erbakan University" } }, "statusModule": { "completionDateStruct": { "date": "2024-06" }, "lastUpdatePostDateStruct": { "date": "2024-03-21" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-05" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Allogeneic NK(CCT-ANK-11)" } ] }, "conditionsModule": { "conditions": [ "Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer)" ] }, "contactsLocationsModule": null, "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" }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 0, "type": "ACTUAL" }, "phases": [ "EARLY_PHASE1" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "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", "nctId": "NCT06284226", "orgStudyIdInfo": { "id": "CCT-ANK-11", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "To evaluate the safety and the efficacy" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Beijing Kejing Biotechnology Co., Ltd." } }, "statusModule": { "completionDateStruct": { "date": "2025-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-16" }, "overallStatus": "WITHDRAWN", "primaryCompletionDateStruct": { "date": "2025-06-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2022-03-25" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "No interventions" } ] }, "conditionsModule": { "conditions": [ "Cognitive Impairment", "Dementia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Los Angeles", "contacts": [ { "email": "[email protected]", "name": "Danny JJ Wang, PhD, MSCE", "phone": "323-442-7246", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Southern California", "geoPoint": { "lat": 34.05223, "lon": -118.24368 }, "state": "California", "status": "RECRUITING", "zip": "90033" }, { "city": "Los Angeles", "contacts": [ { "email": "[email protected]", "name": "Jason Hinman, MD, PhD", "phone": "310-794-1195", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of California Los Angeles", "geoPoint": { "lat": 34.05223, "lon": -118.24368 }, "state": "California", "status": "RECRUITING", "zip": "90095" }, { "city": "Sacramento", "contacts": [ { "email": "[email protected]", "name": "Pauline Maillard, PhD", "phone": "916-734-3588", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of California Davis", "geoPoint": { "lat": 38.58157, "lon": -121.4944 }, "state": "California", "status": "RECRUITING", "zip": "95817" }, { "city": "San Francisco", "contacts": [ { "email": "[email protected]", "name": "Joel Kramer, PsyD", "phone": "415-476-5572", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of California San Francisco", "geoPoint": { "lat": 37.77493, "lon": -122.41942 }, "state": "California", "status": "RECRUITING", "zip": "94158" }, { "city": "Sylmar", "contacts": [ { "email": "[email protected]", "name": "Keith Vossel, MD", "phone": "310-794-1195", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Olive View - UCLA Medical Center", "geoPoint": { "lat": 34.30778, "lon": -118.44925 }, "state": "California", "status": "RECRUITING", "zip": "91342" }, { "city": "Jacksonville", "contacts": [ { "email": "[email protected]", "name": "Gregory Day", "phone": "904-953-0856", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Mayo Clinic Florida", "geoPoint": { "lat": 30.33218, "lon": -81.65565 }, "state": "Florida", "status": "RECRUITING", "zip": "32224" }, { "city": "Chicago", "contacts": [ { "email": "[email protected]", "name": "Konstantinos Arfanakis, PhD", "phone": "312-567-3864", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Rush University Medical Center & Illinois Institute of Technology", "geoPoint": { "lat": 41.85003, "lon": -87.65005 }, "state": "Illinois", "status": "RECRUITING", "zip": "60612" }, { "city": "Lexington", "contacts": [ { "email": "[email protected]", "name": "Gregory Jicha, MD, PhD", "phone": "859-257-1000", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Kentucky", "geoPoint": { "lat": 37.98869, "lon": -84.47772 }, "state": "Kentucky", "status": "RECRUITING", "zip": "40536" }, { "city": "Baltimore", "contacts": [ { "email": "[email protected]", "name": "Peiying Liu, PhD", "phone": "410-706-2441", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Maryland, Baltimore", "geoPoint": { "lat": 39.29038, "lon": -76.61219 }, "state": "Maryland", "status": "RECRUITING", "zip": "21201" }, { "city": "Baltimore", "contacts": [ { "email": "[email protected]", "name": "Hanzhang Lu, PhD", "phone": "410-955-1431", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Johns Hopkins University", "geoPoint": { "lat": 39.29038, "lon": -76.61219 }, "state": "Maryland", "status": "RECRUITING", "zip": "21287" }, { "city": "Rochester", "contacts": [ { "email": "[email protected]", "name": "Ronald Petersen, MD, PhD", "phone": "507-284-1588", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Mayo Clinic Rochester", "geoPoint": { "lat": 44.02163, "lon": -92.4699 }, "state": "Minnesota", "status": "RECRUITING", "zip": "55901" }, { "city": "Jackson", "contacts": [ { "email": "[email protected]", "name": "Gwen Windham, MD", "phone": "601-984-5610", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Mississippi Medical Center", "geoPoint": { "lat": 32.29876, "lon": -90.18481 }, "state": "Mississippi", "status": "RECRUITING", "zip": "39216" }, { "city": "Saint Louis", "contacts": [ { "email": "[email protected]", "name": "Jin-Moo Lee, MD, PhD", "phone": "314-362-7382", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Washington University in St. Louis", "geoPoint": { "lat": 38.62727, "lon": -90.19789 }, "state": "Missouri", "status": "RECRUITING", "zip": "63110" }, { "city": "Albuquerque", "contacts": [ { "email": "[email protected]", "name": "Gary Rosenberg, MD", "phone": "505-272-3315", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of New Mexico", "geoPoint": { "lat": 35.08449, "lon": -106.65114 }, "state": "New Mexico", "status": "RECRUITING", "zip": "87131" }, { "city": "Dallas", "contacts": [ { "email": "[email protected]", "name": "Rong Zhang, PhD", "phone": "214-345-4619", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Texas Southwestern", "geoPoint": { "lat": 32.78306, "lon": -96.80667 }, "state": "Texas", "status": "RECRUITING", "zip": "75390" }, { "city": "Houston", "contacts": [ { "email": "[email protected]", "name": "Sean Savitz, MD", "phone": "713-500-7083", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Texas Health Science Center Houston", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas", "status": "RECRUITING", "zip": "77030" }, { "city": "San Antonio", "contacts": [ { "email": "[email protected]", "name": "Claudia Satizabal, PhD", "phone": "210-450-8417", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Texas Health Science Center San Antonio", "geoPoint": { "lat": 29.42412, "lon": -98.49363 }, "state": "Texas", "status": "RECRUITING", "zip": "78229" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CONTROL", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 1800, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "90 Years", "minimumAge": "60 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "MarkVCID", "briefTitle": "Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium", "nctId": "NCT06284213", "orgStudyIdInfo": { "id": "5U24NS100591", "link": "https://reporter.nih.gov/quickSearch/5U24NS100591", "type": "NIH" }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "SVD progression as measured by decline in global cognition" } ], "secondaryOutcomes": [ { "measure": "SVD progression as measured by decline in executive function" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Duke University" }, { "name": "Johns Hopkins University" }, { "name": "University of New Mexico" }, { "name": "University of Southern California" }, { "name": "University of Kentucky" }, { "name": "Rush University Medical Center" }, { "name": "University of Maryland, Baltimore" }, { "name": "University of California, San Francisco" }, { "name": "University of California, Los Angeles" }, { "name": "University of California, Davis" }, { "name": "University of Texas" }, { "name": "The University of Texas Health Science Center at San Antonio" }, { "name": "The University of Texas Health Science Center, Houston" }, { "name": "Mayo Clinic" }, { "name": "University of Mississippi Medical Center" }, { "name": "Washington University School of Medicine" }, { "name": "Olive View-UCLA Education & Research Institute" } ], "leadSponsor": { "class": "OTHER", "name": "Massachusetts General Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2027-07" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2027-07" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2021-09-29" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": null, "conditionsModule": { "conditions": [ "Sarcopenia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Kocasinan", "contacts": [ { "email": "[email protected]", "name": "MEHMET KÖKSAL, M.D.", "phone": "+905514043114", "phoneExt": null, "role": "CONTACT" } ], "country": "Turkey", "facility": "Health Sciences University, Kayseri Medicine Faculty", "geoPoint": null, "state": "Kayseri", "status": "RECRUITING", "zip": "38125" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "CROSS_SECTIONAL" }, "enrollmentInfo": { "count": 48, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis", "nctId": "NCT06284200", "orgStudyIdInfo": { "id": "sarcopenia eRA", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Evaluation of Muscle Mass" }, { "measure": "Evaluation of Muscle Strength" }, { "measure": "Evaluation of Muscle Performance" } ], "secondaryOutcomes": [ { "measure": "Rheumatoid Arthritis Quality of Life Scale" }, { "measure": "Health Assessment Questionnaire (HAQ)" }, { "measure": "Hospital Anxiety and Depression Scale (HADS)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER_GOV", "name": "Kayseri City Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2024-06-23" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-03-23" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-06-23" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": null, "conditionsModule": { "conditions": [ "Tuberculosis", "Pulmonary" ] }, "contactsLocationsModule": { "locations": [ { "city": "Khon Kaen", "contacts": null, "country": "Thailand", "facility": "Thananit Sangkomkamhang", "geoPoint": { "lat": 16.44671, "lon": 102.833 }, "state": null, "status": null, "zip": "40000" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }, "enrollmentInfo": { "count": 120, "type": "ACTUAL" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "15 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis", "nctId": "NCT06284187", "orgStudyIdInfo": { "id": "KhonKaenH", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Number of participants with pulmonary TB by Allplex™ MTB/MDRe" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER_GOV", "name": "Khon Kaen Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2023-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2023-10-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-01-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Povidone-iodine solution; chlorhexidine gluconate" } ] }, "conditionsModule": { "conditions": [ "Spine Infection" ] }, "contactsLocationsModule": { "locations": [ { "city": "Tainan", "contacts": [ { "email": "[email protected]", "name": "Wei-Ren Su, M.D., M.Sc.", "phone": "886-6-2766689", "phoneExt": null, "role": "CONTACT" } ], "country": "Taiwan", "facility": "National Cheng Kung University Hospital", "geoPoint": { "lat": 22.99083, "lon": 120.21333 }, "state": null, "status": "RECRUITING", "zip": "704" } ] }, "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." }, "designModule": { "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.", "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", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 105, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking.", "nctId": "NCT06284174", "orgStudyIdInfo": { "id": "B-BR-109-054-T", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Bacteria culture and Polymerase chain reaction exam" } ], "secondaryOutcomes": [ { "measure": "Post operative infection" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "National Cheng-Kung University Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2024-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2021-01-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Quadriceps Combined Test" } ] }, "conditionsModule": { "conditions": [ "Amyotrophic Lateral Sclerosis" ] }, "contactsLocationsModule": { "locations": [ { "city": "Clermont-Ferrand", "contacts": [ { "email": "[email protected]", "name": "Lise Laclautre", "phone": "+33473754963", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Nathalie Guy", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "France", "facility": "CHU de Clermont-Ferrand", "geoPoint": { "lat": 45.77966, "lon": 3.08628 }, "state": null, "status": "RECRUITING", "zip": "63000" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "PEM-SLA", "briefTitle": "QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up", "nctId": "NCT06284161", "orgStudyIdInfo": { "id": "RBHP 2020 GUY", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "ANSM", "id": "2020-A02765-34", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" }, { "measure": "Parameters from the QCT (Quadriceps Combined Test)" } ], "secondaryOutcomes": [ { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { "measure": "Clinical and paraclinical likely course data" }, { 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"date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-06-28" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2022-06-28" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
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{ "armsInterventionsModule": { "interventions": [ { "name": "Screening for intimate partner violence" }, { "name": "Assessment and referral" } ] }, "conditionsModule": { "conditions": [ "Violence, Domestic" ] }, "contactsLocationsModule": { "locations": [ { "city": "Charleston", "contacts": null, "country": "United States", "facility": "Biomedical Informatics Center", "geoPoint": { "lat": 32.77657, "lon": -79.93092 }, "state": "South Carolina", "status": null, "zip": "29403" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": "This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SCREENING", "timePerspective": null }, "enrollmentInfo": { "count": 19655, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "49 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Confidential IPV Screening Tool", "nctId": "NCT06284148", "orgStudyIdInfo": { "id": "Pro00093964", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": null, "id": "5R18HS025654-03", "link": "https://reporter.nih.gov/quickSearch/5R18HS025654-03", "type": "AHRQ" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "IPV positive (Yes/No)" }, { "measure": "Screening completed (Yes/No)" } ], "secondaryOutcomes": [ { "measure": "Severity of risk" }, { "measure": "Physician compliance with IPV management tools" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Agency for Healthcare Research and Quality (AHRQ)" } ], "leadSponsor": { "class": "OTHER", "name": "Medical University of South Carolina" } }, "statusModule": { "completionDateStruct": { "date": "2023-07-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2023-07-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2010-10-06" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
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{ "largeDocumentModule": { "largeDocs": [ { "date": "2023-12-01", "filename": "Prot_SAP_000.pdf", "hasIcf": false, "hasProtocol": true, "hasSap": true, "label": "Study Protocol and Statistical Analysis Plan", "size": 179261, "typeAbbrev": "Prot_SAP", "uploadDate": "2024-02-20T12:06" } ] } }
{ "armsInterventionsModule": { "interventions": [ { "name": "Michl-stitch" } ] }, "conditionsModule": { "conditions": [ "Lymphocele After Surgical Procedure" ] }, "contactsLocationsModule": { "locations": [ { "city": "Hamburg", "contacts": null, "country": "Germany", "facility": "Martini-Klinik am UKE GmbH", "geoPoint": { "lat": 53.57532, "lon": 10.01534 }, "state": null, "status": null, "zip": "20246" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 1080, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "MALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles", "nctId": "NCT06284135", "orgStudyIdInfo": { "id": "2017-PS-03", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "Martini-Klinik", "id": "PV6099", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "rate of lymphoceles requiring intervention after RARP" } ], "secondaryOutcomes": [ { "measure": "total lymphocele rate after RARP" }, { "measure": "other complications ≥ grade IIIa according to Clavien-Dindo after RARP" }, { "measure": "continence rates after RARP" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Martini-Klinik am UKE GmbH" } }, "statusModule": { "completionDateStruct": { "date": "2021-05-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2019-10-16" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2017-06-19" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
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{ "armsInterventionsModule": { "interventions": [ { "name": "Mosunetuzumab" }, { "name": "Lenalidomide" }, { "name": "Rituximab" }, { "name": "Obinutuzumab" }, { "name": "Cyclophosphamide" }, { "name": "Doxorubicin" }, { "name": "Vincristin" }, { "name": "Prednisone" }, { "name": "Rituximab" }, { "name": "Obinutuzumab" }, { "name": "Bendamustin" } ] }, "conditionsModule": { "conditions": [ "Follicular Lymphoma" ] }, "contactsLocationsModule": { "locations": [ { "city": "Brugge", "contacts": [ { "email": null, "name": "Sylvia SNAUWAERT, Pr", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Belgium", "facility": "AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie", "geoPoint": { "lat": 51.20892, "lon": 3.22424 }, "state": null, "status": null, "zip": "8000" }, { "city": "Bruxelles", "contacts": [ { "email": null, "name": "Marie MAEREVOET, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Belgium", "facility": "INSTITUT JULES BORDET - Service Hématologie", "geoPoint": { "lat": 50.85045, "lon": 4.34878 }, "state": null, "status": null, "zip": "1070" }, { "city": "Bruxelles", "contacts": [ { "email": null, "name": "Eric VAN DEN NESTE, Pr", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Belgium", "facility": "UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - 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SITE SAINT-CLOUD - Service Hématologie", "geoPoint": { "lat": 48.84598, "lon": 2.20289 }, "state": null, "status": null, "zip": "92210" }, { "city": "Saint-Priest-en-Jarez", "contacts": [ { "email": null, "name": "Ludovic FOUILLET, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie", "geoPoint": { "lat": 45.47501, "lon": 4.37614 }, "state": null, "status": null, "zip": "42270" }, { "city": "Strasbourg", "contacts": [ { "email": null, "name": "Luc-Matthieu FORNECKER, Pr", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique", "geoPoint": { "lat": 48.58392, "lon": 7.74553 }, "state": null, "status": null, "zip": "67033" }, { "city": "Toulouse", "contacts": [ { "email": null, "name": "Loïc YSEBAERT, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "IUCT ONCOPOLE - Service Hématologie", "geoPoint": { "lat": 43.60426, "lon": 1.44367 }, "state": null, "status": null, "zip": "31059" }, { "city": "Tours", "contacts": [ { "email": null, "name": "Laurianne DRIEU LA ROCHELLE, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire", "geoPoint": { "lat": 47.38333, "lon": 0.68333 }, "state": null, "status": null, "zip": "37044" }, { "city": "Valenciennes", "contacts": [ { "email": null, "name": "Sabine TRICOT, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie", "geoPoint": { "lat": 50.35, "lon": 3.53333 }, "state": null, "status": null, "zip": "59322" }, { "city": "Vandœuvre-lès-Nancy", "contacts": [ { "email": null, "name": "Pierre FEUGIER, Pr", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "CHU BRABOIS - Service Hématologie", "geoPoint": { "lat": 48.65, "lon": 6.18333 }, "state": null, "status": null, "zip": "54511" }, { "city": "Vannes", "contacts": [ { "email": null, "name": "Antoine BONNET, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie", "geoPoint": { "lat": 47.66667, "lon": -2.75 }, "state": null, "status": null, "zip": "56017" }, { "city": "Villejuif", "contacts": [ { "email": null, "name": "Vincent RIBRAG, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "France", "facility": "GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique", "geoPoint": { "lat": 48.7939, "lon": 2.35992 }, "state": null, "status": null, "zip": "94085" }, { "city": "Regensburg", "contacts": [ { "email": null, "name": "Stephanie MAYER, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Germany", "facility": "UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III", "geoPoint": { "lat": 49.01513, "lon": 12.10161 }, "state": null, "status": null, "zip": "93053" }, { "city": "Ulm", "contacts": [ { "email": null, "name": "Christian BUSKE, Pr", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Germany", "facility": "UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie", "geoPoint": { "lat": 48.39841, "lon": 9.99155 }, "state": null, "status": null, "zip": "89081" }, { "city": "Lisboa", "contacts": [ { "email": null, "name": "Maria GOMES DA SILVA, Pr", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Portugal", "facility": "INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia", "geoPoint": { "lat": 38.71667, "lon": -9.13333 }, "state": null, "status": null, "zip": "1099" }, { "city": "Salamanca", "contacts": [ { "email": null, "name": "Alejandro MARTIN GARCIA-SANCHO, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Spain", "facility": "HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia", "geoPoint": { "lat": 40.96882, "lon": -5.66388 }, "state": null, "status": null, "zip": "37007" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 790, "type": "ESTIMATED" }, "phases": [ "PHASE3" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "MorningLyte", "briefTitle": "Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5", "nctId": "NCT06284122", "orgStudyIdInfo": { "id": "MorningLyte", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Progression Free Survival (PFS)" }, { "measure": "Progression Free Survival (PFS)" } ], "secondaryOutcomes": [ { "measure": "Overall Response (OR)" }, { "measure": "Complete Metabolic Rate (CMR)" }, { "measure": "Overall Response (OR)" }, { "measure": "Complete Metabolic Rate (CMR)" }, { "measure": "Best Overall Response (CMR + PMR) rate" }, { "measure": "Best Overall Response (CMR + PMR) rate" }, { "measure": "Progression of disease within 2 years (POD24)" }, { "measure": "PFS" }, { "measure": "PFS" }, { "measure": "Event Free Survival (EFS) by Lugano 2014" }, { "measure": "Event Free Survival (EFS) by Lugano 2014" }, { "measure": "Time to Next Anti-Lymphoma Treatment (TTNLT)" }, { "measure": "Time to Next Anti-Lymphoma Treatment (TTNLT)" }, { "measure": "Duration of response" }, { "measure": "Duration of response" }, { "measure": "Overall Response (OR)" }, { "measure": "Complete Metabolic Rate (CMR)" }, { "measure": "Duration of complete response" }, { "measure": "Duration of complete response" }, { "measure": "Overall Survival (OS)" }, { "measure": "Overall Survival (OS)" }, { "measure": "Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs)" }, { "measure": "Incidence and severity of AEs including SAEs and AESIs" }, { "measure": "Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation" }, { "measure": "Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation" }, { "measure": "Incidence of Second Primary Malignancies (SPM)" }, { "measure": "Incidence of Second Primary Malignancies (SPM)" }, { "measure": "anti-drug antibodies (ADA) to mosunetuzumab" }, { "measure": "Time to deterioration in physical functioning" }, { "measure": "Time to deterioration in lymphoma symptoms" }, { "measure": "Maximum serum concentration of mosunetuzumab - Cmax" }, { "measure": "Minimum serum concentration of mosunetuzumab - Cmin" }, { "measure": "Area under the curve of serum concentration of mosunetuzumab - AUC" }, { "measure": "Maximum serum concentration of lenalidomide - Cmax" }, { "measure": "Minimum serum concentration of lenalidomide - Cmin" }, { "measure": "Area under the curve of serum concentration of lenalidomide - AUC" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Lymphoma Study Association" }, { "name": "Swiss Group for Clinical Cancer Research" }, { "name": "Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea" } ], "leadSponsor": { "class": "OTHER", "name": "The Lymphoma Academic Research Organisation" } }, "statusModule": { "completionDateStruct": { "date": "2034-04" }, "lastUpdatePostDateStruct": { "date": "2024-03-15" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2028-11" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Cryoanalgesia" }, { "name": "Sham Cryoanalgesia" } ] }, "conditionsModule": { "conditions": [ "Postoperative Pain" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Pre-Operative Patients will receive cryoanalgesia or sham cryoanalgesia before amputation.", "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", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 20, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain", "nctId": "NCT06284109", "orgStudyIdInfo": { "id": "23-1036", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Residual limb pain" } ], "primaryOutcomes": [ { "measure": "Phantom limb pain score" } ], "secondaryOutcomes": [ { "measure": "Mobility" }, { "measure": "General physical and emotional disability" }, { "measure": "Opioid consumption" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Pacira Pharmaceuticals, Inc" } ], "leadSponsor": { "class": "OTHER", "name": "The Cleveland Clinic" } }, "statusModule": { "completionDateStruct": { "date": "2024-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-23" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Psychoeducation" } ] }, "conditionsModule": { "conditions": [ "Mental Health Recovery", "Schizophrenia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Istanbul", "contacts": null, "country": "Turkey", "facility": "Umraniye Community Mental Health Center affiliated with the Ministry of Health.", "geoPoint": { "lat": 41.01384, "lon": 28.94966 }, "state": "Umraniye", "status": null, "zip": "34760" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Personal Recovery Based Psychoeducation For Schizophrenia", "nctId": "NCT06284096", "orgStudyIdInfo": { "id": "2023/391", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Personal Recovery levels of individuals diagnosed with schizophrenia" } ], "secondaryOutcomes": [ { "measure": "Psychological resilience levels of individuals diagnosed with schizophrenia" }, { "measure": "Hope levels of individuals diagnosed with schizophrenia" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Istanbul University - Cerrahpasa (IUC)" } }, "statusModule": { "completionDateStruct": { "date": "2024-06" }, "lastUpdatePostDateStruct": { "date": "2024-03-07" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-06" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-06" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "taking a blood sample" } ] }, "conditionsModule": { "conditions": [ "Obstructive Sleep Apnea-hypopnea Syndrome" ] }, "contactsLocationsModule": { "locations": [ { "city": "Sivas", "contacts": null, "country": "Turkey", "facility": "Sivas Cumhuriyet University", "geoPoint": { "lat": 39.74833, "lon": 37.01611 }, "state": "Centre", "status": null, "zip": "58140" } ] }, "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." }, "designModule": { "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.", "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "HEALTH_SERVICES_RESEARCH", "timePerspective": null }, "enrollmentInfo": { "count": 90, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "74 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "OUAS", "briefTitle": "Measuring Various Variables in Obstructive Sleep Apnea", "nctId": "NCT06284083", "orgStudyIdInfo": { "id": "Cumhuriyet University Hospital", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity." } ], "secondaryOutcomes": [ { "measure": "Polysomnographic measurement" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Cumhuriyet University" } }, "statusModule": { "completionDateStruct": { "date": "2022-02-07" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2021-01-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2018-12-18" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": null, "conditionsModule": { "conditions": [ "Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Chongqing", "contacts": [ { "email": "[email protected]", "name": "Xiao Chen, Ph.D", "phone": "15922970174", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Xiao Chen, Ph.D", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Jinju Sun, MSc", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "China", "facility": "Department of Nuclear Medicine, Daping Hospital of Army Medical University", "geoPoint": { "lat": 29.56278, "lon": 106.55278 }, "state": "Chongqing", "status": "RECRUITING", "zip": "400010" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_ONLY", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 2000, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer", "nctId": "NCT06284070", "orgStudyIdInfo": { "id": "202433", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Diagnostic efficacy" } ], "secondaryOutcomes": [ { "measure": "SUV" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Daping Hospital and the Research Institute of Surgery of the Third Military Medical University" } }, "statusModule": { "completionDateStruct": { "date": "2029-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2029-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-01-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte" } ] }, "conditionsModule": { "conditions": [ "Safety Issues", "Efficacy, Self" ] }, "contactsLocationsModule": { "locations": [ { "city": "Legnica", "contacts": [ { "email": "[email protected]", "name": "Mateusz Barycki, M.D", "phone": "+48767211446", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Piotr Rola, M.D. Ph.D", "phone": "+48767211446", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Mateusz Barycki, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Piotr Rola, MD PhD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "Poland", "facility": "Department of Cardiology, Provincial Specialized Hospital in Legnica,", "geoPoint": { "lat": 51.21006, "lon": 16.1619 }, "state": "Lower Silesia", "status": "RECRUITING", "zip": "59-220" }, { "city": "Lubin", "contacts": [ { "email": "[email protected]", "name": "Adrian Włodarczak, Assoc Prof.", "phone": "+48768460300", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Szymon Włodarczak, MD", "phone": "+4876 846 03 00", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Adrian Włodarczak, Assoc Prof.", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Szymon Włodarczak, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "Poland", "facility": "Department of Cardiology, The Copper Health Centre (MCZ)", "geoPoint": { "lat": 51.40089, "lon": 16.20149 }, "state": "Lower Silesia", "status": "RECRUITING", "zip": "59-300" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }, "enrollmentInfo": { "count": 400, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "LSCBR", "briefTitle": "Lower Silesia Culotte Bifurcation Registry (LSCBR).", "nctId": "NCT06284057", "orgStudyIdInfo": { "id": "CopperHealthCentre3", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Stent thrombosis" }, { "measure": "Stent restenosis" } ], "primaryOutcomes": [ { "measure": "Target lesion failure (TLF)" } ], "secondaryOutcomes": [ { "measure": "MACE" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland." } ], "leadSponsor": { "class": "OTHER", "name": "Regional Cardiology Center, The Copper Health Centre (MCZ)," } }, "statusModule": { "completionDateStruct": { "date": "2028-04-01" }, "lastUpdatePostDateStruct": { "date": "2024-03-06" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2028-04-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2013-04-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": null, "conditionsModule": { "conditions": [ "Premature Birth" ] }, "contactsLocationsModule": { "locations": [ { "city": "Derby", "contacts": [ { "email": "[email protected]", "name": "Janine Abramson, BSc Hon", "phone": "01332 724690", "phoneExt": null, "role": "CONTACT" } ], "country": "United Kingdom", "facility": "University Hospitals of Derby and Burton", "geoPoint": { "lat": 52.92277, "lon": -1.47663 }, "state": "Derbyshire", "status": "RECRUITING", "zip": "DE22 3DT" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "OTHER" }, "enrollmentInfo": { "count": 250000, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "36 Weeks", "minimumAge": "22 Weeks", "sex": "ALL", "stdAges": [ "CHILD" ] }, "identificationModule": { "acronym": null, "briefTitle": "Facilitating Safe Transition to Home for Preterm Infants - a National Database Study", "nctId": "NCT06284044", "orgStudyIdInfo": { "id": "NIHR204885", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Age and postmenstrual age when each of three physiological barriers are reached" }, { "measure": "Final barrier to discharge home" } ], "secondaryOutcomes": [ { "measure": "Number of days in hospital after surpassing all physiological discharge barriers" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "University Hospitals of Derby and Burton NHS Foundation Trust" } }, "statusModule": { "completionDateStruct": { "date": "2024-11-30" }, "lastUpdatePostDateStruct": { "date": "2024-03-27" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-11-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-12-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "3 fractions HDR brachytherapy" } ] }, "conditionsModule": { "conditions": [ "Cervical Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Singapore", "contacts": [ { "email": "[email protected]", "name": "Fatin Aliyah, BSc", "phone": "+6581005851", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Syadwa Abdul Shukor, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Yiat Horng Leong, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Shing Fung Lee, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Michelle Tseng, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "Singapore", "facility": "National University Hospital", "geoPoint": { "lat": 1.28967, "lon": 103.85007 }, "state": null, "status": "RECRUITING", "zip": "119074" } ] }, "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" }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 56, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "21 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions", "nctId": "NCT06284031", "orgStudyIdInfo": { "id": "Brachy Study", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Local control rate" }, { "measure": "Loco-regional control rate" }, { "measure": "Progression-free survival (PFS)" }, { "measure": "Overall survival (OS)" } ], "secondaryOutcomes": [ { "measure": "Long term toxicities" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "National University Hospital, Singapore" } }, "statusModule": { "completionDateStruct": { "date": "2026-12" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2026-06" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-06-26" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Progressive Muscle Relaxation Exercises" }, { "name": "Pilates Exercises" } ] }, "conditionsModule": { "conditions": [ "Low Back Pain" ] }, "contactsLocationsModule": { "locations": [ { "city": "Giza", "contacts": null, "country": "Egypt", "facility": "faculty of physical therapy: Cairo university", "geoPoint": { "lat": 30.00808, "lon": 31.21093 }, "state": null, "status": null, "zip": "12662" } ] }, "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" }, "designModule": { "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.", "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "35 Years", "minimumAge": "25 Years", "sex": "FEMALE", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain", "nctId": "NCT06284018", "orgStudyIdInfo": { "id": "postnatal low back pain", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Pressure Algometer" } ], "secondaryOutcomes": [ { "measure": "Oswestry Disability Index" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Cairo University" } }, "statusModule": { "completionDateStruct": { "date": "2024-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-24" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "WRL ATP" } ] }, "conditionsModule": { "conditions": [ "Amputation", "Amputation; Traumatic, Leg, Lower" ] }, "contactsLocationsModule": { "locations": [ { "city": "Firenze", "contacts": null, "country": "Italy", "facility": "IRCCS Fondazione Don Carlo Gnocchi", "geoPoint": { "lat": 43.77925, "lon": 11.24626 }, "state": "FI", "status": null, "zip": "50143" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DEVICE_FEASIBILITY", "timePerspective": null }, "enrollmentInfo": { "count": 4, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "75 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "MOTU-ATP", "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", "nctId": "NCT06284005", "orgStudyIdInfo": { "id": "MOTU ATP - Studio clinico", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "ad hoc check-list Adverse Event" }, { "measure": "ad hoc check-list Adverse Event" }, { "measure": "ad hoc check-list Adverse Event" }, { "measure": "ad hoc check-list Adverse Event" }, { "measure": "ad hoc check-list Adverse Event" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Fondazione Don Carlo Gnocchi Onlus" } }, "statusModule": { "completionDateStruct": { "date": "2022-12-22" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2022-11-10" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2020-07-27" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Digital Navigation" } ] }, "conditionsModule": { "conditions": [ "Type 2 Diabetes" ] }, "contactsLocationsModule": { "locations": [ { "city": "Boston", "contacts": [ { "email": null, "name": "Jorge A Rodriguez, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Brigham and Women's Hospital", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts", "status": "RECRUITING", "zip": "02120" } ] }, "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." }, "designModule": { "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).", "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "HEALTH_SERVICES_RESEARCH", "timePerspective": null }, "enrollmentInfo": { "count": 84, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Digital Health Navigation for Latino Patients With Type II Diabetes", "nctId": "NCT06283992", "orgStudyIdInfo": { "id": "2024p000095", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": null, "id": "K23MD016439", "link": "https://reporter.nih.gov/quickSearch/K23MD016439", "type": "NIH" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Proportion of Participants Who Login to the Portal" } ], "secondaryOutcomes": [ { "measure": "Proportion of Participants that Perform Distinct Portal Functions" }, { "measure": "Proportion of participants that complete a telehealth" }, { "measure": "Proportion of participants that are re-admitted" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "National Institute on Minority Health and Health Disparities (NIMHD)" } ], "leadSponsor": { "class": "OTHER", "name": "Brigham and Women's Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2027-05-31" }, "lastUpdatePostDateStruct": { "date": "2024-03-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2026-05-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-31" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "STIMULAN VG" }, { "name": "Standard of Care" } ] }, "conditionsModule": { "conditions": [ "Pressure Ulcer, Stage IV", "Osteomyelitis" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "BLADE OPU2", "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.", "nctId": "NCT06283979", "orgStudyIdInfo": { "id": "199723", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Individual patient success and findings at the 8 week follow-up visit" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "MCRA" } ], "leadSponsor": { "class": "INDUSTRY", "name": "Biocomposites Ltd" } }, "statusModule": { "completionDateStruct": { "date": "2025-12-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "BGF MDI 320/14.4/9.6 μg" }, { "name": "GFF MDI 14.4/9.6 μg" } ] }, "conditionsModule": { "conditions": [ "COPD (Chronic Obstructive Pulmonary Disease)" ] }, "contactsLocationsModule": { "locations": [ { "city": "Athens", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 34.80243, "lon": -86.97219 }, "state": "Alabama", "status": "NOT_YET_RECRUITING", "zip": "35611" }, { "city": "Cullman", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 34.17482, "lon": -86.84361 }, "state": "Alabama", "status": "NOT_YET_RECRUITING", "zip": "35058" }, { "city": "Fairhope", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 30.52297, "lon": -87.90333 }, "state": "Alabama", "status": "RECRUITING", "zip": "36532" }, { "city": "Huntsville", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 34.7304, "lon": -86.58594 }, "state": "Alabama", "status": "NOT_YET_RECRUITING", "zip": "35801" }, { "city": "Mobile", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 30.69436, "lon": -88.04305 }, "state": "Alabama", "status": "NOT_YET_RECRUITING", "zip": "36608" }, { "city": "Sheffield", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 34.76509, "lon": -87.69864 }, "state": "Alabama", "status": "NOT_YET_RECRUITING", "zip": "35660" }, { "city": "Gilbert", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.35283, "lon": -111.78903 }, "state": "Arizona", "status": "NOT_YET_RECRUITING", "zip": "85296" }, { "city": "Glendale", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.53865, "lon": -112.18599 }, "state": "Arizona", "status": "NOT_YET_RECRUITING", "zip": "85308" }, { "city": "Mesa", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.42227, "lon": -111.82264 }, "state": "Arizona", "status": "RECRUITING", "zip": "85206" }, { "city": "Mesa", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.42227, "lon": -111.82264 }, "state": "Arizona", "status": "NOT_YET_RECRUITING", "zip": "85213" }, { "city": "Phoenix", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.44838, "lon": -112.07404 }, "state": "Arizona", "status": "NOT_YET_RECRUITING", "zip": "85006" }, { "city": "Tempe", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.41477, "lon": -111.90931 }, "state": "Arizona", "status": "NOT_YET_RECRUITING", "zip": "85281" }, { "city": "Tempe", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.41477, "lon": -111.90931 }, "state": "Arizona", "status": "NOT_YET_RECRUITING", "zip": "85283" }, { "city": "Tucson", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 32.22174, "lon": -110.92648 }, "state": "Arizona", "status": "NOT_YET_RECRUITING", "zip": "85710" }, { "city": "Apple Valley", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 34.50083, "lon": -117.18588 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "92307" }, { "city": "Banning", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.92557, "lon": -116.87641 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "92220" }, { "city": "Canoga Park", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 34.20112, "lon": -118.59814 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "91303" }, { "city": "Garden Grove", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.77391, "lon": -117.94145 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "92844" }, { "city": "Gardena", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.88835, "lon": -118.30896 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "90247" }, { "city": "Inglewood", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.96168, "lon": -118.35313 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "90301" }, { "city": "La Mesa", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 32.76783, "lon": -117.02308 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "91942" }, { "city": "La Palma", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.8464, "lon": -118.04673 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "90623" }, { "city": "Lomita", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.79224, "lon": -118.31507 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "90717" }, { "city": "Los Alamitos", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.80307, "lon": -118.07256 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "90720" }, { "city": "Newport Beach", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.61891, "lon": -117.92895 }, "state": "California", "status": "NOT_YET_RECRUITING", "zip": "92660" }, { "city": "Newport Beach", "contacts": null, "country": "United States", "facility": "Research Site", "geoPoint": { "lat": 33.61891, "lon": -117.92895 }, "state": "California", "status": "RECRUITING", "zip": "92663" }, { "city": "North Hollywood", 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"BH16 5PW" }, { "city": "Sheffield", "contacts": null, "country": "United Kingdom", "facility": "Research Site", "geoPoint": { "lat": 53.38297, "lon": -1.4659 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "S9 4EU" }, { "city": "Torbay", "contacts": null, "country": "United Kingdom", "facility": "Research Site", "geoPoint": null, "state": null, "status": "NOT_YET_RECRUITING", "zip": "TQ1 4QX" }, { "city": "Whitney", "contacts": null, "country": "United Kingdom", "facility": "Research Site", "geoPoint": { "lat": 52.11667, "lon": -3.08333 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "OX29 4QB" }, { "city": "Witney", "contacts": null, "country": "United Kingdom", "facility": "Research Site", "geoPoint": { "lat": 51.7836, "lon": -1.4854 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "OX28 6JS" } ] }, "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." }, "designModule": { "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.", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 5000, "type": "ESTIMATED" }, "phases": [ "PHASE3" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "80 Years", "minimumAge": "40 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "THARROS", "briefTitle": "A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease", "nctId": "NCT06283966", "orgStudyIdInfo": { "id": "D5989C00001", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "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" } ], "primaryOutcomes": [ { "measure": "Time to first severe cardiac or COPD event" } ], "secondaryOutcomes": [ { "measure": "Time to first severe COPD exacerbation event" }, { "measure": "Time to first severe cardiac event" }, { "measure": "Time to cardiopulmonary death" }, { "measure": "Moderate/severe COPD exacerbation rate" }, { "measure": "Time to Myocardial Infarction (MI) hospitalization or cardiac death" }, { "measure": "Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "AstraZeneca" } }, "statusModule": { "completionDateStruct": { "date": "2028-03-06" }, "lastUpdatePostDateStruct": { "date": "2024-03-12" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2028-03-06" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-21" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Trach@Home" }, { "name": "Trach Me Home" } ] }, "conditionsModule": { "conditions": [ "Tracheostomy", "Caregiver Burden" ] }, "contactsLocationsModule": { "locations": [ { "city": "La Jolla", "contacts": [ { "email": "[email protected]", "name": "Matthew Brigger, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Matthew Brigger, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "University of San Diego Rady Children's Hospital", "geoPoint": { "lat": 32.84727, "lon": -117.2742 }, "state": "California", "status": null, "zip": "92093" }, { "city": "Silver Spring", "contacts": [ { "email": "[email protected]", "name": "Habib Zalzal, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Habib Zalzal, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Children's National Medical Center, Children's Research Institute", "geoPoint": { "lat": 38.99067, "lon": -77.02609 }, "state": "Maryland", "status": null, "zip": "20910" }, { "city": "Boston", "contacts": [ { "email": "[email protected]", "name": "Karen Sepucha, PhD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Christopher Hartnick, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Massachusetts General Hospital", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts", "status": null, "zip": "02114" }, { "city": "Minneapolis", "contacts": [ { "email": "[email protected]", "name": "Asitha Jayawardena, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Asitha Jayawardena, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Children's Hospitals and Clinics of Minnesota", "geoPoint": { "lat": 44.97997, "lon": -93.26384 }, "state": "Minnesota", "status": null, "zip": "55404" }, { "city": "Cincinnati", "contacts": [ { "email": "[email protected]", "name": "Matthew Smith, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Matthew Smith, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Cincinnati Children's Hospital Medical Center", "geoPoint": { "lat": 39.12713, "lon": -84.51435 }, "state": "Ohio", "status": null, "zip": "45229" }, { "city": "Philadelphia", "contacts": [ { "email": "[email protected]", "name": "Luv Javia, MD", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Luv Javia, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Children's Hospital of Philadelphia", "geoPoint": { "lat": 39.95233, "lon": -75.16379 }, "state": "Pennsylvania", "status": null, "zip": "19146" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "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" ] }, "observationalModel": null, "primaryPurpose": "HEALTH_SERVICES_RESEARCH", "timePerspective": null }, "enrollmentInfo": { "count": 480, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "BREATHE", "briefTitle": "Boosting Resources for Tracheostomy Care at Home", "nctId": "NCT06283953", "orgStudyIdInfo": { "id": "2023P001695", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "Patient Centered Outcomes Research Institute (PCORI)", "id": "IHS-2022C1-26100", "link": null, "type": "OTHER_GRANT" } ] }, "outcomesModule": { "otherOutcomes": [ { "measure": "Medical Complications Associated with Tracheostomy" }, { "measure": "Caregiver Burden" }, { "measure": "Number of readmissions" } ], "primaryOutcomes": [ { "measure": "Caregiver Burden" } ], "secondaryOutcomes": [ { "measure": "Medical Complications Associated with Tracheostomy" }, { "measure": "6-month Readmission Rate" }, { "measure": "Frequency of pediatrician communication" }, { "measure": "Primary care pediatrician satisfaction" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Children's Hospital Medical Center, Cincinnati" }, { "name": "Children's Hospital of Philadelphia" }, { "name": "Children's Hospitals and Clinics of Minnesota" }, { "name": "Children's National Research Institute" }, { "name": "Rady Children's Hospital, San Diego" }, { "name": "Patient-Centered Outcomes Research Institute" } ], "leadSponsor": { "class": "OTHER", "name": "Massachusetts General Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2027-10-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-12-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Physiotherapist-led exercise based cardiac rehabilitation (PT-X)" } ] }, "conditionsModule": { "conditions": [ "Aortic Valve Stenosis" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Intervention group and matched controls based on age, gender and exercise capacity in watt.", "maskingInfo": { "masking": "NONE", "maskingDescription": "Data collection will be conducted by a physiotherapist not involved in the intervention.", "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 135, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "65 Years", "sex": "ALL", "stdAges": [ "OLDER_ADULT" ] }, "identificationModule": { "acronym": "TAVI", "briefTitle": "Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation", "nctId": "NCT06283940", "orgStudyIdInfo": { "id": "281694", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Exercise capacity in watt" }, { "measure": "Rating of perceived exertion Borg RPE scale 6-20" }, { "measure": "Exercise capacity in Watt" }, { "measure": "Rating of perceived exertion Borg RPE scale 6-20" }, { "measure": "Muscular endurance test, shoulder flexion" }, { "measure": "Muscular endurance test, shoulder flexion" }, { "measure": "Muscle endurance test, shoulder abduction" }, { "measure": "Muscle endurance test, shoulder abduction" }, { "measure": "Muscle endurance test, unilateral heel-lift" }, { "measure": "Muscle endurance test, unilateral heel-lift" }, { "measure": "Lower extremity function" }, { "measure": "Lower extremity function" }, { "measure": "Physical activity" }, { "measure": "Physical activity" }, { "measure": "Self-assessed level of physical activity" }, { "measure": "Self-assessed level of physical activity" }, { "measure": "Health Related Quality of Life" }, { "measure": "Health Related Quality of Life" } ], "secondaryOutcomes": [ { "measure": "Frailty" }, { "measure": "Frailty" }, { "measure": "Hospital admission" }, { "measure": "Hospital admission" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER_GOV", "name": "Vastra Gotaland Region" } }, "statusModule": { "completionDateStruct": { "date": "2026-01" }, "lastUpdatePostDateStruct": { "date": "2024-04-24" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-08" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Re-resection" }, { "name": "Temozolomide" }, { "name": "Lomustine" }, { "name": "Re-irradiation" }, { "name": "Experimental therapy" }, { "name": "Best supportive care" } ] }, "conditionsModule": { "conditions": [ "Glioblastoma", "Glioblastoma Multiforme", "Glioblastoma, IDH-wildtype", "Glioblastoma Multiforme of Brain", "Glioblastoma Multiforme, Adult", "Recurrent Glioblastoma", "Astrocytoma, Malignant", "Astrocytoma of Brain" ] }, "contactsLocationsModule": { "locations": [ { "city": "San Francisco", "contacts": [ { "email": null, "name": "Mitchel Berger, MD PhD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of California, San Francisco", "geoPoint": { "lat": 37.77493, "lon": -122.41942 }, "state": "California", "status": "RECRUITING", "zip": "94143" }, { "city": "Boston", "contacts": [ { "email": null, "name": "Brian Nahed, MD PhD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Massachusetts General Hospital", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts", "status": "RECRUITING", "zip": "02114" }, { "city": "Leuven", "contacts": [ { "email": null, "name": "Steven De Vleeschouwer, MD PhD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Belgium", "facility": "University Hospital Leuven", "geoPoint": { "lat": 50.87959, "lon": 4.70093 }, "state": null, "status": "RECRUITING", "zip": null }, { "city": "Heidelberg", "contacts": [ { "email": null, "name": "Christine Jungk, Dr. med.", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Germany", "facility": "University Hospital Heidelberg", "geoPoint": { "lat": 49.40768, "lon": 8.69079 }, "state": null, "status": "RECRUITING", "zip": null }, { "city": "Munich", "contacts": [ { "email": null, "name": "Arthur Wagner, MD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Germany", "facility": "Technical University Munich", "geoPoint": { "lat": 48.13743, "lon": 11.57549 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": null }, { "city": "Rotterdam", "contacts": [ { "email": "[email protected]", "name": "Arnaud Vincent, MD PhD", "phone": "+31639428949", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Jasper Gerritsen, MD", "phone": "+31629119553", "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "Erasmus MC", "geoPoint": { "lat": 51.9225, "lon": 4.47917 }, "state": "Zuid-Holland", "status": "RECRUITING", "zip": "3015 CE" }, { "city": "The Hague", "contacts": [ { "email": "[email protected]", "name": "Marike Broekman, MD PhD", "phone": "+31639758253", "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "Medical Center Haaglanden", "geoPoint": { "lat": 52.07667, "lon": 4.29861 }, "state": "Zuid-Holland", "status": "RECRUITING", "zip": "2261 CP" }, { "city": "Bern", "contacts": [ { "email": null, "name": "Philippe Schucht, MD PhD", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Switzerland", "facility": "Inselspital Universitätsspital Bern", "geoPoint": { "lat": 46.94809, "lon": 7.44744 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 464, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "90 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "RECSUR", "briefTitle": "The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)", "nctId": "NCT06283927", "orgStudyIdInfo": { "id": "MEC-2020-0812-5", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Overall survival" }, { "measure": "Neurological morbidity at 6 weeks" } ], "secondaryOutcomes": [ { "measure": "Neurological morbidity at 3 months" }, { "measure": "Neurological morbidity at 6 months" }, { "measure": "Progression-free survival" }, { "measure": "Residual tumor volume" }, { "measure": "Quality of life at 6 weeks (EORTC QLQ C30)" }, { "measure": "Quality of life at 3 months (EORTC QLQ C30)" }, { "measure": "Quality of life at 6 months (EORTC QLQ C30)" }, { "measure": "Quality of life at 6 weeks (EORTC QLQ BN20)" }, { "measure": "Quality of life at 3 months (EORTC QLQ BN20)" }, { "measure": "Quality of life at 6 months (EORTC QLQ BN20)" }, { "measure": "Quality of life at 6 weeks (EQ-5D)" }, { "measure": "Quality of life at 3 months (EQ-5D)" }, { "measure": "Quality of life at 6 months (EQ-5D)" }, { "measure": "Serious Adverse Events" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Haaglanden Medical Centre" }, { "name": "Universitaire Ziekenhuizen KU Leuven" }, { "name": "University Hospital Heidelberg" }, { "name": "Technical University of Munich" }, { "name": "Insel Gruppe AG, University Hospital Bern" }, { "name": "Massachusetts General Hospital" }, { "name": "University of California, San Francisco" } ], "leadSponsor": { "class": "OTHER", "name": "Jasper Gerritsen" } }, "statusModule": { "completionDateStruct": { "date": "2028-01-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2027-01-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-01-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": null, "conditionsModule": { "conditions": [ "Oxygen Saturation", "Respiratory Distress Syndrome", "Anesthesia, General" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 300, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry", "nctId": "NCT06283914", "orgStudyIdInfo": { "id": "BIO-2024-0011", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "SpO2" } ], "primaryOutcomes": [ { "measure": "PaO2" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "American University of Beirut Medical Center" } }, "statusModule": { "completionDateStruct": { "date": "2024-09-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-08-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": null, "conditionsModule": { "conditions": [ "Traumatic Brain Injury", "Intracranial Hemorrhages", "Subarachnoid Hemorrhage", "Meningitis", "Encephalitis", "Stroke" ] }, "contactsLocationsModule": { "locations": [ { "city": "Nijmegen", "contacts": [ { "email": null, "name": "Astrid Hoedemaekers", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "Radboud UMC", "geoPoint": { "lat": 51.8425, "lon": 5.85278 }, "state": "Gelderland", "status": "RECRUITING", "zip": "6525 GA" }, { "city": "Amsterdam", "contacts": [ { "email": "[email protected]", "name": "Wolmet Haksteen, MD", "phone": "+31 020 - 566 9111", "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "Amsterdam UMC", "geoPoint": { "lat": 52.37403, "lon": 4.88969 }, "state": "Noord-Holland", "status": "RECRUITING", "zip": "1105 AZ" }, { "city": "Den Haag", "contacts": [ { "email": null, "name": "Sefanja Achterberg", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "Haaglanden MC, locatie Westeinde", "geoPoint": { "lat": 52.07667, "lon": 4.29861 }, "state": "Zuid-Holland", "status": "RECRUITING", "zip": "2512 VA" }, { "city": "Rotterdam", "contacts": [ { "email": null, "name": "Mathieu van der Jagt", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "Erasmus MC", "geoPoint": { "lat": 51.9225, "lon": 4.47917 }, "state": "Zuid-Holland", "status": "NOT_YET_RECRUITING", "zip": "3015 GD" }, { "city": "Groningen", "contacts": [ { "email": null, "name": "Joukje van der Naalt", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Netherlands", "facility": "UMC Groningen", "geoPoint": { "lat": 53.21917, "lon": 6.56667 }, "state": null, "status": "NOT_YET_RECRUITING", "zip": "9713 GZ" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 160, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "IMPROVE-DOC", "briefTitle": "Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness", "nctId": "NCT06283901", "orgStudyIdInfo": { "id": "NL82013.018.22", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Glasgow Outcome Scale Extended" } ], "secondaryOutcomes": [ { "measure": "Glasgow Outcome Scale Extended" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)" } }, "statusModule": { "completionDateStruct": { "date": "2025-09-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-01-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-01-02" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "CYP2C19 Genotype Guided DAPT" }, { "name": "Conventional DAPT" } ] }, "conditionsModule": { "conditions": [ "ACS - Acute Coronary Syndrome", "CYP2C19 Polymorphism" ] }, "contactsLocationsModule": { "locations": [ { "city": "Zunyi", "contacts": [ { "email": "[email protected]", "name": "Cai De Jin, MD", "phone": "86+173-8576-9997", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Yan Yan Jin, MD, PhD", "phone": "86+157-7229-0925", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Cai De Jin, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Ran Zun Zhao, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "China", "facility": "Affiliated Hospital of Zunyi Medical University", "geoPoint": { "lat": 27.68667, "lon": 106.90722 }, "state": "Guizhou", "status": "RECRUITING", "zip": "563003" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 1200, "type": "ESTIMATED" }, "phases": [ "PHASE4" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "80 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention", "nctId": "NCT06283888", "orgStudyIdInfo": { "id": "PRECISE-PCI", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "NACE (net adverse clinical event)" } ], "secondaryOutcomes": [ { "measure": "Incidence of clinically significant bleeding" }, { "measure": "Incidence of MACCE" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Zunyi Medical College" } }, "statusModule": { "completionDateStruct": { "date": "2028-12-01" }, "lastUpdatePostDateStruct": { "date": "2024-03-20" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2028-04-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": null }, "conditionsModule": { "conditions": [ "Ovarian Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Suzhou", "contacts": [ { "email": "[email protected]", "name": "Jinhua Zhou", "phone": "+86 13914024750", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Songbing Qin", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "China", "facility": "The First Affiliated Hospital of Soochow University", "geoPoint": { "lat": 31.30408, "lon": 120.59538 }, "state": "Jiangsu", "status": null, "zip": "215006" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 80, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "80 Years", "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer", "nctId": "NCT06283875", "orgStudyIdInfo": { "id": "PROMISEPLUS-301", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "DFS of enrolled patients for 2 years" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Geneplus-Beijing Co. Ltd." } }, "statusModule": { "completionDateStruct": { "date": "2029-01-30" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-01-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Educational Session" } ] }, "conditionsModule": { "conditions": [ "Chronic Pain" ] }, "contactsLocationsModule": { "locations": [ { "city": "Ann Arbor", "contacts": [ { "email": "[email protected]", "name": "Vivian Kurtz", "phone": "734-998-7156", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Kevin Boehnke", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "University of Michigan", "geoPoint": { "lat": 42.27756, "lon": -83.74088 }, "state": "Michigan", "status": null, "zip": "48105" } ] }, "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." }, "designModule": { "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.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 468, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "MIVetsCan: Can-Coach Trial (Phase 2)", "nctId": "NCT06283862", "orgStudyIdInfo": { "id": "HUM00231159b", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "Michigan, State of, Licensing and Regulatory Affairs, Department of 573000", "id": "VMR2022-03", "link": null, "type": "OTHER_GRANT" } ] }, "outcomesModule": { "otherOutcomes": null, "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" }, { "measure": "Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1" }, { "measure": "Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1" }, { "measure": "Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1" }, { "measure": "Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation" }, { "measure": "Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Michigan, State of, Licensing and Regulatory Affairs" } ], "leadSponsor": { "class": "OTHER", "name": "University of Michigan" } }, "statusModule": { "completionDateStruct": { "date": "2027-02" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2027-02" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "strategies to break up SB" } ] }, "conditionsModule": { "conditions": [ "Cardiovascular Diseases", "Type 2 Diabetes" ] }, "contactsLocationsModule": { "locations": [ { "city": "Minneapolis", "contacts": [ { "email": "[email protected]", "name": "Mary O Whipple, PhD, RN, PHN", "phone": "612-625-4470", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "University of Minnesota", "geoPoint": { "lat": 44.97997, "lon": -93.26384 }, "state": "Minnesota", "status": null, "zip": "55414" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "55 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study", "nctId": "NCT06283849", "orgStudyIdInfo": { "id": "SON-2024-32671", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "sedentary time" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "University of Minnesota" } }, "statusModule": { "completionDateStruct": { "date": "2026-05-01" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-05-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Dexmedetomidine" }, { "name": "Remifentanil" } ] }, "conditionsModule": { "conditions": [ "Otosclerosis" ] }, "contactsLocationsModule": { "locations": [ { "city": "Cluj Napoca", "contacts": [ { "email": "[email protected]", "name": "Caius Mihai Breazu, MD, PhD", "phone": "+40743010012", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "ioan florin marchis, MD, PhD", "phone": "+40757065205", "phoneExt": null, "role": "CONTACT" } ], "country": "Romania", "facility": "Cluj County Clinical Emergency Hospital", "geoPoint": { "lat": 46.76667, "lon": 23.6 }, "state": "Cluj", "status": null, "zip": "400006" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }, "enrollmentInfo": { "count": 100, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy", "nctId": "NCT06283836", "orgStudyIdInfo": { "id": "Dexrem ATI 4-6", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "the need for adjuncts during intervention" } ], "primaryOutcomes": [ { "measure": "Patient satisfaction" }, { "measure": "Surgeon satisfaction" } ], "secondaryOutcomes": [ { "measure": "mean arterial pressure" }, { "measure": "Heart Rate" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Iuliu Hatieganu University of Medicine and Pharmacy" } }, "statusModule": { "completionDateStruct": { "date": "2025-03-15" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-03-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Thermoformed orthodontic retainer" } ] }, "conditionsModule": { "conditions": [ "Orthodontic Retainer" ] }, "contactsLocationsModule": { "locations": [ { "city": "L'Aquila", "contacts": [ { "email": "[email protected]", "name": "Michele Tepedino, DDS", "phone": "+39 340 276 1456", "phoneExt": null, "role": "CONTACT" } ], "country": "Italy", "facility": "University of L'Aquila", "geoPoint": { "lat": 42.35055, "lon": 13.39954 }, "state": null, "status": "RECRUITING", "zip": "67100" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 36, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "35 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Morphological Changes of Removable Orthodontic Retainers During the Use", "nctId": "NCT06283823", "orgStudyIdInfo": { "id": "41821", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Peer Assessment Rating (PAR) index" }, { "measure": "Volumetric superimposition of digital models" } ], "secondaryOutcomes": [ { "measure": "Thickness" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "University of L'Aquila" } }, "statusModule": { "completionDateStruct": { "date": "2024-12-21" }, "lastUpdatePostDateStruct": { "date": "2024-03-01" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-04-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2021-12-21" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "psychotherapy of interpersonal relationships" }, { "name": "laughter therapy" }, { "name": "Plasebo" } ] }, "conditionsModule": { "conditions": [ "Midwifery Students" ] }, "contactsLocationsModule": { "locations": [ { "city": "Istanbul", "contacts": [ { "email": "[email protected]", "name": "Betül Uncu", "phone": "+095078421227", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Nurten Kaya", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" }, { "email": null, "name": "Betül Uncu", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Turkey", "facility": "Istanbul University-Cerrahpasa", "geoPoint": { "lat": 41.01384, "lon": 28.94966 }, "state": null, "status": "RECRUITING", "zip": "34320" } ] }, "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)" }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 40, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "25 Years", "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy", "nctId": "NCT06283810", "orgStudyIdInfo": { "id": "2023/168", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "self-reflection skills" }, { "measure": "problem solving skills" }, { "measure": "interpersonal relationship skills" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Istanbul University - Cerrahpasa (IUC)" } }, "statusModule": { "completionDateStruct": { "date": "2024-09-30" }, "lastUpdatePostDateStruct": { "date": "2024-03-06" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-06-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "OmniPod 5" }, { "name": "Dexcom G6" }, { "name": "PAID questionnaires" } ] }, "conditionsModule": { "conditions": [ "Diabetes" ] }, "contactsLocationsModule": { "locations": [ { "city": "Angers", "contacts": [ { "email": "[email protected]", "name": "Régis Coutant, MD", "phone": "02 41 35 56 55", "phoneExt": "+33", "role": "CONTACT" } ], "country": "France", "facility": "University Hospital, Angers", "geoPoint": { "lat": 47.46667, "lon": -0.55 }, "state": null, "status": null, "zip": null }, { "city": "Montpellier", "contacts": [ { "email": "[email protected]", "name": "Eric Renard, MD", "phone": "04 67 33 83 82", "phoneExt": "+33", "role": "CONTACT" } ], "country": "France", "facility": "University Hospital, Montpellier", "geoPoint": { "lat": 43.61092, "lon": 3.87723 }, "state": null, "status": null, "zip": null }, { "city": "Paris", "contacts": [ { "email": "[email protected]", "name": "Elise Bismuth Reisman, MD", "phone": "01 40 03 20 67", "phoneExt": "+33", "role": "CONTACT" } ], "country": "France", "facility": "Robert Debré Hospital, AP-HP", "geoPoint": { "lat": 48.85341, "lon": 2.3488 }, "state": null, "status": null, "zip": null }, { "city": "Tours", "contacts": [ { "email": "[email protected]", "name": "Yannis Chartier, MD", "phone": "06 85 67 93 35", "phoneExt": "+33", "role": "CONTACT" } ], "country": "France", "facility": "University Hospital, Tours", "geoPoint": { "lat": 47.38333, "lon": 0.68333 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Randomized control study in parallel groups, followed by a non randomized extension", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 112, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "18 Years", "minimumAge": "2 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT" ] }, "identificationModule": { "acronym": "APATDIAGNOSIS", "briefTitle": "Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes", "nctId": "NCT06283797", "orgStudyIdInfo": { "id": "RECHMPL22_0346", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "ANSM", "id": "2023-A01661-44", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": [ { "measure": "Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis" }, { "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" }, { "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" }, { "measure": "Change of mean glucose level between 1st and 2nd year of use in the group who started HCL early after diagnosis" }, { "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" }, { "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" }, { "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" }, { "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" }, { "measure": "Change of coefficient of glucose variability between 1st and 2nd year of use in the group who started HCL early after diagnosis" }, { "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" }, { "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" }, { "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" }, { "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" }, { "measure": "Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period" }, { "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" }, { "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" }, { "measure": "Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period" }, { "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" }, { "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" }, { "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" }, { "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" }, { "measure": "Difference in the coefficient of glucose variability between the 2 initially randomized groups at the end of the extension period" }, { "measure": "Difference in the score of PAID questionnaire for parents between the 2 initially randomized groups at the end of the extension period" }, { "measure": "Difference in the score of PAID questionnaire for children between the 2 initially randomized groups at the end of the extension period" }, { "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" }, { "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" }, { "measure": "Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs" }, { "measure": "Relatedness of treatment-emergent SUSARs, SAEs, ARs and AEs" }, { "measure": "Severity of treatment-emergent SUSARs, SAEs, ARs and AEs" } ], "primaryOutcomes": [ { "measure": "Glycated hemoglobin (HbA1c) level" } ], "secondaryOutcomes": [ { "measure": "Percent of time spent in the 70-180 mg/dl glucose range" }, { "measure": "Percent of time spent in the 70-140 mg/dl glucose range" }, { "measure": "Mean glucose level" }, { "measure": "Percent of time spent with glucose level below 70 mg/dl" }, { "measure": "Percent of time spent with glucose level below 54 mg/dl" }, { "measure": "Percent of time spent with glucose level above 180 mg/dl" }, { "measure": "Percent of time spent with glucose level above 250 mg/dl" }, { "measure": "Coefficient of glucose variability" }, { "measure": "Score of PAID questionnaire for parents" }, { "measure": "Score of PAID questionnaire for children" }, { "measure": "Stimulated plasma C-peptide level 10-min after 1mg IV glucagon" }, { "measure": "Number of needed interventions by the parents/guardians or care providers" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Hopital Universitaire Robert-Debre" }, { "name": "University Hospital, Tours" }, { "name": "University Hospital, Angers" }, { "name": "University of Virginia" } ], "leadSponsor": { "class": "OTHER", "name": "University Hospital, Montpellier" } }, "statusModule": { "completionDateStruct": { "date": "2027-05" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-05" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Yovis Capsules" }, { "name": "Placebo" } ] }, "conditionsModule": { "conditions": [ "Diarrhea" ] }, "contactsLocationsModule": { "locations": [ { "city": "Sanremo", "contacts": null, "country": "Italy", "facility": "General Practitioner Ambulatory", "geoPoint": { "lat": 43.81725, "lon": 7.7772 }, "state": "Italy/Imperia", "status": null, "zip": "18038" } ] }, "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)" }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "This is a double blind, randomized, placebo-controlled study.", "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", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 100, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients", "nctId": "NCT06283784", "orgStudyIdInfo": { "id": "YOVIS Capsules", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy" } ], "secondaryOutcomes": [ { "measure": "Severity and duration of AAD" }, { "measure": "Severity and duration of AAD" }, { "measure": "Evaluation of duration and severity of gastrointestinal symptoms" }, { "measure": "Evaluation of duration and severity of gastrointestinal symptoms" }, { "measure": "Evaluation of duration and severity of gastrointestinal symptoms" }, { "measure": "Impact of bowel habits on QoL" }, { "measure": "Effects of YOVIS, versus placebo, at each visit on the overall health status" }, { "measure": "Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo" }, { "measure": "Global Patient's self-reported acceptance at the end of study" }, { "measure": "Global acceptability (investigator) at the end of study" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Hippocrates Research" } ], "leadSponsor": { "class": "INDUSTRY", "name": "Biofarma" } }, "statusModule": { "completionDateStruct": { "date": "2022-05-18" }, "lastUpdatePostDateStruct": { "date": "2024-03-18" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2021-11-02" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2021-09-05" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Heated socks to be developed with wearable technology" } ] }, "conditionsModule": { "conditions": [ "Wearable Technology", "Hypothermia", "Shivering", "Thermal Comfort Perception" ] }, "contactsLocationsModule": { "locations": null }, "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" }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": "The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study", "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", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 70, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": null, "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering", "nctId": "NCT06283771", "orgStudyIdInfo": { "id": "TU-BOZKUL-007", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Body temperature" }, { "measure": "Shivering level" }, { "measure": "Thermal comfort perception" }, { "measure": "Descriptive Characteristics" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Mersin University" } ], "leadSponsor": { "class": "OTHER", "name": "Tarsus University" } }, "statusModule": { "completionDateStruct": { "date": "2025-05-15" }, "lastUpdatePostDateStruct": { "date": "2024-03-01" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-09-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-15" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "focused power ultrasound mediate inferior perirenal adipose tissue modification" }, { "name": "Sham-control group" } ] }, "conditionsModule": { "conditions": [ "Hypertension", "Blood Pressure", "Cardiovascular Diseases" ] }, "contactsLocationsModule": { "locations": [ { "city": "Nanjing", "contacts": [ { "email": null, "name": "Yuqing Zhang", "phone": "13851672168", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Qin Tao", "phone": "1585062208", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Yuqing Zhang", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "China", "facility": "The Affiliated Jiangning Hospital of Nanjing Medical University", "geoPoint": { "lat": 32.06167, "lon": 118.77778 }, "state": "Jiangsu", "status": null, "zip": "210000" }, { "city": "Nanjing", "contacts": [ { "email": "[email protected]", "name": "Fang Zhou", "phone": "13815401066", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Wei Sun", "phone": "13815860536", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Fang Zhou", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "China", "facility": "The first Affiliated Hospital of Nanjing Medical University", "geoPoint": { "lat": 32.06167, "lon": 118.77778 }, "state": "Jiangsu", "status": null, "zip": "210000" }, { "city": "Nantong", "contacts": [ { "email": null, "name": "Hongzhuan Sheng", "phone": "13515203348", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Jian Zhuo", "phone": "18206297131", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Hongzhuan Sheng", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "China", "facility": "Affiliated Hospital of Nantong University", "geoPoint": { "lat": 32.03028, "lon": 120.87472 }, "state": "Jiangsu", "status": null, "zip": "210000" }, { "city": "Suzhou", "contacts": [ { "email": "[email protected]", "name": "Yanhui Sheng", "phone": "13851647530", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Yang Hua", "phone": "13851624359", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Yanhui Sheng", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "China", "facility": "Suzhou Municipal Hospital", "geoPoint": { "lat": 31.30408, "lon": 120.59538 }, "state": "Jiangsu", "status": null, "zip": "210000" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)", "nctId": "NCT06283758", "orgStudyIdInfo": { "id": "PARADISE HTN-III", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Incidence of adverse events" } ], "primaryOutcomes": [ { "measure": "Ambulatory Blood Pressure" } ], "secondaryOutcomes": [ { "measure": "Ambulatory Blood Pressure" }, { "measure": "Office Systolic Blood Pressure" }, { "measure": "Office Systolic Blood Pressure" }, { "measure": "Ambulatory Blood Pressure" }, { "measure": "Ambulatory Blood Pressure" }, { "measure": "Home Blood Pressure" }, { "measure": "Home Blood Pressure" }, { "measure": "Blood pressure control rate" }, { "measure": "Antihypertensive drug load index" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "The Affiliated Jiangning Hospital of Nanjing Medical University" }, { "name": "The First Affiliated Hospital with Nanjing Medical University" }, { "name": "Affiliated Hospital of Nantong University" } ], "leadSponsor": { "class": "OTHER", "name": "Suzhou Municipal Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2026-10" }, "lastUpdatePostDateStruct": { "date": "2024-03-04" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-07" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Platelet-rich Plasma (PRP)" }, { "name": "Saline" } ] }, "conditionsModule": { "conditions": [ "Paraosmia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Palo Alto", "contacts": [ { "email": "[email protected]", "name": "Homer Abaya, BS", "phone": "650-725-6500", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Maxime Fieux, MD, PhD", "phone": "+33621611643", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Zara Patel, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Stanford Sinus Center / Stanford University School of Medicine", "geoPoint": { "lat": 37.44188, "lon": -122.14302 }, "state": "California", "status": null, "zip": "94304" } ] }, "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." }, "designModule": { "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.", "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 40, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia", "nctId": "NCT06283745", "orgStudyIdInfo": { "id": "73225", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Change in Sniffin Sticks Parosmia Test (SSParoT)" }, { "measure": "Change in questionnaire of olfactory disorders (QOD) scale score" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Stanford University" } }, "statusModule": { "completionDateStruct": { "date": "2027-03-22" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2027-03-22" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-23" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Greens powder" } ] }, "conditionsModule": { "conditions": [ "Digestive System Disease" ] }, "contactsLocationsModule": { "locations": [ { "city": "Santa Monica", "contacts": null, "country": "United States", "facility": "Citruslabs", "geoPoint": { "lat": 34.01945, "lon": -118.49119 }, "state": "California", "status": null, "zip": "90404" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 70, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.", "nctId": "NCT06283732", "orgStudyIdInfo": { "id": "20392", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Digestive Health Improvement" } ], "secondaryOutcomes": [ { "measure": "Quality of Life and Well-being Enhancement" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Citruslabs" } ], "leadSponsor": { "class": "INDUSTRY", "name": "Amway Corp" } }, "statusModule": { "completionDateStruct": { "date": "2024-02-15" }, "lastUpdatePostDateStruct": { "date": "2024-03-05" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2024-02-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-11-15" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "ZG006" } ] }, "conditionsModule": { "conditions": [ "Small Cell Lung Cancer", "Neuroendocrine Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Shanghai", "contacts": [ { "email": null, "name": "Shun Lu", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Shun Lu, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "China", "facility": "Shanghai Chest Hospital", "geoPoint": { "lat": 31.22222, "lon": 121.45806 }, "state": "Shanghai", "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 105, "type": "ESTIMATED" }, "phases": [ "PHASE1", "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "75 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "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", "nctId": "NCT06283719", "orgStudyIdInfo": { "id": "ZG006-002", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Objective response rate (ORR)" } ], "secondaryOutcomes": [ { "measure": "Number of participants with adverse events (AEs)" }, { "measure": "Number of participants with serious adverse events (SAEs)" }, { "measure": "Duration of response (DOR)" }, { "measure": "Disease control rate (DCR)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Suzhou Zelgen Biopharmaceuticals Co.,Ltd" } }, "statusModule": { "completionDateStruct": { "date": "2026-04" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-04" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Tryptophan" } ] }, "conditionsModule": { "conditions": [ "Healthy Aging" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "BASIC_SCIENCE", "timePerspective": null }, "enrollmentInfo": { "count": 40, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "90 Years", "minimumAge": "60 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Tryptophan Requirement in Healthy Adults", "nctId": "NCT06283706", "orgStudyIdInfo": { "id": "1000081113", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Determination of tryptophan requirement in adults >60 years of age." } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Canadian Institutes of Health Research (CIHR)" } ], "leadSponsor": { "class": "OTHER", "name": "The Hospital for Sick Children" } }, "statusModule": { "completionDateStruct": { "date": "2025-12-01" }, "lastUpdatePostDateStruct": { "date": "2024-03-01" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-07-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-06-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "mindfulness-based stress reduction" } ] }, "conditionsModule": { "conditions": [ "Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels", "Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program" ] }, "contactsLocationsModule": { "locations": [ { "city": "Istanbul", "contacts": null, "country": "Turkey", "facility": "Saglık Bilimleri Universitesi", "geoPoint": { "lat": 41.01384, "lon": 28.94966 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Randomized controlled classical experimental study", "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" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 86, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "45 Years", "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women", "nctId": "NCT06283693", "orgStudyIdInfo": { "id": "RojdaBAYARYILDIRIM", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Perceived Stress Scale (Appendix 3):" }, { "measure": "Depression-Anxiety-Stress Scale (Appendix 4)" }, { "measure": "Collection and study of salivary cortisol samples" } ], "primaryOutcomes": [ { "measure": "Informed Voluntary Consent Form (Annex 1)" }, { "measure": "Identifying Characteristics Information Form (Annex 2)" }, { "measure": "Perceived Stress Scale (Appendix 3):" }, { "measure": "Depression-Anxiety-Stress Scale (Appendix 4)" }, { "measure": "Collection and study of salivary cortisol samples" } ], "secondaryOutcomes": [ { "measure": "Perceived Stress Scale (Appendix 3):" }, { "measure": "Depression-Anxiety-Stress Scale (Appendix 4)" }, { "measure": "Collection and study of salivary cortisol samples" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Saglik Bilimleri Universitesi" } }, "statusModule": { "completionDateStruct": { "date": "2025-06-10" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-05-10" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-20" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Lung transplantation" } ] }, "conditionsModule": { "conditions": [ "Lung Transplant" ] }, "contactsLocationsModule": { "locations": [ { "city": "Istanbul", "contacts": null, "country": "Turkey", "facility": "OkanU", "geoPoint": { "lat": 41.01384, "lon": 28.94966 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }, "enrollmentInfo": { "count": 213, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "19 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients", "nctId": "NCT06283680", "orgStudyIdInfo": { "id": "2024", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "BMI" } ], "secondaryOutcomes": [ { "measure": "Nutrition risk index" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Koşuyolu Yüksek İhtisas Training and Research Hospital" } ], "leadSponsor": { "class": "OTHER", "name": "Aylin Seylam Küşümler" } }, "statusModule": { "completionDateStruct": { "date": "2024-05-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-08" }, "overallStatus": "ACTIVE_NOT_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-04-28" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-02-28" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Semaglutide" } ] }, "conditionsModule": { "conditions": [ "Obesity" ] }, "contactsLocationsModule": { "locations": [ { "city": "Tokyo", "contacts": null, "country": "Japan", "facility": "Novo Nordisk Investigational Site", "geoPoint": { "lat": 35.6895, "lon": 139.69171 }, "state": "Chiyoda City", "status": null, "zip": "100-0005" } ] }, "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)." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 1000, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": null, "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Special Use - Results Surveillance on Long-term Use With Wegovy®", "nctId": "NCT06283667", "orgStudyIdInfo": { "id": "NN9536-4872", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "World Health Organization (WHO)", "id": "U1111-1266-3863", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Number of Adverse Reactions (ARs)" } ], "secondaryOutcomes": [ { "measure": "Number of Adverse Events (AEs)" }, { "measure": "Number of serious adverse events (SAEs)" }, { "measure": "Number of Serious Adverse Reactions (SARs)" }, { "measure": "Change in body weight (Percent (%))" }, { "measure": "Change in body weight (Kilograms (Kg))" }, { "measure": "Change in waist circumference" }, { "measure": "Change in BMI (Body Mass Index)" }, { "measure": "Change in body weight after treatment discontinuation" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Novo Nordisk A/S" } }, "statusModule": { "completionDateStruct": { "date": "2028-01-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-06-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-22" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "1-lead ECG" } ] }, "conditionsModule": { "conditions": [ "Atrial Fibrillation" ] }, "contactsLocationsModule": { "locations": [ { "city": "Amsterdam", "contacts": null, "country": "Netherlands", "facility": "Amsterdam UMC -vumc", "geoPoint": { "lat": 52.37403, "lon": 4.88969 }, "state": null, "status": null, "zip": null } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 204, "type": "ACTUAL" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "relievED", "briefTitle": "Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation", "nctId": "NCT06283654", "orgStudyIdInfo": { "id": "VUmc 2018.539", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "number of ED visits" } ], "secondaryOutcomes": [ { "measure": "ratio of the number of cardioversions emergency vs planned" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Amsterdam UMC, location VUmc" } }, "statusModule": { "completionDateStruct": { "date": "2023-01-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-26" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2021-09-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2018-09-30" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Liraglutide" } ] }, "conditionsModule": { "conditions": [ "Obesity" ] }, "contactsLocationsModule": { "locations": [ { "city": "Taipei City", "contacts": null, "country": "Taiwan", "facility": "National Taiwan University Hospital", "geoPoint": { "lat": 25.04776, "lon": 121.53185 }, "state": null, "status": null, "zip": "100229" }, { "city": "Taipei City", "contacts": null, "country": "Taiwan", "facility": "National Taiwan University Hospital", "geoPoint": { "lat": 25.04776, "lon": 121.53185 }, "state": null, "status": null, "zip": "100" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 288, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "12 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.", "nctId": "NCT06283641", "orgStudyIdInfo": { "id": "NN8022-7780", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "World Health Organization (WHO)", "id": "U1111-1289-9747", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Incidence of adverse events (AEs) by preferred term (PT)" } ], "secondaryOutcomes": [ { "measure": "Number of adverse drug reaction (ADRs)" }, { "measure": "Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)" }, { "measure": "Number of unexpected AEs and unexpected ADRs" }, { "measure": "Number of unexpected SAEs and unexpected SADRs" }, { "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" }, { "measure": "Body weight loss Percent (%) (Adult)" }, { "measure": "Body weight loss (%) (Adult)" }, { "measure": "Body weight loss Kilogram(Kg) (Adult)" }, { "measure": "Body weight loss (kg) (Adult)" }, { "measure": "The proportion of adult subjects losing at least 5% of baseline body weight" }, { "measure": "The proportion of adult subjects losing at least 5% of baseline body weight" }, { "measure": "The proportion of adult subjects losing more than 10% of baseline body weight" }, { "measure": "The proportion of adult subjects losing more than 10% of baseline body weight" }, { "measure": "The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda®" }, { "measure": "Change in body mass index (BMI) (kg/m^2) (Adolescent)" }, { "measure": "Change in body mass index (BMI) (kg/m^2) (Adolescent)" }, { "measure": "Change in body mass index (BMI) (%) (Adolescent)" }, { "measure": "Change in body mass index (BMI) (%) (Adolescent)" }, { "measure": "Change in body mass index standard deviation score (BMI SDS) (Adolescent)" }, { "measure": "Change in body mass index standard deviation score (BMI SDS) (Adolescent)" }, { "measure": "Body weight loss (%) (Adolescent)" }, { "measure": "Body weight loss (%) (Adolescent)" }, { "measure": "Body weight loss (kg) (Adolescent)" }, { "measure": "Body weight loss (kg) (Adolescent)" }, { "measure": "The proportion of adolescent subjects losing at least 4% of baseline BMI" }, { "measure": "The proportion of adolescent subjects losing at least 4% of baseline BMI" }, { "measure": "The proportion of adolescent subjects losing at least 10% of baseline BMI" }, { "measure": "The proportion of adolescent subjects losing at least 10% of baseline BMI" }, { "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®" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Novo Nordisk A/S" } }, "statusModule": { "completionDateStruct": { "date": "2025-02-28" }, "lastUpdatePostDateStruct": { "date": "2024-04-04" }, "overallStatus": "ENROLLING_BY_INVITATION", "primaryCompletionDateStruct": { "date": "2025-02-28" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-23" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Radiofrequency ablation of lumbar medial branch nerves." } ] }, "conditionsModule": { "conditions": [ "Lumbar Spondylosis" ] }, "contactsLocationsModule": { "locations": [ { "city": "Hershey", "contacts": [ { "email": "[email protected]", "name": "Nancy Ruth Jarbadan, BS", "phone": "717-531-6135", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Penn State Hershey College of Medicine", "geoPoint": { "lat": 40.28592, "lon": -76.65025 }, "state": "Pennsylvania", "status": null, "zip": "17033" } ] }, "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." }, "designModule": { "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,", "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", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 25, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "LMB-RFA", "briefTitle": "Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves", "nctId": "NCT06283628", "orgStudyIdInfo": { "id": "STUDY00023737", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Number of subjects who ceased requiring analgesia" }, { "measure": "Number of subjects who ceased requiring analgesia" }, { "measure": "Number of subjects who ceased requiring analgesia" } ], "primaryOutcomes": [ { "measure": "The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)." }, { "measure": "The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)." }, { "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)" }, { "measure": "Oswestry Disability index (ODI)" }, { "measure": "Oswestry Disability index (ODI)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Milton S. Hershey Medical Center" } }, "statusModule": { "completionDateStruct": { "date": "2025-12" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-12" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Vitamin D" } ] }, "conditionsModule": { "conditions": [ "Intestinal Failure" ] }, "contactsLocationsModule": { "locations": [ { "city": "Nanning", "contacts": [ { "email": "[email protected]", "name": "Xinying Wang, MD", "phone": "+86 13913028866", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Xuejin Gao, MD", "phone": "+86 18251937684", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Xinying Wang, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Xuejin Gao, MD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "China", "facility": "Xinying Wang", "geoPoint": { "lat": 22.81667, "lon": 108.31667 }, "state": "Jiangsu", "status": "RECRUITING", "zip": "210002" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 84, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "70 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency", "nctId": "NCT06283615", "orgStudyIdInfo": { "id": "2024-01-01", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Quality of life score" }, { "measure": "Muscle function status" } ], "secondaryOutcomes": [ { "measure": "Serum vitamin D levels" }, { "measure": "Hepatic and renal function" }, { "measure": "Bone mineral density" }, { "measure": "Thyroid and parathyroid-related hormones" }, { "measure": "Nutritional status indicators" }, { "measure": "Number of participants with treatment-related adverse events" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Jinling Hospital, China" } }, "statusModule": { "completionDateStruct": { "date": "2024-11-30" }, "lastUpdatePostDateStruct": { "date": "2024-03-22" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-11-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-12" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "oral health status" } ] }, "conditionsModule": { "conditions": [ "Pediatric Obesity", "Pediatric Dentistry" ] }, "contactsLocationsModule": { "locations": [ { "city": "Mersin", "contacts": null, "country": "Turkey", "facility": "Aslı Soğukpınar Önsüren", "geoPoint": { "lat": 36.79526, "lon": 34.61792 }, "state": null, "status": null, "zip": null } ] }, "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)." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }, "enrollmentInfo": { "count": 82, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "16 Years", "minimumAge": "6 Years", "sex": "ALL", "stdAges": [ "CHILD" ] }, "identificationModule": { "acronym": null, "briefTitle": "Oral Health in Children and Adolescents With Obesity and Normal Weight", "nctId": "NCT06283602", "orgStudyIdInfo": { "id": "2020/17", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "the results of DMFT, plaque and gingival indies" }, { "measure": "the results of dmft, BEWE, ICDAS-II, probing dept" }, { "measure": "Comparison of demographic attributes between obese and normal weights" } ], "secondaryOutcomes": [ { "measure": "biochemical parameters of obese individuals" }, { "measure": "other biochemical parameters of obese individuals" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Kahramanmaras Sutcu Imam University" } }, "statusModule": { "completionDateStruct": { "date": "2021-04-29" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2021-03-05" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2020-01-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "INZ-701" } ] }, "conditionsModule": { "conditions": [ "Calciphylaxis" ] }, "contactsLocationsModule": { "locations": [ { "city": "Coral Springs", "contacts": [ { "email": "[email protected]", "name": "Ashgar Chaudhry, MD", "phone": "954-510-7620", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "South Florida Nephrology Research", "geoPoint": { "lat": 26.27119, "lon": -80.2706 }, "state": "Florida", "status": "RECRUITING", "zip": "33071" }, { "city": "Hollywood", "contacts": [ { "email": "[email protected]", "name": "Steven Zeig", "phone": "954-900-1101", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Elixia Health", "geoPoint": { "lat": 26.0112, "lon": -80.14949 }, "state": "Florida", "status": "RECRUITING", "zip": "33024" } ] }, "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." }, "designModule": { "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.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 10, "type": "ESTIMATED" }, "phases": [ "PHASE1" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "69 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis", "nctId": "NCT06283589", "orgStudyIdInfo": { "id": "INZ701-401", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Determine if INZ-701 increases PPi levels" } ], "secondaryOutcomes": [ { "measure": "Assess the Time to Maximum Serum Concentration (Tmax)" }, { "measure": "Assess the Maximum Serum Concentration (Cmax) of INZ-701" }, { "measure": "Assess the Area under the concentration-time curve over the dosing interval (AUCtau)" }, { "measure": "Assess the Clearance after extravascular administration of drug (CL/F)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Inozyme Pharma" } }, "statusModule": { "completionDateStruct": { "date": "2024-08-19" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-07-19" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-12" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Liquid biopsy" } ] }, "conditionsModule": { "conditions": [ "Pancreatic Cancer", "IPMN, Pancreatic", "Individuals at Risk", "Chronic Pancreatitis" ] }, "contactsLocationsModule": { "locations": [ { "city": "Stockholm", "contacts": null, "country": "Sweden", "facility": "Gastrocentrum, KarolinskaUniversity Hospital", "geoPoint": { "lat": 59.33258, "lon": 18.0649 }, "state": null, "status": null, "zip": "14186" } ] }, "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)." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 200, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "PANCAID", "briefTitle": "Pancreatic Cancer Initial Detection Via Liquid Biopsy", "nctId": "NCT06283576", "orgStudyIdInfo": { "id": "PANCAID-00-08", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Cancer detection" } ], "secondaryOutcomes": [ { "measure": "Overall survival" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Umeå University" } ], "leadSponsor": { "class": "OTHER", "name": "Karolinska University Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2027-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-24" }, "overallStatus": "ENROLLING_BY_INVITATION", "primaryCompletionDateStruct": { "date": "2027-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Physical activity tracking" }, { "name": "No physical activity tracking" } ] }, "conditionsModule": { "conditions": [ "Multiple Sclerosis" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 10, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Online Physical Activity Tracking in Patients With Multiple Sclerosis", "nctId": "NCT06283563", "orgStudyIdInfo": { "id": "2023/5474", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Smartphone pedometer" }, { "measure": "Smartphone pedometer" }, { "measure": "International Physical Activity Questionnaire - Short Form" }, { "measure": "International Physical Activity Questionnaire - Short Form" } ], "secondaryOutcomes": [ { "measure": "Beck Depression Inventory II" }, { "measure": "Beck Depression Inventory II" }, { "measure": "Beck Anxiety Inventory" }, { "measure": "Beck Anxiety Inventory" }, { "measure": "Fatigue Severity Scale" }, { "measure": "Fatigue Severity Scale" }, { "measure": "Multiple Sclerosis Quality of Life-54" }, { "measure": "Multiple Sclerosis Quality of Life-54" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Inonu University" } }, "statusModule": { "completionDateStruct": { "date": "2025-02-28" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-02-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02-28" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Abrocitinib 200 mg" }, { "name": "Abrocitinib 100 mg" }, { "name": "Placebo" } ] }, "conditionsModule": { "conditions": [ "Chronic Hand Eczema" ] }, "contactsLocationsModule": { "locations": [ { "city": "Montréal", "contacts": [ { "email": "[email protected]", "name": "Rosanna Ottoni, BSc", "phone": "514-521-4285", "phoneExt": "107", "role": "CONTACT" } ], "country": "Canada", "facility": "Innovaderm Research Inc.", "geoPoint": { "lat": 45.50884, "lon": -73.58781 }, "state": "Quebec", "status": null, "zip": "H2X 2V1" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 84, "type": "ESTIMATED" }, "phases": [ "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy", "nctId": "NCT06283550", "orgStudyIdInfo": { "id": "INNO-6052", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "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)" }, { "measure": "Reduction from baseline in hand Physician's Global Assessment (PGA)" }, { "measure": "Change from baseline in Hand Eczema Severity Index (HECSI)" }, { "measure": "Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE)" }, { "measure": "Patient Global Assessment (PaGA) measurements" }, { "measure": "Change from baseline in hand Dermatology Life Quality Index (DLQI)" }, { "measure": "Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)" }, { "measure": "Change from baseline in pain Numerical Rating Scale (NRS)" }, { "measure": "Change from baseline in itch Numerical Rating Scale (NRS)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Innovaderm Research Inc." } }, "statusModule": { "completionDateStruct": { "date": "2025-08" }, "lastUpdatePostDateStruct": { "date": "2024-02-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-05" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Effect of training method" } ] }, "conditionsModule": { "conditions": [ "Training Group, Sensitivity" ] }, "contactsLocationsModule": { "locations": null }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "A comparative randomized controlled trial", "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" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": null, "sex": "FEMALE", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Online Episiotomy Simulation Training for Midwifery Students", "nctId": "NCT06283537", "orgStudyIdInfo": { "id": "KÜBAP-01/2023-39", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "Self-confidence in learning" } ], "primaryOutcomes": [ { "measure": "episiotomy skill performances" } ], "secondaryOutcomes": [ { "measure": "Satisfaction with education" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Kastamonu University" } }, "statusModule": { "completionDateStruct": { "date": "2024-05-30" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-03-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Eye-Tracking" } ] }, "conditionsModule": { "conditions": [ "Multiple Sclerosis" ] }, "contactsLocationsModule": { "locations": [ { "city": "Montréal", "contacts": [ { "email": "[email protected]", "name": "Yousri Benchaar", "phone": "514-906-3876", "phoneExt": "6026", "role": "CONTACT" }, { "email": null, "name": "Alexander Saveriano, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "Canada", "facility": "Genge Partners, Inc.", "geoPoint": { "lat": 45.50884, "lon": -73.58781 }, "state": "Quebec", "status": null, "zip": "H4A 3T4" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "CROSS_SECTIONAL" }, "enrollmentInfo": { "count": 100, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Eye-tracking Investigation of Clinical Measures in Multiple Sclerosis", "nctId": "NCT06283524", "orgStudyIdInfo": { "id": "ETNA-TrainMS", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "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)." }, { "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)." }, { "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)." }, { "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)." }, { "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)." } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Innodem Neurosciences" } }, "statusModule": { "completionDateStruct": { "date": "2026-03-18" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-10-18" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-03-18" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "educational workshops" } ] }, "conditionsModule": { "conditions": [ "Invasive Breast Cancer" ] }, "contactsLocationsModule": null, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_ONLY", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 200, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "99 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Evaluation of the RESTART Survival Programme", "nctId": "NCT06283511", "orgStudyIdInfo": { "id": "IJB-RESTART", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "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" }, { "measure": "assessemnt of health literacy via HLQ questionnaire" }, { "measure": "assessment of professional status" }, { "measure": "assessment of level of physical activity" }, { "measure": "assessment of emotionnal distress" }, { "measure": "assessment of the intensity of residual fatigue" }, { "measure": "assessment of sleep quality" }, { "measure": "Measuring the rate of participation in the programme" }, { "measure": "assessment of quality of life" }, { "measure": "assessment of emotionnal distress" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Jules Bordet Institute" } }, "statusModule": { "completionDateStruct": { "date": "2026-12" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-08" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-02" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "Device Morpheus8V" } ] }, "conditionsModule": { "conditions": [ "Overactive Bladder Syndrome" ] }, "contactsLocationsModule": { "locations": [ { "city": "Corona Del Mar", "contacts": null, "country": "United States", "facility": "Mickey Karram MD", "geoPoint": { "lat": 33.59808, "lon": -117.87311 }, "state": "California", "status": null, "zip": "92625" }, { "city": "Knoxville", "contacts": null, "country": "United States", "facility": "Institute for Female Pelvic Medicine", "geoPoint": { "lat": 35.96064, "lon": -83.92074 }, "state": "Tennessee", "status": null, "zip": "37932" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 20, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "80 Years", "minimumAge": "21 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder", "nctId": "NCT06283498", "orgStudyIdInfo": { "id": "DO612574A", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Change in urgency incontinence episodes after 3 month" } ], "secondaryOutcomes": [ { "measure": "Change in urgency incontinence episodes after 1 month" }, { "measure": "Change in urgency incontinence episodes" }, { "measure": "Change in urgency incontinence episodes" }, { "measure": "Analysis to assess the urinary frequency" }, { "measure": "Analysis to assess urinary frequency" }, { "measure": "Analysis to assess the urinary frequency." }, { "measure": "Analysis to assess the urinary frequency." }, { "measure": "Assessment of the impact of the treatment on Overactive Bladder symptoms" }, { "measure": "Assessment of the impact of the treatment on Overactive Bladder symptoms" }, { "measure": "Assessment of the impact of the treatment on Overactive Bladder symptoms" }, { "measure": "Assessment of the impact of the treatment on Overactive Bladder symptoms" }, { "measure": "Patient-reported Pain assessment" }, { "measure": "Patient-reported outcome measure" }, { "measure": "Patient-reported outcome measure" }, { "measure": "Patient-reported outcome measure" }, { "measure": "Patient-reported outcome measure" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "InMode MD Ltd." } }, "statusModule": { "completionDateStruct": { "date": "2026-07" }, "lastUpdatePostDateStruct": { "date": "2024-03-01" }, "overallStatus": "ENROLLING_BY_INVITATION", "primaryCompletionDateStruct": { "date": "2025-11" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-11-10" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "ultrasound examination" } ] }, "conditionsModule": { "conditions": [ "Artificial Intelligent", "Ultrasound Therapy; Complications", "Nerve Block" ] }, "contactsLocationsModule": { "locations": [ { "city": "Konya", "contacts": [ { "email": "[email protected]", "name": "Yasin Tire", "phone": "+905055367970", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Betül Afşar", "phone": null, "phoneExt": null, "role": "CONTACT" } ], "country": "Turkey", "facility": "Yasin Tire", "geoPoint": { "lat": 37.87135, "lon": 32.48464 }, "state": "Meram", "status": "RECRUITING", "zip": "42140" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CONTROL", "primaryPurpose": null, "timePerspective": "CROSS_SECTIONAL" }, "enrollmentInfo": { "count": 150, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Real-time Anatomy Recognition Tool Accuracy Research for Ultrasound-guided PENG and Suprainguinal Fascia Iliaca Blocks", "nctId": "NCT06283485", "orgStudyIdInfo": { "id": "Study Artificial intelligence", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Artificial intelligence Program size" }, { "measure": "Score of assessment the pictures" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Betül Afşar" } ], "leadSponsor": { "class": "OTHER", "name": "Konya City Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2024-05-25" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-04-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-12-15" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "High-Intensity Cue" }, { "name": "Low-Intensity Cue" } ] }, "conditionsModule": { "conditions": [ "Alcohol Use Disorder" ] }, "contactsLocationsModule": null, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups.", "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }, "enrollmentInfo": { "count": 150, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "60 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": "BEAM", "briefTitle": "Enhancing Prospective Thinking in Early Recovery (BEAM)", "nctId": "NCT06283472", "orgStudyIdInfo": { "id": "1805574553; Aims 14-16", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "National Institute on Alcohol Abuse and Alcoholism", "id": "2P60AA007611-403343", "link": null, "type": "OTHER_GRANT" }, { "domain": null, "id": "2P60AA007611", "link": "https://reporter.nih.gov/quickSearch/2P60AA007611", "type": "NIH" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Increase Prospective Thinking" }, { "measure": "Delayed Rewards" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Indiana University" } }, "statusModule": { "completionDateStruct": { "date": "2027-02-01" }, "lastUpdatePostDateStruct": { "date": "2024-03-01" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-12-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-06-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "IMNN-101" } ] }, "conditionsModule": { "conditions": [ "SARS CoV 2 Infection" ] }, "contactsLocationsModule": { "locations": [ { "city": "Boston", "contacts": [ { "email": "[email protected]", "name": "Elizabeth Oginni", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Ai-Ris Y Collier, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Beth Israel Deaconess Medical Center", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts", "status": null, "zip": "02215" }, { "city": "Philadelphia", "contacts": [ { "email": "[email protected]", "name": "Kyle Bramble", "phone": null, "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Kem Yenal, MD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "DM Clinical Research", "geoPoint": { "lat": 39.95233, "lon": -75.16379 }, "state": "Pennsylvania", "status": null, "zip": "19107" } ] }, "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)." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 74, "type": "ESTIMATED" }, "phases": [ "PHASE1", "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2", "nctId": "NCT06283459", "orgStudyIdInfo": { "id": "301-23-101", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Number of participants with local and systemic reactogenicity adverse events and all adverse events" }, { "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" }, { "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." }, { "measure": "Number of participants with seroresponse rate (SRR)." } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Imunon" } }, "statusModule": { "completionDateStruct": { "date": "2025-09-30" }, "lastUpdatePostDateStruct": { "date": "2024-04-05" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-09-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-01" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null
{ "armsInterventionsModule": { "interventions": [ { "name": "High-Intensity Cue" }, { "name": "Low-Intensity Cue" } ] }, "conditionsModule": { "conditions": [ "Alcohol Use Disorder" ] }, "contactsLocationsModule": { "locations": [ { "city": "Indianapolis", "contacts": [ { "email": "[email protected]", "name": "Sarah Turo, BA", "phone": "317-963-7220", "phoneExt": null, "role": "CONTACT" }, { "email": "[email protected]", "name": "Colton Lind, BS", "phone": "317-963-2554", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Brandon G Oberlin, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "Indiana University School of Medicine - Goodman Hall", "geoPoint": { "lat": 39.76838, "lon": -86.15804 }, "state": "Indiana", "status": "RECRUITING", "zip": "46202" } ] }, "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups.", "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "BASIC_SCIENCE", "timePerspective": null }, "enrollmentInfo": { "count": 98, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "60 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": "NERF", "briefTitle": "Enhancing Prospective Thinking in Early Recovery", "nctId": "NCT06283446", "orgStudyIdInfo": { "id": "1805574553; Aims 11-13", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": null, "id": "1R21AA029760-01", "link": "https://reporter.nih.gov/quickSearch/1R21AA029760-01", "type": "NIH" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Increase Prospective Thinking" }, { "measure": "Delayed Rewards" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" } ], "leadSponsor": { "class": "OTHER", "name": "Indiana University" } }, "statusModule": { "completionDateStruct": { "date": "2024-07-31" }, "lastUpdatePostDateStruct": { "date": "2024-02-28" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-07-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-12-20" }, "studyFirstPostDateStruct": { "date": "2024-02-28" } } }
false
null