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protocolSection identificationModule nctId: NCT06315946, orgStudyIdInfo id: 17E3241, briefTitle: Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product., statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-04, primaryCompletionDateStruct date: 2019-01-07, completionDateStruct date: 2019-03-11, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Oystershell NV, class: INDUSTRY, descriptionModule briefSummary: Evaluate the efficacy of the test medical device (Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover)., conditionsModule conditions: Skin Tags, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Pixie® skin tag, interventions name: Wortie® Skin Tag Remover, outcomesModule primaryOutcomes measure: Percentage of subjects with successful treatment, secondaryOutcomes measure: Number of treatments, secondaryOutcomes measure: Visual aspect, secondaryOutcomes measure: Macrophotographs on skin tag remission, secondaryOutcomes measure: Evaluation of the skin condition, secondaryOutcomes measure: Degree of pain, secondaryOutcomes measure: Recording of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: DERMSCAN - PharmScan, city: Villeurbanne, zip: 69100, country: France, geoPoint lat: 45.76667, lon: 4.88333, hasResults: False
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protocolSection identificationModule nctId: NCT06315933, orgStudyIdInfo id: S-K1093, briefTitle: Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-01-13, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: In the past, a large number of animal studies have suggested that anesthesia exposure has potential neurotoxic effects, resulting in persistent cognitive and behavioral deficits. At present, there is still a lack of sufficient clinical research evidence to prove whether anesthesia exposure has long-term effects on neurodevelopment. The existing clinical research data suggests that a single short-time anesthesia exposure in young children does not affect long-term neurodevelopmental outcomes. Early onset scoliosis, including congenital scoliosis, is a type of scoliosis deformity that occurs before the age of 10. Posterior scoliosis correction surgery is one of the common treatment. There is currently no research indicating the impact of early single or multiple long-duration anesthesia exposure on the neurological development of children with congenital scoliosis. The aim of this study is to determine the long-term effect of general anesthesia exposure on neurocognitive function and behavior in children with congenital scoliosis, in order to provide reference for related clinical work., conditionsModule conditions: General Anesthetics Toxicity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: General anesthesia, outcomesModule primaryOutcomes measure: full-scale intelligence quotient, FSIQ, secondaryOutcomes measure: Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI), Working Memory Index (WMI), Processing Speed Index (PSI), secondaryOutcomes measure: CBCL Total score, CBCL Internalizing score, CBCL Externalizing score, secondaryOutcomes measure: SDQ Emotional symptoms, SDQ conduct problems, SDQ hyperactivity, SDQ peer problems, SDQ total difficulties, SDQ prosocial behaviors, SDQ impact factor, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Lulu Ma, Dr., role: CONTACT, phone: 0086-010-13811049619, email: malulu@pumch.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06315920, orgStudyIdInfo id: AFMS-MREC 009/2021, briefTitle: Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department, acronym: PASC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Oman Medical Speciality Board, class: OTHER_GOV, collaborators name: Armed Forces Hospital, Oman, descriptionModule briefSummary: Introduction: This study focuses on the treatment of painful crises in Sickle Cell Disease (SCD) patients using Paracoxib, a non-opioid, compared to Morphine. It addresses the need for alternative medications that reduce opioid dependency while providing effective analgesia.Objectives:Primary: Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises.Secondary: Reduce opioid use/dependence, decrease the length of hospital stays, and monitor side effects related to Paracoxib.Methodology: A double-blinded randomized controlled trial, conducted in a tertiary care emergency department. The study includes adult SCD patients with moderate to severe crises, excluding non-VOC pain, certain medications, and specific medical conditions. The sample size is 226 patients, split equally into two groups.Intervention: Patients receive either Morphine or Paracoxib, with periodic assessment of vital signs and pain. Additional Morphine is administered if required. Data collection and analysis are meticulously planned.Expected Outcomes: Improvement in SCD pain management, reduction in opioid usage, and potential benefits in terms of hospital stays and patient satisfaction., conditionsModule conditions: Sickle-Cell Disease With Crisis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The masking process involves the following steps:Preparation of Medication: A nurse, who is not involved in the direct care or assessment of the patients, will prepare the medications. This nurse is the only individual aware of the specific treatment being administered to each patient. The medications are prepared in a manner that makes them indistinguishable from each other in appearance, labeling, and administration method.Administration of Medication: The medications are then administered to the patients by healthcare providers who are blinded to the nature of the medication. This ensures that their assessment of the patient's response is not influenced by knowledge of the treatment being given.Assessment and Data Collection: The assessment of pain relief, side effects, and other relevant clinical outcomes is conducted by healthcare providers who are blinded to the treatment allocation. This minimizes bias in the evaluation of the treatment's efficacy and safety., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 226, type: ESTIMATED, armsInterventionsModule interventions name: Parecoxib, interventions name: Morphine, outcomesModule primaryOutcomes measure: Pain reduction at 60 mins., secondaryOutcomes measure: Adverse Events/Side Effects, secondaryOutcomes measure: The need of rescue pain medications, secondaryOutcomes measure: Recurrent visit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315907, orgStudyIdInfo id: PBRC 2024-012, briefTitle: Development and Validation of a Brief Food Noise Questionnaire, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-05-24, completionDateStruct date: 2024-05-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Pennington Biomedical Research Center, class: OTHER, collaborators name: Weight Watchers International, descriptionModule briefSummary: The purpose of the research is to develop and test the reliability and validity of a brief questionnaire to measure food noise., conditionsModule conditions: Eating Behavior, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Responses to survey questions, outcomesModule primaryOutcomes measure: Scores on the food noise questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pennington Biomedical Research Center, city: Baton Rouge, state: Louisiana, zip: 70806, country: United States, geoPoint lat: 30.45075, lon: -91.15455, hasResults: False
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protocolSection identificationModule nctId: NCT06315894, orgStudyIdInfo id: PI-22-191, briefTitle: Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study), acronym: SuperCAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, class: OTHER, collaborators name: Institut de Recerca de la SIDA IrsiCaixa, collaborators name: Germans Trias i Pujol Hospital, descriptionModule briefSummary: SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition., conditionsModule conditions: Post-COVID Condition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: SuperCAP Program, outcomesModule primaryOutcomes measure: Change in Self-reported Cognitive Functioning, secondaryOutcomes measure: Change in Performance-based Cognitive Functioning, secondaryOutcomes measure: Change in Depression Symptoms, secondaryOutcomes measure: Change in Anxiety Symptoms, secondaryOutcomes measure: Change in Daily Activities Functioning, secondaryOutcomes measure: Change in Physical Activity, secondaryOutcomes measure: Change in Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Germans Trias I Pujol Hospital, status: RECRUITING, city: Badalona, state: Barcelona, zip: 08916, country: Spain, contacts name: Jose A MUñoz-Moreno, MD,PhD, role: CONTACT, phone: 93 465 7897, email: jmuñoz@lluita.org, contacts name: Jose A. Muñoz-Moreno, MD,PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, hasResults: False
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protocolSection identificationModule nctId: NCT06315881, orgStudyIdInfo id: OSU-23116, secondaryIdInfos id: NCI-2024-00666, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: U54CA287392, type: NIH, link: https://reporter.nih.gov/quickSearch/U54CA287392, briefTitle: Informing Oral Nicotine Pouch Regulations to Promote Public Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ohio State University Comprehensive Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs., conditionsModule conditions: Tobacco-Related Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Cigarette, interventions name: Nicotine Oral Pouch, interventions name: Nicotine Oral Pouch, interventions name: Nicotine Oral Pouch, interventions name: Nicotine Oral Pouch, interventions name: Smokeless Tobacco, interventions name: Survey Administration, interventions name: Text Message-Based Navigation Intervention, outcomesModule primaryOutcomes measure: Increased nicotine delivery, primaryOutcomes measure: Liking, primaryOutcomes measure: Craving/withdrawal suppression, primaryOutcomes measure: Rate of switching to ONP, primaryOutcomes measure: Rate of switching to ONPs, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Brittney L. Keller-Hamilton, PhD, MPH, role: CONTACT, phone: 614-366-9652, contacts name: Brittney L. Keller-Hamilton, PhD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06315868, orgStudyIdInfo id: 5590, briefTitle: Breast Cancer Subtype Characterization Through Patient's Derived Organoids., acronym: BCinsightPDO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2026-06-15, completionDateStruct date: 2027-06-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for BC patients lacking targeted therapies, such as TNBC, or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies.The refinement of 3D-cultivation techniques, experienced in the last decade, has allowed cultivation of patients-derived cancer cells in organotypic structures, named patient-derived organoids (PDO), which preserve histologic, genomic and transcriptomic features of primary tumors. PDO allow propagation, pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting, thus representing a promising tool in the development of personalized therapies, conditionsModule conditions: Breast Cancer, conditions: Organoids, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 306, type: ESTIMATED, outcomesModule primaryOutcomes measure: evaluate the histological and molecular conformity (yes/no) between PDO and matched primary and/or recurrent BC sample, in order to develop a live biobank of ER/PR+, HER2+ and TNBC PDO., primaryOutcomes measure: evaluate the sensitivity of ER/PR+, HER2+ and TNBC PDO to novel therapeutic agents in clinical trials for BC or other cancer types, secondaryOutcomes measure: test the sensitivity of PDO to splicing-targeting treatments, either alone or in combination with other therapies, secondaryOutcomes measure: test the synergizing effects of agents splicing-targeting treatments to immunotherapies by co-culture experiments with autologous immune cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Policlinico A. Gemelli, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: alba di leone, MD, role: CONTACT, phone: 0039 3474980503, email: alba.dileone@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06315855, orgStudyIdInfo id: STUDY00006928, briefTitle: Leveraging Telehealth to Improve Oral Health Among Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-03-25, completionDateStruct date: 2025-12-25, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Georgetown University, class: OTHER, descriptionModule briefSummary: The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors., conditionsModule conditions: Oral Mucositis, conditions: Periodontal Diseases, conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Telehealth Intervention (THI), outcomesModule primaryOutcomes measure: mucositis, primaryOutcomes measure: gingival inflammation and periodontal disease, primaryOutcomes measure: tooth decay, primaryOutcomes measure: oral health related quality of life, secondaryOutcomes measure: systemic inflammation, secondaryOutcomes measure: overall health related quality of life, secondaryOutcomes measure: comorbidities, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06315842, orgStudyIdInfo id: CSAPG-44, briefTitle: Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients, acronym: NIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de l'Alt Penedès i Garraf, class: OTHER, descriptionModule briefSummary: The objective of this clinical trial is to investigate the impact of implementing a tool for adjusting the level of diagnostic and therapeutic intensity in the clinical practice of physicians attending hospitalized patients.The goal of this clinical trial is to investigate the impact of a tool for adjusting diagnostic and therapeutic intensity in hospitalized patients. The main question it aims to answer is: Is there a difference in patient mortality when using the aforementioned tool? The participating physicians will be grouped into 4 groups (5 physicians each). Each group will progressively (every 3 months) incorporate the use of the aforementioned tool into their usual clinical practice., conditionsModule conditions: Acute Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The participating physicians will be grouped into 4 clusters (5 physicians each). Each cluster will progressively (every 3 months) incorporate the use of a level of diagnostic and therapeutic intensity tool into their usual clinical practice., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col., interventions name: Usual clinical practice, outcomesModule primaryOutcomes measure: In-hospital Patient Mortality at 90 days from hospital discharge, secondaryOutcomes measure: In-hospital Patient Mortality at 6 months from hospital discharge, secondaryOutcomes measure: In-hospital Patient Mortality at 1 year from hospital discharge, secondaryOutcomes measure: Delirium Incidence, secondaryOutcomes measure: Pressure Ulcer Incidence, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: Hospital readmission for any reason, secondaryOutcomes measure: Hospital readmission for same reason, secondaryOutcomes measure: Patients admitted to the Intensive Care Unit (ICU), secondaryOutcomes measure: Calls to the "on-call doctor", secondaryOutcomes measure: Healthcare expenditure, secondaryOutcomes measure: Mortality at ICU, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Consorci Sanitari Alt Penedes i Garraf, city: Vilafranca Del Penedès, state: Barcelona, zip: 08720, country: Spain, contacts name: Helena Camell, role: CONTACT, phone: +34 938960025, phoneExt: 46048, email: hcamell@csapg.cat, contacts name: Noemí Casaponsa, role: CONTACT, phone: +34 938960025, phoneExt: 43197, email: recerca@csapg.cat, geoPoint lat: 41.34618, lon: 1.69713, hasResults: False
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protocolSection identificationModule nctId: NCT06315829, orgStudyIdInfo id: IRB00429753, briefTitle: Artificial Intelligence-based Video Analysis to Detect Infantile Spasms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment. The purpose of this study is to develop a computer program that can reliably differentiate infantile spasms from similar, yet benign movements in videos. This computer program will learn from videos taken by parents of study participants. Quickly recognizing and treating infantile spasms is crucial for ensuring the best developmental outcomes., conditionsModule conditions: Infantile Spasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Spasm Vision, outcomesModule primaryOutcomes measure: Model Sensitivity (Recall), primaryOutcomes measure: Model Specificity, primaryOutcomes measure: Model Positive Predictive Value (Precision), primaryOutcomes measure: Model Negative Predictive Value, eligibilityModule sex: ALL, maximumAge: 2 Years, stdAges: CHILD, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Glenn Rivera, MD, role: CONTACT, phone: 410-955-4259, email: griver14@jh.edu, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06315816, orgStudyIdInfo id: DokuzEU-1, briefTitle: Virtual Reality Used During Tooth Extraction and Extirpation Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Murat Bektaş, class: OTHER, descriptionModule briefSummary: This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years., conditionsModule conditions: Anxiety and Fear, conditions: Tooth Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The population will consist of children between the ages of 7-10 who presented to the pediatric dental clinic of an oral and dental health center Turkey. The sample size of the study was calculated as GPOWER 3.1 statistical analysis software, based on a significance level of 0.05, a power value of 80%, and an effect size of 0.15 (medium effect size). Considering 10% attrition, it will plan to sample a total of 80 children, including 40 in the experimental group and 40 in the control group. Eventually, a total of 120 children, 60 in the experimental group and 60 in the control group,will include in the study to reveal the relationship between the variables more clearly., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The data will be analyzed by a statistician blind to the groups., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: virtual reality glasses used during tooth extraction and extirpation treatment, outcomesModule primaryOutcomes measure: Anxiety Means, primaryOutcomes measure: Fear Means, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hakkari University, status: RECRUITING, city: Hakkari, state: Merkez, country: Turkey, contacts name: Dilek Demir Kösem, PhD, role: CONTACT, phone: +9005534813290, email: dilekdemir624@gmail.com, geoPoint lat: 37.57444, lon: 43.74083, locations facility: Hakkari University, status: RECRUITING, city: Hakkari, country: Turkey, contacts name: Dilek Demir Kösem, PhD, role: CONTACT, phone: +9005534813290, email: dilekdemir624@gmail.com, geoPoint lat: 37.57444, lon: 43.74083, hasResults: False
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protocolSection identificationModule nctId: NCT06315803, orgStudyIdInfo id: ChinaPLAGH20230601, briefTitle: Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-23, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Yi Mao, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question\[s\] it aims to answer are:* The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography.* The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster.Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score., conditionsModule conditions: Lumbar Disc Herniation, conditions: Percutaneous Endoscopic Lumbar Discectomy, conditions: Three-dimension Ultrasound, conditions: Learning Curves, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: There are practical differences in operation and blind methods cannot be achieved., enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: Real-time 3D Xplane ultrasound, outcomesModule primaryOutcomes measure: the first success rate, primaryOutcomes measure: number of punctures, primaryOutcomes measure: number of radiographies, primaryOutcomes measure: puncture time, secondaryOutcomes measure: operator confidence score, secondaryOutcomes measure: operative time, secondaryOutcomes measure: incidence of puncture relevant complications, secondaryOutcomes measure: satisfaction of patients, otherOutcomes measure: visual analog scale of pain, otherOutcomes measure: Oswestry disability index, otherOutcomes measure: modified Macnab criteria type, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100853, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06315790, orgStudyIdInfo id: TN BTX-A Trial, briefTitle: Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Henrik Schytz, class: OTHER, descriptionModule briefSummary: This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1., conditionsModule conditions: Trigeminal Neuralgia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Botulinum toxin A, interventions name: Isotonic saline, outcomesModule primaryOutcomes measure: Proportion of responders in botulunim toxin A and placebo group, secondaryOutcomes measure: Biomarkers, secondaryOutcomes measure: Tear fluid CGRP, secondaryOutcomes measure: 50 % reduction, secondaryOutcomes measure: 75 % reduction, secondaryOutcomes measure: Prolonged 30 % reduction, secondaryOutcomes measure: Change in paroxysms, secondaryOutcomes measure: PGI-C, secondaryOutcomes measure: PENN Facial Pain Scale-Revised (PENN-FPS-R), secondaryOutcomes measure: Patient's guess, secondaryOutcomes measure: Dropouts, secondaryOutcomes measure: Side effects, otherOutcomes measure: Pure paroxysmal pain vs. paroxysms with concomitant pain, otherOutcomes measure: Idiopathic vs. classical trigeminal neuralgia, otherOutcomes measure: Patients with severe pain, otherOutcomes measure: Gender distribution, otherOutcomes measure: Disease duration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danish Headache Center, status: RECRUITING, city: Glostrup, zip: 2600, country: Denmark, contacts name: Henrik Schytz, MD, role: CONTACT, phone: +4528761824, email: henrik.winther.schytz.01@regionh.dkonh.dk, contacts name: Henrik Schytz, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.6666, lon: 12.40377, hasResults: False
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protocolSection identificationModule nctId: NCT06315777, orgStudyIdInfo id: FRGS/1/2021/SKK01/UKM/02/1, briefTitle: GREM1, HAS2 and PTGS2 Gene Expression Following the in Vitro Maturation (IVM), statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: National University of Malaysia, class: OTHER, descriptionModule briefSummary: Poor ovarian reserve (POR) is an adverse prognostic factor for In-Vitro Fertilization (IVF) success. Numerous established data showed low live birth rates per IVF cycle; 6 to 10%, including the usage of In-Vitro Maturation (IVM). In Malaysia, POR incidence increases mainly from cancer survival, endometriosis, and autoimmune diseases women; therefore, IVM implementation is paramount. In the molecular level, the low competence oocytes showed a low expression of GREM1, HAS2 and PTGS2 in human cumulus cells, thus leading to poor oocyte quality(OQ). Various IVM media had been formulated to enhance the competency and quality of the oocytes to date. Therefore, our study aims to elucidate the GREM1, HAS2 and PTGS2 gene expression as oocyte developmental competency markers among POR women following IVM and tailored to the IVF outcome., conditionsModule conditions: Increased Oocyte Death, conditions: in Vitro Maturation, conditions: GREM1 Gene Mutation, conditions: Cumulus Cell, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: cumulus cell oocytes complex (COC) among women with poor ovarian reserve, outcomesModule primaryOutcomes measure: normal ovarian reserve, primaryOutcomes measure: poor ovarian reserve, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Advanced Reproductive Centre, status: RECRUITING, city: Kuala Lumpur, state: Wilayah Persekutuan Kuala Lumpur, zip: 56000, country: Malaysia, contacts name: Muhammad Azrai AA Abu, role: CONTACT, phone: +60196410944, email: azraiabu1983@gmail.com, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False
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protocolSection identificationModule nctId: NCT06315764, orgStudyIdInfo id: Hypertensive patients, briefTitle: Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2022-01-30, completionDateStruct date: 2023-05-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group (A):It consists of twenty female patients suffering from hypertension who underwent medical treatment as well as peddler training three times per week for eight weeks. After four weeks of treatment (post-1) and another four weeks of treatment, the post evaluation was used (post-2).Group (B):This group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Reflexology, outcomesModule primaryOutcomes measure: Insomnia severity index, primaryOutcomes measure: Short form 36 quality of life questionnaire (SF-36):, primaryOutcomes measure: Blood pressure measurements:, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Heba Mousa, city: Cairo, zip: 11517, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06315751, orgStudyIdInfo id: NOE-TTS-201, briefTitle: Efficacy and Safety of Gemlapodect in Adults and Adolescents With Tourette Syndrome, acronym: Allevia2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Noema Pharma AG, class: INDUSTRY, descriptionModule briefSummary: This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS. Adolescents will be enrolled after a sentinel cohort of adults is complete., conditionsModule conditions: Tourette Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Gemlapodect, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R), secondaryOutcomes measure: Impact on patient functioning, secondaryOutcomes measure: Change in PUTS, secondaryOutcomes measure: Safety and Tolerability of gemlapodect, secondaryOutcomes measure: Assessment of suicidality and suicidal ideation, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315738, orgStudyIdInfo id: ST266-NEC-201, briefTitle: Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Noveome Biotherapeutics, formerly Stemnion, class: INDUSTRY, collaborators name: Parexel, descriptionModule briefSummary: The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC., conditionsModule conditions: Necrotizing Enterocolitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ST266, outcomesModule primaryOutcomes measure: Safety and Tolerability endpoint: incidence of adverse events, primaryOutcomes measure: Safety and Tolerability endpoint: incidence of serious adverse events, primaryOutcomes measure: Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression, secondaryOutcomes measure: Efficacy endpoint: Time to pneumatosis resolution, secondaryOutcomes measure: Efficacy endpoint: Time to full enteral nutrition assessment, secondaryOutcomes measure: Efficacy endpoint: Incidence of abdominal surgical intervention, secondaryOutcomes measure: Efficacy endpoint: Change in Neonatal Sequential Organ Failure Assessment (nSOFA) score, otherOutcomes measure: Exploratory endpoint: All cause mortality, otherOutcomes measure: Exploratory endpoint: Length of stay in the NICU, otherOutcomes measure: Exploratory endpoint: Change in weight over time, otherOutcomes measure: Exploratory endpoint: Change in length over time, otherOutcomes measure: Exploratory endpoint: Change in head circumference over time, otherOutcomes measure: Exploratory endpoint: Number of significant apnea events/day over time, otherOutcomes measure: Exploratory endpoint: Number of significant bradycardia events/day over time, otherOutcomes measure: Exploratory endpoint: Number of significant temperature instability events/day over time, otherOutcomes measure: Exploratory endpoint: Time to return to normal bowel sounds, otherOutcomes measure: Exploratory endpoint: Change in serum C-reactive protein (CRP), otherOutcomes measure: Exploratory endpoint: Time to return to normal serum platelet count levels, otherOutcomes measure: Exploratory endpoint: Incidence of intestinal or colonic strictures, otherOutcomes measure: Exploratory endpoint: Incidence of sepsis, otherOutcomes measure: Exploratory endpoint: Incidence of retinopathy, otherOutcomes measure: Exploratory endpoint: Incidence of bronchopulmonary dysplasia (BPD), otherOutcomes measure: Exploratory endpoint: Incidence of pulmonary hypertension (PH), otherOutcomes measure: Exploratory endpoint: Incidence of periventricular leukomalacia, eligibilityModule sex: ALL, minimumAge: 2 Weeks, maximumAge: 8 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: BayCare Health System-St. Joseph's Women's Hospital, status: RECRUITING, city: Tampa, state: Florida, zip: 33607, country: United States, contacts name: Jenelle Ferry, MD, role: CONTACT, phone: 813-872-2924, email: jenelle.ferry@baycare.org, contacts name: Jenelle Ferry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
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protocolSection identificationModule nctId: NCT06315725, orgStudyIdInfo id: 2024-10504, briefTitle: Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D), acronym: AFS_T1D, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time.Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level.To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study.Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker., conditionsModule conditions: Type 1 Diabetes (T1D), conditions: Healthy Subjects, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: OTHER, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Sweet taste perception with/without sweet taste blockade, outcomesModule primaryOutcomes measure: Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals, primaryOutcomes measure: Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption., secondaryOutcomes measure: Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315712, orgStudyIdInfo id: 004201, briefTitle: Inspiratory Muscle Training in Burned Adults, acronym: Burns, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-15, primaryCompletionDateStruct date: 2022-06-16, completionDateStruct date: 2023-09-11, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Qassim University, class: OTHER, collaborators name: Cairo University, descriptionModule briefSummary: The study outlines burn injury impact, emphasizes need for long-term rehabilitation. Study assesses inspiratory muscle training efficacy in improving respiratory strength, lung function, and exercise capacity in adult burn patients., conditionsModule conditions: Burn Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: inspiratory exercise, interventions name: Pulmonary rehabilitation, outcomesModule primaryOutcomes measure: maximal inspiratory pressure, primaryOutcomes measure: maximal inspiratory pressure, primaryOutcomes measure: maximal expiratory pressure, primaryOutcomes measure: maximal expiratory pressure, primaryOutcomes measure: Forced expiratory volume in 1 second, primaryOutcomes measure: Forced expiratory volume in 1 second, primaryOutcomes measure: forced vital capacity, primaryOutcomes measure: forced vital capacity, primaryOutcomes measure: Forced expiratory volume in 1 second/ forced vital capacity ratio, primaryOutcomes measure: Forced expiratory volume in 1 second/ forced vital capacity ratio, secondaryOutcomes measure: Functional exercise capacity, secondaryOutcomes measure: Functional exercise capacity, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, Cairo University, city: Giza, state: Dokki, zip: 11432, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06315699, orgStudyIdInfo id: QL000001, secondaryIdInfos id: MR-37-24-002019, type: REGISTRY, domain: Chinese Clinical Trial Registry, briefTitle: Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-03-02, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: This study focuses on therapeutic targets for cognitive, motor, and social impairments in Williams syndrome by reversing brain myelin defects caused by GTF2I. The primary objective of the study was to test and evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome., conditionsModule conditions: Williams Syndrome, conditions: Child, conditions: Neurodevelopmental Delay, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Clemastine Fumarate Tablets, interventions name: fructose, outcomesModule primaryOutcomes measure: Anisotropy Score (FA), primaryOutcomes measure: Radial diffusion rate (RD), primaryOutcomes measure: Apparent dispersion coefficient（ADC）, primaryOutcomes measure: Magnetization transfer ratio（MTR）, primaryOutcomes measure: SRS Score 2(Social Response Scale2) score, primaryOutcomes measure: Peabody（Motion Estimation Timewarp）score, primaryOutcomes measure: Gesell Development Scale, secondaryOutcomes measure: Differential pressure across valves, secondaryOutcomes measure: Thyroid hormone value, secondaryOutcomes measure: Conners Parent Symptoms Questionnaire Score, secondaryOutcomes measure: Vailand-3 scale, secondaryOutcomes measure: CSHQ Children's Sleep Habits Questionnaire Score, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Tainan, state: Shangdong, zip: 250012, country: China, contacts name: cao aihua, role: CONTACT, phone: +18560086317, email: xinercah@163.com, contacts name: Liu zhiyue, role: CONTACT, phone: 15665785296, email: mikeydrakon8@gmail.com, hasResults: False
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protocolSection identificationModule nctId: NCT06315686, orgStudyIdInfo id: MA-ENDO-202209, briefTitle: The Dynamic Monitoring of Cerebrospinal Fluid ctDNA, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-29, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Jiangsu Province Nanjing Brain Hospital, class: OTHER, descriptionModule briefSummary: Focusing on advanced EGFR mutation in NSCLC patients with leptomeningeal metastasis, vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was used to dynamically monitor ctDNA in cerebrospinal fluid (CSF), analyze the ctDNA gene mutation profile of CSF in different patients, and explore the relationship between ctDNA and efficacy and prognosis., conditionsModule conditions: NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: pemetrexed, outcomesModule primaryOutcomes measure: The progression-free survival time（PFS）, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing Brain Hospital, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 210029, country: China, contacts name: fang S Cun, M.D., role: CONTACT, phone: 83728558, phoneExt: 025, email: fang1984@aliyun.com, contacts name: fang S cun, role: CONTACT, phone: 83728558, email: fang1984@aliyun.com, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False
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protocolSection identificationModule nctId: NCT06315673, orgStudyIdInfo id: STUDY00024562, briefTitle: Digital Assessment of Speech and Fine Motor Control in ALS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: BioSensics, descriptionModule briefSummary: This is a single-session, case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease. Patients with motor neuron disease (including amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA)) and age-matched healthy controls will be enrolled. Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer (BioSensics LLC, Newton, MA). We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised (ALFRS-R) \[1\]. We will also compare assessment data between the patient and control groups., conditionsModule conditions: Amyotrophic Lateral Sclerosis, conditions: Primary Lateral Sclerosis, conditions: Progressive Muscular Atrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Digital Speech and Handwriting Assessment, outcomesModule primaryOutcomes measure: Speaking rate during a standardized passage, primaryOutcomes measure: Residual on spiral tracing task, secondaryOutcomes measure: ALS Functional Rating Scale- Revised (ALSFRS-R), secondaryOutcomes measure: Forced vital capacity (FVC), secondaryOutcomes measure: Upper motor neuron function, secondaryOutcomes measure: Strength testing, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315660, orgStudyIdInfo id: P-2021-627, briefTitle: VR Based Therapy to Treat Anxiety in Dual Diagnosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mental Health Centre Sct. Hans, class: OTHER_GOV, descriptionModule briefSummary: Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual diagnosis is therefore a challenging condition to treat, and the group typically represents the most vulnerable individuals in society. Historically, research on dual diagnosis has been underprioritized, and thus, we still do not know enough about how to best assist this vulnerable group.However, new studies indicate that virtual reality programs can reduce anxiety in patients with psychotic disorders. They achieve this by providing access to a virtual therapist and lifelike environments where patients can challenge their thoughts about the dangers of navigating the world. For both psychotic disorders and substance abuse, we know that anxiety often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on dual diagnosis patients, where it is crucial in maintaining substance abuse and functional impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is too resource-intensive in addition to an already intensive treatment process.This study investigates whether the resource barrier can be overcome and whether hospitalized dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes after discharge when their anxiety is treated through partially automated virtual reality therapy., conditionsModule conditions: Dual Diagnosis, conditions: Psychosis, conditions: Agoraphobia, conditions: Social Anxiety Disorder, conditions: Substance Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a parallel group, investigator initiated, pragmatic, assessor-blinded, 1:1 randomized, clinical feasibility trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: When a participant is randomized to TAU+VR, the senior researcher reveals the allocation to the assigned clinician via secure e-mail. The assigned clinician then schedules the eight therapy sessions with the participant who is thus unblinded to their treatment allocation. If the participant is randomized to TAU, the assigned clinician will inform the participant as soon as possible. The researchers collecting data from the patient and the researchers performing data analysis remain blinded. There are no circumstances wherein unblinding of outcome assessors or data analysists is permissible., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Miljeu Therapy, interventions name: Virtual Reality based CBT for Anxiety, outcomesModule primaryOutcomes measure: Oxford Agoraphobic Avoidance Scale, primaryOutcomes measure: Client Satisfaction Questionnaire, primaryOutcomes measure: Systems Useability Scale, secondaryOutcomes measure: Timeline Followback, secondaryOutcomes measure: The Six-item Positive and Negative Symptom Syndrome Scale, secondaryOutcomes measure: The Social Functioning Scale, secondaryOutcomes measure: The Questionnaire about the Process of Recovery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315647, orgStudyIdInfo id: Difficult CBD cannulation, briefTitle: Comparison Between Different Techniques in Difficult CBD Cannulation, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-12-01, primaryCompletionDateStruct date: 2023-01-19, completionDateStruct date: 2023-11-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Menoufia University, class: OTHER, descriptionModule briefSummary: This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation., conditionsModule conditions: ERCP, Difficult CBD Cannulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation, outcomesModule primaryOutcomes measure: Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National liver Institute, city: Shibīn Al Kawm, state: Menofia, zip: 32951, country: Egypt, geoPoint lat: 30.55258, lon: 31.00904, hasResults: False
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protocolSection identificationModule nctId: NCT06315634, orgStudyIdInfo id: AP210330102, briefTitle: Intrathecal Dexmedetomidine vs Midazolame, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-15, primaryCompletionDateStruct date: 2022-03-10, completionDateStruct date: 2022-03-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute, Egypt, class: OTHER, descriptionModule briefSummary: Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries, conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Midazolam, interventions name: Bupivacain, outcomesModule primaryOutcomes measure: Duration of sensory block, secondaryOutcomes measure: Incidence of vomiting occurrence, secondaryOutcomes measure: Sedation, secondaryOutcomes measure: Change in mean arterial blood pressure, secondaryOutcomes measure: Duration of motor block, secondaryOutcomes measure: Change in heart rate, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National cancer institute, city: Cairo, zip: 11796, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06315621, orgStudyIdInfo id: 36124, briefTitle: Accuracy of Conventional Impression Versus Intraoral Scanner in Capturing Three Different Nasal Defects, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1).Group 2, involves nasal defects which will be optically scanned using IOS(medit 700 wireless) without facial markers Group 3 involves nasal defects which will be optically scanned using IOS(medit 700 wireless) with facial markers.STL files of the facial scans and scanned cast obtained from the impression will be exported and saved to be used later for outcome assessment., conditionsModule conditions: Nasal Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Scanning using intraoral scanner with markers, interventions name: Scanning using intraoral scanner without markers, interventions name: Physical Impression, outcomesModule primaryOutcomes measure: Dimensional accuracy of intraoral scanners, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University, city: Cairo, zip: 11865, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06315608, orgStudyIdInfo id: MRG24ALS, briefTitle: MRG-001 in Patients With Amyotrophic Lateral Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: MedRegen LLC, class: INDUSTRY, descriptionModule briefSummary: The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months., conditionsModule conditions: Amyotrophic Lateral Sclerosis, conditions: Lou Gehrig Disease, conditions: Motor Neuron Disease, conditions: Motor Neuron Atrophy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: MRG-001, outcomesModule primaryOutcomes measure: Assessment of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Stem Cell Mobilization, secondaryOutcomes measure: Regulatory T-cell Mobilization, secondaryOutcomes measure: Change in Disease Progression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315595, orgStudyIdInfo id: 15-003511, secondaryIdInfos id: NCI-2024-01895, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 15-003511, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: P30CA015083, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA015083, secondaryIdInfos id: R01EB031790, type: NIH, link: https://reporter.nih.gov/quickSearch/R01EB031790, briefTitle: Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion, statusModule overallStatus: RECRUITING, startDateStruct date: 2015-09-30, primaryCompletionDateStruct date: 2030-09-30, completionDateStruct date: 2030-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: National Institute for Biomedical Imaging and Bioengineering (NIBIB), descriptionModule briefSummary: This study evaluates contrast-enhanced MR angiography and contrast-enhanced MR perfusion imaging for the visualization of blood vessels and enhancing tissues with better spatial detail and improved temporal fidelity compared to current methods., conditionsModule conditions: Prostate Neoplasm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Improved performance in contrast-enhanced magnetic resonance imaging (MRI) as used for angiography and perfusion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, status: ACTIVE_NOT_RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, contacts name: Stephen J. Riederer, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06315582, orgStudyIdInfo id: STU00220487, briefTitle: Surgical Approach to Uterine Septum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-08-26, completionDateStruct date: 2026-02-26, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures., conditionsModule conditions: Uterine Septum, conditions: Surgical Complication, conditions: Septum; Uterus, conditions: Treatment Side Effects, conditions: Treatment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized single blinded study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants will be randomized using www.randomizer.org algorithm. They will be assigned to arm in the operating room where they will get that intervention. When they get to Post Anesthesia Care Unit, they will be unblinded. Surgeon will be blinded until patient is in operating room and envelope with randomization is opened., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Removal of uterine septum with hysteroscopic scissors without electrosurgery., interventions name: Hysteroscopic septoplasty utilizing bipolar electrosurgery, outcomesModule primaryOutcomes measure: Procedure-level variables: operative time hysteroscopic septoplasty, primaryOutcomes measure: Procedure-level variables: Surgical Cost, primaryOutcomes measure: Procedure-level variables: Fluid deficit, primaryOutcomes measure: Resolution of uterine septum, secondaryOutcomes measure: Compare adverse events, secondaryOutcomes measure: Comparing patient recovery and satisfaction, eligibilityModule sex: FEMALE, minimumAge: 22 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Northwestern Medicine Prentice Women's Hospital, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Milad Madgy, MD, role: CONTACT, email: mmilad@nm.org, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06315569, orgStudyIdInfo id: KY20242030-C-1, briefTitle: A Multicentre Clinical Study on the Correlation Between Exercise and Hyperuricemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, collaborators name: Air Force 986 Hospital, descriptionModule briefSummary: This project is a multi-center clinical study on the correlation between exercise and hyperuricemia. The purpose is to explore the correlation between exercise and hyperuricemia, find out the metabolic rule of uric acid after exercise, and provide scientific evidence and clinical guidance for how to exercise scientifically and reasonably in patients with hyperuricemia. This trial is a multicenter, prospective, randomized controlled clinical trial with 100 participants. Inclusion criteria: 1. Patients with hyperuricemia (fasting uric acid \> 420μmol/L twice on different days); 2. Men aged between 18 and 35; 3. Able to complete baseline fitness test (3000m run time less than 14 minutes); 4. Fully informed consent, signed informed consent exclusion criteria: 1. Heart, liver and kidney insufficiency; 2. Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, diabetes mellitus; 3. Patients with secondary hyperuricemia caused by medicine or other diseases; 4. People who take uric acid lowering drugs; 5. People with related motor dysfunction or other factors that can easily cause discomfort after exercise 6. Those with mental disorders or communication disorders, and those who do not cooperate during the experiment A total of 100 subjects were included according to the scheduling criteria. SPSS23.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. According to the contents of the envelopes, the subjects were divided into group A, which exercised for 24 hours after 3000m exercise, and group B, which exercised for 48 hours after 3000m exercise. During the 48-hour observation period after each exercise, the changes of uric acid after exercise were explored. To provide scientific evidence and clinical guidance for patients with hyperuricemia how to exercise scientifically and rationally.Patients must meet all inclusion and exclusion criteria to be eligible to participate in the study. After determining patients' eligibility for the study, the researcher should fully explain the nature, purpose, risks and benefits of the study to the subjects before the study, and assure the patients that they have the right to withdraw at any time after agreeing to participate in the study, and the subjects should sign a written informed consent after fully considering and agreeing to participate in the study. The process of obtaining informed consent should be correctly recorded in all case report forms in this study.Baseline data such as blood uric acid, blood biochemistry, blood routine, urine routine, uric acid and demographic characteristics were collected after the patients were enrolled.The patients were randomly divided into two groups: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A.Within 48 hours after each 3000m exercise, the subjects' blood uric acid was detected immediately after exercise (within 5 minutes), 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, 36 hours, 48 hours. Blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid and other information were collected again 24 hours after intervention.From January 2024 to February 2024, we plan to draft clinical study protocols, investigator manuals, case reports, informed consent forms and other documents, and submit them to the Ethics Committee of the research sponsor for review and approval; February 2024 - March 2024: Complete the training of all researchers and officially start the research; March 2024 - August 2024: Participants were enrolled for the experiment; August 2024 - November 2024: collate and collect data, conduct statistical analysis, and confirm research results, conditionsModule conditions: Hyperuricemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Run 3000 meters, outcomesModule primaryOutcomes measure: Uric acid metabolism in patients with hyperuricemia after exercise, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xijing Hospital, status: RECRUITING, city: Xi'an, state: Shanxi, zip: 710032, country: China, contacts name: XiangLiang Meng, role: CONTACT, phone: +8613730192056, email: 997815173@qq.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
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protocolSection identificationModule nctId: NCT06315556, orgStudyIdInfo id: 22539, briefTitle: An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied.ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth.Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina.Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner.Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown.The main purpose of this study is to:* find the number of preterm babies who are treated with aflibercept using a PDD in the UK* inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROPAn additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD.The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027.In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study., conditionsModule conditions: Retinopathy of Prematurity, conditions: Preterm Infants, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Aflibercept (Eylea), outcomesModule primaryOutcomes measure: Number of participants treated with Eylea PFS+PDD upon completion of 1- or 3-years following market introduction, secondaryOutcomes measure: Summary of patient characteristics reported as number of participants with different categories, secondaryOutcomes measure: Summary of maternal factors reported as number of participants with different categories, secondaryOutcomes measure: Summary of comorbidities reported as number of participants with different categories, secondaryOutcomes measure: Summary of clinical condition and resource utilization reported as number of participants with different categories, secondaryOutcomes measure: Summary of clinical condition and resource utilization reported as days, secondaryOutcomes measure: Summary of outcomes of the premature infants reported as number of participants with different categories, secondaryOutcomes measure: Summary of ocular disease and treatment reported as number of participants with different categories, eligibilityModule sex: ALL, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Many locations, status: RECRUITING, city: Multiple Locations, country: United Kingdom, hasResults: False
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protocolSection identificationModule nctId: NCT06315543, orgStudyIdInfo id: KY20222255-F-1, briefTitle: A Multicentre Clinical Study on the Correlation Between Drinking Water and Hyperuricemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, collaborators name: Air Force 986 Hospital, descriptionModule briefSummary: The name of this study is a multicentre clinical study on the correlation between drinking water and hyperuricemia. The purpose of this study is to clarify the correlation between drinking water and hyperuricemia. To explore the clinical effect of reducing uric acid by drinking water, and provide scientific evidence and clinical guidance for reducing uric acid by drinking water. The study design was a multicenter, prospective, randomized controlled clinical trial with a total of 88 participants. 1. Inclusion criteria: patients with hyperuricemia (fasting uric acid between 420-540μmol/L twice on different days and no drug treatment); Aged 18-65 years; Less than 1500mL of daily water intake recommended by the minimum dietary guidelines (assessed by dietary review combined with water diaries); Fully informed consent. Sign informed consent. 2. Exclusion criteria: patients with heart, liver and renal insufficiency; Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, polycystic ovary syndrome, diabetes mellitus; Patients with secondary hyperuricemia caused by medicine or other diseases; People who have gastrointestinal discomfort or have a history of gastrointestinal surgery, or other people who are not suitable for drinking more water; Patients with mental disorders or communication disorders, and those who did not cooperate during the experiment. A total of 88 subjects were included according to the exclusion criteria. SPSS26.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. The subjects were divided into two groups according to the contents of the envelopes: A constant drinking water observation group (maintaining the original drinking water volume) and B adequate drinking water intervention group (drinking an additional 1650mL of water per day (3 bottles of 550mL bottled water) on the basis of the original drinking water volume). During the 2-week observation period, the effects of constant drinking water and sufficient drinking water on blood uric acid, 24 h uric acid determination, urine osmotic pressure and other indicators were evaluated, and the effectiveness of sufficient drinking water in reducing blood uric acid was determined, and the applicable population was explored.Observation items and detection time: 1. During the screening period, the following data were collected: age, nationality, place of residence, education, occupation, height, weight, waist circumference, disease history, drug use history, drinking, smoking, normal water intake, urine volume, urine color and uric acid value. 2. Pre-test data: drinking water, urination, diet, psychological investigation, blood uric acid, blood biochemistry, routine blood routine, urine routine, uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure, heart rate, frequency of gout attack, whether to take urico-lowering drugs, whether to take other drugs that affect uric acid. 3. After the test: Fasting blood uric acid was monitored on the 2nd, 4th, 6th, 8th, 10th and 14th day respectively; Urge patients to record water diary and urination diary every day. At the end of the experiment, blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure and heart rate were tested again. Safety assessment indicators: edema, gastrointestinal discomfort, electrolytes, blood pressure, heart rate., conditionsModule conditions: Hyperuricemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Drink water, outcomesModule primaryOutcomes measure: Blood uric acid change, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital, status: RECRUITING, city: Xi'an, state: Shanxi, zip: 710032, country: China, contacts name: Li Peng, role: CONTACT, phone: 029-84771794, email: XJYYLLWYH@163.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
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protocolSection identificationModule nctId: NCT06315530, orgStudyIdInfo id: sh12053, briefTitle: Effect of Telitacicept on Antibody Titers in Primary APS Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles., conditionsModule conditions: Antiphospholipid Syndrome (APS), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Telitacicept, interventions name: SOC, outcomesModule primaryOutcomes measure: The proportion of patients with decreased aPL titer at week 48 of treatment, secondaryOutcomes measure: new thrombotic event, secondaryOutcomes measure: Effects of Telitacicept on the genotype, phenotype, and functional heterogeneity of T and B cells, otherOutcomes measure: The incidence and severity of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruijin Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200025, country: China, contacts role: CONTACT, phone: 0086-0021-64370045, contacts name: Chengde Yang, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Hui Shi, Dr, role: SUB_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06315517, orgStudyIdInfo id: AU24, secondaryIdInfos id: 1792-23P, type: OTHER_GRANT, domain: The Dairy Alliance, briefTitle: Double Crossover Casein Type Tolerance Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Auburn University, class: OTHER, descriptionModule briefSummary: The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind, double-crossover study in which the physiological responses to increasing doses of lactose-free (A1-rich milk), A2 milk, and lactose-free A2 milk will be explored., conditionsModule conditions: Dairy Intolerance, conditions: Healthy Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized controlled, double-blinded, double-crossover trial, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Conventional lactose-free cow's milk, interventions name: Nonconventional (A2) cow's milk, interventions name: Nonconventional (A2) lactose-free cow's milk, outcomesModule primaryOutcomes measure: Gastrointestinal Distress Scores, secondaryOutcomes measure: Breath Hydrogen (ppm), secondaryOutcomes measure: Breath Methane (ppm), secondaryOutcomes measure: Blood Glucose (mg/dl), secondaryOutcomes measure: Stool microbiome composition, secondaryOutcomes measure: Stool Beta-casomorphin-7 (BCM-7), secondaryOutcomes measure: Stool intestinal fatty acid binding protein (I-FABP), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Auburn University, city: Auburn, state: Alabama, zip: 36849, country: United States, contacts name: Andrew D Frugé, PhD, role: CONTACT, geoPoint lat: 32.60986, lon: -85.48078, hasResults: False
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protocolSection identificationModule nctId: NCT06315504, orgStudyIdInfo id: Nephrotic Syndrome Cohort, briefTitle: Circulating Factors in Nephrotic Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2034-04-01, completionDateStruct date: 2034-04-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Iain Bressendorff, class: OTHER, descriptionModule briefSummary: A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy., conditionsModule conditions: Nephrotic Syndrome, conditions: Membranous Nephropathy, conditions: Minimal Change Disease, conditions: Primary Focal Segmental Glomerulosclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: levels of anti-nephrin in blood by ELISA, secondaryOutcomes measure: changes in auto-antibodies in blood associated with membranous nephropathy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315491, orgStudyIdInfo id: CBX-12-201, briefTitle: A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cybrexa Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days., conditionsModule conditions: Platinum-resistant Ovarian Cancer, conditions: Refractory Ovarian Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: CBX-12, outcomesModule primaryOutcomes measure: Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)], secondaryOutcomes measure: Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Median Duration of Response (DoR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Plasma levels of CBX-12 (AUC0-24hr), secondaryOutcomes measure: Plasma levels of CBX-12 (Cmax), secondaryOutcomes measure: Plasma levels of CBX-12 (Tmax), secondaryOutcomes measure: Plasma levels of CBX-12 (T1/2), secondaryOutcomes measure: Plasma levels of Exatecan (AUC0-24hr), secondaryOutcomes measure: Plasma levels of Exatecan (Cmax), secondaryOutcomes measure: Plasma levels of Exatecan (Tmax), secondaryOutcomes measure: Plasma levels of Exatecan (T1/2), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315478, orgStudyIdInfo id: Hybrid regimen for H.pylori, briefTitle: Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2021-03-16, completionDateStruct date: 2021-11-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Helwan University, class: OTHER, descriptionModule briefSummary: Our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H. pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance, conditionsModule conditions: H.Pylori Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Omeprazole 20 MG Oral Tablet, interventions name: Amoxicillin 500Mg Tab, interventions name: Clarithromycin 500Mg Tab, outcomesModule primaryOutcomes measure: stool antigen retest, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Badr hospital, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06315465, orgStudyIdInfo id: AIIMSA00647, briefTitle: Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: All India Institute of Medical Sciences, New Delhi, class: OTHER, descriptionModule briefSummary: In general ketogenic diet is a recognized as an efficient non pharmacological treatment for children with refractory epilepsy. However, in the last decade, it has been tried for many neurological disorders in children including ASD, neurodegenerative disorders.Studies have shown that KD also helps in improvement of cognition, social skills, language function, and stereotypies. There is a limited number of reports of improvements after KD treatment, was insufficient evidence to attest the practicability of the KD as a treatment for ASD, but it is still a good indicator that this diet is a promising therapeutic option for this disorder. There are no major RCT's, hence raises concerns about the reliability and generalizability of findings. Majority of studies have used combined ketogenic diet therapy rather than single diet therapy and not many studies have compared add-on dietary intervention with standard of care. When compared to classic KD diet Modified Atkin's Diet is less restrictive, more palatable, more feasible and early response can be achieved. In summary, the rationale for conducting this study lies in the importance of add on dietary therapy in form of Modified Atkin's Diet along with standard of care for improvement of behavioral symptoms in children with ASD aged 3-8 years.This study aims to provide valuable insights that it can improve behavioral symptoms in ASD, early and ultimately improve the developmental outcomes in these children., conditionsModule conditions: Modified Atkins Diet, conditions: Autism Spectrum Disorder, conditions: Standard of Care, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open Label Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Modified Atkin's Diet with standard of care, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years, secondaryOutcomes measure: To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years, secondaryOutcomes measure: To compare the change in the cognitive ability as measured by Developmental Quotient(DQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years., secondaryOutcomes measure: To compare the change in the cognitive ability as measured by Social Quotient(SQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years., secondaryOutcomes measure: To compare the change in the cognitive ability as measured by Intelligence Quotient(IQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years., secondaryOutcomes measure: To compare the quantitative reduction in behavioral problems using Child Behavior Checklist (CBCL) in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder aged 3-8 years., secondaryOutcomes measure: To compare the change in sleep related problems using Children's Sleep Habit Questionnaire (CSHQ)children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder age, secondaryOutcomes measure: To compare the resting state fMRI findings in a subset of patients in the two arms, secondaryOutcomes measure: To assess the compliance in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care, secondaryOutcomes measure: To assess the adverse effect profile in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315452, orgStudyIdInfo id: PremaVitaD, briefTitle: FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g, acronym: PremaVitaD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Fondation Hôpital Saint-Joseph, class: OTHER, descriptionModule briefSummary: Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month.The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns., conditionsModule conditions: Vitamin D Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 110, type: ACTUAL, outcomesModule primaryOutcomes measure: Vitamine D deficiency frequency, secondaryOutcomes measure: vitamine D deficiency and maternal or feotal caracteristics, secondaryOutcomes measure: vitamine D deficiency and premature newborn comorbidities, secondaryOutcomes measure: effect of supplementation, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 6 Months, stdAges: CHILD, contactsLocationsModule locations facility: Hôpital Saint Joseph, city: Paris, zip: 75014, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06315439, orgStudyIdInfo id: Multi-RELAMI, briefTitle: Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion, acronym: Multi-RELAMI, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Campus Bio-Medico University, class: OTHER, descriptionModule briefSummary: Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results.Ex-vivo fluorescence confocal laser microscopy (FCM) with MAVIG VivaScope® 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample., conditionsModule conditions: Pancreas Adenocarcinoma, conditions: Endoscopic Ultrasound, conditions: Digital Pathology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: Endoscopic ultrasound fine needle biopsy, outcomesModule primaryOutcomes measure: Diagnostic accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Campus Bio Medico, city: Rome, state: Roma, zip: 00191, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06315426, orgStudyIdInfo id: GR1802-011, briefTitle: A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Genrix (Shanghai) Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease., conditionsModule conditions: Allergic Rhinitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: GR1802 injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in rTNSS( reflective total nasal symptom scores), secondaryOutcomes measure: Change from Baseline in rTOSS( reflective total ocular symptom scores), secondaryOutcomes measure: Change from Baseline in rTNSS, secondaryOutcomes measure: Mean change from baseline in iTNSS(instantaneous total nasal symptom scores), secondaryOutcomes measure: Mean change from baseline in iTOSS(instantaneous total ocular symptom scores), secondaryOutcomes measure: Change from baseline in VAS(Visual Analog Scale) score, secondaryOutcomes measure: Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores, secondaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Immunogenicity characteristics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315413, orgStudyIdInfo id: Composite plug vs d-PTFE, briefTitle: Composite Plug vs d-PTFE Membrane in Socket Preservation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of the current study is to compare the effect socket sealing with flowable resin composite compared to dense polytetrafluoroethylene membrane after filling the extraction site with xenograft particles in terms of soft and hard tissue changes, procedural time, post operative pain, patients' satisfaction, and cost effectiveness., conditionsModule conditions: Alveolar Bone Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Socket preservation using xenograft and composite plug, interventions name: Socket preservation using xenograft and intentionally exposed d-PTFE, outcomesModule primaryOutcomes measure: Change in horizontal bone dimension, secondaryOutcomes measure: Change in Vertical bone dimension, secondaryOutcomes measure: Keratinized tissue thickness, secondaryOutcomes measure: Procedural time, secondaryOutcomes measure: Post-operative pain, secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Incidence of complications, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of oral and dental medicine, Cairo university, city: Cairo, zip: 4240310, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06315400, orgStudyIdInfo id: ING-07-2023, briefTitle: Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo., conditionsModule conditions: Influenza, Human, conditions: Acute Respiratory Infection, conditions: Common Cold, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Ingavirin®, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of patients with normalization of body temperature at Visit 3 (Day 3), secondaryOutcomes measure: Timeframe for normalization of body temperature from the start of treatment, measured in hours, secondaryOutcomes measure: Time of cough disappearance from the moment of treatment initiation, secondaryOutcomes measure: Percentage of patients with absence of catarrhal syndrome, secondaryOutcomes measure: Percentage of patients with absence of intoxication syndrome, secondaryOutcomes measure: Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy, secondaryOutcomes measure: Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration, secondaryOutcomes measure: Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration, secondaryOutcomes measure: Assessment of vital signs: blood pressure, secondaryOutcomes measure: Assessment of vital signs: heart rate, secondaryOutcomes measure: Assessment of vital signs: respiratory rate, secondaryOutcomes measure: Assessment of vital signs: body temperature, secondaryOutcomes measure: Evaluation of concomitant therapy, secondaryOutcomes measure: Laboratory evaluation: leukocyte formula, secondaryOutcomes measure: Laboratory evaluation: hemoglobin, secondaryOutcomes measure: Laboratory evaluation: leukocyte count, secondaryOutcomes measure: Laboratory evaluation: platelet count, secondaryOutcomes measure: Laboratory evaluation: red blood cell count, secondaryOutcomes measure: Laboratory evaluation: hematocrit, secondaryOutcomes measure: Laboratory evaluation: erythrocyte sedimentation rate, secondaryOutcomes measure: Laboratory evaluation: blood glucose, secondaryOutcomes measure: Laboratory evaluation: total protein, secondaryOutcomes measure: Laboratory evaluation: total bilirubin, secondaryOutcomes measure: Laboratory evaluation: AST, secondaryOutcomes measure: Laboratory evaluation: ALT, secondaryOutcomes measure: Laboratory evaluation: creatinine, secondaryOutcomes measure: Laboratory evaluation: urea, secondaryOutcomes measure: Laboratory evaluation: triglycerides, secondaryOutcomes measure: Laboratory evaluation: urinalysis, secondaryOutcomes measure: Frequency of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Percentage of patients who discontinued study due to AE/SAE, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Rostov-na-Donu, country: Russian Federation, contacts name: Tatiana V Zolotova, Prof., role: CONTACT, phone: +7-928-1049101, email: tvzolotova1953@yandex.ru, geoPoint lat: 47.23135, lon: 39.72328, locations facility: GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Tomsk, country: Russian Federation, contacts name: Yulia G Samoilova, MD, PhD, role: CONTACT, phone: +7-3822530127, email: samoilova_y@inbox.ru, geoPoint lat: 56.49771, lon: 84.97437, locations facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Yaroslavl, zip: 150000, country: Russian Federation, contacts name: Ivan G Sitnikov, Prof., role: CONTACT, phone: +7-4852-736769, email: sitnikov@ysmu.ru, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False
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protocolSection identificationModule nctId: NCT06315387, orgStudyIdInfo id: GIB-01-01-2023, briefTitle: Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers, conditionsModule conditions: Cholecystitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: 4-MUST, 1 tablet, interventions name: 4-MUST, 2 tablets, interventions name: 4-MUST, 3 tablets, outcomesModule primaryOutcomes measure: Pharmacokinetics - Cmax, primaryOutcomes measure: Pharmacokinetics - tmax, primaryOutcomes measure: Pharmacokinetics - AUC0-t, primaryOutcomes measure: Pharmacokinetics - AUC0-inf, primaryOutcomes measure: Pharmacokinetics - AUCextr, primaryOutcomes measure: Pharmacokinetics - t1/2, primaryOutcomes measure: Pharmacokinetics - kel, primaryOutcomes measure: Pharmacokinetics - MRT, primaryOutcomes measure: Pharmacokinetics - Vd, primaryOutcomes measure: Pharmacokinetics - CL, primaryOutcomes measure: Pharmacokinetics - number of terminal timepoints, secondaryOutcomes measure: Adverse event type, secondaryOutcomes measure: Adverse event frequency, secondaryOutcomes measure: Adverse event severety, secondaryOutcomes measure: Drop-outs associated with adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Limited Liability Company "Medical Center Eco-Safety", status: RECRUITING, city: St. Petersburg, zip: 19119, country: Russian Federation, contacts name: Vasiliy Vasilyuk, MD,PhD, Prof., role: CONTACT, phone: +7 (812) 500-52-03, phoneExt: 5001, email: vasilyuk_vb@ecosafety.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
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protocolSection identificationModule nctId: NCT06315374, orgStudyIdInfo id: FJUH112267, briefTitle: 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Fu Jen Catholic University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the auxiliary benefits of three-dimensional printed activating assistive devices for soft-mist inhaler on patients' utilization habit., conditionsModule conditions: Chronic Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Use soft mist inhaler, interventions name: Use soft mist inhaler with a 3D assistive device, outcomesModule primaryOutcomes measure: satisfaction survey, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University, city: New Taipei City, zip: 24352, country: Taiwan, contacts name: Ke-Yun Chao, PhD, role: CONTACT, phone: +886-905-301-879, email: ck_qq@hotmail.com, contacts name: Ke-Yun Chao, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.01111, lon: 121.44583, hasResults: False
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protocolSection identificationModule nctId: NCT06315361, orgStudyIdInfo id: 2445, briefTitle: DIAbetes and NAFLD, acronym: DIANA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-05-20, primaryCompletionDateStruct date: 2035-12-31, completionDateStruct date: 2035-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Non-alcoholic hepatic steatosis (NAFLD) is characterised by the excessive accumulation of triglycerides in the liver and is often associated, in the absence of significant alcohol consumption, with insulin resistance and metabolic syndrome with which it shares the most frequent clinical manifestations (hypertension, dyslipidaemia, visceral adiposity, glucose intolerance). Due to the pandemic spread of obesity and diabetes and by virtue of better control of viral hepatitis, NAFLD is the most common cause of liver damage in Western countries with a prevalence of around 20-30% of the general population.The clinical impact of NAFLD in diabetes is considerable and represents a real driver of the major clinical outcomes that impact on the health of the individual, consequently creating a real 'burden of disease' especially in those populations considered to be at higher risk of disease severity.Individuals with diabetes are, in fact, those at greatest risk of developing the clinical sequelae of NAFLD and often do not receive adequate hepatological support and a correct hepatic pathology. In fact, it has been documented in the literature that the presence of diabetes increases the severity of liver damage, bringing the risk of NASH up to 80% and increasing the risk of significant fibrosis to 30-40% of subjects with hepatic steatosis as well as representing an independent predictor for significant fibrosis. Lastly, the increased risk of hepatocarcinoma in subjects with diabetes and NAFLD should not be overlooked, as documented by our group and confirmed in a large Italian case series.In subjects with diabetes, moreover, the presence of NAFLD is not only associated with worse glycaemic control, but also with micro- and macro-vascular complications as well as nephrological and neuropathic complications and increased mortality.Therefore, the possibility of applying the non-invasive fibrosis scores currently available for NAFLD on a large scale, in a population at high risk of progressive liver disease, would make it possible to characterise (a) the true epidemiology of significant fibrosis (F3 or higher); (b) allow primary prevention actions to be carried out by optimising the use of resources or by identifying subjects at greater risk of damage progression; (c) understand, in cases with a long history of disease the true prevalence of clinical outcomes; (d) understand the epidemiology of comorbidities and polypharmacy as a function of significant fibrosis., conditionsModule conditions: NAFLD, conditions: Diabetes, conditions: NASH, conditions: Fibrosis, Liver, conditions: Cirrhosis, Liver, conditions: Liver Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of significant fibrosis by non invasive tests, secondaryOutcomes measure: Identification of MALO (major liver outcomes), secondaryOutcomes measure: Identification of MACE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOSD Diabetologia, Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS, city: Roma, state: Rome/lazio/italy, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06315348, orgStudyIdInfo id: URI_116301123, briefTitle: Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment, acronym: Piezo_Ortho, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Universidad Complutense de Madrid, class: OTHER, collaborators name: Osteology Foundation, descriptionModule briefSummary: Research QuestionWhile the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials.Aims of the ProjectThe aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups., conditionsModule conditions: Dental Malocclusion, conditions: Maxillary Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Comparative 2-arm parallel double-blinded randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Blinded parties will not be aware of the type augmentation used during the intervention., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: flapless alveolar decortication with augmentation, outcomesModule primaryOutcomes measure: Soft tissue contour changes pre- and post- orthodontic therapy, primaryOutcomes measure: Plaque index (PlI), primaryOutcomes measure: Bleeding on probbing (BoP), primaryOutcomes measure: Probing depth (PD), primaryOutcomes measure: External apical root resorption (EARR), primaryOutcomes measure: Orthodontic tooth movement, secondaryOutcomes measure: Percentage of residual pockets (PD>4 mm)., secondaryOutcomes measure: Soft tissue thickness by PIROP ultrasound scanner, secondaryOutcomes measure: Gingival microvasculature, secondaryOutcomes measure: PROMs, secondaryOutcomes measure: Adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Odontology, University Complutense Madrid, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Eduardo Montero, Prof, role: CONTACT, phone: +34 91 3941901, email: eduardomonterosolis@ucm.es, contacts name: Conchita Martin, Prof, role: CONTACT, phone: +34 91 3941901, email: mariacom@ucm.es, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06315335, orgStudyIdInfo id: UP0118, briefTitle: A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-07-29, completionDateStruct date: 2025-07-29, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: UCB Biopharma SRL, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: UCB9741, interventions name: Placebo, outcomesModule primaryOutcomes measure: Occurrence of TEAEs, primaryOutcomes measure: Occurrence of treatment-emergent SAEs, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: AUCinf, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315322, orgStudyIdInfo id: EP0224, secondaryIdInfos id: 2023-508095-11-00, type: REGISTRY, domain: EU Trial Number, secondaryIdInfos id: U1111-1303-1174, type: OTHER, domain: Universal Trial Number, briefTitle: A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-02-28, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: UCB Biopharma SRL, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy., conditionsModule conditions: Childhood Absence Epilepsy, conditions: Juvenile Absence Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Brivaracetam Film-coated tablet, interventions name: Brivaracetam oral solution, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs) during the study, primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study, secondaryOutcomes measure: Incidence of serious adverse events (SAEs) during the study, secondaryOutcomes measure: Incidence of IMP related TEAEs during the study, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315309, orgStudyIdInfo id: IRB-300012281 (UAB 23146), briefTitle: Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-29, primaryCompletionDateStruct date: 2025-10-29, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD., conditionsModule conditions: GVHD,Acute, conditions: Acute Leukemia, conditions: Myelodysplastic Syndromes, conditions: Myeloproliferative Disorders, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 29, type: ESTIMATED, armsInterventionsModule interventions name: ATG Combined with Tacrolimus and Mini Methotrexate, outcomesModule primaryOutcomes measure: To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Zaid S Al Kadhimi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Manuel Espinoza-Gutarra, MD, role: SUB_INVESTIGATOR, contacts name: Omer Jamy, MD, role: SUB_INVESTIGATOR, contacts name: Donna Salzman, MD, role: SUB_INVESTIGATOR, contacts name: Razan Mohty, MD, role: SUB_INVESTIGATOR, contacts name: Lauren Shea, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
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protocolSection identificationModule nctId: NCT06315296, orgStudyIdInfo id: iRISID-2023-1985, briefTitle: An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Thomas Jefferson University, class: OTHER, descriptionModule briefSummary: This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and improving survival outcomes after stereotactic radiosurgery in patients with breast or lung cancer that has spread to the brain (brain metastases). Lung cancer and breast cancer are the two most frequent causes of brain metastases. The diagnosis of brain metastases is associated with poorer survival and tumor-induced and treatment-related side effects. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. Patients who receive stereotactic radiosurgery for brain metastases may experience less neurocognitive side effects than with other types of brain radiation, but may still be at risk for their brain metastases growing, spreading, or getting worse. Patients with obesity and diabetes have been shown to have worse survival and increased radiation-related side effects. Evidence demonstrates that simply changing meal timing can have a positive impact on multiple health outcomes. Time-restricted eating, or prolonged nighttime fasting, has been proven to have positive effects on heart disease risk reduction, weight control management and chemotherapy side effect reduction. Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain metastases from breast or lung cancer., conditionsModule conditions: Anatomic Stage IV Breast Cancer AJCC v8, conditions: Metastatic Breast Carcinoma, conditions: Metastatic Lung Carcinoma, conditions: Metastatic Malignant Neoplasm in the Brain, conditions: Stage IV Lung Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Dietary Intervention, interventions name: Text Message-Based Navigation Intervention, interventions name: Internet-Based Intervention, interventions name: Dietary Counseling and Surveillance, interventions name: Stereotactic Radiosurgery, interventions name: Biospecimen Collection, interventions name: Magnetic Resonance Imaging, interventions name: Neurocognitive Assessment, interventions name: Questionnaire Administration, interventions name: Interview, interventions name: Internet-Based Intervention, interventions name: Stereotactic Radiosurgery, interventions name: Text Message-Based Navigation Intervention, interventions name: Biospecimen Collection, interventions name: Magnetic Resonance Imaging, interventions name: Neurocognitive Assessment, interventions name: Questionnaire Administration, interventions name: Interview, outcomesModule primaryOutcomes measure: Accrual rate, primaryOutcomes measure: Attrition rate, primaryOutcomes measure: Time-restricted eating (TRE) compliance rate, primaryOutcomes measure: Incidence of adverse effects (AEs), primaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Intracranial progression free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sidney Kimmel Cancer Center at Thomas Jefferson University, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Nicole Simone, role: CONTACT, phone: 215-955-6702, email: Nicole.Simone@jefferson.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06315283, orgStudyIdInfo id: TV44749-BA-10196, secondaryIdInfos id: 2023-505664-11-00, type: REGISTRY, domain: CTIS, briefTitle: An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Teva Branded Pharmaceutical Products R&D, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia.Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.The total duration of participation in the trial for each participant is planned to be approximately 21 weeks., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: TV-44749, interventions name: Oral olanzapine, outcomesModule primaryOutcomes measure: Area under the curve (AUC) of TV-44749, primaryOutcomes measure: AUC of oral olanzapine, secondaryOutcomes measure: Number of participants with at least one treatment-emergent adverse event during treatment with TV-44749, secondaryOutcomes measure: Number of participants with at least one treatment-emergent serious adverse event during treatment with TV-44749, secondaryOutcomes measure: Number of participants with at least one injection site adverse event during treatment with TV-44749, secondaryOutcomes measure: Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749, secondaryOutcomes measure: Minimum observed plasma drug concentration at steady state (Cmin,ss) of TV-44749, secondaryOutcomes measure: Cmax,ss of oral olanzapine, secondaryOutcomes measure: Cmin,ss of oral olanzapine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Teva Investigational Site 15739, status: RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Teva Investigational Site 15740, status: RECRUITING, city: Torrance, state: California, zip: 90504, country: United States, geoPoint lat: 33.83585, lon: -118.34063, locations facility: Teva Investigational Site 15738, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Teva Investigational Site 15741, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30308, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Teva Investigational Site 15742, status: RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Teva Investigational Site 15737, status: RECRUITING, city: Marlton, state: New Jersey, zip: 08053, country: United States, geoPoint lat: 39.89122, lon: -74.92183, hasResults: False
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protocolSection identificationModule nctId: NCT06315270, orgStudyIdInfo id: 24K040-001, briefTitle: To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2029-03-20, completionDateStruct date: 2029-03-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, descriptionModule briefSummary: This project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of TCR diversity with clinical outcomes and the potential role of TCR profiling in cancer prognosis., conditionsModule conditions: Epithelial Ovarian Cancer, conditions: Stage III Ovarian Cancer, conditions: Stage IV Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Analysis of TCR genealogy data, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315257, orgStudyIdInfo id: J23105sIRB, secondaryIdInfos id: IRB00388854, type: OTHER, domain: Johns Hopkins, briefTitle: A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy., conditionsModule conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: PVX7, outcomesModule primaryOutcomes measure: Safety of PVX7 as assessed by adverse events, primaryOutcomes measure: Feasibility of PVX7, secondaryOutcomes measure: Cellular Immune Response, secondaryOutcomes measure: Immune Response, secondaryOutcomes measure: Presence of circulating HPV DNA, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315244, orgStudyIdInfo id: 2558, briefTitle: Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sisli Hamidiye Etfal Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome., conditionsModule conditions: Coccyx Disorder, conditions: Coccyx Injury, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: US Guided Perineural Injection and Neuroprolotherapy, outcomesModule primaryOutcomes measure: Effectiveness of Perforating Cutaneous Nerve Injection, secondaryOutcomes measure: Change in Pressure Pain Threshold, secondaryOutcomes measure: Change in Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sisli Hamidiye Etfal Training and Research Hospital, status: RECRUITING, city: Istanbul, zip: 34371, country: Turkey, contacts name: Enes Efe Is, MD, role: CONTACT, phone: +902123735000, email: enefeis@gmail.com, contacts name: Enes Efe Is, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06315231, orgStudyIdInfo id: SIM0308-02-Y-2-201, briefTitle: Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Simcere Pharmaceutical Co., Ltd, class: OTHER, descriptionModule briefSummary: This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial.The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke.Participants will be required to receive 12 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo., conditionsModule conditions: Post-stroke Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Edaravone dexborneol sublingual tablet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Number of discontinuation/withdrawal patients, primaryOutcomes measure: The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores., secondaryOutcomes measure: The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group, secondaryOutcomes measure: The changes of Mini-Mental State Examination (MMSE) score, secondaryOutcomes measure: The changes of Montreal Cognitive Assessment (MoCA) scale, secondaryOutcomes measure: The changes of MoCA subscales, secondaryOutcomes measure: Modified Rankin Scale (mRS) scores, secondaryOutcomes measure: The changes of National Institutes of Health Stroke Scale, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of USTC Anhui Provincial Hospital, city: Hefei, state: Anhui, country: China, contacts name: Jiong Shi, Doctor, role: CONTACT, email: Jshi2022@ustc.edu.cn, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, country: China, contacts name: Li Sun, role: CONTACT, email: sunli99@jlu.edu.cn, geoPoint lat: 43.88, lon: 125.32278, locations facility: The First People's Hospital of Huzhou, city: Huzhou, state: Zhejiang, country: China, contacts name: Ru Sun, Doctor, role: CONTACT, email: sunjin2010@tom.com, geoPoint lat: 30.8703, lon: 120.0933, hasResults: False
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protocolSection identificationModule nctId: NCT06315218, orgStudyIdInfo id: Pro2023000968, briefTitle: Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, collaborators name: Positive Impact Health Centers, collaborators name: George Washington University, collaborators name: Carnegie Mellon University, collaborators name: Emory University, collaborators name: Columbia University, collaborators name: Arizona State University, collaborators name: THRIVE Social Services Inc, descriptionModule briefSummary: This research study aims to test the effectiveness, reach, and maintenance over time of the iTHRIVE 365 intervention for Black same gender loving men (SGLM) living with HIV. iTHRIVE 365 is a SGLM community-developed multicomponent mHealth intervention that aims to: 1) Support daily health promotion via HIV and psychological health education and health maintenance reminders; 2) Foster positive social connections among SGLM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to SGLM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment., conditionsModule conditions: Sexual and Gender Minorities, conditions: Social Stigma, conditions: Medication Adherence, conditions: Depressive Symptoms, conditions: Anxiety Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: iTHRIVE 365 HIV care intervention, outcomesModule primaryOutcomes measure: Antiretroviral (ART) Medication Use, primaryOutcomes measure: ART adherence-Long Lag Assessments, secondaryOutcomes measure: Daily Diary Substance Use, secondaryOutcomes measure: Substance Use-Long Lag Assessments, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Depressive Symptoms-Long Lag, secondaryOutcomes measure: Anxiety Symptoms, secondaryOutcomes measure: Anxiety Symptoms-Long Lag, secondaryOutcomes measure: Emotion Regulation Emotion Regulation, secondaryOutcomes measure: Emotion Regulation-Long Lag Assessments, secondaryOutcomes measure: COPE, secondaryOutcomes measure: COPE-Long Lag Assessments, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315205, orgStudyIdInfo id: ROV-LEBE-2023-01, secondaryIdInfos id: 2023-503948-13, type: EUDRACT_NUMBER, briefTitle: Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women, acronym: LEILA-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-26, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Rovi Pharmaceuticals Laboratories, class: INDUSTRY, descriptionModule briefSummary: This is a Phase I, open label, sequential, single ascending dose (SAD) study to evaluate the pharmacokinetic (PK), safety, and tolerability of Letrozole LEBE in healthy post-menopausal women., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Letrozole LEBE 75 mg, interventions name: Letrozole LEBE 150 mg, interventions name: Letrozole LEBE 225 mg, outcomesModule primaryOutcomes measure: λz, primaryOutcomes measure: Cmax, primaryOutcomes measure: Clast, primaryOutcomes measure: tmax, primaryOutcomes measure: tlag, primaryOutcomes measure: t1/2, primaryOutcomes measure: AUC∞, primaryOutcomes measure: AUClast, secondaryOutcomes measure: E1, secondaryOutcomes measure: SE1, secondaryOutcomes measure: E2, secondaryOutcomes measure: λz, secondaryOutcomes measure: Cav, secondaryOutcomes measure: Cmin, ss, secondaryOutcomes measure: Cmax,ss, secondaryOutcomes measure: tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: AUCτ, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Investigational Site number CZ-01, status: RECRUITING, city: Praha, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
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protocolSection identificationModule nctId: NCT06315192, orgStudyIdInfo id: CIV-22-10-041006, briefTitle: Stroke Alarm Efficacy Trial, acronym: StrokeAlarmEFF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, descriptionModule briefSummary: The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset.This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population.A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size.Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study.Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by:1. recent TIA, OR2. recent stroke without persisting arm motor deficit, OR3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard., conditionsModule conditions: Stroke Acute, conditions: Atrial Fibrillation, conditions: TIA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Stroke Alarm, outcomesModule primaryOutcomes measure: Time from onset of stroke with unilateral arm motor deficit until alarm by the device., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skane University hospital, city: Lund, zip: 22185, country: Sweden, contacts name: Johan Wasselius, MD, PhD, role: CONTACT, phone: 800-555-5555, phoneExt: +46-46173082, email: johan.wasselius@gmail.com, contacts name: Magnus Esbjörnsson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False
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protocolSection identificationModule nctId: NCT06315179, orgStudyIdInfo id: STUDY00004616, briefTitle: Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE), acronym: STRIDE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2030-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: Allen Institute, descriptionModule briefSummary: This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Crohn Disease, conditions: Ulcerative Colitis, conditions: Indeterminate Colitis, conditions: Functional Abdominal Pain Syndrome, conditions: Functional Bowel Disorder, conditions: Esophageal Diseases, conditions: Gastroduodenal Disorder, conditions: Bowel Dysfunction, conditions: Gallbladder Diseases, conditions: Sphincter of Oddi Dysfunction, conditions: Anorectal Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Esophagogastroduodenoscopy (EGD) with biopsy, interventions name: Colonoscopy w/ biopsy, outcomesModule primaryOutcomes measure: Bio-repository sample collection for spatial transcriptomics, secondaryOutcomes measure: Paris Classification of Crohn's Disease, secondaryOutcomes measure: Montreal Classification of Crohn's disease, secondaryOutcomes measure: Paris Classification of Ulcerative Colitis/Indeterminate Colitis, secondaryOutcomes measure: Montreal Classification of Ulcerative Colitis/Indeterminate Colitis, secondaryOutcomes measure: Disorder of Gut-Brain Interaction classification, secondaryOutcomes measure: Physician's Global Assessment (PGA), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, contacts name: Mason E Nuding, role: CONTACT, phone: 206-987-0055, email: mason.nuding@seattlechildrens.org, contacts name: Clinical Research Coordinator, role: CONTACT, phone: 206-987-2521, email: giresearch@seattlechidlrens.org, contacts name: Hengqi Zheng, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06315166, orgStudyIdInfo id: CIP-PLG_CLINICAL-22-04, briefTitle: Study on Using Radiofrequency to Treat Moderate to Severe Acne, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Pollogen, class: INDUSTRY, collaborators name: Lumenis Be Ltd., descriptionModule briefSummary: Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris., conditionsModule conditions: Moderate to Severe Acne Vulgaris, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: triLift/Legend Pro+ Fractional RF System, outcomesModule primaryOutcomes measure: Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris, secondaryOutcomes measure: Overall Improvement of Acne, secondaryOutcomes measure: Subjective Satisfaction with the Treatment Results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cosmedic Dermatology (CosmedicDerm), status: RECRUITING, city: Grosse Pointe, state: Michigan, zip: 48230, country: United States, contacts name: Shauna Ryder Diggs, MD, role: CONTACT, phone: 313-882-5777, email: hello@drshaunadiggs.com, contacts name: Jamila Ammary, role: CONTACT, phone: +1-313-882-5777, email: hello@drshaunadiggs.com, contacts name: Shauna Ryder Diggs, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.38615, lon: -82.91186, hasResults: False
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protocolSection identificationModule nctId: NCT06315153, orgStudyIdInfo id: KS2023077-1, briefTitle: Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model, acronym: CAIS-pre, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-01-03, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, collaborators name: The First Hospital of Jilin University, descriptionModule briefSummary: This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke.The objectives of the study were as follows: first, to integrate the degree of carotid stenosis and plaque characteristics assessed by vascular ultrasound for a comprehensive assessment of plaque vulnerability; second, to develop an assessment tool for the risk of future ischemic stroke in patients with asymptomatic carotid stenosis by combining vascular risk factors, serologic markers, carotid ultrasound characteristics, and contrast-enhanced ultrasonographic parameters; and third, to incorporate vascular ultrasound parameters into existing predictive models of ischemic stroke recurrence risk to develop a risk assessment tool for atherosclerotic ischemic stroke.The main questions it aims to answer are:* How to screen high-risk patients and those eligible for revascularization from asymptomatic carotid stenosis patients for primary prevention of stroke.* How to improve the prediction accuracy of atherosclerotic ischemic stroke based on existing prediction models for secondary prevention of stroke., conditionsModule conditions: Carotid Stenosis, conditions: Ischemic Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The occurrence of ischemic stroke, primaryOutcomes measure: The recurrence of ischemic stroke, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The first hospital of Jilin university, city: Changchun, state: Jilin, zip: 130021, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06315140, orgStudyIdInfo id: 22-00248, secondaryIdInfos id: 1R01ES033545-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01ES033545-01, secondaryIdInfos id: 5R01ES033545-02, type: NIH, link: https://reporter.nih.gov/quickSearch/5R01ES033545-02, briefTitle: Assessing and Addressing Community Exposures to Environmental Contaminants, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-16, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute of Environmental Health Sciences (NIEHS), descriptionModule briefSummary: The purpose of this study is to build on our equitable, eight-year Tribal-academic partnership with the Ramapough Nation of northern NJ to advance tradition-centered farming practices and management strategies supporting sustainable food systems to relieve local food insecurity and nutritional deficiency, prevent disease and promote health. Furthermore, assessing the extent of environmental contamination, individual toxicant burdens and micronutrient levels and health disorders in Ramapough Tribal members of both sexes as outlined in the following:* Collect in-person/online survey information on demographics, health and food intake, nutrition, food security, and psychosocial stressors, and perform core anthropometric measurements (i.e., height, weight, body mass index, body circumference and blood pressure) at enrollment on Tribal members to inform health promotion strategies and community actions.* Determine individual-level contaminant burdens and micronutrient concentrations (e.g., iron, calcium, folate, vitamins) in urine and blood from surveyed (sub-aim 1a) Ramapough Turtle Clan volunteers.* Test soil, plants and surface water where Turtle Clan residents live, recreate and attend church in Ringwood, NJ using a community-based, citizen scientist approach., conditionsModule conditions: Environmental Exposure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Proportion of individuals with heavy metal contaminants in home water samples, primaryOutcomes measure: Proportion of individuals with heavy metal and metalloid contaminations in blood biospecimens, primaryOutcomes measure: Proportion of individuals with heavy metal and metalloid contaminations in urine biospecimens, primaryOutcomes measure: Proportion of individuals with insufficient blood serum micronutrient levels, primaryOutcomes measure: Proportion of individuals with health disorders, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06315127, orgStudyIdInfo id: 23-0119-A, briefTitle: The CanDo (Canadian Donor Milk) Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2024-11-28, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mount Sinai Hospital, Canada, class: OTHER, collaborators name: Mitacs, descriptionModule briefSummary: The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units. It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months. The Investigators will also explore whether the type of supplementation will positively affect measures of newborns' health, growth, behavior, feeding efficacy, and parental stress. Each participating infant born to a diabetic mother OR born small for his/her gestational age (\<2500 grams) is assigned at random to 2 groups. The groups are: 1) Donor milk: all babies in this group will receive pasteurized donor milk from a trusted milk bank. 2) Formula: all babies in this group will receive formula as a standard of care., conditionsModule conditions: Small for Gestational Age at Delivery, conditions: Gestational Diabetes, conditions: type1diabetes, conditions: Type2diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Human donor milk, interventions name: Formula, outcomesModule primaryOutcomes measure: Donor milk supplementation and exclusive breastfeeding rate at 4 months, secondaryOutcomes measure: Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 months, secondaryOutcomes measure: Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 4 months, secondaryOutcomes measure: Exploring donor milk supplementation and glucose concentrations during hospital stay, secondaryOutcomes measure: Exploring donor milk supplementation and percent weight loss during hospital stay, secondaryOutcomes measure: Exploring donor milk supplementation and the length of hospital stay, secondaryOutcomes measure: Exploring donor milk supplementation and weight measurements, secondaryOutcomes measure: Exploring donor milk supplementation and length measurements, secondaryOutcomes measure: Exploring donor milk supplementation and head circumference measurements, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and infant temperament scores, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and parent's anxiety, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and parent's depression, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and maternal cortisol concentrations, eligibilityModule sex: ALL, maximumAge: 2 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Labour and Delivery at Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1X5, country: Canada, contacts name: Kim Dart, RN, role: CONTACT, phone: 4165864800, phoneExt: 6825, email: kim.dart@sinaihealth.ca, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Maternal Fetal Medicine and Placenta clinics, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1Z5, country: Canada, contacts name: Natasha Milligan, role: CONTACT, phone: 4165864800, phoneExt: 6419, email: natasha.milligan@sinaihealth.ca, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Placenta Clinic, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1Z5, country: Canada, contacts name: Jennifer Vaughan, role: CONTACT, email: jennifer.vaughan@sinaihealth.ca, geoPoint lat: 43.70011, lon: -79.4163, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-09-11, uploadDate: 2024-03-13T17:34, filename: Prot_000.pdf, size: 425804, hasResults: False
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protocolSection identificationModule nctId: NCT06315114, orgStudyIdInfo id: p-2023-15049, secondaryIdInfos id: H-23064491, type: OTHER, domain: Regional Committee of Health Research Ethics (VEK), briefTitle: A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders, acronym: LIGHTHOUSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mental Health Services in the Capital Region, Denmark, class: OTHER, collaborators name: University of Copenhagen, descriptionModule briefSummary: The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service., conditionsModule conditions: Mental Disorder, conditions: Behavior Disorders, conditions: Diagnosis, Psychiatric, conditions: Diagnosis Dual, conditions: Severe Mental Disorder, conditions: Mental Illness, conditions: Psychiatric Disorder, conditions: Psychiatric Disease, conditions: Psychiatric Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Lighthouse MBT Parenting Program (LPP), interventions name: Care as usual (CAU), outcomesModule primaryOutcomes measure: Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF), secondaryOutcomes measure: Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ), secondaryOutcomes measure: Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF), secondaryOutcomes measure: Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF)., secondaryOutcomes measure: Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW), secondaryOutcomes measure: Parenting competence assessed with the Parenting Sense of Competence (PSOC), secondaryOutcomes measure: Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI), secondaryOutcomes measure: Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D), otherOutcomes measure: Parental mentalizing assessed with the Parental Reflective Functioning Questionnaire (PRFQ), otherOutcomes measure: Mind-mindedness assessed with the Representational Mind-Mindedness (MM) interview, otherOutcomes measure: Epistemic trust assessed with the Epistemic Trust, Mistrust, and Credulity Ques-tionnaire (ETMCQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Psychotherapeutic Centre Stolpegaard, status: RECRUITING, city: Gentofte, state: Capital Region, zip: 2820, country: Denmark, contacts name: Emilie Hestbaek, role: CONTACT, phone: +4528302849, email: emilie.hestbaek.jacobsen@regionh.dk, geoPoint lat: 55.74903, lon: 12.54601, locations facility: Psychotherapeutic Centre Stolpegård, status: RECRUITING, city: Gentofte, zip: 2820, country: Denmark, contacts name: Emilie Hestbaek, Msc in Psyc, role: CONTACT, phone: +4528302849, email: emilie.hestbaek.jacobsen@regionh.dk, contacts name: Sebastian Simonsen, Doctor, role: CONTACT, email: sebastian.simonsen@regionh.dk, geoPoint lat: 55.74903, lon: 12.54601, hasResults: False
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protocolSection identificationModule nctId: NCT06315101, orgStudyIdInfo id: K-2023-092, briefTitle: Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Guangzhou University of Chinese Medicine, class: OTHER, descriptionModule briefSummary: This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China., conditionsModule conditions: Unresectable Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 142, type: ACTUAL, armsInterventionsModule interventions name: Chinese Herbal Medicine, outcomesModule primaryOutcomes measure: Efficacy outcomes, primaryOutcomes measure: Survival analysis, primaryOutcomes measure: Survival analysis, secondaryOutcomes measure: Adverse Events assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital of Guangzhou University of Chinese Medicine, city: Guangzhou, state: Guangdong, zip: 510407, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06315088, orgStudyIdInfo id: 69HCL24_0144, briefTitle: Food Biodiversity and Human Health, acronym: BIOQUALIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: In Western countries, one of the major nutritional challenges requires reducing the proportion of animal proteins and increasing the proportion of vegetable proteins in the daily plate. Added to this nutritional challenge is an environmental challenge, with plant proteins being much less expensive to produce. However, plant proteins are mainly provided by cereals and legumes, a large diversity of which is necessary to cover the recommended daily intake of amino acids. However, given the collapse of cultivated biodiversity (loss of 75% in 100 years, FAO), the diversity of the supply is very reduced.Furthermore, for several years, public health studies have indicated a chronic deficit in micronutrients (minerals/trace elements, vitamins, antioxidants) as well as fiber in the diet of the French population. This comes in particular from the impoverishment of the nutritional quality of the fruits/vegetables/cereals/legumes consumed. In general, diet plays a major role in the primary prevention of chronic diseases (cardiovascular, diabetes, cancer) including periodontal disease. Thus, a diet low in sugars, saturated fats and rich in fiber would reduce the appearance of periodontal disease by strengthening salivary capacity. However, certain pathogenic periodontal bacteria (such as Porphyromonas gingivalis) can migrate (blood, digestive or respiratory routes) to reach other organs and represent a risk factor for other chronic diseases. Thus, the prevention of periodontal diseases through diet control would also contribute to the prevention of other chronic diseases.The benefit of plant-based diets to reduce the risk of cancer is now established. In addition, certain cereals such as spelled have superior nutritional qualities to common wheat, notably their protein content and they also contain higher quantities of certain bioactive compounds with anti-cancer properties (such as phytosterols).Furthermore, the potential impact of the oral microbiota on chronic diseases is now being studied: in healthy adults, a dysbiotic periodontal microbiota may be likely to lead to systemic para-inflammation. It has also been shown that a dietary change (Mediterranean diet) could lead to a reduction in pathogenic bacteria in the oral microbiota (including P. gingivalis). However, the link between the introduction of cereals into the diet and the evolution of cancer risk factor bacteria in the oral microbiota has never been demonstrated.This pilot clinical study plans to focus on the oral microbiota, with the aim of objectivizing a possible link between a modification of the diet by the introduction of cereals (einkorn type) and the evolution of certain bacteria of this microbiota., notably P. gingivalis (but also T. forsythia, S. anginosus, A. actinomycetemcomitans, T. denticola and F. nucleatum), considered as cancer risk factors and thus observe an improvement in health status oral and general., conditionsModule conditions: Oral Microbiota, conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Einkorn Diet, interventions name: Intermediate oral microbiota, interventions name: Periodontal health status, interventions name: General health status, outcomesModule primaryOutcomes measure: Total periodontal bacteria count, secondaryOutcomes measure: Intermediate periodontal bacteria count, secondaryOutcomes measure: Periodontal health analysis:plaque index, secondaryOutcomes measure: Periodontal health analysis: gingival index, secondaryOutcomes measure: Periodontal health analysis : pocket depth and loss of clinical attachment, secondaryOutcomes measure: Periodontal health analysis : interdental inflammation, secondaryOutcomes measure: Periodontal health analysis : salivary pH, secondaryOutcomes measure: General health analysis : body mass index, secondaryOutcomes measure: General health analysis : measurement of abdominal circumference, secondaryOutcomes measure: General health analysis : blood pressure, secondaryOutcomes measure: General health analysis : MOS SF-36 quality of life questionnaire, secondaryOutcomes measure: General health analysis : eating habits, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Maison des professionnels, city: Lyon, zip: 69000, country: France, contacts name: Bourgeois Denis, MD,PhD, role: CONTACT, phone: 04 27 85 40 00, email: denis.bourgeois@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
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protocolSection identificationModule nctId: NCT06315075, orgStudyIdInfo id: 657876, briefTitle: Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:* to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.* to investigate how well DBT-A works at 12 months follow-up* to investigate whether pre-treatment factors can predict who will benefit from treatment, conditionsModule conditions: Self-harm, conditions: Suicidal Ideation, conditions: Suicide and Self-harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group, uncontrolled, pre-post-one year follow-up study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: An independent evaluator will assess participants at post treatment and one year follow-up. Due to the single group design, the assessor will be aware that participants have received the intervention, but will not be involved in recruitment and treatment., enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Dialectical behavior therapy for adolescents (DBT-A), outcomesModule primaryOutcomes measure: Lifetime Parasuicide Count Interview, primaryOutcomes measure: Number of participants in need of emergency department visits caused by suicidal behavior, secondaryOutcomes measure: Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ), secondaryOutcomes measure: Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10), secondaryOutcomes measure: Barriers to Treatment Participation Scale (BTPS) score, secondaryOutcomes measure: Perceived benefit of skills training in DBT-A measured by a study specific questionnaire., eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Dept. of child and adolescent psychiatry, Haukeland University Hospital, status: RECRUITING, city: Bergen, zip: 5021, country: Norway, contacts name: Gro Janne H. Wergeland, MD, PhD, role: CONTACT, phone: +47 48176828, email: gneh@helse-bergen.no, contacts name: Anne Mari Syversen, Psychol, role: CONTACT, phone: +4755975000, email: anne.mari.syversen@helse-bergen.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
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protocolSection identificationModule nctId: NCT06315062, orgStudyIdInfo id: CEC-UNIBE-07-2023, briefTitle: Efficacy of Rezum® in Reducing Prostate Volume, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Urología Costa Rica, class: OTHER, descriptionModule briefSummary: This study aimed to assess the efficacy of Rezum® water vapor therapy in reducing prostate volume in patients aged 40 years or older with Benign Prostate Hyperplasia (BPH) at UNIBE Hospital in Costa Rica. A retrospective analysis will be conducted on 289 patient records, focusing on prostate volume, International Prostate Symptom Score (IPSS), and urinary flow rate. Statistical analyses included two-sample mean comparisons, effect size estimation, and linear regression., conditionsModule conditions: Benign Hyperplasia of Prostate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 289, type: ACTUAL, outcomesModule primaryOutcomes measure: Prostate volume, secondaryOutcomes measure: International Prostate Symptome Score, secondaryOutcomes measure: Urinary flow rate, eligibilityModule sex: MALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital UNIBE, city: San José, zip: 11301, country: Costa Rica, geoPoint lat: 9.93333, lon: -84.08333, hasResults: False
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protocolSection identificationModule nctId: NCT06315049, orgStudyIdInfo id: 2023-ENFPOD-2621979, briefTitle: Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-26, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Universitat Politècnica de València, class: OTHER, collaborators name: University of Valencia, descriptionModule briefSummary: This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session., conditionsModule conditions: Severe Mental Disorder, conditions: Schizophrenia, conditions: Bipolar Disorder, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Music therapy, outcomesModule primaryOutcomes measure: IDARE test, primaryOutcomes measure: SBP, primaryOutcomes measure: DBP, primaryOutcomes measure: HR, primaryOutcomes measure: RR, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Universitat Politècnica de València, city: Valencia, zip: 46022, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06315036, orgStudyIdInfo id: 32/2021, briefTitle: Effects of Developmental Gymnastics on Preschoolers' Motor Skills, acronym: GymKids, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-05, primaryCompletionDateStruct date: 2021-09-10, completionDateStruct date: 2022-05-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of Novi Sad, class: OTHER, descriptionModule briefSummary: Background: During childhood, physical activity (PA) is considered indispensable for developing motor skills through movement in the early stages of human development. Being active helps individuals develop fine and gross motor skills (GMS) by promoting an active lifestyle. Notably, this phase, characterized by regular PA and attaining motor competence, is associated with many health-related benefits. Early motor intervention programs have garnered attention for their positive influence on children's motor skills, as evidenced by various studies. A spectrum of more specialized methods is available alongside these general approaches, including programs designed to augment the time dedicated to general PA within school environments. Previous research has demonstrated the efficacy of incorporating experimental exercise interventions, grounded in enjoyable activities and game drills, into the curriculum, significantly improving children's basic motor skills. Many research articles have explored the impact of developmental gymnastics (DG) on children's fitness, indicating that gymnastics training can produce numerous beneficial outcomes for children's physical fitness.Method and Materials: Three hundred preschool children were assigned to either a gender-balanced group participating in a DG exercise program (EG; n=99) or a control group (CG; n=121). While individuals in the CG followed three structured extracurricular physical activities per week in kindergarten, the EG participants received 60 minutes of the DG exercise program two days a week. The Test of Gross Motor Development-2 (TGMD-2) was used to assess GMS.Aim: The study aimed to determine if participation in a structured DG program could improve GMS among preschool children compared to those in a group that attended extracurricular physical activities in a kindergarten., conditionsModule conditions: Motor Activity, conditions: Child Development, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: Developmental gymnastics, outcomesModule primaryOutcomes measure: Test of gross motor development (tgmd-2): Locomotor Skills - Run, primaryOutcomes measure: Test of gross motor development (tgmd-2): Locomotor skills - Gallop, primaryOutcomes measure: Test of gross motor development (tgmd-2): Locomotor skills - Hop, primaryOutcomes measure: Test of gross motor development (tgmd-2): Locomotor skills - Leap, primaryOutcomes measure: Test of gross motor development (tgmd-2): Locomotor skills - Horizontal jump, primaryOutcomes measure: Test of gross motor development (tgmd-2): Locomotor skills - skip, primaryOutcomes measure: Test of gross motor development (tgmd-2): Locomotor skills - slide, primaryOutcomes measure: Test of gross motor development (tgmd-2): Object control skill- two-hand strike, primaryOutcomes measure: Test of gross motor development (tgmd-2): Object control skill- stationary bounce, primaryOutcomes measure: Test of gross motor development (tgmd-2): Object control skill- catch, primaryOutcomes measure: Test of gross motor development (tgmd-2): Object control skill- kick, primaryOutcomes measure: Test of gross motor development (tgmd-2): Object control skill- overhand throw, primaryOutcomes measure: Test of gross motor development (tgmd-2): Object control skill- underhand roll, secondaryOutcomes measure: Sex, secondaryOutcomes measure: Date of birth, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Adherence, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of sport and Physical Education, University of Novi Sad, city: Novi Sad, state: Vojvodina, zip: 21000, country: Serbia, geoPoint lat: 45.25167, lon: 19.83694, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-07, uploadDate: 2024-03-13T15:29, filename: Prot_000.pdf, size: 1944925, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2020-06-10, uploadDate: 2024-03-13T15:30, filename: ICF_001.pdf, size: 147616, hasResults: False
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protocolSection identificationModule nctId: NCT06315023, orgStudyIdInfo id: CP-0029, briefTitle: The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry), acronym: PTAB1, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2028-06-07, completionDateStruct date: 2032-06-07, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Endologix, class: INDUSTRY, collaborators name: Fivos, collaborators name: Massachusetts General Hospital, collaborators name: Society for Vascular Surgery Patient Safety Organization, descriptionModule briefSummary: The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments., conditionsModule conditions: Peripheral Arterial Disease, conditions: Symptomatic Femoropopliteal Lesions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: DETOUR System, outcomesModule primaryOutcomes measure: Freedom from CD-TLR, primaryOutcomes measure: Freedom from MAE, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Medical Center, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06315010, orgStudyIdInfo id: MedOPP662, secondaryIdInfos id: CA127-1061, type: OTHER, domain: Bristol-Myers Squibb GmbH & Co, secondaryIdInfos id: 2023-508112-35, type: EUDRACT_NUMBER, briefTitle: REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis, acronym: REPOSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: MedSIR, class: OTHER, collaborators name: Medical University of Vienna, descriptionModule briefSummary: REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene., conditionsModule conditions: NSCLC, conditions: Brain Metastases, conditions: ROS1 Gene Rearrangement, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Repotrectinib, outcomesModule primaryOutcomes measure: Intracranial Objective Response Rate (IC-ORR), secondaryOutcomes measure: Clinical Benefit Rate (CBR) for intracranial (IC) lesions, secondaryOutcomes measure: Disease Control Rate (DCR) for IC lesions, secondaryOutcomes measure: Time to Response (TTR) for IC lesions, secondaryOutcomes measure: Duration of Response (DoR) for IC lesions, secondaryOutcomes measure: Objective Response Rate for extracranial (EC) and overall lesions (EC-ORR), secondaryOutcomes measure: CBR for EC and overall lesions, secondaryOutcomes measure: DCR for EC and overall lesions, secondaryOutcomes measure: TTR for EC and overall lesions, secondaryOutcomes measure: DoR for EC and overall lesions, secondaryOutcomes measure: Best percentage of change in tumor burden, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Neurologic function, secondaryOutcomes measure: Quality of life (QoL) with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30), secondaryOutcomes measure: QoL with the brain cancer specific questionnaire (QLQ-C20)., secondaryOutcomes measure: Safety and tolerability, otherOutcomes measure: Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes, otherOutcomes measure: Exploratory endpoint: ROS1 gene expression analysis using baseline tissue samples to investigate the potential association with clinical outcomes, otherOutcomes measure: Exploratory endpoint: Analysis of medical imaging to identify potential biomarkers associated with clinical outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314997, orgStudyIdInfo id: 2013.34, briefTitle: Dynamic Changes in Circulating Tumour Cells Protein Expression, acronym: Liquid-DRER2, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-14, primaryCompletionDateStruct date: 2024-12-17, completionDateStruct date: 2027-12-18, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Matteo's Friends, class: OTHER, descriptionModule briefSummary: This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4)., conditionsModule conditions: Recurrence Free Survival, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: panitumumab (EGFR inhibitors), outcomesModule primaryOutcomes measure: The primary efficacy end point was recurrence- free survival at 12 months., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Natalia Malara, status: RECRUITING, city: Germaneto, zip: 88100, country: Italy, geoPoint lat: 38.88496, lon: 16.57673, hasResults: False
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protocolSection identificationModule nctId: NCT06314984, orgStudyIdInfo id: A10040521, briefTitle: Jet Injectors Versus Conventional Anesthetic Technique in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-21, primaryCompletionDateStruct date: 2022-11-15, completionDateStruct date: 2023-03-21, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of1. Pain level during the administration of local anesthesia in children.2. Their effectiveness during pulpotomy procedures in primary molars.Whether comfort-in jet injector device will achieve sufficient anesthesia for the procedures undertaken during pulpotomy or not when compared to the conventional technique and the pain levels of both techniques during the anesthesia step., conditionsModule conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: Group I A (Conventional needle syringe), interventions name: Group I B (Conventional needle syringe), interventions name: Group II A (Comfort-in Jet Injector), interventions name: Group II B (Comfort-in Jet Injector), outcomesModule primaryOutcomes measure: Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale, primaryOutcomes measure: Pain levels during pulpotomy procedures steps by Wong-Baker faces pain rating scale, primaryOutcomes measure: Pain level during administration of local anesthesia in children by FLACC scale., primaryOutcomes measure: Pain levels during pulpotomy procedures steps by FLACC scale., eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Dentistry, Mansoura University., city: Mansoura, state: Dakahlia, zip: 35516, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06314971, orgStudyIdInfo id: 23228/T1CR, briefTitle: Predicting Local and Distant Recurrence in T1 Colorectal Cancer, acronym: T1CR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, conditions: Colorectal Adenocarcinoma, conditions: Colorectal Cancer Stage I, conditions: Colorectal Neoplasms Malignant, conditions: Colorectal Cancer Recurrent, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Tw1CE, outcomesModule primaryOutcomes measure: Recurrence-free Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Takayuki Noma, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alessandro Mannucci, role: SUB_INVESTIGATOR, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Tokushima University, status: RECRUITING, city: Tokushima, country: Japan, contacts name: Mitsuo Shimada, PhD, role: CONTACT, email: mitsuo.shimada@tokushima-u.ac.jp, contacts name: Katsuki Miyazaki, role: SUB_INVESTIGATOR, contacts name: Takayuki Noma, MD, role: SUB_INVESTIGATOR, contacts name: Yuma Wada, PhD, role: SUB_INVESTIGATOR, contacts name: Mistuo Shimada, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.06667, lon: 134.56667, locations facility: Barcelona University, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Maria Pellise, role: CONTACT, email: mpellise@clinic.cat, contacts name: Karmele Saez de Gordoa, role: SUB_INVESTIGATOR, contacts name: María Daca, role: SUB_INVESTIGATOR, contacts name: Francesc Balaguer, role: PRINCIPAL_INVESTIGATOR, contacts name: Maria Pellise, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06314958, orgStudyIdInfo id: 23228/CENSURE, briefTitle: Stage II/III Colorectal Cancer Recurrence, acronym: CENSURE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, descriptionModule briefSummary: This study will develop an assay to predict disease recurrence in patients with stage II/III CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Adenocarcinoma, conditions: Colorectal Cancer Stage II, conditions: Colorectal Cancer Stage III, conditions: Colorectal Cancer Recurrent, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: CENSURE, outcomesModule primaryOutcomes measure: Recurrence-Free Survival, secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Monrovia, state: California, zip: 91016, country: United States, contacts name: Ajay Goel, PhD, role: CONTACT, phone: 626-218-3452, email: AJGOEL@COH.ORG, contacts name: Caiming Xu, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ajay Goel, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alessandro Mannucci, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.14806, lon: -117.99895, locations facility: Second Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, country: China, contacts name: Man Li, role: CONTACT, email: man_li@dmu.edu.cn, contacts name: Man Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.91222, lon: 121.60222, locations facility: Barcelona University, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Francesc Balaguer, MD, PhD, role: CONTACT, email: fprunes@clinic.cat, contacts name: Francesc Balaguer, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: La Paz University Hospital, status: RECRUITING, city: Madrid, country: Spain, contacts name: Marta Mendiola, role: CONTACT, email: marta.mendiola@salud.madrid.org, contacts name: Marta Mendiola, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06314945, orgStudyIdInfo id: #11280-4\12-2023, briefTitle: Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Perianal fistula is a common anal problem. It needs only surgery. MRI is the best preoperative diagnostic tool, but it is demanding as it is expensive, time consuming and needs an experienced radiologist. So, we tried to find an alternative diagnostic tool which is cheaper, time saving and accurate and comparing its preoperative reports with intraoperative findings.study was held in surgery department in Zagazig University Hospitals from September 2023 to March 2024. It included 93 patients with perianal fistula who were diagnosed clinically and radiological by trans recto-perineal ultrasound and comparing pre-operative ultrasound findings with intra-operative surgical findings., conditionsModule conditions: Perianal Fistula, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 93, type: ACTUAL, outcomesModule primaryOutcomes measure: age, primaryOutcomes measure: sex, primaryOutcomes measure: body mass index, primaryOutcomes measure: history of abscess drainage, primaryOutcomes measure: Internal opening, primaryOutcomes measure: fistula branches, primaryOutcomes measure: type fistulous tract, primaryOutcomes measure: abscess cavity, secondaryOutcomes measure: other anal disease, secondaryOutcomes measure: external openings, secondaryOutcomes measure: anal discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zagazig University Hospitals, city: Zagazig, zip: 44519, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06314932, orgStudyIdInfo id: spe123.23, briefTitle: Role of Ultra-processed Foods in Modulating the Effect of Mediterranean Diet, acronym: PROMENADE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of Milan, class: OTHER, collaborators name: University of Florence, collaborators name: University of Teramo, descriptionModule briefSummary: Mediterranean diet is worldwide promoted as one of the healthiest and most sustainable dietary patterns. One of the main pillars of Mediterranean diet is the abundant consumption of plant-based ingredients typically consumed as raw or minimally processed. However, even in the Mediterranean countries, these fresh foods are increasingly replaced by ultra-processed foods (UPF). Epidemiological evidence suggests that consumption of UPF may be detrimental to human health, but there is only one clinical trial on this topic which is largely debated in the scientific community due to limitations related to the short duration of the trial and the composition of dietary interventions.The present study aims at exploring whether the inclusion of UPF within a Mediterranean-based dietary pattern can impact on cardiometabolic markers, gut microbiota and other health markers in a dietary intervention performed in Italian subjects. For this purpose, 50 clinically healthy subjects will be recruited for a 7-month randomized, open, cross-over dietary trial. Eligible participants will be randomly assigned to consume a 3-month Mediterranean diet high in UPF (intervention group) or a low-UPF Mediterranean diet (control group), spaced by a 1-month wash-out period. The two diets will have the same composition in terms of food groups. However, in the high-UPF Mediterranean diet group, 5 servings/day of UPF, as defined by the NOVA system, will be consumed (e.g., flavored yogurt, breakfast cereals with added sugar, processed meat). In the control group, these foods will be replaced by products from the same food group, but not UPF (e.g., plain yogurt, breakfast cereals with no added sugar, unprocessed meat). The inflammatory potential of pairs of food products, both UPF and non UPF, will be evaluated using an in vitro cell model testing the modulation of inflammatory markers. Before and after each intervention blood, urine and fecal samples will be collected. The primary endpoint is change in low-density lipoprotein (LDL) cholesterol levels from baseline. Among the other markers, blood pressure and anthropometric parameters will be measured; biochemical parameters, adipokines, inflammatory and oxidative stress markers, fecal microbiota composition and short chain fatty acids (SCFAs) will be analyzed. Adherence to the study, dietary intake and food waste production will be evaluated through specific food diaries, useful also for estimating the metabolic food waste., conditionsModule conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: MD high in UPF, interventions name: MD low in UPF, outcomesModule primaryOutcomes measure: Low-density lipoprotein (LDL) cholesterol levels, secondaryOutcomes measure: Total cholesterol levels, secondaryOutcomes measure: High-density lipoprotein (HDL) cholesterol levels, secondaryOutcomes measure: Triglycerides levels, secondaryOutcomes measure: Fasting blood glucose levels, secondaryOutcomes measure: Insulin levels, secondaryOutcomes measure: Aspartate aminotransferase (AST) levels, secondaryOutcomes measure: Alanine aminotransferase (ALT) levels, secondaryOutcomes measure: Gamma-glutamyl transferase (GGT) levels, secondaryOutcomes measure: Folates levels, secondaryOutcomes measure: Vitamin B12 levels, secondaryOutcomes measure: Urea levels, secondaryOutcomes measure: Creatinine levels, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Concentration of ghrelin in plasma, secondaryOutcomes measure: Concentration of leptin in plasma, secondaryOutcomes measure: Concentration of adiponectin in plasma, secondaryOutcomes measure: Concentration of resistin in plasma, secondaryOutcomes measure: Concentration of visfatin in plasma, secondaryOutcomes measure: Concentration of interleukin (IL)-4 in plasma, secondaryOutcomes measure: Concentration of interleukin (IL)-6 in plasma, secondaryOutcomes measure: Concentration of interleukin (IL)-10 in plasma, secondaryOutcomes measure: Concentration of Protein C-reactive (PCR) in plasma, secondaryOutcomes measure: Concentration of interferon gamma (IFN-γ) in plasma, secondaryOutcomes measure: Concentration of tumor necrosis factor -alpha (TNF-α) in plasma, secondaryOutcomes measure: DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2), secondaryOutcomes measure: Concentration of F2-isoprostanes in urine, secondaryOutcomes measure: Gut microbiota composition and function changes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Florence, city: Florence, zip: 54141, country: Italy, contacts name: Monica Dinu, role: CONTACT, phone: +39 349 3465184, email: monica.dinu@unifi.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: University of Milan, city: Milan, zip: 20133, country: Italy, contacts name: Daniela Martini, role: CONTACT, phone: +39 02503 16727, email: daniela.martini@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06314919, orgStudyIdInfo id: BR-PEC-OS-401, briefTitle: A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Boryung Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition, conditionsModule conditions: Primary Hypercholesterolemia, conditions: Mixed Dyslipidemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 8606, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of reaching the target LDL Cholesterol level, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ewha Womans University Seoul Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Wook-Bum Pyun, M.D., Ph.D., role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06314906, orgStudyIdInfo id: SHLU-2024001, briefTitle: Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Feixue Song, class: OTHER, descriptionModule briefSummary: This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment., conditionsModule conditions: Electroacupuncture, conditions: Olanzapine-contained Four-drug Antiemetic, conditions: Nausea and Vomiting, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 370, type: ESTIMATED, armsInterventionsModule interventions name: Electroacupuncture, interventions name: Antiemetic Therapy, interventions name: Sham electroacupuncture, interventions name: Antiemetic Therapy, outcomesModule primaryOutcomes measure: Proportion of Patients Free from Nausea Throughout Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Hospital of Lanzhou University, status: RECRUITING, city: Lanzhou, state: Gansu, zip: 730000, country: China, contacts name: Feixue Song, Dr, role: CONTACT, phone: 13639336037, email: 13639336037@139.com, geoPoint lat: 36.05701, lon: 103.83987, hasResults: False
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protocolSection identificationModule nctId: NCT06314893, orgStudyIdInfo id: LMCII2022-001, briefTitle: Establishing a Correlation Between HRM and UGI MM Studies, acronym: MMvsMANO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-24, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Lexington Health Incorporated, class: OTHER, descriptionModule briefSummary: A retrospective and prospective cohort, quantitative data collection with the goal of comparing preoperative High Resolution Manometry(HRM) results to Upper Gastrointestinal Marshmallow(UGI MM) results, in patients undergoing preoperative esophageal motility assessments. The aim of this study is to establish a correlation between HRM and UGI MM in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment., conditionsModule conditions: Esophageal Motility Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Determining the correlation between HRM and UGI MM assessments among preoperative candidates will provide an evidenced based evaluation strategy for establishing procedural candidacy and predicting postoperative outcomes., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lexington Health Incorporated, status: RECRUITING, city: West Columbia, state: South Carolina, zip: 29169, country: United States, contacts name: Kimberly Pressley, role: CONTACT, phone: 803-935-8794, email: kmpressley@lexhealth.org, contacts name: Marc Antonetti, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lori Norris, APRN, role: SUB_INVESTIGATOR, contacts name: Brandi O'Neal, RN,MSN, role: SUB_INVESTIGATOR, geoPoint lat: 33.99349, lon: -81.07398, hasResults: False
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protocolSection identificationModule nctId: NCT06314880, orgStudyIdInfo id: 2022112701, briefTitle: Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-22, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), interventions name: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose), interventions name: Placebo control, outcomesModule primaryOutcomes measure: The incidence rate of all AEs within 0-30 days after each dose of vaccination, primaryOutcomes measure: The incidence rate of solicited AEs within 30 minutes after each dose of vaccination, primaryOutcomes measure: The incidence rate of solicited AEs within 0-14 days after each dose of vaccination, primaryOutcomes measure: The incidence rate of unsolicited AEs within 0-30 days after each dose of vaccination, primaryOutcomes measure: The incidence rate of grade 3 and higher AEs within 0-30 days after each dose of vaccination, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, status: RECRUITING, city: Nanning, state: Guangxi, zip: 530028, country: China, contacts name: Lirong Huang, role: CONTACT, phone: +86-13978620932, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False
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protocolSection identificationModule nctId: NCT06314867, orgStudyIdInfo id: 20220231, briefTitle: Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-30, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 990, type: ACTUAL, armsInterventionsModule interventions name: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1), interventions name: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2), interventions name: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3), outcomesModule primaryOutcomes measure: Geometric mean concentration (GMC) levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sichuan Center for Disease Control and Prevention, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06314854, orgStudyIdInfo id: P202300046, briefTitle: The Effect of Running Water Sound Listened to Patients During Hemodialysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Kırklareli University, class: OTHER, descriptionModule briefSummary: It is known that being in nature and the visual perception of nature positively affects an individual's mood and self-confidence (Bratman et al., 2012). Studies have reported that natural sounds have a positive effect in situations such as pain, anxiety, and stress (Arai et al., 2008; Thoma et al., 2018). This finding means that listening to natural sounds may be a simple and easily accessible intervention that can positively impact key human stress systems.Although many non-pharmacological methods are used in the literature to reduce the invasive pain and anxiety experienced by hemodialysis (HD) patients during cannulation, the most popular recently; However, we aimed to determine the effect of the sound of running water, which we have not yet encountered in dialysis patients, on invasive pain and anxiety experienced during fistula access., conditionsModule conditions: Hemodialysis Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: he forms were collected by dialysis unit nurses who did not know the groups the patients were assigned to. Information and training on how to collect the forms were provided to the nurses by the secondco-author. The current study was therefore performed asan assessor-blinded randomized controlled trial, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Running water sound, outcomesModule primaryOutcomes measure: Pain Assessment, secondaryOutcomes measure: State and Trait Anxiety Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aas, status: RECRUITING, city: Kırklareli, state: Center, zip: 39000, country: Turkey, contacts name: Samet Sayilan, role: CONTACT, phone: 05079404528, email: sametsayilan@hotmail.com, geoPoint lat: 41.73508, lon: 27.22521, hasResults: False
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protocolSection identificationModule nctId: NCT06314841, orgStudyIdInfo id: LBG-AUVA, briefTitle: Polytrauma and Resuscitation Impact on Innate Immunity, acronym: PRIME, statusModule overallStatus: TERMINATED, startDateStruct date: 2017-06-01, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2022-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ludwig Boltzmann Gesellschaft, class: OTHER, collaborators name: AUVA, descriptionModule briefSummary: Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression., conditionsModule conditions: Wounds and Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 62, type: ACTUAL, outcomesModule primaryOutcomes measure: Immunocompetence, secondaryOutcomes measure: Changes in cellular immuno-status, secondaryOutcomes measure: Release of extracellular vesicles and associated content, secondaryOutcomes measure: Platelet-leukocyte aggregates, secondaryOutcomes measure: Immunocompetence clusters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Trauma Center Vienna, Meidling, city: Vienna, zip: 1120, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center, city: Vienna, zip: 1200, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Trauma Center Vienna, Lorenz Böhler, city: Vienna, zip: 1200, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06314828, orgStudyIdInfo id: RJMty19-B-NHL002, briefTitle: A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2025-05-20, completionDateStruct date: 2027-05-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Guangdong Ruishun Biotech Co., Ltd, class: INDUSTRY, collaborators name: Ruijin Hospital, collaborators name: Southern Medical University, China, collaborators name: Beijing GoBroad Hospital, descriptionModule briefSummary: This is a Phase 1, open-label, single-arm study to evaluate tolerability, safety and efficacy of RJMty19 in adult subjects with r/r B-NHL., conditionsModule conditions: B-cell Non-Hodgkin's Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: RJMty19 (CD19-CAR-DNT cells), outcomesModule primaryOutcomes measure: Dose-Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), primaryOutcomes measure: Incidence of abnormalities, secondaryOutcomes measure: Pharmacokinetics (PK) indicator (Cmax), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (AUC), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (Tmax), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (T1/2), secondaryOutcomes measure: Overall Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Response Rate at 3 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314815, orgStudyIdInfo id: Shouldice hospital, briefTitle: Ilioinguinal-iliohypogastric Nerve Block Prior to Shouldice Inguinal Hernia Repair, acronym: NBSS, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-11, primaryCompletionDateStruct date: 2024-03-10, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Shouldice Hospital, class: OTHER, descriptionModule briefSummary: The introduction of ilioinguinal-iliohypogastric nerve blocks into the preoperative care regimen at Shouldice Hospital for inguinal hernia repair marks a significant shift in pain management strategies. While Shouldice Hospital has traditionally not employed this technique, recent literature highlighting its potential benefits has prompted its trial within their patient population.Research in this area, although limited, suggests promising outcomes. Studies such as those by Beaussier et al. (2005) and Nehra et al. (1995) have demonstrated decreased postoperative pain and opioid use, as well as increased mobility associated with the use of ilioinguinal-iliohypogastric nerve blocks. However, concerns such as orthostatic hypotension and rebound pain have also been noted, indicating the need for careful consideration and monitoring of potential adverse effects.More recent studies, particularly those focusing on the Lichtenstein repair, have further supported the potential benefits of ilioinguinal-iliohypogastric nerve blocks. Kacmaz and Bolat (2020) found improved patient satisfaction, reduced opioid consumption, and shorter hospital stays associated with nerve block techniques. Additionally, the use of adjuncts such as dexamethasone has shown promise in reducing rebound pain and opioid requirements postoperatively.The purpose of evaluating the use of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital is multifaceted. Not only does it aim to enhance patient care and satisfaction by improving pain management strategies, but it also provides valuable insights for anesthetists and surgeons regarding the utility and efficacy of this technique within the context of inguinal hernia repair. Furthermore, the trial may facilitate the refinement of current practices, potentially leading to standardized protocols that optimize patient outcomes while minimizing adverse effects.In summary, the introduction of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital represents a proactive approach toward enhancing perioperative care for inguinal hernia patients. By leveraging emerging evidence and adapting to evolving clinical practices, the hospital stands to benefit from improved patient outcomes and potentially contribute to the advancement of pain management strategies in hernia surgery., conditionsModule conditions: Inguinal Hernia, conditions: Pain, Postoperative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Compare pain and pain medication use between patients receiving an ilioinguinal-iliohypogastric nerve block prior to hernia surgery with those who do not., secondaryOutcomes measure: Evaluate the impact of the ilioinguinal-iliohypogastric nerve block on patients with pain conditions, mental health conditions, and substance use histories., secondaryOutcomes measure: Determine sample size for future prospective trial., eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shouldice hospital, city: Thornhill, state: Ontario, zip: L3T 4A3, country: Canada, hasResults: False
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protocolSection identificationModule nctId: NCT06314802, orgStudyIdInfo id: LCSR, briefTitle: Learning Curve of the Shouldice Procedure, acronym: LCSR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-05-11, completionDateStruct date: 2024-06-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Shouldice Hospital, class: OTHER, descriptionModule briefSummary: Hernia repair surgery is common, especially the Shouldice repair for primary inguinal hernias, which is considered a top-notch nonmesh technique. However, outcomes can vary, possibly due to differences in surgical skill and experience. Many surgeons are trained more in mesh repairs like the Lichtenstein technique, rather than nonmesh repairs like Shouldice.Understanding a surgeon's learning curve-how many surgeries they need to do to become proficient-is crucial. Yet, there's not much research on this for the Shouldice repair. This project aims to fill that gap and improve surgeon education.The study's goal is to find out how the learning curve affects Shouldice repair for primary inguinal hernias. They'll look at how operative time changes over a surgeon's first 300 repairs compared to their 900-1000th. They'll also check for complications and recurrence rates.The study objectives are:1. Explore the learning curve and factors affecting Shouldice repair.2. Compare operative times between a surgeon's early and later surgeries.3. Look at complications during the learning curve.4. Determine how long training takes at Shouldice Hospital and the surgeons' previous experience.5. Review recurrence rates between the first 300 and 900-1000 surgeries.This research aims to give surgeons and the hernia community valuable insights into improving surgical techniques and patient outcomes., conditionsModule conditions: Groin Hernia, conditions: Shouldice Procedure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Operating time I, secondaryOutcomes measure: Operating time II, secondaryOutcomes measure: Operating time III, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shouldice hospital, status: RECRUITING, city: Thornhill, state: Ontario, zip: L3T 4A3, country: Canada, contacts name: Christoph Paasch, role: CONTACT, phone: 9058891125, email: cpaasch@shouldice.com, contacts name: Marguerite Mainprize, role: CONTACT, phone: 9058891125, email: mmainprize@shouldice.com, hasResults: False
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protocolSection identificationModule nctId: NCT06314789, orgStudyIdInfo id: G1201, briefTitle: The Use of Lung Ultrasonography in the Delivery Room in Neonates, acronym: LUSIN, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Kırıkkale University, class: OTHER, descriptionModule briefSummary: Lung ultrasonography has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. (1, 2) In our clinic, lung ultrasonography imaging is performed in infants hospitalized with respiratory distress.Lung ultrasonography is widely used especially in conditions that mainly cause respiratory distress such as respiratory distress syndrome (RDS), pneumonia, neonatal transient tachypnea (NTRT), congenital pneumonia, meconium aspiration syndrome and pneumothorax. (1, 2) The reliability and specificity of AUS imaging especially in the diagnosis of NTRT have been proven in many studies.AUS imaging has become an objective value by scoring today. Images will be obtained using the linear probe of the device to be used for lung ultrasound and transferred to a cell phone, both lungs will be evaluated as three areas on the right and left (anterior upper, anterior lower and lateral) and scored separately. Anteriorly, the region between the anterior axillary line and the parasternal line is divided into two by the line passing through the nipple. Above is considered as the upper anterior region and below as the lower anterior region. The area in the middle of the anterior and posterior axillary line is evaluated as the lateral region. Each area is scored from 0 to 3 points. If A lines are present, 0 points are given, if there are more than 3 B lines in an area, 1 point is given, if B lines are very dense and there are no A lines, it is considered as white lung and 2 points are given. If there is a consolidation image on AUS, 3 points were given. The maximum total score was 18 (8,9) (Figure 1).In this study, both AUS imaging and scoring will be performed in the delivery room within the first 30 minutes and AUS score evaluation will be performed at postnatal 2nd, 6th and 24th hours in the intensive care unit for inpatients and in the maternal ward for maternal patients. The hypothesis of this study is that newborns with high AUS scores will have high rates of respiratory morbidities and respiratory support in the neonatal unit. The primary aim of the study was to determine the role and importance of AUS scores measured in the delivery room in predicting respiratory morbidities of infants. The secondary aim was to investigate the value of the course of AUS scores at postnatal 2, 6 and 24 hours in predicting the respiratory prognosis of the newborn infant., conditionsModule conditions: Suspected Damage to Fetus From Other Disease in the Mother, Affecting Management of Mother, With Delivery, conditions: Patient Death or Serious Disability Associated With A Haemolytic Reaction Due to the Administration of ABO-Incompatible Blood or Blood Products, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: doing lung ultrasonography, outcomesModule primaryOutcomes measure: LUS in delivery room, secondaryOutcomes measure: LUS in NICU or room, eligibilityModule sex: ALL, minimumAge: 1 Minute, maximumAge: 1 Month, stdAges: CHILD, contactsLocationsModule locations facility: Kirikkale University, city: Kirikkale, country: Turkey, geoPoint lat: 39.84528, lon: 33.50639, hasResults: False
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protocolSection identificationModule nctId: NCT06314776, orgStudyIdInfo id: NEURO24, briefTitle: Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Universidad de Almeria, class: OTHER, descriptionModule briefSummary: Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution, conditionsModule conditions: Cerebral Palsy, conditions: Neurologic Disorder, conditions: Gait Disorders in Children, conditions: Hemiplegia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Usual physiotherapy without Whole-Body Vibration, interventions name: Pre-Usual physiotherapy, interventions name: Post-Usual physiotherapy, outcomesModule primaryOutcomes measure: Test Time Up and Go, primaryOutcomes measure: Timed 10-Meter Walk Test, primaryOutcomes measure: Gross Motor Function Measure, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: María del Mar Sánchez-Joya, status: RECRUITING, city: Almería, zip: 04120, country: Spain, contacts name: María del Mar Sánchez-Joya, PhD, role: CONTACT, contacts name: Pilar Pérez Guillén, role: SUB_INVESTIGATOR, geoPoint lat: 36.83814, lon: -2.45974, hasResults: False
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protocolSection identificationModule nctId: NCT06314763, orgStudyIdInfo id: ROSIE, briefTitle: Rivaroxaban Sotorasib Interaction Study, acronym: ROSIE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-09, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, collaborators name: Amgen, descriptionModule briefSummary: Venous thromboembolic Events (VTEs) are common in lung cancer patients with an incidence of \>15%, requiring anticoagulant treatment or prophylaxis. Although direct acting oral anticoagulants (DOACs) are the agents of first choice due to ease and patient friendliness, these drugs are often avoided in cancer patients due to suspected pharmacokinetic drug-drug interactions with oncolytic drugs. Sotorasib is the first KRASG12C inhibitor that has been approved by the US \[FDA\] and EU \[EMA\] for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Sotorasib has a potential to cause CYP3A-mediated drug-drug interactions due to induction of CYP3A and inhibition of P-GP. Rivaroxaban is the most frequently prescribed DOAC in the Netherlands. As rivaroxaban is a substrate for this enzyme and efflux pump, sotorasib may increase or decrease the exposure to rivaroxaban and, thus, impact its benefit-to-risk ratio. To enable safe combination of sotorasib and rivaroxaban, it is pivotal to investigate the magnitude of the pharmacokinetic interaction between these drugs., conditionsModule conditions: Drug Drug Interaction Study, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: An open label single-sequence pharmacokinetic drug-drug interaction study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Rivaroxaban 20mg, interventions name: Sotorasib 960mg, outcomesModule primaryOutcomes measure: The pharmacokinetics (AUC) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state., primaryOutcomes measure: The pharmacokinetics (Cmax) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state., secondaryOutcomes measure: The pharmacokinetics (AUC) of sotorasib in healthy volunteers., secondaryOutcomes measure: The pharmacokinetics (Cmax) of sotorasib in healthy volunteers., secondaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v6.0, secondaryOutcomes measure: Pharmacokinetic variability in AUC of rivaroxaban., secondaryOutcomes measure: Pharmacokinetic variability in Cmax of rivaroxaban., secondaryOutcomes measure: Pharmacokinetic variability in AUC of sotorasib., secondaryOutcomes measure: Pharmacokinetic variability in Cmax of sotorasib., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud university medical centre, status: RECRUITING, city: Nijmegen, country: Netherlands, contacts name: Rob ter Heine, role: CONTACT, email: R.terHeine@radboudumc.nl, contacts name: Rob ter Heine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False
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protocolSection identificationModule nctId: NCT06314750, orgStudyIdInfo id: 2023ZSLYEC-680, briefTitle: Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 186, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314737, orgStudyIdInfo id: 2021ZSLYEC-192, briefTitle: Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-10-02, primaryCompletionDateStruct date: 2018-12-06, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally advanced rectal cancer, explore the population benefiting most from neoadjuvant therapy, and provide evidence-based medicine for the benefits of neoadjuvant therapy in patients with colorectal cancer in the real world., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3515, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314724, orgStudyIdInfo id: PRO-VZV-4006, briefTitle: Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sinovac (Dalian) Vaccine Technology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac")., conditionsModule conditions: Varicella, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 642, type: ESTIMATED, armsInterventionsModule interventions name: Varicella Vaccine, interventions name: Varivax, outcomesModule primaryOutcomes measure: Seroresponse rate of varicella-zoster virus (VZV) antibody, secondaryOutcomes measure: Geometric mean concentrations (GMCs) of VZV antibody, secondaryOutcomes measure: GMC of VZV antibody, secondaryOutcomes measure: seropositive rate, secondaryOutcomes measure: Geometric mean fold rise (GMFR) from before vaccination of VZV antibody, secondaryOutcomes measure: Incidence of adverse reactions within 0~42 days after vaccination, secondaryOutcomes measure: Incidence of adverse reactions within 0~14 days after vaccination, secondaryOutcomes measure: Incidence of serious adverse events (SAE) within 0~42 days after vaccination, eligibilityModule sex: ALL, minimumAge: 12 Months, maximumAge: 15 Months, stdAges: CHILD, contactsLocationsModule locations facility: San Juan de Dios Educational Foundation, lnc., city: Pasay, zip: 1300, country: Philippines, geoPoint lat: 14.53748, lon: 121.00144, locations facility: Cardinal Santos Medical Center, city: San Juan City, zip: 1502, country: Philippines, geoPoint lat: 14.6, lon: 121.0333, hasResults: False
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protocolSection identificationModule nctId: NCT06314711, orgStudyIdInfo id: Ex Vivo US for OPC, briefTitle: Ex Vivo 3D-ultrasound for Oropharyngeal Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: Patients with biopsy-verified oropharyngeal squamous cell carcinoma or Human Papillomavirus (HPV)-positive unknown primary treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment., conditionsModule conditions: Oropharyngeal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Fresh ex vivo US Tumor detection (blinded to histopathology), primaryOutcomes measure: Margin assessment (blinded to histopathology), primaryOutcomes measure: Fresh ex vivo US tumor volume (blinded to histopathology), primaryOutcomes measure: Fresh ex vivo US margin distance (blinded to histopathology), primaryOutcomes measure: Fresh ex vivo tumor visible on specimen mecrophoto (blinded to histopathology), secondaryOutcomes measure: Fresh ex vivo US tumor volume (unblinded to histopathology), secondaryOutcomes measure: Formalin-fixed ex vivo US tumor volume (unblinded to histopathology), secondaryOutcomes measure: Fresh ex vivo US margin distance (unblinded to histopathology), secondaryOutcomes measure: Formalin-fixed ex vivo US margin distance (unblinded to histopathology), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06314698, orgStudyIdInfo id: IIT-2024-0011, briefTitle: Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Shanghai JMT-Bio Inc., descriptionModule briefSummary: The purpose of this study is to determine if narlumosbart is non-inferior to denosumab in the treatment of bone diseases from multiple myeloma (MM)., conditionsModule conditions: Multiple Myeloma, conditions: Bone Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 478, type: ESTIMATED, armsInterventionsModule interventions name: Narlumosbart, interventions name: Denosumab, outcomesModule primaryOutcomes measure: Percent change from baseline in urinary N-terminal telopeptide of type 1 collagen corrected for urinary creatinine (uNTx/uCr) at week 13, secondaryOutcomes measure: The proportion of subjects with a change in uNTx/uCr greater than 65% from baseline to week 13, secondaryOutcomes measure: Time to first on-study skeletal related event, secondaryOutcomes measure: Percentage of participants with an on-study SRE at different time points, secondaryOutcomes measure: Time to first and subsequent on-study SRE, secondaryOutcomes measure: Percent changes of serum bone alkaline phosphatase (BALP) and serum C-terminal telopeptide of type 1 collagen (sCTX-I), secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Incidence and type of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314685, orgStudyIdInfo id: 2020040C-2, briefTitle: Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-12-10, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old., conditionsModule conditions: Healthy Population, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2450, type: ACTUAL, armsInterventionsModule interventions name: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, interventions name: Group A and C Meningococcal Polysaccharide Vaccine, interventions name: Group ACYW135 Meningococcal Polysaccharide Vaccine, outcomesModule primaryOutcomes measure: Antibody positive conversion rate, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hunan Center for Disease Control and Prevention, city: Changsha, state: Hunan, zip: 410005, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06314672, orgStudyIdInfo id: OSU-22318, secondaryIdInfos id: NCI-2023-02217, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: U01CA274999, type: NIH, link: https://reporter.nih.gov/quickSearch/U01CA274999, briefTitle: Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ohio State University Comprehensive Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials., conditionsModule conditions: Hematopoietic and Lymphoid System Neoplasm, conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule interventions name: Accrual, interventions name: Discussion, interventions name: Educational Activity, interventions name: Interview, interventions name: Review, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Change in referral to clinical trials (CTs) (short-term outcomes), primaryOutcomes measure: Change in accrual of minorities to CTs (short-term outcomes), primaryOutcomes measure: CT accrual and retention due to patient navigation (short-term outcomes), primaryOutcomes measure: Identification of program gaps in trial accrual (long-term outcomes), primaryOutcomes measure: Uptake of program in other clinics (long-germ outcomes), secondaryOutcomes measure: Probability of trial enrollment and retention, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Electra D. Paskett, PhD, role: CONTACT, phone: 614-293-3917, email: electra.paskett@osumc.edu, contacts name: Electra D. Paskett, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06314659, orgStudyIdInfo id: 2020020C, briefTitle: Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-09-17, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old., conditionsModule conditions: Healthy Population, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 630, type: ACTUAL, armsInterventionsModule interventions name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), interventions name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax), interventions name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax), outcomesModule primaryOutcomes measure: Analysis of antibody positivity conversion rate of serogroup A, primaryOutcomes measure: Analysis of antibody positivity conversion rate of serogroup C, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 5 Months, stdAges: CHILD, contactsLocationsModule locations facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, city: Nanning, state: Guangxi, zip: 530028, country: China, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False
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