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protocolSection identificationModule nctId: NCT06375772, orgStudyIdInfo id: 2-DG-02, briefTitle: A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: G.ST Antivirals GmbH, class: INDUSTRY, descriptionModule briefSummary: 2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants., conditionsModule conditions: Acute Nasopharyngitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: 2-Deoxy-D-glucose, interventions name: Placebo, outcomesModule primaryOutcomes measure: The difference in the rate of rhinovirus-associated illness between 2-DG and placebo, secondaryOutcomes measure: Number of infected subjects, secondaryOutcomes measure: Difference in percent of infected subjects, secondaryOutcomes measure: Difference in percent of days virus positive, secondaryOutcomes measure: Difference in peak nasal virus load, secondaryOutcomes measure: Difference in AUC nasal virus load, secondaryOutcomes measure: Difference in Total Jackson Symptom Score, secondaryOutcomes measure: Duration of illness, secondaryOutcomes measure: Difference in percent of days Jackson Symptom Score positive, secondaryOutcomes measure: Difference in Peak Jackson Symptom Score, secondaryOutcomes measure: Difference in peak total WURSS-21, secondaryOutcomes measure: Difference in AUC total WURSS-21, secondaryOutcomes measure: Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs), secondaryOutcomes measure: Biodistribution of multiple doses of 2-DG in plasma samples, secondaryOutcomes measure: Biodistribution of multiple doses of 2-DG in nasal wash samples, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centre for Human Drug Research, status: RECRUITING, city: Leiden, zip: 2333, country: Netherlands, contacts name: Ingrid de Visser- Kamerling, PhD, role: CONTACT, phone: +31 71 5246400, email: [email protected], geoPoint lat: 52.15833, lon: 4.49306, hasResults: False |
protocolSection identificationModule nctId: NCT06375759, orgStudyIdInfo id: XWSSB, briefTitle: Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: To determine whether Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia., conditionsModule conditions: Syringomyelia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Subarachnoid-Subarachnoid (S-S) Bypass, interventions name: Intradural Adhesion Lysis, outcomesModule primaryOutcomes measure: complication, secondaryOutcomes measure: improvement or resolution of the syrinx,, secondaryOutcomes measure: ASIA score, secondaryOutcomes measure: Klekamp and Sammi syringomyelia scale, secondaryOutcomes measure: modified Japanese Orthopaedic Association Scores (mJOA), secondaryOutcomes measure: xuanwu syringomyelia scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fengzeng Jian, status: RECRUITING, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Yuan Chenghua, role: CONTACT, email: [email protected], contacts name: Jian Fengzeng, role: CONTACT, email: [email protected], contacts name: jian guan, dr, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06375746, orgStudyIdInfo id: 0091-22-WOMC, briefTitle: The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Wolfson Medical Center, class: OTHER_GOV, descriptionModule briefSummary: To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling., conditionsModule conditions: Induction of Labor Affected Fetus / Newborn, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Personalized video, outcomesModule primaryOutcomes measure: STAI questionnaire score, secondaryOutcomes measure: satisfaction questionnaire, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375733, orgStudyIdInfo id: GFH009X1202, briefTitle: A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Zhejiang Genfleet Therapeutics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), conditionsModule conditions: Large B-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: GFH009, interventions name: Zanubrutinib, interventions name: GFH009, interventions name: Zanubrutinib, outcomesModule primaryOutcomes measure: Phase Ib: adverse events(AEs), primaryOutcomes measure: Phase II: ORR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute, status: RECRUITING, city: Nanning, country: China, contacts name: Cen Hong, role: CONTACT, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital, status: RECRUITING, city: Zhengzhou, country: China, contacts name: Keshu Zhou, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False |
protocolSection identificationModule nctId: NCT06375720, orgStudyIdInfo id: FujianUTCM-2, briefTitle: Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Lidian Chen, class: OTHER, collaborators name: Peking University Third Hospital, descriptionModule briefSummary: To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Lower frequency, shorter period of Tai Chi Chuan, interventions name: Higher frequency, shorter period of Tai Chi Chuan, interventions name: Lower frequency, longer period of Tai Chi Chuan, interventions name: Higher frequency, longer period of Tai Chi Chuan, interventions name: Standard Health Education, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: Wechsler Memory Scale, secondaryOutcomes measure: Digit Symbol Substitution Test, secondaryOutcomes measure: Trial Making Test part B, secondaryOutcomes measure: Stroop Color Word Test, secondaryOutcomes measure: Boston Naming Test, secondaryOutcomes measure: Rey-Osterrieth Complex Graphics Test, secondaryOutcomes measure: Rey Auditory Verbal Learning Test, otherOutcomes measure: The Pittsburgh Sleep Quality Index (PSQI), otherOutcomes measure: 12-Item Short Form Health Survey, otherOutcomes measure: Blood glucose metabolism index, otherOutcomes measure: Blood lipid metabolism index, otherOutcomes measure: functional Magnetic Resonance Imaging, otherOutcomes measure: Electroencephalogram, otherOutcomes measure: Heart rate variability, otherOutcomes measure: Gut microflora, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06375707, orgStudyIdInfo id: HERO-KC23, briefTitle: Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-09, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, collaborators name: Zhejiang Cancer Hospital, descriptionModule briefSummary: Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS, interventions name: Ribociclib combined with NSAI±OFS, outcomesModule primaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Progression Free Survival2, secondaryOutcomes measure: Time to treatment failure, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Overall survival(OS), secondaryOutcomes measure: Time To Response (TTR), secondaryOutcomes measure: Clinical benefit rate(CBR), secondaryOutcomes measure: Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire, secondaryOutcomes measure: Frequency/severity of adverse events, lab abnormalities, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiangsu Provincial People's Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Wei Li, Ph.D, role: CONTACT, phone: 025-68306360, email: [email protected], contacts name: Wei Li, Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06375694, orgStudyIdInfo id: IRB00025485, briefTitle: Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN ), acronym: OPEDNPN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Wake Forest University, class: OTHER, collaborators name: University of South Florida, descriptionModule briefSummary: Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic.In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions.The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate).In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo.While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics., conditionsModule conditions: Hypertension, conditions: Cardiovascular Diseases, conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized into two groups with one group receiving the oral probiotic and the other receiving the placebo. Each group will take their intervention 2X a day for 7 days., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participants will not know which group they are in. The lozenges will be distributed in unmarked bottles, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Herbiotics Oral + Ent Probiotic, outcomesModule primaryOutcomes measure: Dietary Nitrate Conversion to Plasma Nitrite, secondaryOutcomes measure: Percentage Lactobaciluus, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375681, orgStudyIdInfo id: 2019-1378: R01, secondaryIdInfos id: 1R01AG076157-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01AG076157-01, secondaryIdInfos id: A487400, type: OTHER, domain: UW Madison, briefTitle: Effectiveness of Cognitive Training in Older and Younger Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks., conditionsModule conditions: Cognitive Change, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Following Pre-testing, participants randomly assigned into the full study will be further randomly assigned to a total of 9 unique experimental conditions for the full 2x2x2+1 factorial design.The full description of the study's 9 arms will be registered after data collection is completed to preserve the scientific integrity of the study., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: All researchers that have contact with participants will be unaware of the tested hypothesis of the study.Participants will be unaware of the experimental conditions.Researchers and participants will be unaware (blinded) to the game conditions assigned to the participant, except for researchers in charge of supervising the training part of the study who will be aware what training the participant is undergoing.More information on how this was achieved will be registered after data collection is completed to preserve the scientific integrity of the study., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: Visual and / or Auditory Cognitive Tasks (1), interventions name: Visual and / or Auditory Cognitive Tasks (2), outcomesModule primaryOutcomes measure: Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task, primaryOutcomes measure: Change in the proportion of correctly reported sequences in the Corsi Complex task, primaryOutcomes measure: Change in the proportion of correctly reported number and letter sets in the Letter-Number task, primaryOutcomes measure: Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task, primaryOutcomes measure: Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task, primaryOutcomes measure: Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task, primaryOutcomes measure: Change in the proportion of correct responses on the Useful Field of View (UFOV) Task, primaryOutcomes measure: Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task, primaryOutcomes measure: Change in the response time and percentage of correct responses in the Mental Rotation Task, primaryOutcomes measure: Change in the percentage of correct responses in the Paper Folding task, primaryOutcomes measure: Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task, primaryOutcomes measure: Change in the sum of correctly solved items in the UC Matrix Reasoning task, primaryOutcomes measure: Change in the percentage of accuracy in the Shipley Institute of Living Scale, primaryOutcomes measure: Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale, secondaryOutcomes measure: Big-5-Inventory 10-item version (BFI-10) Score, secondaryOutcomes measure: Behavioral Inhibition/Activation System (BIS/BAS) Score, secondaryOutcomes measure: Grit and Conscientiousness Score, secondaryOutcomes measure: Meta-Cognition Score, secondaryOutcomes measure: Theories of Intelligence - Mindset (Fixed vs Growth) Score, secondaryOutcomes measure: Schutte self-report emotional intelligence test (SSEIT) Score, secondaryOutcomes measure: Work and Family Orientation (WOFO) Score, secondaryOutcomes measure: Brief Pittsburgh Sleep Quality Index (B-PSQI) Score, secondaryOutcomes measure: Participant Experience Measure 1, secondaryOutcomes measure: Participant Experience Measure 2, secondaryOutcomes measure: Participant Experience Measure 3, secondaryOutcomes measure: Participant Experience Measure 4, secondaryOutcomes measure: Participant Experience Measure 5, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Riverside, city: Riverside, state: California, zip: 92521, country: United States, contacts name: Aaron Seitz, PhD, role: CONTACT, phone: 951-827-6422, email: [email protected], geoPoint lat: 33.95335, lon: -117.39616, locations facility: Northeastern University, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Susanne Jaeggi, PhD, role: CONTACT, phone: 617-373-3653, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Wisconsin - Madison, city: Madison, state: Wisconsin, zip: 53706, country: United States, contacts name: C. Shawn Green, PhD, role: CONTACT, phone: 608-263-4868, email: [email protected], geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06375668, orgStudyIdInfo id: CT/NB/140/2020/PR-MS, briefTitle: The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nordic Biotic Sp. z o.o., class: INDUSTRY, descriptionModule briefSummary: Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months., conditionsModule conditions: Osteoporosis, Postmenopausal, conditions: Bone Density, Low, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 170, type: ACTUAL, armsInterventionsModule interventions name: Probiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: The effect of intervention on bone mineral density, secondaryOutcomes measure: Changes in the level of calcium, secondaryOutcomes measure: Changes in the level of phosphorus, secondaryOutcomes measure: Changes in the level of alkaline phosphatase, secondaryOutcomes measure: Changes in the level of vitamin D, secondaryOutcomes measure: Changes in the level of C-reactive protein, secondaryOutcomes measure: Changes in Body Mass Index (BMI), secondaryOutcomes measure: Changes in type of stools, secondaryOutcomes measure: Changes in the number of bowel movements, secondaryOutcomes measure: Changes in severity of abdominal pain, secondaryOutcomes measure: Changes in severity of bloating, secondaryOutcomes measure: Occurrence of adverse events, secondaryOutcomes measure: Satisfaction with the intervention, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Private Specialist Practice, city: Bytom, zip: 41-902, country: Poland, geoPoint lat: 50.34802, lon: 18.93282, locations facility: Specialist Practice, city: Katowice, zip: 40-750, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Clinical Research Center, city: Poznań, zip: 60-773, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False |
protocolSection identificationModule nctId: NCT06375655, orgStudyIdInfo id: STUDY20240085, briefTitle: Texting to Promote Breastfeeding (TOPS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Lydia Furman, class: OTHER, descriptionModule briefSummary: The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Text4baby), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC., conditionsModule conditions: Increased Breastfeeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Team2BF, interventions name: Text4baby, outcomesModule primaryOutcomes measure: Percentage of participants who do not opt out of receipt of text messages, primaryOutcomes measure: Percentage of participants who said texts were helpful as measured by questionnaire, primaryOutcomes measure: Percentage of participants who would refer a friend/family to the texting program, secondaryOutcomes measure: Percentage of participants who are exclusively breastfeeding at 2 months postpartum as measured by participant report/chart review, secondaryOutcomes measure: Percentage of participants who are exclusively breastfeeding as measured by participant report/chart review, secondaryOutcomes measure: Percentage of participants who are partially breastfeeding as measured by participant report/chart review, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ahuja Rainbow Center for Women and Children, city: Cleveland, state: Ohio, zip: 44103, country: United States, contacts name: Lydia Furman, MD, role: CONTACT, phone: 216-675-6691, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, hasResults: False |
protocolSection identificationModule nctId: NCT06375642, orgStudyIdInfo id: SHR1316-HMPL012-HAIC-01, briefTitle: A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs.Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma.Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma.Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells.Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R.This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, outcomesModule primaryOutcomes measure: Objective Response Rate, primaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progress-Free Survival, secondaryOutcomes measure: Incidence and severity of AE and SAE, secondaryOutcomes measure: Dose suspension rate caused by adverse events, secondaryOutcomes measure: dose termination rate caused by adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Cancer Hospital Airport Hospital, city: Tianjin, state: Tianjin, zip: 300308, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06375629, orgStudyIdInfo id: EDAP TMS, briefTitle: ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer, acronym: ES-HIFU, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-20, primaryCompletionDateStruct date: 2027-04-20, completionDateStruct date: 2027-04-20, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: EDAP TMS S.A., class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: FocalOne, outcomesModule primaryOutcomes measure: Evaluation of adverse events, primaryOutcomes measure: Evaluation of quality of life, primaryOutcomes measure: Evaluation of urinary incontinence, primaryOutcomes measure: Erectile function assessment, primaryOutcomes measure: Urinary Symptoms, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Puerta del Mar, status: RECRUITING, city: Cadiz, zip: 21 11009, country: Spain, contacts name: Cristina Salvatierra Pérez, Doctor, role: CONTACT, phone: +34 956 00 21 00, email: [email protected], geoPoint lat: 36.52672, lon: -6.2891, locations facility: Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo, status: RECRUITING, city: Madrid, zip: 46 28007, country: Spain, contacts name: Carlos Hernández Fernández, Doctor, role: CONTACT, phone: +34 912 05 38 54, email: [email protected], geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Central De Asturias, status: RECRUITING, city: Oviedo, zip: 33011, country: Spain, contacts name: Jorge Garcia Rodriguez, Doctor, role: CONTACT, phone: +34 985 10 80 00, email: [email protected], geoPoint lat: 43.36029, lon: -5.84476, locations facility: Hospital Universitario Marqués De Valdecilla, status: RECRUITING, city: Santander, zip: 39008, country: Spain, contacts name: Mario Dominguez Esteban, role: CONTACT, phone: +34 942 42 06 26, email: [email protected], geoPoint lat: 43.46472, lon: -3.80444, locations facility: Hospital Consorcio General Universitario de Valencia, status: RECRUITING, city: Valencia, zip: 46014, country: Spain, contacts name: Emilio Mr López Alcina, Doctor, role: CONTACT, phone: +34 960 64 00 78, email: [email protected], geoPoint lat: 39.46975, lon: -0.37739, hasResults: False |
protocolSection identificationModule nctId: NCT06375616, orgStudyIdInfo id: KY2024-023, briefTitle: Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shen Lei, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the safety and efficacy of nafamostat mesylate (NM) and unfractionated heparin (UFH) in the process of renal replacement therapy (RRT) for patients suffering from sepsis associated acute kidney injury (SA-AKI). The main questions it aims to answer are:The impact of NM and UFH on platelet count in septic patients undergoing RRT treatment.The satisfaction with anticoagulation of NM and UFH in septic patients undergoing RRT treatment.The 28-day all-cause mortality rate of septic patients undergoing RRT treatment with NM and UFH.Researchers will use NM or UFH as anticoagulation during RRT in SA-AKI patients, assessing effects on platelet count, anticoagulation satisfaction, and mortality.Participants will receive NM or UFH as anticoagulation during RRT for a minimum of 7 days. Bleeding symptoms, platelet count and coagulation function will be monitored daily. Platelet changes during the 7-day treatment period and survival status at 28 days post-treatment will be recorded., conditionsModule conditions: Sepsis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Nafamostat Mesylate, interventions name: Unfractionated Heparin, outcomesModule primaryOutcomes measure: Platelet decline rate, secondaryOutcomes measure: Satisfaction of filter anticoagulation, otherOutcomes measure: All-cause mortality at 28 days, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huashan Hospital, Fudan University, city: Shanghai, state: Shanghai, country: China, contacts name: Lei Shen, MD, role: CONTACT, phone: 86-021-52887920, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06375603, orgStudyIdInfo id: SMARTALPHA-NERVEBLOX-1001, briefTitle: Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Smart Alfa Teknoloji San. ve Tic. A.S., class: INDUSTRY, collaborators name: Ankara University, descriptionModule briefSummary: The primary objective of this observational study is to acquire ultrasound images (raw data) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices., conditionsModule conditions: Ultrasound Imaging of Anatomical Structures, conditions: Nerve Block, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound scans, outcomesModule primaryOutcomes measure: Assessment of image quality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara University School of Medicine, city: Ankara, zip: 06230, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06375590, orgStudyIdInfo id: 2024-NavIIcusp, briefTitle: NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Didier TCHETCHE, class: OTHER, collaborators name: Abbott, descriptionModule briefSummary: The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring)., conditionsModule conditions: Bicuspid Aortic Valve, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Transcatheter Aortic Valve Implantation, outcomesModule primaryOutcomes measure: 30-day device success (Rate), secondaryOutcomes measure: 1 year at least moderate bioprosthetic valve deterioration, secondaryOutcomes measure: 1 year severe patient-prosthesis mismatch, secondaryOutcomes measure: 30 days and 1 year all-cause and cardiovascular mortality, secondaryOutcomes measure: 30 days and 1 year stroke, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique Pasteur, city: Toulouse, state: Occitanie, zip: 31076, country: France, contacts name: Didier Tchétché, MD, role: CONTACT, contacts name: Didier Tchétché, role: PRINCIPAL_INVESTIGATOR, contacts name: Chiara De Biase, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False |
protocolSection identificationModule nctId: NCT06375577, orgStudyIdInfo id: LMS-24-Dean-1, briefTitle: Speed of Absorption, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Lancaster University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to look at how fast commercially available supplements containing carbohydrate can get into the bloodstream. If carbohydrate, in the form of glucose, gets into the blood faster, this can provide an instant energy source and help fuel the body during exercise. We will be testing three supplements, namely Voom Pocket Rocket, SIS Go Isotonic Energy Gel, and Maurten Gel 160. Each participant will complete all three conditions, consuming one of each supplement at random per condition. The study requires participation from male runners, cyclists and triathletes who are aged between 18-35.Each visit will take approximately 1 hour and 30 minutes, and three experimental visits per participant. The study will involve frequent blood sampling and the continuous monitoring of gas exchange (oxygen/carbon dioxide). Blood sampling via cannulation will be used to analyse the lactate, glucose, and insulin content of the blood. Gas exchange will measure the oxygen breathed in and carbon dioxide breathed out throughout the study.The investigators plan to carry out the study on 16 participants who will be a mix of male runners, cyclists and triathletes., conditionsModule conditions: Healthy, conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This will be a double-blind randomised crossover design. There will be 1 group of participants who will complete all three conditions at random:Condition 1 - consume Voom Pocket Rocket. Condition 2 - consume SIS Isotonic Energy Gel. Condition 3 - consume Maurten Gel 160.All participants will undergo the same measures - blood sampling for blood glucose, blood lactate, and insulin, and monitoring of gas exchange during each study visit., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Both the participants and investigators will be blinded to what supplement they are consuming on each visit. Each supplement will taste the same, and be placed into identical packaging, and be randomly labelled (e.g., A, B, C). This will be done to avoid potential bias., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: 45 grams Voom Pocket Rocket Electro Energy, interventions name: 45 grams SIS Go Isotonic Energy Gel, interventions name: 45 grams Maurten Gel 160, outcomesModule primaryOutcomes measure: Blood Glucose, primaryOutcomes measure: Blood Lactate, primaryOutcomes measure: Insulin, primaryOutcomes measure: Gas Exchange, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lancaster University, status: RECRUITING, city: Lancaster, state: Lancashire, zip: LA1 4AT, country: United Kingdom, geoPoint lat: 54.04649, lon: -2.79988, hasResults: False |
protocolSection identificationModule nctId: NCT06375564, orgStudyIdInfo id: XMYY-2020KY067-05, briefTitle: Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD., conditionsModule conditions: Refractory Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: 177Lu-AB-3PRGD2 radioligand therapy, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Incidence of treatment-related adverse events (safety and tolerability), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361003, country: China, contacts name: Haojun Chen, role: CONTACT, phone: +8618659285282, email: [email protected], contacts name: Hao Fu, MD, PhD, role: CONTACT, phone: +8615959230059, email: [email protected], contacts name: Haojun Chen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Hao Fu, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False |
protocolSection identificationModule nctId: NCT06375551, orgStudyIdInfo id: 1171-0623, secondaryIdInfos id: K01MH128761, type: NIH, link: https://reporter.nih.gov/quickSearch/K01MH128761, briefTitle: K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions, acronym: K-ORCA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Chestnut Health Systems, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention., conditionsModule conditions: Child Abuse, conditions: Decision Making, conditions: Child Welfare, conditions: Decision Making, Shared, conditions: Decision Support Technique, conditions: Social Facilitation, conditions: Implementation Science, conditions: Policy, conditions: Organizations, conditions: Consensus, conditions: Mental Health, conditions: Family, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Optimizing Responses with Collaborative Assessments-Automated (ORCA-A), interventions name: Optimizing Responses with Collaborative Assessments-Live (ORCA-L), outcomesModule primaryOutcomes measure: Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention, primaryOutcomes measure: Mean changes in decision experience quality pre-post intervention, primaryOutcomes measure: Mean changes in decision commitment pre-post intervention, primaryOutcomes measure: Mean changes in perceived potential community health impact pre-post intervention, primaryOutcomes measure: Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA), primaryOutcomes measure: Qualitatively described rationale for program adoption from pre-post intervention, primaryOutcomes measure: Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention, primaryOutcomes measure: Descriptive, mean group-level changes in perceived acceptability of intervention for implementation, primaryOutcomes measure: Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation, primaryOutcomes measure: Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA, primaryOutcomes measure: Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA, secondaryOutcomes measure: Qualitative changes in decision reasoning pre- post-intervention, secondaryOutcomes measure: Qualitative changes in decision goals pre- post-intervention, secondaryOutcomes measure: Qualitative changes in decision consensus pre- post-intervention, secondaryOutcomes measure: Time to adoption or re-adoption of interventions with ORCA, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375538, orgStudyIdInfo id: B2022-527, briefTitle: Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-21, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: The study aims to predict the failure of High-flow Nasal Cannula oxygenation therapy by ultrasound evaluation of diaphragm and intercostal muscle contraction during the first 24 hours., conditionsModule conditions: High-flow Nasal Cannula, conditions: Ultrasound Evaluation, conditions: Diaphragm and Intercostal Muscle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Ultrasound evaluation of diaphragm, primaryOutcomes measure: Ultrasound evaluation of intercostal muscle movement index, primaryOutcomes measure: The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation., secondaryOutcomes measure: ICU stay, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: all cause mortality, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: respiratory rate, secondaryOutcomes measure: oxygen concentration, secondaryOutcomes measure: flow velocity of HFNC, secondaryOutcomes measure: VT, secondaryOutcomes measure: duration on HFNC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Zhongshan Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Wei Wu, role: CONTACT, phone: 13817976707, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06375525, orgStudyIdInfo id: SHEBA-15-2635-SMC, briefTitle: Clinical Trial: The Efficacy of Janssen's Icon Application (App) in Improving Adherence to Treatment With Stimulant Medications in Children With Attention Deficit/Hyperactivity Disorder, acronym: App ADHD, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-11, primaryCompletionDateStruct date: 2017-08, completionDateStruct date: 2017-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Prof. Doron Gothelf MD, class: OTHER_GOV, descriptionModule briefSummary: The overarching aim of the study is to assess the efficacy of Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD.Our specific hypotheses are:1. In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual (i.e., not provided with the App tool).2. Adherent patients will show greater improvement of ADHD symptoms and related dysfunction., conditionsModule conditions: Children Aged 6-18 Years With the Diagnosis of ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ACTUAL, armsInterventionsModule interventions name: Janssen's icon Application (App), outcomesModule primaryOutcomes measure: Attention Module of the Kiddie-SADS questionniare, secondaryOutcomes measure: MINI-KID, otherOutcomes measure: ADHD-Rating Scale Questionnaire (ADHD-RS), otherOutcomes measure: Clinical Global Impression Scale (CGI), otherOutcomes measure: the Barkley Side Effects Rating Scale, otherOutcomes measure: Drug accountability by reviewing the completed medication logs, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center, city: Ramat-Gan, country: Israel, geoPoint lat: 32.08227, lon: 34.81065, hasResults: False |
protocolSection identificationModule nctId: NCT06375512, orgStudyIdInfo id: IN001001, briefTitle: A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shenzhen Shenxin Biotechnology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age, conditionsModule conditions: Herpes Zoster, 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: 150, type: ESTIMATED, armsInterventionsModule interventions name: HZ Vaccine (IN001), interventions name: Placebo, interventions name: Shingrix, outcomesModule primaryOutcomes measure: Percentage of Participants Reporting Solicited Local Reactions, primaryOutcomes measure: Percentage of Participants Reporting Solicited Systemic Reactions, primaryOutcomes measure: Percentage of Participants With Unsolicited Adverse Events (AEs), primaryOutcomes measure: Percentage of Participants With Any Medically Attended AEs (MAAEs), primaryOutcomes measure: Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal, secondaryOutcomes measure: Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA), secondaryOutcomes measure: Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA, secondaryOutcomes measure: Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA, secondaryOutcomes measure: Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay, secondaryOutcomes measure: Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay, secondaryOutcomes measure: Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay, secondaryOutcomes measure: gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot), secondaryOutcomes measure: Frequencies of gE-specific CD4+ and CD8+ T Cells Expressing Activation Markers (i.e., IFN-γ, IL-2, TNFα, CD40L) as Measured by Intracellular Cytokine Staining (ICS), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375499, orgStudyIdInfo id: LT2769-004, briefTitle: Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-04-28, completionDateStruct date: 2025-04-28, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Laboratoires Thea, class: INDUSTRY, descriptionModule briefSummary: The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.The investigation is defined as a post-market stage. The clinical investigation design is confirmatory., conditionsModule conditions: Dry Eye Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: T2769, interventions name: Hylo-Forte®, outcomesModule primaryOutcomes measure: To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375486, orgStudyIdInfo id: AK112-IIT-TianjinCIH-LHK, briefTitle: Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-03-14, completionDateStruct date: 2026-06-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first., conditionsModule conditions: Hepatocellular Carcinoma Non-resectable, conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）, outcomesModule primaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Progress Free Survival （PFS）, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Adverse Events（AEs）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Cancer Hospital Airport Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300308, country: China, contacts name: Huikai Li, Doctor, role: CONTACT, phone: 18622228639, email: [email protected], contacts name: Yang Liu, MD, role: CONTACT, phone: 17694950696, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06375473, orgStudyIdInfo id: MA-PC-RWS-011, briefTitle: Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients, acronym: MA-PC-RWS-011, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2027-04-19, completionDateStruct date: 2027-04-19, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen., conditionsModule conditions: Pancreatic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Irinotecan liposome II combination therapy regimen, outcomesModule primaryOutcomes measure: rwTEAE, secondaryOutcomes measure: OS, secondaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: TTP, secondaryOutcomes measure: DCR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06375460, orgStudyIdInfo id: STUDY24020141, secondaryIdInfos id: 1R01DK137803-01A1, type: OTHER_GRANT, domain: NIDDK, briefTitle: Real-time Engagement for Learning to Effectively Control Type 2 Diabetes, acronym: REFLECT2D, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: Dartmouth College, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), collaborators name: University of Michigan, collaborators name: San Diego State University, descriptionModule briefSummary: This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Lifestyle, conditions: Hyperglycemia, conditions: Physical Inactivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Focused App Prompt, interventions name: No App Prompt, outcomesModule primaryOutcomes measure: Glucose time above 180mg/dL, primaryOutcomes measure: Mean daily glucose, primaryOutcomes measure: Maximum daily glucose, primaryOutcomes measure: Minimum daily glucose, primaryOutcomes measure: Glucose coefficient of variability, primaryOutcomes measure: Mean amplitude of glycemic excursions, primaryOutcomes measure: Hemoglobin A1c, primaryOutcomes measure: Fasting glucose, primaryOutcomes measure: Objective physical activity (step count), primaryOutcomes measure: Objective physical activity (moderate-vigorous physical activity), primaryOutcomes measure: Self-reported physical activity, primaryOutcomes measure: Diet quality, primaryOutcomes measure: Capability, primaryOutcomes measure: Healthmine app use, primaryOutcomes measure: Continuous glucose monitor use use, primaryOutcomes measure: Motivation to engage in diabetes self-management, secondaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Diabetes distress, secondaryOutcomes measure: Diabetes family support and conflict, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Children's Hospital of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06375447, orgStudyIdInfo id: Insomnia, briefTitle: Intelligent Diagnosis and Treatment Model for Insomnia Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, collaborators name: West China Hospital, collaborators name: Beijing Tiantan Hospital, collaborators name: Ningcheng Center Hospital, collaborators name: Second Affiliated Hospital of Soochow University, descriptionModule briefSummary: To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder., conditionsModule conditions: Insomnia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 16000, type: ESTIMATED, armsInterventionsModule interventions name: Routine clinical treatment, outcomesModule primaryOutcomes measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., secondaryOutcomes measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, status: RECRUITING, city: Beijing, zip: 100053, country: China, contacts name: Hongxing Wang, MD & PhD, role: CONTACT, phone: 01083198650, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tiantan Hospital, Capital Medical University, status: RECRUITING, city: Beijing, zip: 100070, country: China, contacts name: Yi Zhang, MD & PhD, role: CONTACT, phone: 15801203052, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Bethune Hospital of Jilin University, status: NOT_YET_RECRUITING, city: Changchun, country: China, contacts name: Zan Wang, MD & PhD, role: CONTACT, geoPoint lat: 43.88, lon: 125.32278, locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, zip: 610041, country: China, contacts name: Lan Zhang, MD & PhD, role: CONTACT, phone: 18980601706, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Second Affiliated Hospital of Soochow University, status: NOT_YET_RECRUITING, city: Suzhou, country: China, contacts name: Hua Hu, MD & PhD, role: CONTACT, phone: 051268282030, email: [email protected], geoPoint lat: 31.30408, lon: 120.59538, hasResults: False |
protocolSection identificationModule nctId: NCT06375434, orgStudyIdInfo id: 20240101-01, briefTitle: Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer, acronym: GMRSC-LARC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Jing-kun Liu, class: OTHER, descriptionModule briefSummary: The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy., conditionsModule conditions: Locally Advanced Rectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Diameter of tumor, secondaryOutcomes measure: Change in Gut Microbiota Composition, secondaryOutcomes measure: Change in Plasma metabolites, otherOutcomes measure: Five-year survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06375421, orgStudyIdInfo id: GR018280, briefTitle: Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: This is a pilot and feasibility study for a mobile phone-delivered intervention for memory, called MEMI (memory ecological momentary intervention), that was designed to support adults with chronic traumatic brain injury with their memory. The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The order of conditions and the order of word list presentation will be counterbalanced. The order of condition/word list combination will be pre-determined, and participants will be assigned to the next available combination based on when they join the study (i.e., a counterbalanced within-person crossover design)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval, interventions name: Blocked Retrieval, outcomesModule primaryOutcomes measure: Acceptability, primaryOutcomes measure: Feasibility (Engagement), secondaryOutcomes measure: Free Recall of Word Forms, secondaryOutcomes measure: Cued Recall of Word Forms, secondaryOutcomes measure: Cued Recall of Word Meanings, otherOutcomes measure: Number of Spatial Contexts, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False |
protocolSection identificationModule nctId: NCT06375408, orgStudyIdInfo id: KS2022212, briefTitle: Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage, acronym: TACS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-24, primaryCompletionDateStruct date: 2026-02-24, completionDateStruct date: 2026-03-24, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about using the latest transcranial alternating current stimulation (tACS) to reduce the incidence of delirium in patients with subarachnoid hemorrhage. The main question it aims to answer is:• To evaluate the effect of tACS on reducing delirium in patients with subarachnoid hemorrhage.Participants will treated with real tACS or sham tACS. Researchers will mainly compare the two groups to see if patients' delirium will reduce by using tACS., conditionsModule conditions: Subarachnoid Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: The random number table method was used for randomization, and the envelope method was used for randomization. The random serial number was stored in an airtight envelope, an envelope was opened when a patient was admitted., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Real transcranial alternating electrical stimulation, interventions name: Sham transcranial alternating electrical stimulation, outcomesModule primaryOutcomes measure: Incidence of delirium, secondaryOutcomes measure: Sleep quality score, secondaryOutcomes measure: Anxiety score, secondaryOutcomes measure: Duration of delirium, secondaryOutcomes measure: Cognitive function score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Jun Wang, role: CONTACT, phone: 18612583695, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06375395, orgStudyIdInfo id: Memory Updating Tasks, briefTitle: Boosting The Intervention Effect of Negative Memory Through tACS Stimulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, collaborators name: Beijing Normal University, descriptionModule briefSummary: The objectives of this study include: 1) investigating the impact of negative memory substitution on an individual's other intellectual memories (i.e., neutral memories) and the underlying neurocognitive mechanisms; 2) investigating the memory enhancement effect resulting from retrieval practice associated with memory substitution intervention along with an examination of the neurocognitive mechanisms responsible for this enhancement., conditionsModule conditions: Seizures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Active tACS Device, interventions name: Sham tACS Device, outcomesModule primaryOutcomes measure: Negative memory retention, secondaryOutcomes measure: The negative emotional intensity of negative memory, secondaryOutcomes measure: The retention of associated neutral memories as assesses by the proportions of responses of correctly choosing picture category of B picture (A-Bneu) in last A-B paired associate memory test, secondaryOutcomes measure: The negative emotional intensity of neutral memory, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375382, orgStudyIdInfo id: ZYS2024-01, briefTitle: Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-03-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shanghai Institute of Acupuncture, Moxibustion and Meridian, class: OTHER, descriptionModule briefSummary: Crohn's disease is an intestinal inflammatory disease, causing abdominal pain, diarrhea and other symptoms. The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. This study is to screen the intestinal bacteria related to abdominal pain in CD, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in CD patients., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: acupuncture, interventions name: Sham acupuncture, outcomesModule primaryOutcomes measure: Abdominal pain remission rate, secondaryOutcomes measure: Crohn's disease activity index （CDAI）, secondaryOutcomes measure: Hospital anxiety and depression scale (HADS), secondaryOutcomes measure: Inflammatory bowel disease questionnaire (IBDQ), secondaryOutcomes measure: Safety evaluation (number of participants with abnormal routine blood tests), secondaryOutcomes measure: Safety evaluation (number of participants with abnormal Liver function tests), secondaryOutcomes measure: Safety evaluation (number of participants with abnormal Renal function tests), otherOutcomes measure: Gut microbiota composition structure and function, otherOutcomes measure: Correlation between changes in relative abundance of gut microbes and abdominal pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian, city: Shanghai, zip: 200000, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06375369, orgStudyIdInfo id: Pro00127121, briefTitle: Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy, acronym: DECIDE-T, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, collaborators name: Alberta Innovates Health Solutions, descriptionModule briefSummary: The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy/LTV). These patients represent a small portion of Alberta's population but account for over 50% of pediatric patients hospitalized for more than 180 days. The pathway will include a hospital-to-home directive that incorporates digital health solutions to provide support to families, caregivers, and healthcare professionals. Digital supports will include a Connect Care pathway, resources for informed decision-making, educational modules, high-fidelity simulations for family and caregiver education, an online parental resource center, and access to peer support within the hospital and community, as well as a post-discharge telehealth program.The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy/LTV, as well as to decrease mental distress and burnout experienced by their caregivers and families., conditionsModule conditions: Tracheostomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T), outcomesModule primaryOutcomes measure: Hospital length of stay, primaryOutcomes measure: ICU length of stay, primaryOutcomes measure: ICU readmission, primaryOutcomes measure: Mortality, primaryOutcomes measure: Decannulation, primaryOutcomes measure: Duration of tracheostomy, primaryOutcomes measure: Tracheostomy adverse events, primaryOutcomes measure: Hospital cost, primaryOutcomes measure: Hospital readmission, primaryOutcomes measure: Net-monetary benefit of DECIDE-T, secondaryOutcomes measure: Caregivers mental stress, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Alberta Children's Hospital, city: Calgary, state: Alberta, country: Canada, contacts name: Karen Kam, MD, role: CONTACT, email: [email protected], contacts name: Karen Kam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Stollery Children's Hospital, city: Edmonton, state: Alberta, country: Canada, contacts name: Michael van Manen, MD, role: CONTACT, email: [email protected], contacts name: Michael van Manen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False |
protocolSection identificationModule nctId: NCT06375356, orgStudyIdInfo id: 75119, briefTitle: Stronger: Muscle Strengthening for Menopause, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention., conditionsModule conditions: Resistance Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Resistance Training, outcomesModule primaryOutcomes measure: number of strength exercises the participant logged over the intervention, primaryOutcomes measure: Liking of the intervention, secondaryOutcomes measure: Number of participants completing post 3 month measure / those randomized and consented, secondaryOutcomes measure: Change in total seconds a participant can remain in a wall sit, secondaryOutcomes measure: Change in number of full body weight squats in 60 seconds, eligibilityModule sex: FEMALE, minimumAge: 35 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University School of Medicine, city: Stanford, state: California, zip: 94305-7240, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False |
protocolSection identificationModule nctId: NCT06375343, orgStudyIdInfo id: SOPH240-0923/I, briefTitle: Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-30, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®., conditionsModule conditions: Dry Eye Disease, conditions: Dry Eye Sensation, conditions: Ocular Surface Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase I, controlled, comparative, single-blind, single-center, comparative clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: PRO-240, interventions name: Optive®, outcomesModule primaryOutcomes measure: Incidence of unexpected adverse events related to the interventions, secondaryOutcomes measure: Changes in the Ocular Comfort Index score, secondaryOutcomes measure: Adherence to treatment (adherence) Adherence to treatment (adherence), secondaryOutcomes measure: Changes in Best Corrected Visual Acuity (BCVA), secondaryOutcomes measure: Changes in tear film breakup time, secondaryOutcomes measure: Changes in intraocular pressure (IOP), secondaryOutcomes measure: Changes in the integrity of the ocular surface (fluorescein staining), secondaryOutcomes measure: Changes in lissamine green staining of the conjunctival surface, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375330, orgStudyIdInfo id: Poli.01, briefTitle: Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-18, primaryCompletionDateStruct date: 2024-01-08, completionDateStruct date: 2024-04-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Sidoti & Tartaglia Srl, class: OTHER, descriptionModule briefSummary: The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy., conditionsModule conditions: TMJ Disease, conditions: TMJ Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: PoliArt, outcomesModule primaryOutcomes measure: Maximum mouth opening, secondaryOutcomes measure: Lateral movements improvements, secondaryOutcomes measure: Pain assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, city: Milan, state: MI, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06375317, orgStudyIdInfo id: HCC-HAIC-001, briefTitle: HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Yehua Shen, class: OTHER, descriptionModule briefSummary: For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy, there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value., conditionsModule conditions: HCC - Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets, outcomesModule primaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375304, orgStudyIdInfo id: MP-37-2024-10384, briefTitle: The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have)., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: B/F/TAF, outcomesModule primaryOutcomes measure: Feasibility of the switch, primaryOutcomes measure: Acceptability, primaryOutcomes measure: acceptability of the regimen, primaryOutcomes measure: Acceptability of the intervention, primaryOutcomes measure: Fidelity, secondaryOutcomes measure: ART initiation (HIV care cascade milestones), secondaryOutcomes measure: Viral suppression (HIV care cascade milestones), secondaryOutcomes measure: Retention in HIV care (HIV care cascade milestones), secondaryOutcomes measure: consultations at the study site (Nature of clinical pathways), secondaryOutcomes measure: consultations at other care centres or organizations (Nature of clinical pathways), secondaryOutcomes measure: healthcare coverage, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Institute of the McGill University Health Centre, city: Montréal, state: Quebec, zip: H4A3T2, country: Canada, contacts name: Bertrand Lebouché, MD, PhD, role: CONTACT, phone: +1-514-843-2090, email: [email protected], contacts name: Ashkan Baradaran, MD, MSc, role: CONTACT, phone: +1 514-863-4468, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06375291, orgStudyIdInfo id: MersinTRHpregcts, briefTitle: Pregnancy-Related Carpal Tunnel Syndrome Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Mersin Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: The current retrospective study aimed to compare the effectiveness of local steroid injection plus splinting with that of local steroid injection or splinting alone. To assess the primary outcome, The Boston Carpal Tunnel Symptom Severity Scale was used. The secondary aim was the efficacy of the treatment on the patient's function severity and depression assessed by The Boston Carpal Tunnel Symptom Function Scale Edinburgh Depression Scale., conditionsModule conditions: Carpal Tunnel Syndrome Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: splint /steroid injection/both, outcomesModule primaryOutcomes measure: Symptom severity, secondaryOutcomes measure: function severity, secondaryOutcomes measure: pregnancy and postpartum depression, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Suna Aşkın Turan, city: Mersin, state: Yenişehir, zip: 33020, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False |
protocolSection identificationModule nctId: NCT06375278, orgStudyIdInfo id: DC019586, secondaryIdInfos id: 5R44DC019586, type: NIH, link: https://reporter.nih.gov/quickSearch/5R44DC019586, briefTitle: Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Restorear Devices LLC, class: INDUSTRY, collaborators name: University of Miami, collaborators name: National Institute on Deafness and Other Communication Disorders (NIDCD), descriptionModule briefSummary: The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:1. Is mild therapeutic hypothermia safe for use during cochlear implantation?2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy)., conditionsModule conditions: Cochlear Implants, conditions: Cochlear Implantation, conditions: Hearing Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Intra-Ear Canal Cooling Catheter, interventions name: Intra-Ear Canal Cooling Catheter (Sham), outcomesModule primaryOutcomes measure: Cochlear Implant (CI) Device Performance Following Hypothermia Treatment, primaryOutcomes measure: Residual Hearing, secondaryOutcomes measure: Electrophysiological Impedance, secondaryOutcomes measure: Electrically Evoked Compound Action Potential (ECAP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False |
protocolSection identificationModule nctId: NCT06375265, orgStudyIdInfo id: 2024P000780-1, briefTitle: Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients, acronym: SLEEP-BOOST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy)., conditionsModule conditions: Insomnia, conditions: Postoperative Delirium, conditions: Delayed Neurocognitive Recovery, conditions: Postoperative Neurocognitive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), interventions name: Sleep Health Education, outcomesModule primaryOutcomes measure: Adherence, primaryOutcomes measure: Insomnia Severity, secondaryOutcomes measure: Sleep Diary Completion, secondaryOutcomes measure: Homework Completion, secondaryOutcomes measure: Utility, secondaryOutcomes measure: Satisfaction with intervention, secondaryOutcomes measure: Cognition, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Mood, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Function, secondaryOutcomes measure: Postoperative Delirium Incidence, secondaryOutcomes measure: Postoperative Delirium Severity, secondaryOutcomes measure: Delayed Neurocognitive Recovery, secondaryOutcomes measure: Postoperative Neurocognitive Disorders (NCD), secondaryOutcomes measure: Sleep Efficiency, otherOutcomes measure: Circadian Rest-Activity Rhythms, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06375252, orgStudyIdInfo id: sbughfyaseminozkan1985, briefTitle: Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use, acronym: CJVClumen, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2024-05-16, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder., conditionsModule conditions: Central Venous Catheterization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Central Jugular Vein Catheter Lumen Holder Apparatus, outcomesModule primaryOutcomes measure: demographic information, secondaryOutcomes measure: comfort effect, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06375239, orgStudyIdInfo id: RTx-VRAI-NHS01, briefTitle: Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Retinitis Pigmentosa Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ray Therapeutics, Inc., class: INDUSTRY, collaborators name: The Vision Research and Assessment Institute (VRAI), descriptionModule briefSummary: RayTx established The Vision Research and Assessment Institute (VRAI) with the express purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision. The mission of the VRAI is to enable the highest quality, standardized efficacy testing of patients with visual impairment to be performed by expert clinicians in an optimized environment. The proposed assessments or testing modalities to be evaluated in this non-interventional study are published in some capacity, and some of these publications already include patients with severe-to-profound vision loss from retinitis pigmentosa and other inherited retinal diseases., conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Operational feasibility of testing severe to profound vision impaired patients with RP on a battery of visual assessments, secondaryOutcomes measure: To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification), secondaryOutcomes measure: To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vision Research and Assessment Institute, status: RECRUITING, city: Irvine, state: California, zip: 92612, country: United States, contacts name: Shawn Yu, OD, role: CONTACT, phone: 949-264-3793, email: [email protected], geoPoint lat: 33.66946, lon: -117.82311, hasResults: False |
protocolSection identificationModule nctId: NCT06375226, orgStudyIdInfo id: 2023.17, secondaryIdInfos id: 2023.0871, type: OTHER, domain: METC Amsterdam UMC, briefTitle: Autism and Attachment. An Explorative Study of Attachment Styles in Autistic Adults., acronym: ASDA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Parnassia Groep, class: OTHER, descriptionModule briefSummary: The present study examines the relationship between attachment and autism spectrum disorder (ASD) in adults., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, outcomesModule primaryOutcomes measure: The Social Responsiveness Scale - Adult version (SRS-A), primaryOutcomes measure: The Attachment Styles Questionnaire (ASQ), primaryOutcomes measure: Experiences in Close Relationships - Revised questionnaire (ECR-r), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ParnassiaGroep Antes, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3083 AK, country: Netherlands, contacts name: Stephanie Bohnen, MSc, role: CONTACT, phone: +31653386139, email: [email protected], contacts name: Richard Vuijk, Dr., role: CONTACT, phone: +31883585428, email: [email protected], geoPoint lat: 51.9225, lon: 4.47917, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-19, uploadDate: 2024-03-29T08:28, filename: Prot_SAP_000.pdf, size: 287252, hasResults: False |
protocolSection identificationModule nctId: NCT06375213, orgStudyIdInfo id: 425/66, briefTitle: Investigating Neurocognitive Disorders Epidemiology, acronym: INDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-24, primaryCompletionDateStruct date: 2035-08-24, completionDateStruct date: 2035-08-24, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: King Chulalongkorn Memorial Hospital, class: OTHER, collaborators name: Health Systems Research Institute,Thailand, descriptionModule briefSummary: This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population. The main predictor variables to be evaluated are plasma phosphorylated tau (p-tau) level and cognitive test scores, which will be combined using statistical/computational modeling. Additionally, it seeks to evaluate biomarkers for diagnosing disease pathologies, understand their correlation with clinical outcomes, and explore the socioeconomic impact of neurocognitive disorders. The study invites both participants for biospecimen collection, structured interviews, and cognitive examinations and schedules follow-up visits annually or biennially., conditionsModule conditions: Dementia, conditions: Cognitive Decline, conditions: Alzheimer Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 990, type: ESTIMATED, armsInterventionsModule interventions name: Plasma tau phosphorylated at Thr217, interventions name: Neurocognitive examination, outcomesModule primaryOutcomes measure: Progression to dementia, primaryOutcomes measure: Changes in Sum of Boxes of the Clinical Dementia Rating Scale, secondaryOutcomes measure: Changes in the Montreal Cognitive Assessment, secondaryOutcomes measure: Changes in the Montreal Cognitive Assessment - Memory Index Score, secondaryOutcomes measure: Changes in the Mini Mental State Examination, secondaryOutcomes measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score, secondaryOutcomes measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score, secondaryOutcomes measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates Scaled Score, secondaryOutcomes measure: Biological diagnosis of Alzheimer's disease, secondaryOutcomes measure: Biological staging of Alzheimer's disease, secondaryOutcomes measure: Quantitative amyloid PET uptake., secondaryOutcomes measure: Quantitative tau PET uptake in various cortical regions., secondaryOutcomes measure: Future diagnosis of Alzheimer's disease dementia., otherOutcomes measure: Quality of life (WHOQOL-BREF), otherOutcomes measure: Quality of life (EQ-5D-5L), otherOutcomes measure: Number of modifiable risk factors, eligibilityModule sex: ALL, minimumAge: 35 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Chulalongkorn Memorial Hospital, status: RECRUITING, city: Pathum Wan, state: Bangkok, zip: 10330, country: Thailand, contacts name: Adipa Chongsuksantikul, D.Eng., role: CONTACT, phone: +66 (0)84 1134443, email: [email protected], geoPoint lat: 13.73649, lon: 100.5239, hasResults: False |
protocolSection identificationModule nctId: NCT06375200, orgStudyIdInfo id: ONZ-2024-0066, briefTitle: Healthcare for Men With Suicidal Thoughts: Needs Assessment, acronym: KUJK2NEEDS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-10-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, descriptionModule briefSummary: The aim of the current project is twofold, namely1. To gain insight into needs related to help-seeking among men with (previous) suicidal thoughts (STUDY 1). More specifically, this study examines help-seeking behaviour, possible barriers to seeking help and needs with regard to existing tools and health care among men who had suicidal thoughts. In other words, is there a difference in help-seeking behaviour between men and women with suicidal thoughts in the past and what factors contribute to this difference? More specifically: 1. To what extent do men with suicidal thoughts in the past recognize their need for help, compared to women with suicidal thoughts in the past? 2. What barriers and needs do men with suicidal thoughts in the past experience towards seeking help, compared to women with suicidal thoughts in the past? 3. What barriers and needs do men with suicidal thoughts in the past experience to remain engaged in help, compared to women with suicidal thoughts in the past?2. To map out needs of healthcare providers in working with men with suicidal thoughts and/or behaviour (STUDY 2). More specifically, how do healthcare providers experience working with men who are feeling suicidal and what are their experienced barriers and needs. Two main research questions were formulated: 1. How do health care providers experience working with men (in comparison to women or people of other genders) who are feeling suicidal? 2. What needs and barriers do health care providers experience when working with men (in comparison to women or people of other genders) who are feeling suicidal?, conditionsModule conditions: Suicide Prevention, conditions: Help-Seeking Behavior, conditions: Men, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 586, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: STUDY 1: Help-seeking behavior, primaryOutcomes measure: STUDY 1: Experienced need, primaryOutcomes measure: STUDY 1: Emotional Openness, primaryOutcomes measure: STUDY 1: Barriers, primaryOutcomes measure: STUDY 1: Self-reliance, primaryOutcomes measure: STUDY 1: Stigma, primaryOutcomes measure: STUDY 1: needs of individuals with suicidal ideation, primaryOutcomes measure: STUDY 2: needs of healthcare providers, otherOutcomes measure: STUDY 1: Socio-demographic characteristics, otherOutcomes measure: STUDY 1: Suicidality, otherOutcomes measure: STUDY 2: socio-demographic variables, otherOutcomes measure: STUDY 2: Professional experience with men with suicidal thoughts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University, status: RECRUITING, city: Ghent, zip: 9000, country: Belgium, contacts name: Eva De Jaegere, MSc, role: CONTACT, phone: +3293320775, email: [email protected], geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06375187, orgStudyIdInfo id: GC203 TIL-ST-Ⅰ, briefTitle: Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors, acronym: KUNLUN-001, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Shanghai Juncell Therapeutics, class: INDUSTRY, descriptionModule briefSummary: A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors, conditionsModule conditions: Solid Tumor, conditions: Gynecologic Cancer, conditions: Breast Cancer, conditions: Gastrointestinal Cancer, conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Engineering Tumor Infiltrating Lymphocytes, outcomesModule primaryOutcomes measure: Maximal Tolerance Dose, primaryOutcomes measure: Dose Limiting Toxicity, primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Quality of Life Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06375174, orgStudyIdInfo id: NSISTRCR_2202, briefTitle: PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY), acronym: SWISS-PRECISE, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-09, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Dr. med. Carlo Cereda, class: OTHER_GOV, descriptionModule briefSummary: We hypothesize that patients with a favorable Critical Area Perfusion Score (CAPS≤3) on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS\>3 will not, conditionsModule conditions: Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Thrombectomy, outcomesModule primaryOutcomes measure: mRS score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neurocenter of Southern Switzerland, Ospedale Civico, city: Lugano, state: Ticino, zip: CH-6900, country: Switzerland, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False |
protocolSection identificationModule nctId: NCT06375161, orgStudyIdInfo id: CD19-CN-A6, briefTitle: Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2025-12-10, completionDateStruct date: 2039-12-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shanghai Tongji Hospital, Tongji University School of Medicine, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.In this study phase, a traditional "3+3" trial design is employed for dose escalation., conditionsModule conditions: B Cell Malignancies, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: anti-CD19-CAR-T cells, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicity, eligibilityModule sex: ALL, minimumAge: 18 Weeks, maximumAge: 70 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Shanghai Tongji Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200333, country: China, contacts name: Aibin Liang, role: CONTACT, phone: +8618601670600, email: [email protected], contacts name: Ping LI, role: CONTACT, phone: +86 135 6418 1131, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06375148, orgStudyIdInfo id: Yan2024-0052, briefTitle: A Questionnaire Survey on Cognition of Enteral Nutrition Implementation in Patients Requiring Mechanical Ventilation in Prone Position, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: Prone ventilation is an important treatment for respiratory failure with intractable hypoxia, and the Corona Virus Disease 2019(COVID-19 ) outbreak has further elevated the status of prone ventilation. Early enteral nutrition (EN) is also recognised as an important measure to improve the prognosis of critically ill patients. However, the administration of enteral nutrition during prone position is still quite controversial. In this paper, we analysed the tolerance and safety of enteral nutrition in the prone position by reviewing studies before and after the COVID-19 outbreak. Key strategies to improve the tolerability of enteral nutrition in the prone position are also summarised and discussed., conditionsModule conditions: Enteral Nutrition, conditions: Prone Position, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Enteral nutrition, outcomesModule primaryOutcomes measure: A questionnaire survey on cognition of enteral nutrition implementation in patients requiring mechanical ventilation in prone position, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, city: Zhenjiang, country: China, geoPoint lat: 32.21086, lon: 119.45508, hasResults: False |
protocolSection identificationModule nctId: NCT06375135, orgStudyIdInfo id: R1MD017205, briefTitle: mHealth + e-Navigator Stepped Care on ART Adherence in Latino MSM, acronym: Project STEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Florida International University, class: OTHER, collaborators name: Ann & Robert H Lurie Children's Hospital of Chicago, collaborators name: Care Resource Community Health Centers, descriptionModule briefSummary: The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims:Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up., conditionsModule conditions: ART Adherence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: We will enroll 250 adults Latino MSM with HIV with suboptimal ART adherence and randomize (1:1) into two arms: TXTXT (n=125) or TXTXT + e-Navigation (n=125). Those in Arm 1 who continue to have suboptimal adherence (\<90% pills taken) at 3-months will be re-randomized (1:1) to continue TXTXT or add e-Navigation; those in Arm 2 who have suboptimal adherence will be re-randomized (1:1) to continue TXTXT + e-Navigation or add EMA support. At 6-months, the intervention arms will cease to receive any intervention components and be followed for an additional 6-months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: TXTXT, interventions name: e-Navigation, interventions name: Ecological Momentary Assessment (EMA) supported e-Navigation., outcomesModule primaryOutcomes measure: ART adherence, secondaryOutcomes measure: HIV viral load, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE, city: Miami, state: Florida, zip: 331370000, country: United States, contacts name: Sheryl J Zayas, MD, role: CONTACT, phone: 305-576-1234, email: [email protected], contacts name: Sheryl J Zayas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False |
protocolSection identificationModule nctId: NCT06375122, orgStudyIdInfo id: 10001951, secondaryIdInfos id: 001951-C, briefTitle: Natural History Study of Kaposi Sarcoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2034-12-31, completionDateStruct date: 2036-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: Background:Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs.Objective:To learn more about the natural history of KS.Eligibility:People aged 18 years and older with KS.Design:Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed.Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include:Eye exam.Ultrasound exam of the heart (electrocardiogram).Collection of saliva and urine samples.Biopsies of the skin or lymph nodes.Swabs of the anus and cervix.Photographs of skin lesions.Removal of fluid samples from the space around the lungs, intestine, or heart.The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years.Participants will follow their standard treatment for KS during the study., conditionsModule conditions: Kaposi Sarcoma, conditions: HIV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype, secondaryOutcomes measure: To evaluate differences in rates of KS recurrence by HIV status and CD4 T cell count, secondaryOutcomes measure: To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: National Cancer Institute Referral Office, role: CONTACT, phone: 888-624-1937, email: [email protected], geoPoint lat: 38.98067, lon: -77.10026, hasResults: False |
protocolSection identificationModule nctId: NCT06375109, orgStudyIdInfo id: BJXK-2023-KY-53, secondaryIdInfos id: NeoSCLC-001, type: OTHER, domain: Beijing Chest Hospital, Capital Medical University, briefTitle: PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC, acronym: NeoSCLC-001, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2029-04-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Beijing Chest Hospital, Capital Medical University, class: OTHER, descriptionModule briefSummary: This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC., conditionsModule conditions: Limited-stage Small-cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: Carboplatin injection, interventions name: Cisplatin injection, interventions name: Etoposide injection, outcomesModule primaryOutcomes measure: Pathologic Complete Response (pCR) Rate, secondaryOutcomes measure: Major Pathologic Response (MPR) Rate, secondaryOutcomes measure: Event-Free Survival (EFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Safety: frequency of severe adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375096, orgStudyIdInfo id: Graves' disease, briefTitle: Bone Mineral Density in Children With Graves' Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-25, primaryCompletionDateStruct date: 2025-06-25, completionDateStruct date: 2025-06-25, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: to evaluate bone mineral density in children with graves' disease, conditionsModule conditions: Bone Density, Low, conditions: Bone Mineral Density in Children With Graves' Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: evaluate bone mineral density, outcomesModule primaryOutcomes measure: bone mineral density, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375083, orgStudyIdInfo id: 23-1231, briefTitle: Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: VA Eastern Colorado Health Care System, class: FED, descriptionModule briefSummary: This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors., conditionsModule conditions: Suicide, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) and Cognitive Behavioral Therapy for Depression (cCBT-D), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 472, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy, outcomesModule primaryOutcomes measure: Client Satisfaction Questionnaire, primaryOutcomes measure: Internet Evaluation and Utility Questionnaire, primaryOutcomes measure: Internet Impact and Effectiveness Questionnaire, primaryOutcomes measure: Narrative Evaluation of Intervention Interview, primaryOutcomes measure: Recruitment Rate, primaryOutcomes measure: Completion of intervention, secondaryOutcomes measure: Beck Scale for Suicide Ideation, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Posttraumatic Stress Disorder Checklist-5, secondaryOutcomes measure: Generalized Anxiety Disorder-7, secondaryOutcomes measure: Computerized Adaptive Testing - Suicide Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eastern Colorado Health Care System, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Lisa A Brenner, PhD, role: CONTACT, phone: 720-723-6488, email: [email protected], contacts name: Kelly A Stearns-Yoder, MA, role: CONTACT, phone: 720-723-6477, email: [email protected], geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06375070, orgStudyIdInfo id: RMeng1, briefTitle: Anticoagulants for PFO Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-08, primaryCompletionDateStruct date: 2022-08, completionDateStruct date: 2022-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality., conditionsModule conditions: Patent Foramen Ovale, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 277, type: ACTUAL, armsInterventionsModule interventions name: PFO closure, interventions name: anticoagulant, outcomesModule primaryOutcomes measure: whether occur recurrent stroke or migraine relief, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06375057, orgStudyIdInfo id: asiamkfv49wurfpylld2m6g7cr4kz6, briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-03, primaryCompletionDateStruct date: 2024-02-26, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Roma La Sapienza, class: OTHER, descriptionModule briefSummary: Many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain.The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:* predict the severity of pain;* select most suitable pain relief therapy for the patient., conditionsModule conditions: Post Operative Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: laparoscopic cholecystectomy, outcomesModule primaryOutcomes measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy, primaryOutcomes measure: Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy, primaryOutcomes measure: Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy, primaryOutcomes measure: Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy, primaryOutcomes measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Augusto Lauro, status: RECRUITING, city: Roma, zip: 000186, country: Italy, contacts name: Augusto Lauro, role: CONTACT, phone: +39 388 8663 879, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-03-03, uploadDate: 2024-04-16T07:17, filename: Prot_SAP_000.pdf, size: 179155, hasResults: False |
protocolSection identificationModule nctId: NCT06375044, orgStudyIdInfo id: SIM0500-101, briefTitle: Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Jiangsu Simcere Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Xianxiang Medical Technology Co., Ltd., descriptionModule briefSummary: This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial., conditionsModule conditions: Relapsed or Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: SIM0500, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Yan Xu, role: CONTACT, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06375031, orgStudyIdInfo id: HR011408-103, briefTitle: Comparison of HR011408 and NovoRapid® in Subjects With Diabetics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study was designed as a multi-center, randomized, double-blind, three-cycle crossover, positive drug control (NovoRapid ®) To compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single injection of HR011408 or NovoRapid ® before or after a standard meal test in patients with type 1 or type 2 diabetes., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: HR011408 injection; HR011408 injection Placebo, interventions name: NovoRapid®; HR011408 injection Placebo, interventions name: HR011408 injection Placebo; HR011408 injection, outcomesModule primaryOutcomes measure: Area under the serum concentration-time curve of insulin aspart, secondaryOutcomes measure: Area under the serum concentration-time curve of insulin aspart, secondaryOutcomes measure: Plasma glucose concentration, secondaryOutcomes measure: Number of subjects with adverse events and severity of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Second Hospital of Anhui Medical University, city: Hefei, state: Anhui, zip: 230601, country: China, contacts name: 230601 Pan, Doctor, role: CONTACT, phone: 0551-65997421, email: [email protected], contacts name: Wei Hu, Doctor, role: CONTACT, phone: 0551-65997421, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06375018, orgStudyIdInfo id: OST1_011, briefTitle: Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Escola Superior de Tecnologia da Saúde do Porto, class: OTHER, descriptionModule briefSummary: This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain., conditionsModule conditions: Nonspecific Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Placebo Technique, interventions name: Diaphragm Stretching, outcomesModule primaryOutcomes measure: Change in level of inspiratory capacity immediately after intervention, primaryOutcomes measure: Change in the level of disability derived from low back pain immediately after the intervention, primaryOutcomes measure: Change in the level of functionality of the lumbar spine immediately after the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Escola Superior de Saúde do Porto, city: Porto, zip: 4200-072, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False |
protocolSection identificationModule nctId: NCT06375005, orgStudyIdInfo id: 2024-0381, briefTitle: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment., conditionsModule conditions: Diffuse Cutaneous Systemic Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Telitacicept, interventions name: Mycophenolate Mofetil, outcomesModule primaryOutcomes measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48, primaryOutcomes measure: Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24, secondaryOutcomes measure: Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48, secondaryOutcomes measure: American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48, secondaryOutcomes measure: Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Patient's Global Assessment at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Physician's Global Assessment at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Tender Joint Counts at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Swollen Joint Counts at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Yangzhou University, city: Yangzhou, state: Jiangsu, zip: 225009, country: China, geoPoint lat: 32.39722, lon: 119.43583, locations facility: Huashan Hospital of Fudan University, city: Shanghai, state: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Hangzhou First People's Hospital, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Jing Xue, PhD, role: CONTACT, phone: 86-13858121751, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, locations facility: Changxing People's Hospital, city: Huzhou, state: Zhejiang, zip: 313100, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: The First Hospital of Jiaxing, city: Jiaxing, state: Zhejiang, zip: 314000, country: China, geoPoint lat: 30.7522, lon: 120.75, locations facility: Ningbo First Hospital, city: Ningbo, state: Zhejiang, zip: 315000, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: The First Affiliated Hospital of Wenzhou Medical University, city: Wenzhou, state: Zhejiang, zip: 325000, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False |
protocolSection identificationModule nctId: NCT06374992, orgStudyIdInfo id: Pro00114569, briefTitle: Family Involvement Hospital Ethnography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the role of family members in caring for hospitalized older adults with cognitive impairment. The main questions it aims to answer are:1. What features of the healthcare system facilitate or hinder family involvement in care from the perspective of patients, families, and healthcare workers?2. How do hospital leaders understand the facilitators and barriers to family involvement?Data collection will occur via semi-structure interviews, direct observation, and artifact analysis., conditionsModule conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Faciltators and Barriers to Family Involvement in Care of Hospitalized Older Adults with Cognitive Impairment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374979, orgStudyIdInfo id: 2024-0047, briefTitle: Efficacy and Safety of Ixekizumab in Patients With Refractory Guttate Psoriasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is:What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index., conditionsModule conditions: Guttate Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ixekizumab, outcomesModule primaryOutcomes measure: PASI 90 response, secondaryOutcomes measure: PGA 0/1 response, secondaryOutcomes measure: PASI 100 response, secondaryOutcomes measure: Relapse, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374966, orgStudyIdInfo id: 2024-0246, briefTitle: Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, collaborators name: Hangzhou Children's Hospital, collaborators name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, collaborators name: Jinhua Second Hospital, collaborators name: Ningbo Medical Center Lihuili Hospital, collaborators name: Ningbo Women & Children's Hospital, collaborators name: Yuyao People's Hospital, collaborators name: Huzhou Third People's Hospital, collaborators name: The Second Affiliated Hospital of Jiaxing University, collaborators name: Lishui Country People's Hospital, descriptionModule briefSummary: Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition., conditionsModule conditions: Epilepsies, Partial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Zonisamide, outcomesModule primaryOutcomes measure: Effective rate at 6 months of treatment, secondaryOutcomes measure: Effective rate at 3 months of treatment, secondaryOutcomes measure: Total time to treatment failure, secondaryOutcomes measure: Incidence of side effects, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hangzhou Children's Hospital, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Zhanli Liu, doctorate, role: CONTACT, phone: 15968194368, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Shuang Wang, doctorate, role: CONTACT, phone: 13588817561, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, locations facility: Huzhou Third People's Hospital, city: Huzhou, state: Zhejiang, zip: 313002, country: China, contacts name: Changguo Zhang, doctorate, role: CONTACT, phone: 15957288075, email: [email protected], geoPoint lat: 30.8703, lon: 120.0933, locations facility: Jiaxing Second hospital, city: Jiaxing, state: Zhejiang, zip: 314099, country: China, contacts name: Xiaoxiang Yu, doctorate, role: CONTACT, phone: 13567340650, email: [email protected], geoPoint lat: 30.7522, lon: 120.75, locations facility: Jinhua Second hospital, city: Jinhua, state: Zhejiang, zip: 321016, country: China, contacts name: Suhong Ye, doctorate, role: CONTACT, phone: 13757990511, email: [email protected], geoPoint lat: 29.10678, lon: 119.64421, locations facility: The Fourth Affilicated Hospital of Zhejiang University School of Medicine, city: Jinhua, state: Zhejiang, zip: 322099, country: China, contacts name: Jiajia Fang, doctorate, role: CONTACT, phone: 15215880868, email: [email protected], geoPoint lat: 29.10678, lon: 119.64421, locations facility: Lishui People's Hospital, city: Lishui, state: Zhejiang, zip: 323050, country: China, contacts name: Likang Lan, doctorate, role: CONTACT, phone: 18957090351, email: [email protected], geoPoint lat: 28.46042, lon: 119.91029, locations facility: Ningbo Women And Children's Hospital, city: Ningbo, state: Zhejiang, zip: 315012, country: China, contacts name: Minghai Huang, doctorate, role: CONTACT, phone: 13605742462, email: [email protected], geoPoint lat: 29.87819, lon: 121.54945, locations facility: Ningbo Medical center Lihuili hospital, city: Ningbo, state: Zhejiang, zip: 315048, country: China, contacts name: Xiaoqin Fan, doctorate, role: CONTACT, phone: 13685739576, email: [email protected], geoPoint lat: 29.87819, lon: 121.54945, locations facility: Yuyao People's hospital, city: Yuyao, state: Zhejiang, zip: 315499, country: China, geoPoint lat: 30.05, lon: 121.14944, hasResults: False |
protocolSection identificationModule nctId: NCT06374953, orgStudyIdInfo id: 2024-0182, briefTitle: A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: This study compares the results of the existing fibrinolysis monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients., conditionsModule conditions: Hyperfibrinolysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-based viscoelastic hemostasis analysis, outcomesModule primaryOutcomes measure: Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Fengjiang ZHANG, role: CONTACT, phone: +8613858007629, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06374940, orgStudyIdInfo id: Lütfi Kırdar City Hospital, briefTitle: Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2024-05-17, completionDateStruct date: 2024-05-18, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Dr. Lutfi Kirdar Kartal Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomyStudy design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.Primary outcomes: (1) Operation Time.Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications, conditionsModule conditions: Gynecologic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Manipulator-assisted Abdominal Hysterectomy, outcomesModule primaryOutcomes measure: Duration of the surgical procedure, secondaryOutcomes measure: Postoperative pain at 6th hours, secondaryOutcomes measure: Postoperative pain at 24th hours, secondaryOutcomes measure: intraoperative complications, secondaryOutcomes measure: Postoperative complications, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr.Lütfi Kırdar City Hospital, city: Istanbul, zip: 34000, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06374927, orgStudyIdInfo id: PHRASE-2023, briefTitle: Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study, acronym: PHRASE-2023, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Donders Centre for Neuroscience, class: OTHER, descriptionModule briefSummary: The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge.The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge.Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientific principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home.There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales.The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience.The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke.Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation Gaming System (VR-based mobile application), outcomesModule primaryOutcomes measure: Usability, primaryOutcomes measure: User experience, primaryOutcomes measure: Adherence, primaryOutcomes measure: Acceptance, secondaryOutcomes measure: The Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE), secondaryOutcomes measure: Hamilton Depression Rating Scale (HDRS), secondaryOutcomes measure: Fatigue Severity Scale (FSS), secondaryOutcomes measure: Pain Visual Analogue Scale (VAS), secondaryOutcomes measure: Barthel Index (BI), secondaryOutcomes measure: EuroQol - 5 Dimension - 5 Level (EQ-5D-5L), secondaryOutcomes measure: Modified Ashworth scale (MAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre hospitalier universitaire de Limoges, status: NOT_YET_RECRUITING, city: Limoges, zip: 87000, country: France, contacts name: Stephane Mandigout, Dr., role: CONTACT, email: [email protected], geoPoint lat: 45.83153, lon: 1.25781, locations facility: Cluj Rehabilitation Hospital, status: NOT_YET_RECRUITING, city: Cluj-Napoca, state: Cluj, zip: 400066, country: Romania, contacts name: Stefan Strilciuc, PhD., role: CONTACT, email: [email protected], geoPoint lat: 46.76667, lon: 23.6, locations facility: Parc Sanitari Sant Joan de Déu, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Raffaele Fiorillo, Dr., role: CONTACT, email: [email protected], contacts name: Raffaele Fiorillo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: IRF La Salle, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Miguel Gómez Martínez, Dr., role: CONTACT, email: [email protected], contacts name: Miguel Gómez Martínez, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06374914, orgStudyIdInfo id: TUO-UR-23-05, briefTitle: Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2026-04-09, completionDateStruct date: 2026-04-09, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients., conditionsModule conditions: Bladder Cancer, conditions: BCG, conditions: Gemcitabine, conditions: Docetaxel, conditions: Intravesical Instillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Intravesical Solution, outcomesModule primaryOutcomes measure: Recurrence rate, primaryOutcomes measure: Progression rate, primaryOutcomes measure: Adverse effects of intravesical chemotherapy, primaryOutcomes measure: Intravesical chemotherapy versus radical cystectomy, secondaryOutcomes measure: treatment change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dokuz Eylul University Faculty of Medicine Department of Urology, city: Izmir, state: Other (Non U.s.), zip: 35330, country: Turkey, contacts name: Muhammed Selcuk Ozer, Medical Doctor, role: CONTACT, phone: +905543078941, email: [email protected], contacts name: Ozan Bozkurt, Professor, role: CONTACT, email: [email protected], contacts name: Ozan Bozkurt, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False |
protocolSection identificationModule nctId: NCT06374901, orgStudyIdInfo id: IRB-2024-311, briefTitle: Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Xiangdong Cheng, class: OTHER, collaborators name: Liaoning Tumor Hospital & Institute, collaborators name: Shanxi Province Cancer Hospital, collaborators name: Sichuan Cancer Hospital and Research Institute, collaborators name: The Second Affiliated Hospital of Harbin Medical University, descriptionModule briefSummary: To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR)., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: SOX/XELOX, outcomesModule primaryOutcomes measure: MRP (Main pathological response), secondaryOutcomes measure: pCR (pathologic complete response), secondaryOutcomes measure: DFS (Disease free survival), secondaryOutcomes measure: OS (Overall survival), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06374888, orgStudyIdInfo id: CVL009-2002, briefTitle: Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-07-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Convalife (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis., conditionsModule conditions: Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Her2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Neratinib maleate in combination with capecitabine, outcomesModule primaryOutcomes measure: Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1, secondaryOutcomes measure: Central nervous response rate, secondaryOutcomes measure: Objective response rates outside the central nervous system, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Duration of reaction, secondaryOutcomes measure: Clinical benefit rate, secondaryOutcomes measure: overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374875, orgStudyIdInfo id: 24-213, briefTitle: Fibrosis Lessens After Metabolic Surgery, acronym: FLAMES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ali Aminian, class: OTHER, descriptionModule briefSummary: Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point., conditionsModule conditions: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), conditions: Non-Alcoholic Fatty Liver Disease, conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH), conditions: Liver Fibrosis, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized in a 1:1 ratio into 1 of the 2 arms using a computer-generated randomization plan, stratified to ensure that there are equal number of patients with/without T2DM and with/without F4 (cirrhosis) according to the baseline liver biopsy in each treatment group (surgical group vs non-surgical group). The participant sites are regrouped into three geographic regions. All patients in each region will be randomized separately to have equal number of patients with/without T2DM and with/without F4 in each treatment group in each region., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients and investigators will not be blinded to treatment assignment. The treatment assignment will remain unknown until the patient is randomized after meeting all eligibility requirements.Pathologists who report the liver biopsies (to assess the primary end point of study) are blinded to treatment assignment, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Metabolic surgery, interventions name: Incretin-Based Therapy, outcomesModule primaryOutcomes measure: Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy., secondaryOutcomes measure: MASH resolution in the repeat liver biopsy, secondaryOutcomes measure: MASH resolution and fibrosis improvement in the repeat liver biopsy, secondaryOutcomes measure: Fibrosis progression in the repeat liver biopsy, secondaryOutcomes measure: Average Weight loss percentage, secondaryOutcomes measure: Disease-specific Quality of Life (QoL), otherOutcomes measure: MASLD-related histopathologic end points, otherOutcomes measure: MASLD-related laboratory end points, otherOutcomes measure: MASLD-related liver scan end points, otherOutcomes measure: MASLD-related clinical end points, otherOutcomes measure: Achieved Weight-loss proportions, otherOutcomes measure: Weight change (kg), otherOutcomes measure: BMI change (kg/m^2), otherOutcomes measure: Excess weight loss, %, otherOutcomes measure: Change in waist circumference, cm, otherOutcomes measure: Systolic blood pressure trends, mmHg, otherOutcomes measure: Mean and change from baseline in lipid panel, mg/dl, otherOutcomes measure: Changes in glucose hemostasis markers, otherOutcomes measure: Percentage of patients with T2DM meeting predefined HbA1c targets, otherOutcomes measure: Changes in inflammatory markers, CRP mg/L, otherOutcomes measure: Change in cardiovascular and diabetes medications, otherOutcomes measure: SF-Bari Score, otherOutcomes measure: Quality of life end points, otherOutcomes measure: Safety end points, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Banner Health Center, city: Phoenix, state: Arizona, zip: 85006, country: United States, contacts name: Farah Husain, MD, role: CONTACT, email: [email protected], geoPoint lat: 33.44838, lon: -112.07404, locations facility: Indiana University, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Dimitrios Stefanidis, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: 39.76838, lon: -86.15804, locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Omar Ghanem, MD, role: CONTACT, email: [email protected], geoPoint lat: 44.02163, lon: -92.4699, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Ali Aminian, MD, role: CONTACT, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, locations facility: Hospital Alemão Oswaldo Cruz, city: São Paulo, country: Brazil, contacts name: Ricardo Cohen, MD, role: CONTACT, email: [email protected], geoPoint lat: -23.5475, lon: -46.63611, locations facility: McGill University, city: Montréal, country: Canada, contacts name: Amin Andalib, MDCM, MSc, role: CONTACT, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, locations facility: Turku University Hospital, city: Turku, country: Finland, contacts name: Paulina Salminen, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: 60.45148, lon: 22.26869, locations facility: Sri Aurobindo Institute of Medical Sciences, city: Indore, country: India, geoPoint lat: 22.71792, lon: 75.8333, locations facility: The Digestive Health Institute, city: Mumbai, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: University College Dublin, city: Dublin, country: Ireland, contacts name: Helen Heneghan, MB BCh BAO, PhD, role: CONTACT, email: [email protected], geoPoint lat: 53.33306, lon: -6.24889, locations facility: Università Cattolica del Sacro Cuore, city: Milan, country: Italy, contacts name: Geltrude Mingrone, M.D. PhD, role: CONTACT, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, locations facility: Sapienza Università di Roma, city: Roma, country: Italy, contacts name: Giovanni Casella, MD, role: CONTACT, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, locations facility: Kuwait University, city: Kuwait, country: Kuwait, geoPoint lat: 29.36972, lon: 47.97833, locations facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador, city: Mexico City, country: Mexico, contacts name: Mauricio Sierra, MD, role: CONTACT, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Hospital Clínic Barcelona, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Linköping University, city: Linköping, country: Sweden, geoPoint lat: 58.41086, lon: 15.62157, locations facility: Örebro University, city: Örebro, country: Sweden, contacts name: Erik Stenberg, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: 59.27412, lon: 15.2066, locations facility: Clarunis Universitäres, city: Basel, country: Switzerland, contacts name: Ralph Peterli, Dr. med, role: CONTACT, email: [email protected], geoPoint lat: 47.55839, lon: 7.57327, locations facility: Hôpitaux universitaires de Genève, city: Geneva, country: Switzerland, contacts name: Minoa Jung, PD Dr. med., role: CONTACT, email: [email protected], geoPoint lat: 46.20222, lon: 6.14569, locations facility: Nuffield Health Bristol Hospital, city: Bristol, country: United Kingdom, contacts name: Dimitri Pournaras, PhD, role: CONTACT, email: [email protected], geoPoint lat: 51.45523, lon: -2.59665, locations facility: King's College Hospital, city: London, country: United Kingdom, contacts name: Francesco Rubino, MD, role: CONTACT, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, locations facility: Queen Mary University, city: London, country: United Kingdom, contacts name: William Alazawi, MB BChir PhD, role: CONTACT, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06374862, orgStudyIdInfo id: PI2024_843_0008, briefTitle: Effects of Specific Thoracic Spine Mobilizations on Muscle Activity in a Healthy Volunteer Population, acronym: RACHI-MOB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, descriptionModule briefSummary: In this study, the investigators will examine the effect of manual therapy on the thoracic spine and its impact on the muscular strength gain of the thoracic extensors. Treatment with manual therapy, as described by Maitland, consists of a specific mobilization of the thoracic spine in the postero-anterior direction on the transverse and spiny processes of the thoracic vertebrae. To ensure the relevance of the measures, and to better control the occurrence of biases inherent to the practice of manual therapy, the investigators constituted three distinct groups: an intervention group, a control group and a group without intervention. In short, this methodology will allow us to explore in detail the effects of specific spinal mobilization on motor control, while taking into account placebo response elements and natural variations in the results, conditionsModule conditions: Musculoskeletal Manipulations, conditions: Range of Motion, conditions: Muscle Strength, conditions: Peripheral Joints in Upper Quarters, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: mobilization, interventions name: no effect, outcomesModule primaryOutcomes measure: electrical activity assessment of the spine extensor muscles using EMG, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens Picardie, status: RECRUITING, city: Amiens, state: Picardie, zip: 80054, country: France, contacts name: Vicente BELTRAN AIBAR, role: CONTACT, phone: 03.22.45.59.92, email: [email protected], contacts name: François-Régis Sarhan, role: SUB_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False |
protocolSection identificationModule nctId: NCT06374849, orgStudyIdInfo id: PI2023_843_0173, briefTitle: Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery, acronym: ISPAIN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-17, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, descriptionModule briefSummary: Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery., conditionsModule conditions: Chronic Postsurgical Pain, conditions: Chronic Pain, conditions: Abdominal Surgery, conditions: Sufentanil, conditions: Risk Factors, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 855, type: ESTIMATED, armsInterventionsModule interventions name: phone interview, outcomesModule primaryOutcomes measure: Incidence of CPSP, secondaryOutcomes measure: Post-operative pain intensity, secondaryOutcomes measure: Post-operative pain intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens-Picardie, status: RECRUITING, city: Amiens, zip: 80054, country: France, contacts name: Paul TARPIN, MD, role: CONTACT, phone: 0322087980, email: [email protected], contacts name: Ottilie Fumery, MD, role: SUB_INVESTIGATOR, contacts name: Stephane BAR, Pr, role: SUB_INVESTIGATOR, contacts name: Benjamin Mestan, MD, role: SUB_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False |
protocolSection identificationModule nctId: NCT06374836, orgStudyIdInfo id: nWMO 2024.040, briefTitle: The Contractile Response of the Thoracic Aorta to Vasoactive Substances, acronym: AorticContract, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Catharina Ziekenhuis Eindhoven, class: OTHER, collaborators name: Maastricht University, descriptionModule briefSummary: Hypertension affects 32-35% of the global adult population. Despite many drugs being available hypertension is not controlled in 50% of the over 500 million treated people leaving patients with an elevated blood pressure for life.In the development of isolated systolic hypertension, the aorta plays a pivotal role. With each heartbeat, the heart empties its stroke volume into the large arteries. These arteries, particularly the thoracic part of the aorta, temporarily distend to buffer the stroke volume and thereby dampen the pressure fluctuation: they have a Windkessel function. When this function is reduced (and arterial stiffness is increased), the heart needs to contract more forcefully during ejection, leading to isolated systolic hypertension.Likely, the aorta is not just a passive structure (the aorta as an elastic 'bicycle tube'). Rather, the smooth muscle cells in the aorta wall can presumably actively change the aorta's dimension through vasoconstriction/-dilation. If this is the case, such vasoconstriction/-dilation will have direct consequences for the aorta's Windkessel function and, since this Windkessel function directly influences the blood pressure flucturation, also for hypertension and its progression. Therefore, the aim of this study is to quantify the thoracic aorta's ability to vasoconstrict, and to assess whether this contractility is related to specific predictors.During the study we will measure in the operating room the thoracic descending and ascending aortic diameter with transoesopahgeal echocardiography (part of standard clinical care), before and after administration of vasoactive drugs (phenylephrine and norepinephrine; also part of standard clinical care). During these measurements we will simultanesouly measure peripheral arterial blood pressure and an electrocardiogram (ECG, to monitor sympathetic activity as estimated using heart rate variability analysis). Measurements will be performed at Catharina Hospital Eindhoven, the Netherlands (NL), where patients undergo elective cardiac surgery. Using the data obtained, we will 1) establish and quantify the in vivo contractility of the human thoracic aorta, and 2) study whether and to which extent potential predictors (age, sex, smoking status, antihypertensive medication use/class, mean arterial pressure, pulse pressure as an indirect measure of arterial stiffness, diabetes, chronic kidney disease, total cholesterol, and sympathetic activity) influence contractility, conditionsModule conditions: Human Thoracic Aorta Contractility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: Phenylephrine, outcomesModule primaryOutcomes measure: To establish and quantify the in vivo contractility of the human thoracic aorta, secondaryOutcomes measure: To quantify the magnitude of contractile response, secondaryOutcomes measure: To study whether and to which extent potential predictors influence contractility., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Catharina hospital, city: Eindhoven, state: Noord-Brabant, zip: 5623 EJ, country: Netherlands, contacts name: Frederique de Raat, Msc., role: CONTACT, phone: +31615137244, email: [email protected], contacts name: Angélique Burmanje, Msc., role: CONTACT, phone: +316 44 15 00 18, email: [email protected], geoPoint lat: 51.44083, lon: 5.47778, hasResults: False |
protocolSection identificationModule nctId: NCT06374823, orgStudyIdInfo id: IIT2023-020-002, briefTitle: Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke, acronym: MERIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Capital Medical University, class: OTHER, descriptionModule briefSummary: Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline., conditionsModule conditions: Critical Care, conditions: Hyperchloremia, conditions: Hemorrhagic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 342, type: ESTIMATED, armsInterventionsModule interventions name: Multiple Electrolyte, interventions name: Normal Saline, outcomesModule primaryOutcomes measure: Hyperchloremia, secondaryOutcomes measure: Hyperchloremia acidosis, secondaryOutcomes measure: Plasma osmolality, secondaryOutcomes measure: AKI, secondaryOutcomes measure: RRT, secondaryOutcomes measure: hospital length of stay, secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: hospitalization expense, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Shijitan Hospital, city: Beijing, state: Beijing, zip: 100038, country: China, contacts name: Jian-Xin Zhou, MD, role: CONTACT, phone: +8613801183875, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06374810, orgStudyIdInfo id: CCB1, briefTitle: Does Conscious Connected Breathwork Reduce Symptoms of Anxiety?, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-21, primaryCompletionDateStruct date: 2023-12-20, completionDateStruct date: 2023-12-20, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Richard Blake, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale.The main questions aims to answer:1. Does conscious connected breathwork reduce symptoms of anxiety?2. Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms.there is a comparison group: Researchers will compare whether people doing the breathwork to see if \[insert effects\].Participants will participate in 1, 90 minute breath workshop per week for 6 weeks. These sessions will be held on Zoom by 2 facilitators. Participants will also be given a 10 minute recording of a guided conscious connected breathwork session that they will be encouraged to complete daily., conditionsModule conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants were randomly assigned to either the breathwork group or they were told that they had been placed on a waitlist and that they would participate in the 2nd cohort, which would take place after the 1st 6-week program had been completed.Participants in the breathwork groups were also given a 10 minute guided conscious connected breathwork recording. They were advised to do this daily to support the integration of their process. This was not mandatory. At the end of the study participants were asked how often they used the guided self-practice. The frequency of use of the self-practice was used a covariate., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants in group 2 were told that the trial was full but actually they were just placed in the placebo control group., whoMasked: PARTICIPANT, enrollmentInfo count: 108, type: ACTUAL, armsInterventionsModule interventions name: Conscious Connected Breathwork, interventions name: Placebo waitlist, outcomesModule primaryOutcomes measure: Changes in anxiety symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CIIS, city: San Francisco, state: California, zip: 94103, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False |
protocolSection identificationModule nctId: NCT06374797, orgStudyIdInfo id: CMZ-207, briefTitle: A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk", acronym: KOURAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: CalciMedica, Inc., class: INDUSTRY, descriptionModule briefSummary: Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions., conditionsModule conditions: Acute Kidney Injury, 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: 150, type: ESTIMATED, armsInterventionsModule interventions name: Auxora, interventions name: Placebo, outcomesModule primaryOutcomes measure: Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30, secondaryOutcomes measure: Major adverse kidney event (MAKE) 90-1: ≥25% decline in estimated glomerular filtration rate (eGFR) from baseline, incident KRT, and all-cause mortality at 90 days, secondaryOutcomes measure: MAKE 90-2: ≥35% decline in eGFR from baseline, incident KRT, and all-cause mortality at 90 days, secondaryOutcomes measure: Proportion of patients alive at Day 30, secondaryOutcomes measure: Proportion of patients alive at Day 90, secondaryOutcomes measure: Days alive and ventilator-free from start of first infusion of study drug (SFISD) through Day 30, secondaryOutcomes measure: Days alive and KRT-free from SFISD through Day 30, secondaryOutcomes measure: Proportion of patients recovered from AHRF through Day 30 as categorized by an 8-point ordinal scale, secondaryOutcomes measure: Proportion of patients receiving KRT at Day 30, secondaryOutcomes measure: Proportion of patients receiving KRT at Day 90, secondaryOutcomes measure: Number of patients with treatment-related adverse events (TEAE), secondaryOutcomes measure: Number of patients with grade 3 TEAEs, otherOutcomes measure: Days alive and not hospitalized through Day 30, otherOutcomes measure: Proportion of patients re-hospitalized through Day 30, otherOutcomes measure: Proportion of patients re-hospitalized through Day 90, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06374784, orgStudyIdInfo id: perio2023ARP, briefTitle: Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-10-20, completionDateStruct date: 2024-11-20, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth, conditionsModule conditions: Alveolar Bone Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole, interventions name: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF, interventions name: Alveolar ridge preservation using autogenous demineralized dentin graft alone, outcomesModule primaryOutcomes measure: Alveolar ridge apico-coronal height change in mm, secondaryOutcomes measure: Alveolar ridge bucco-lingual width change in mm, secondaryOutcomes measure: Histological assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Cairo, country: Egypt, contacts name: Cairo University, role: CONTACT, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06374771, orgStudyIdInfo id: MD-15-2022, briefTitle: Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-27, primaryCompletionDateStruct date: 2024-06-27, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, collaborators name: Theodor Bilharz Research Institute, descriptionModule briefSummary: The goal of this clinical trial is to compare the analgesic effect of melatonin, and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours e.g. radical cystectomy, radical prostatectomy, colectomy, sigmoidectomy, splenectomy, and CBD exploration through mid-line incision.This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause:* More reduction in total morphine consumption in the first 24 hours postoperatively* More reduction of the incidence of chronic post-surgical pain, than using each adjuvant alone.Participants will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration; 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group.Researchers will compare:* The effect of melatonin, vitamin C, and their combination on postoperative opioid consumption* The severity of postoperative pain, using the Numerical Rating Scale (NRS)* Patients' satisfaction with a three-point scale* The time of the first requirement for rescue analgesia* The effect on the incidence of chronic post-surgical pain., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Melatonin 10 MG, interventions name: Vitamin C, outcomesModule primaryOutcomes measure: Total morphine consumption, secondaryOutcomes measure: Numeric Rating Scale, secondaryOutcomes measure: Richmond Agitation Sedation Scale, secondaryOutcomes measure: Time to first analgesic request, secondaryOutcomes measure: chronic post-surgical pain, secondaryOutcomes measure: patient satisfaction using Likert three-point scale, secondaryOutcomes measure: systolic blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Intra-operative mean consumption of sevoflurane per hour., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine - Cairo University, city: Cairo, state: Manial, zip: 11553, country: Egypt, contacts name: Waleed Hamimy, MD, role: CONTACT, phone: 01150377770, phoneExt: +2, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06374758, orgStudyIdInfo id: MU-2096449, briefTitle: Accelerated ART Initiation for PWHIV Who Are Out of Care, acronym: ACCELERATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Missouri-Columbia, class: OTHER, collaborators name: Gilead Sciences, descriptionModule briefSummary: The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care., conditionsModule conditions: HIV Infections, conditions: ART, conditions: Noncompliance, Patient, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: The Accelerate model of care, interventions name: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg, outcomesModule primaryOutcomes measure: The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24., primaryOutcomes measure: To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants., primaryOutcomes measure: To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants, primaryOutcomes measure: To study the change over time in feasibility of the ACCELERATE model of care in patient and staff participants, primaryOutcomes measure: To study the change over time in sustainability of the ACCELERATE model of care in patient and staff participants, primaryOutcomes measure: Qualitative data, secondaryOutcomes measure: To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care., secondaryOutcomes measure: To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care, secondaryOutcomes measure: To assess change in health-related quality of life (HRQoL), secondaryOutcomes measure: To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF, secondaryOutcomes measure: To measure Retention in Care, secondaryOutcomes measure: To assess the adherence to the study treatment, secondaryOutcomes measure: To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care., secondaryOutcomes measure: To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care., secondaryOutcomes measure: To assess staff impact of ACCELERATE model of care on staff satisfaction, secondaryOutcomes measure: To assess staff impact of ACCELERATE model of care on staff burnout, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Missouri-Columbia, status: RECRUITING, city: Columbia, state: Missouri, zip: 65212, country: United States, contacts name: Dima Dandachi, MD, role: CONTACT, phone: 573-884-8728, email: [email protected], geoPoint lat: 38.95171, lon: -92.33407, hasResults: False |
protocolSection identificationModule nctId: NCT06374745, orgStudyIdInfo id: 2020-01307; mu24Kappos, briefTitle: An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol, statusModule overallStatus: RECRUITING, startDateStruct date: 2015-01-02, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: Sana Kliniken Düsseldorf GmbH, descriptionModule briefSummary: The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema., conditionsModule conditions: Lymphedema, conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery., primaryOutcomes measure: Date of follow-up procedure, primaryOutcomes measure: Follow-up and type of lymphedema surgery, primaryOutcomes measure: Circumferences of the affected and unaffected side, primaryOutcomes measure: Postoperative complications, primaryOutcomes measure: Surgery duration., primaryOutcomes measure: Type of lymphedema surgery, primaryOutcomes measure: Date of lymphedema surgery, primaryOutcomes measure: Use of compression stockings, primaryOutcomes measure: Number of lymphedema drainages per week, primaryOutcomes measure: Stage of lymphedema, primaryOutcomes measure: Duration of lymphedema, primaryOutcomes measure: Location of lymphedema, primaryOutcomes measure: Subsequent cancer treatment, primaryOutcomes measure: Date of cancer related surgery, primaryOutcomes measure: Tumor staging, primaryOutcomes measure: Tumor location, primaryOutcomes measure: BMI, primaryOutcomes measure: Comorbidities, primaryOutcomes measure: Age, primaryOutcomes measure: Gender, secondaryOutcomes measure: Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema, secondaryOutcomes measure: Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer, secondaryOutcomes measure: Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history, secondaryOutcomes measure: Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history, secondaryOutcomes measure: Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS, secondaryOutcomes measure: Analysis of cohort subgroups: exploratory, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, status: RECRUITING, city: Basel, zip: 4031, country: Switzerland, contacts name: Elisabeth A Kappos, PD Dr. med., role: CONTACT, phone: 0041 61 265 25 25, email: [email protected], contacts name: Adriano Fabi, BMed, role: CONTACT, phone: 0041 79 888 12 51, email: [email protected], geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06374732, orgStudyIdInfo id: TY2024002, briefTitle: The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, collaborators name: China Scholarship Council, collaborators name: Ningbo University, descriptionModule briefSummary: A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: High-intensity interval training, interventions name: Control group, outcomesModule primaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Muscular strength, secondaryOutcomes measure: Wellbeing, secondaryOutcomes measure: Enjoyment, secondaryOutcomes measure: Motivation, secondaryOutcomes measure: Affect, secondaryOutcomes measure: Academic performance, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Body fat percentage, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Bone health, secondaryOutcomes measure: Perceived physical ability, secondaryOutcomes measure: Flanker task, secondaryOutcomes measure: Visual 2-back task, secondaryOutcomes measure: Colour-shape switch task, otherOutcomes measure: Confounding variables, otherOutcomes measure: Interview, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Exeter, status: RECRUITING, city: Exeter, state: Devon, zip: EX1 2LU, country: United Kingdom, contacts name: Yong Liu, role: CONTACT, phone: +447570013632, email: [email protected], contacts role: CONTACT, phoneExt: Liu, email: [email protected], contacts name: yong Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.7236, lon: -3.52751, hasResults: False |
protocolSection identificationModule nctId: NCT06374719, orgStudyIdInfo id: WiTNNess, briefTitle: WiTNNess - TNNT1 Myopathy Natural History Study, acronym: WiTNNess, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-09-23, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Clinic for Special Children, class: OTHER, descriptionModule briefSummary: WiTNNess is designed to accurately document the natural course and variation of muscle disease caused by pathogenic changes of the TNNT1 gene. The primary aim of the study is to specify meaningful outcome measures for future clinical trials. WiTNNess is open to children and adults worldwide. Participants can choose to include their information once (cross-sectional cohort) or every few months (prospective cohort)., conditionsModule conditions: TNNT1-associated Myopathy, conditions: Infantile-onset Nemaline Rod Myopathy, conditions: Myopathies, Nemaline, conditions: Myopathy, conditions: Myopathy, Rod, conditions: Myopathy; Hereditary, conditions: Amish Nemaline Myopathy, conditions: Nemaline Myopathy 5, conditions: NEM5, conditions: Genetic Muscle Disease, conditions: Recessive Hereditary Disorder (Autosomal), conditions: ANM, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Motor Milestones, secondaryOutcomes measure: Thriving, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinic for Special Children, status: RECRUITING, city: Strasburg, state: Pennsylvania, zip: 17579, country: United States, contacts name: Joelle FS Williamson, MPH, role: CONTACT, phone: 717-687-9407, email: [email protected], geoPoint lat: 39.98316, lon: -76.18412, hasResults: False |
protocolSection identificationModule nctId: NCT06374706, orgStudyIdInfo id: 23-0129, briefTitle: Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: The University of Texas Medical Branch, Galveston, class: OTHER, descriptionModule briefSummary: In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards., conditionsModule conditions: Stroke, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Morning Walk training for stroke, interventions name: Morning Walk training for healthy, outcomesModule primaryOutcomes measure: The Number of Participants with Kinematic representation of the temporal events during end-effector robot training, primaryOutcomes measure: Muscle Activity in the lower extremities, primaryOutcomes measure: Spatiotemporal Patterns of Walking, Speeds, primaryOutcomes measure: Spatiotemporal Patterns of Walking, Parameters, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas Medical Branch, city: Galveston, state: Texas, zip: 77555, country: United States, contacts name: Mansoo Ko, Ph.D., role: CONTACT, phone: 409-772-9555, email: [email protected], contacts name: Judith L Linton, MS, role: CONTACT, phone: 4092661767, email: [email protected], geoPoint lat: 29.30135, lon: -94.7977, hasResults: False |
protocolSection identificationModule nctId: NCT06374693, orgStudyIdInfo id: STH22772, briefTitle: Investigating the Tolerability and Feasibility of Transcutaneous Vagus Nerve Stimulation Following Aneurysmal Subarachnoid Haemorrhage, acronym: tVNS in aSAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Sheffield Teaching Hospitals NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: After a subarachnoid haemorrhage, complications are common and increase the overall rate of disability and death from the condition. Despite some advances in preventing, detecting and treating these complications, the rates of complications and associated risks remain high. Further research into ways to reduce complications of subarachnoid haemorrhage.Transcutaneous vagus nerve stimulation (tVNS) is a technique where a small handheld device is attached to an earpiece which stimulates the nerves to the ear. This is given for short periods and may help improve blood flow and reduce inflammation in the brain. The intervention has been safely used and licensed in seizures, headache and severe depression.This study will look to see if it is feasible and tolerable to have tVNS twice daily for 5 days after subarachnoid haemorrhage, and whether it can help reduce the risk of complications from subarachnoid haemorrhage.The participant will be randomly allocated to receive either tVNS or a dummy intervention, known as sham.The researchers will collect some personal and clinical details such as diagnosis, medications, age, blood test results, as well as some details about the subarachnoid haemorrhage.The researchers will also complete brief questionnaires with the participant to assess symptoms. They will take measurements of heart rate, pupil response, and brain activity using a cap. The participant will then be randomly allocated to either receive the tVNS or sham intervention.Next, the research team will apply the earpiece to their ear twice a day for 45 minutes, for a total of 5 days.At the end of the 5-day study period, the intervention will be complete. The researchers will arrange a follow-up meeting on discharge and at 6 weeks, to assess the participants symptoms and recovery.Previous studies have shown that tVNS is safe and well tolerated, including a recent review of tVNS studies which evaluated the side effects experienced by 1322 patients receiving tVNS.The main side effects include localised tingling/numbness/pain/redness around the ear (17%), headaches (3%), dizziness (1%), facial droop (1%), nausea (1%), nasal discharge (2%). Rarely, palpitations or a slow heart rate may occur.They will continue to receive full medical treatment and observation alongside the study. They are free to withdraw from this study if they find it too demanding on top of their other activities., conditionsModule conditions: Subarachnoid Haemorrhage From Cerebral Aneurism Rupture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Vagus Nerve Stimulation, interventions name: Sham Transcutaneous Vagus Nerve Stimulation, outcomesModule primaryOutcomes measure: Monitor tolerability for tVNS, primaryOutcomes measure: Assess study feasibility, secondaryOutcomes measure: Monitor safety criteria for tVNS, secondaryOutcomes measure: Rates of delayed cerebral ischaemia (DCI), secondaryOutcomes measure: Inpatient mortality, secondaryOutcomes measure: Length of inpatient stay, secondaryOutcomes measure: Rates of inpatient complications, secondaryOutcomes measure: Modified rankin score, secondaryOutcomes measure: Barthel Index, secondaryOutcomes measure: Inflammatory markers, secondaryOutcomes measure: Headache scores, secondaryOutcomes measure: Cerebral functional near-infrared spectroscopy, secondaryOutcomes measure: Heart rate variability, secondaryOutcomes measure: Pupillary light reactivity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Sheffield, city: Sheffield, state: South Yorkshire, zip: S10 2HQ, country: United Kingdom, contacts name: Dr Ali Ali, role: CONTACT, phone: +4401142159114, email: [email protected], contacts name: Mr Matthew Myers, role: SUB_INVESTIGATOR, geoPoint lat: 53.38297, lon: -1.4659, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-16, uploadDate: 2024-01-12T08:49, filename: Prot_000.pdf, size: 2294124, hasResults: False |
protocolSection identificationModule nctId: NCT06374680, orgStudyIdInfo id: C3 ectomy, briefTitle: C3 Laminectomy With Cervical Laminoplasty, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2017-03-20, primaryCompletionDateStruct date: 2021-12-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: 1. Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.2. Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.3. Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty., conditionsModule conditions: Neck Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: laminectomy at C3 level, outcomesModule primaryOutcomes measure: neck pain, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, zip: 110-744, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06374667, orgStudyIdInfo id: KY2024-071-02, briefTitle: The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction, acronym: SOLUTION-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: yilong Wang, class: OTHER, descriptionModule briefSummary: A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes., conditionsModule conditions: Stroke, Acute Ischemic, conditions: Blood-Brain Barrier, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Y-3 ICO injection, interventions name: Y-3 intravenous injection, interventions name: Conventional treatment, outcomesModule primaryOutcomes measure: 90-day favorable clinical outcome, secondaryOutcomes measure: Change of infarct volume from baseline to 8-day, secondaryOutcomes measure: Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) ., secondaryOutcomes measure: Patients with symptoms improvement from baseline to 14-day, secondaryOutcomes measure: Rate of decompressive hemicraniectomy, secondaryOutcomes measure: Depression scale scores at 90-day, secondaryOutcomes measure: Proportion of combined adverse events at 90-day, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The first affiliated hospital of Wannan Medical College, status: NOT_YET_RECRUITING, city: Wuhu, state: Anhui, country: China, contacts name: Shoucai Zhao, MD, role: CONTACT, contacts name: Zhenbao Li, MD, role: CONTACT, geoPoint lat: 31.33728, lon: 118.37351, locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Yilong Wang, PhD，MD, role: CONTACT, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Tangshan Municipal Worker's Hospital, status: NOT_YET_RECRUITING, city: Tangshan, state: Heibei, country: China, contacts name: Jun Hong, MD, role: CONTACT, geoPoint lat: 39.63333, lon: 118.18333, locations facility: Shaanxi Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Xi'an, state: Shaanxi, country: China, contacts name: Wei Hu, MD, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06374654, orgStudyIdInfo id: 2023P003272, briefTitle: RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit., conditionsModule conditions: Achilles Tendinopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Home-based Exercise Protocol, interventions name: Formal Physical Therapy, outcomesModule primaryOutcomes measure: Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A), secondaryOutcomes measure: PROMIS Pain Interference (4a), secondaryOutcomes measure: PROMIS Pain Intensity (3a), secondaryOutcomes measure: PROMIS Depression (4a), secondaryOutcomes measure: Patient Acceptable Symptom State Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02130, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06374641, orgStudyIdInfo id: 5514255, briefTitle: The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function, acronym: MCh1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, collaborators name: Mitocholine Ltd, collaborators name: Innovate UK, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of taking a new supplement for 16 days on cognitive function and exercise performance, compared to a placebo (a supplement that looks and tastes the same, but doesn't have the same ingredients) in 40 healthy individuals - 20 young individuals (aged 18-30) and 20 older individuals (aged 50-65).The main questions it aims to answer are:* If taking the supplement for 16 days improves exercise performance, or the speed with which the body responds to the commencement of exercise.* If taking the supplement improves cognitive function.Participants will visit the lab on 5 separate occasions to:* complete some cognitive tests* complete exercise performance tests* provide blood samplesAll exercise tests will be on an exercise bike.After 28 (or 46 for pre-menopausal females) days to make sure the supplement has left the body fully, participants will consume the opposite supplement and repeat the tests., conditionsModule conditions: Exercise Performance, conditions: Cognitive Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Trials will be randomised and counterbalanced to remove any trial-order effect., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Partners Innovate UK and Mitocholine Ltd will also be masked. Masking will be performed by an individual outside of the research group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mitochondrial Substrate Supplement, interventions name: Placebo Supplement, outcomesModule primaryOutcomes measure: Exercise Capacity, primaryOutcomes measure: VO2 kinetic response to exercise, primaryOutcomes measure: Cognitive Function (Stroop test), primaryOutcomes measure: Cognitive Function (decision reaction test), primaryOutcomes measure: Grip Strength, secondaryOutcomes measure: Capillary Blood Lactate, secondaryOutcomes measure: Questionnaire 1, secondaryOutcomes measure: Questionnaire 2, secondaryOutcomes measure: Venous Blood [Betaine], secondaryOutcomes measure: Venous Blood [Choline], secondaryOutcomes measure: Venous blood [S-Adenosyl methionine], secondaryOutcomes measure: Venous blood [glucose]., secondaryOutcomes measure: Venous blood [insulin]., secondaryOutcomes measure: Venous blood [trimethylamine N-oxide]., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Richards Building St. Lukes Campus University of Exeter, status: RECRUITING, city: Exeter, state: Devon, zip: EX2 4TH, country: United Kingdom, contacts name: Jimmy T Wangdi, PhD, role: CONTACT, phone: 01392 661000, email: [email protected], contacts name: Matthew I Black, PhD, role: CONTACT, email: [email protected], geoPoint lat: 50.7236, lon: -3.52751, hasResults: False |
protocolSection identificationModule nctId: NCT06374628, orgStudyIdInfo id: 0001, briefTitle: Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-06-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Rossella Elia, MD PhD, class: OTHER, descriptionModule briefSummary: The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: breast reconstruction, outcomesModule primaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Pain Evaluation, otherOutcomes measure: Complication rate, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOU Policlinico, status: RECRUITING, city: Bari, state: BA, country: Italy, contacts name: Rossella Elia, role: CONTACT, phone: 3409616476, email: [email protected], geoPoint lat: 41.11148, lon: 16.8554, hasResults: False |
protocolSection identificationModule nctId: NCT06374615, orgStudyIdInfo id: 2024-07, briefTitle: Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy, acronym: TICKTOC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is a monocentric, experimental, non-pharmacological and non-device no profit study.The study is experimental because all the visits and blood withdrawals foreseen by the protocol do not fall within the normal clinical practice., conditionsModule conditions: Tick-Borne Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 384, type: ESTIMATED, armsInterventionsModule interventions name: IgG and IgM search for specific Tick-Borne Patogens, outcomesModule primaryOutcomes measure: Number of individuals diagnosed with Tick-Borne Diseases (TBD) over the total number of individuals who were bitten by a tick which carried an identified TBP., secondaryOutcomes measure: Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks, secondaryOutcomes measure: Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period, secondaryOutcomes measure: Number of individuals who developed specific antibodies against a TBP after tick bite., secondaryOutcomes measure: List of novel TBPs that were not previously found in the study areas., eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Andrea Tedesco, role: CONTACT, email: [email protected], contacts name: Andrea Tedesco, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False |
protocolSection identificationModule nctId: NCT06374602, orgStudyIdInfo id: 33, briefTitle: Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2026-03-25, completionDateStruct date: 2026-06-25, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Saint Petersburg State University, Russia, class: OTHER, descriptionModule briefSummary: This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints., conditionsModule conditions: Anaplastic Thyroid Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab + Lenvatinib, outcomesModule primaryOutcomes measure: Objective response rate, primaryOutcomes measure: Progression-Free Survival, primaryOutcomes measure: Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: The assessment of conversion to resectability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Saint Petersburg State University Hospital, status: RECRUITING, city: Saint Petersburg, zip: 190020, country: Russian Federation, contacts name: Ernest Dzhelialov, role: CONTACT, phone: +7(911)134-50-44, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, hasResults: False |
protocolSection identificationModule nctId: NCT06374589, orgStudyIdInfo id: 202303123, briefTitle: Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients (CLOUDHFOT), acronym: CLOUDHFOT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, collaborators name: Hamilton Medical AG, descriptionModule briefSummary: High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface \[Mauri et al, 2017; Möller et al, 2017\].As hyperoxia is considered not desirable \[Barbateskovic et al, 2019\] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present \[O'Driscoll et al, 2017; Beasley et al, 2015\]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.A new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.A short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy \[Roca et al, 2022\]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO., conditionsModule conditions: Acute Hypoxemic Respiratory Failure, conditions: Acute Hypercapnic Respiratory Failure, conditions: Respiratory Depression, conditions: Respiratory Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Closed-loop FiO2 controller, interventions name: Conventional, outcomesModule primaryOutcomes measure: Percentage of time spent in optimal SpO2 range, secondaryOutcomes measure: Percentage of time with SpO2 signal available, secondaryOutcomes measure: Percentage of time with SpO2 below target range, secondaryOutcomes measure: Percentage of time with SpO2 above target range, secondaryOutcomes measure: Percentage of time with SpO2 outside optimal range, secondaryOutcomes measure: Percentage of time with with FiO2 below 40%, secondaryOutcomes measure: Percentage of time with with FiO2 above 60%, secondaryOutcomes measure: Percentage of time with with FiO2 = 100%, secondaryOutcomes measure: Mean SpO2/FiO2, secondaryOutcomes measure: Number of events with SpO2 below of target range (duration >10 s), secondaryOutcomes measure: Number of events with SpO2 below of target range (duration >60 s), secondaryOutcomes measure: Number of events with SpO2 below the predefined low SpO2 emergency limit, secondaryOutcomes measure: Number of events with SpO2 above the predefined low SpO2 emergency limit, secondaryOutcomes measure: Total oxygen use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr.Suat Seren Chest Diseasees Hospital, city: Izmir, zip: 35230, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False |
protocolSection identificationModule nctId: NCT06374576, orgStudyIdInfo id: GCIEL, briefTitle: Improving eHealth Literacy of Older Adults in Hong Kong, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Sino Group, collaborators name: NG TENG FONG Charitable Foundation, descriptionModule briefSummary: This study is an randomized controlled trial (RCT) study to examine the feasibility and effectiveness of a community-based health promotion education intervention for improving the eHealth literacy of older adults, conditionsModule conditions: eHealth Literacy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 184, type: ESTIMATED, armsInterventionsModule interventions name: Lecture on eHealth literacy, interventions name: Digital intervention on eHealth literacy, interventions name: Lecture on general health, interventions name: Digital intervention on general health, outcomesModule primaryOutcomes measure: eHealth literacy, secondaryOutcomes measure: Health Knowledge Learning Intention, secondaryOutcomes measure: Online Health Information Seeking, secondaryOutcomes measure: Online Health Information Scanning, secondaryOutcomes measure: Health-promotion behaviors, secondaryOutcomes measure: Health Decision Change, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Hong Kong, city: Hong Kong, country: China, contacts name: Sophia SC Chan, PhD, role: CONTACT, phone: 85239176610, email: [email protected], contacts name: Sophia SC Chan, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.39407, lon: 114.13737, hasResults: False |
protocolSection identificationModule nctId: NCT06374563, orgStudyIdInfo id: BUC-IACUC-221109-6, briefTitle: Tackling Pressure Ulcer Via Bee Venom Phonophoresis, acronym: ulcer, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-09, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Badr University, class: OTHER, descriptionModule briefSummary: This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer, conditionsModule conditions: Bee Venom, conditions: Pressure Ulcers, conditions: Phonophoresis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: group 1 received topical Bee venom gel, interventions name: Group 2: Phonophoresis of Bee Venom gel, outcomesModule primaryOutcomes measure: wound surface area wound surface area, primaryOutcomes measure: wound volume, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Badr University in Cairo, city: Cairo, zip: 11837, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06374550, orgStudyIdInfo id: 20231026, briefTitle: Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Miami, class: OTHER, descriptionModule briefSummary: The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings., conditionsModule conditions: Mental Health Wellness 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Jump Start on the Go, interventions name: Jump Start Plus Coronavirus Support, outcomesModule primaryOutcomes measure: Change in classroom practices as measured by Health Environment Rating Scale, secondaryOutcomes measure: Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA), secondaryOutcomes measure: Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ), secondaryOutcomes measure: Change in resiliency as measured by Brief Resiliency Coping Scale, secondaryOutcomes measure: Change in stress as measured by Childcare Worker Job Stress Index, secondaryOutcomes measure: Change in stress as measured by Everyday Stressors Index, secondaryOutcomes measure: Change in satisfaction as measured by Teacher Opinion and Satisfaction survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Ruby Natale, PhD, PsyD, role: CONTACT, phone: 305-243-4617, email: [email protected], contacts name: Ruby Natale, PhD, PsyD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False |
protocolSection identificationModule nctId: NCT06374537, orgStudyIdInfo id: 2017-0784, briefTitle: Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2019-05-22, primaryCompletionDateStruct date: 2026-05-22, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients., conditionsModule conditions: Frailty, conditions: Pain, Chronic, conditions: Dialysis; Complications, conditions: Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Muscle Therapy, outcomesModule primaryOutcomes measure: Rate at which subjects will see changes in their physical abilities., secondaryOutcomes measure: Rate at which exercise will change body composition, secondaryOutcomes measure: Rate at which exercise will change handgrip strength., secondaryOutcomes measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being., secondaryOutcomes measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life., secondaryOutcomes measure: Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression., secondaryOutcomes measure: Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois at Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Ilaria Santi, role: CONTACT, phone: 312-996-9594, email: [email protected], contacts name: Natalie Isho, role: CONTACT, phone: 312-996-4708, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-25, uploadDate: 2024-04-15T15:15, filename: Prot_SAP_000.pdf, size: 1911663, hasResults: False |
protocolSection identificationModule nctId: NCT06374524, orgStudyIdInfo id: R24-03, briefTitle: Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: SIH is a debilitating neurological disorder caused by a cerebrospinal fluid leak, with an estimated incidence of 5 per 100,000 persons per year, of which mostly women between the ages of 35 years and 55 years (1). The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms, that significantly impact patients' quality of life (2).Treatment of SIH usually starts with conservative measures, consisting of strict supine bed rest, hydration, caffeine, and simple analgesics (3). The vast majority of patients will require invasive treatments for their CSF leak, such as epidural blood patches, fibrin glue patches, endovascular coiling, and/or surgical repair (4). These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources, which implicates a certain waiting time for the patients before permanent treatment is offered (5). In the meantime, due to the lack of an effective and accessible alternative, patients continue to suffer.The GONB has been reported as a simple, safe, and effective treatment to provide short-to-intermediate term relief of migraine (6), cervicogenic headache, cluster headache (7), occipital neuralgia, and more recently, post-dural puncture headaches (PDPH) (8). As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar (9), it is stipulated that the effect of GONB will be similar for SIH patients. However, to date, no studies exploring the efficacy of GONB for SIH have been performed.We propose to do a prospective observational study to explore the outcome of GONB for SIH. GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment. Moreover, GONB can be performed by physicians of different specialties including neurology, which makes it an accessible treatment for all patients. Lastly, by offering better symptom control, this intervention could potentially restore patients' ability to work and reduce healthcare costs., conditionsModule conditions: Spontaneous Intracranial Hypotension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: greater occipital nerve block, outcomesModule primaryOutcomes measure: Change in headache intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06374511, orgStudyIdInfo id: NFEC-2023-546, briefTitle: Prospective Cohort Study of Complications and Outcomes in Cirrhosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-04-04, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on Cytomegalovirus (CMV) reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acutely decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples were harvested. Complications were assessed during hospitalization. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90., conditionsModule conditions: Decompensated Cirrhosis, conditions: CMV Reactivation, conditions: Overt Hepatic Encephalopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 660, type: ESTIMATED, armsInterventionsModule interventions name: Test for CMV reactivation, outcomesModule primaryOutcomes measure: Incidence of CMV reactivation, primaryOutcomes measure: Incidence of hepatic encephalopathy, secondaryOutcomes measure: Response to anti-CMV therapy, secondaryOutcomes measure: Response to treatment for hepatic encephalopathy (HE), secondaryOutcomes measure: Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jinjun Chen, PHD, role: CONTACT, phone: 86-18588531001, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06374498, orgStudyIdInfo id: 2023P003247, briefTitle: Study to Determine the Clinical Significance of Intravascular OCT-NIRAF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that:1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.2. NIRAF coronary artery signal level is a predictor of plaque progression on a per patient, per artery, or per lesion basis., conditionsModule conditions: Cardiovascular Diseases, conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: OCT-NIRAF, outcomesModule primaryOutcomes measure: Plaque size estimation using OCT-NIRAF, primaryOutcomes measure: Plaque progression estimate using OCT-NIRAF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Nitasha Bhat, MD, role: CONTACT, phone: 617-724-4515, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06374485, orgStudyIdInfo id: AU409-LEES-2021-03, briefTitle: Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-08-28, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Lee's Pharmaceutical Limited, class: INDUSTRY, descriptionModule briefSummary: This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC., conditionsModule conditions: Advanced Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: AU409 capsules, outcomesModule primaryOutcomes measure: Dose Limiting Toxicity, secondaryOutcomes measure: Maximum Tolerated Dose, secondaryOutcomes measure: Recommended Phase 2 Dose, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Clinical Oncology, Queen Mary Hospital, status: RECRUITING, city: Hong Kong, country: China, contacts name: Chi Leung Chiang, role: PRINCIPAL_INVESTIGATOR, contacts name: Albert Chan, role: SUB_INVESTIGATOR, contacts name: Aya El HELALI, role: SUB_INVESTIGATOR, geoPoint lat: 22.39407, lon: 114.13737, hasResults: False |
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