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protocolSection identificationModule nctId: NCT06378372, orgStudyIdInfo id: ETICA-ULE-064-2023, briefTitle: How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: David Franco Castellanos, class: OTHER, collaborators name: Jesús Ángel Seco Calvo, collaborators name: Javier Tejada Garcia, descriptionModule briefSummary: The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease.The key question is: Can pianistic practice influence the development of Alzheimer's disease?Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out., conditionsModule conditions: Dementia of Alzheimer Type, conditions: Dementia, conditions: Dementia, Vascular, conditions: Dementia, Mixed, conditions: Dementia Frontal, conditions: Dementia With Lewy Bodies, conditions: Cognitive Decline, conditions: Neurologic Disorder, conditions: Neurologic Dysfunction, conditions: Neurologic Deficits, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: An intervention based on teaching the piano in an individualized way, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Music therapy based on piano learning, outcomesModule primaryOutcomes measure: State of global deterioration, primaryOutcomes measure: Minimental Test, primaryOutcomes measure: RDRS-2 Rapid Disability Assessment Scale, primaryOutcomes measure: MONTREAL COGNITIVE ASSESSMENT (MOCA), primaryOutcomes measure: WAIS-IV, primaryOutcomes measure: Behavioral disorders: BEHAVE-AD, primaryOutcomes measure: NPI - CUMMINGS, primaryOutcomes measure: Evaluation of the caregiver's burden (Zarit test), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad de León, city: León, state: Castilla Y León, zip: 24004, country: Spain, geoPoint lat: 42.60003, lon: -5.57032, hasResults: False |
protocolSection identificationModule nctId: NCT06378359, orgStudyIdInfo id: IDIM-2023-32364, briefTitle: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent.The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap.The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome., conditionsModule conditions: Staphylococcus Aureus Colonization, conditions: Surgical Site Infections, conditions: Healthcare Associated Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Screening and decolonization for SA carriers with the 3 drug bundle, interventions name: No screening for SA, interventions name: no screening, interventions name: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening., interventions name: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening, outcomesModule primaryOutcomes measure: Efficacy in eradicating Staphylococcus aureus (SA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota Medical Center and Clinics, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Pragya Karki, MD, role: CONTACT, phone: 612-301-6316, email: [email protected], geoPoint lat: 44.97997, lon: -93.26384, hasResults: False |
protocolSection identificationModule nctId: NCT06378346, orgStudyIdInfo id: 2023-077, briefTitle: GU-01: Glycyrrhizin in Prostate Cancer, acronym: GU-01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy), conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Glycyrrhizin, interventions name: Glycyrrhizin, interventions name: Observation, outcomesModule primaryOutcomes measure: Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration, primaryOutcomes measure: Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy, secondaryOutcomes measure: The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0)., secondaryOutcomes measure: Assessment of plasma GLY levels after GLY administration, secondaryOutcomes measure: Assessment of blood sodium levels after GLY administration, secondaryOutcomes measure: Assessment of blood potassium after GLY administration, secondaryOutcomes measure: Assessment of serum creatinine after GLY administration, secondaryOutcomes measure: Assessment of serum testosterone levels after GLY administration, secondaryOutcomes measure: Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration, secondaryOutcomes measure: Assessment of interleukin-1β (IL-1β) after GLY administration, secondaryOutcomes measure: Assessment of Tumor necrosis factor α (TNFα) after GLY administration, secondaryOutcomes measure: Assessment of interleukin 6 (IL-6) after GLY administration, secondaryOutcomes measure: Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration, secondaryOutcomes measure: Assessment of Hepatocyte Growth Factor (HGF) after GLY, secondaryOutcomes measure: Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY, secondaryOutcomes measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration, secondaryOutcomes measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration, secondaryOutcomes measure: Gene expression analysis in tumor specimens obtained before administration of GLY, secondaryOutcomes measure: Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Natalie Reizine, MD, role: CONTACT, phone: 312-996-1581, email: [email protected], contacts name: Omer Qazi, MBBS, role: CONTACT, phone: 312-413-1069, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06378333, orgStudyIdInfo id: 2024-01-023, briefTitle: Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area., acronym: ICAR, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-27, primaryCompletionDateStruct date: 2024-01-27, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations \< 99 percentile (undetectable: \<5ng/l or non-elevated: \<14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes)., conditionsModule conditions: Unstable Angina, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 210, type: ACTUAL, armsInterventionsModule interventions name: patients who underwent coronary angiography, outcomesModule primaryOutcomes measure: Hospitalisation for of unstable Angina, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Montpellier, city: Montpellier, zip: 34295, country: France, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False |
protocolSection identificationModule nctId: NCT06378320, orgStudyIdInfo id: STUDY20240287, briefTitle: eHealth for Breastfeeding Support - the HOTSPOT Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospitals Cleveland Medical Center, class: OTHER, descriptionModule briefSummary: This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text "nudges" to look at it compared to not getting those "nudges". The research project is being conducted by Lydia Furman MD.The purpose of the app (which is currently in clickable "wireframe" status, a "pre" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned.Up to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding., conditionsModule conditions: Breast Feeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a prospective randomized two arm study for expectant women and a prospective randomized two arm study for fathers/partners. All participants receive access to the wireframe app. Maternal participants will be randomized to nudge or no nudge via text with those in the app "nudge" group receiving questions weekly prior to delivery and biweekly (every 2 weeks) after delivery through 3 months postpartum. The purpose of these "nudges" is to assess whether participants are more likely to access and benefit from the app if they are encouraged to explore it. Father/partner participants will also be randomized to either a nudge or no nudge group with those in the "nudge" group receiving questions weekly for the first two months and then biweekly (every 2 weeks) for another two months., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: App access and Text message, interventions name: App access only, outcomesModule primaryOutcomes measure: Maternal participants app usability score, primaryOutcomes measure: Father/partner participants app usability score, primaryOutcomes measure: Maternal participants app engagement score, primaryOutcomes measure: Father/partner participants app engagement score, secondaryOutcomes measure: Maternal participants breastfeeding knowledge at enrollment, secondaryOutcomes measure: Maternal participants breastfeeding knowledge after app exposure, secondaryOutcomes measure: Father/partner participants breastfeeding knowledge at enrollment, secondaryOutcomes measure: Father/partner participants breastfeeding knowledge after app exposure, eligibilityModule sex: ALL, 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, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Passages, Inc., 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, locations facility: University Hospital MacDonald Women's Hospital, city: Cleveland, state: Ohio, zip: 44106, country: United States, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False |
protocolSection identificationModule nctId: NCT06378307, orgStudyIdInfo id: CHUBX2022-06, briefTitle: A Transferability Study on the Conditions for a Successful Inclusive Education, acronym: TIAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: The investigators are conducting a realist evaluation study with a multi-case and qualitative design. The study aims to identify the conditions that promote successful students with disabilities inclusive education at school. This study is nested in the TIAP research (Research to explore the conditions transfer of innovations in the field of disability, with a view to developing a transfer framework)., conditionsModule conditions: Inclusive Education, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Effect of inclusive education on children with disabilities autonomy and social participation at school, primaryOutcomes measure: Effect of inclusive education on children with disabilities autonomy and social participation in their proximal living environment (leisures participation), primaryOutcomes measure: Effect of inclusive education on social participation of families with children with disabilities, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06378294, orgStudyIdInfo id: UHACoruna, briefTitle: Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA), acronym: MACMA, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Hospital A Coruña, class: OTHER, collaborators name: Complejo Hospitalario Universitario de Pontevedra, collaborators name: Complejo Hospitalario Universitario de Vigo, collaborators name: Complejo Hospitalario Universitario de Santiago, collaborators name: Hospital Universitario Lucus Augusti, collaborators name: Complexo Hospitalario de Ourense, descriptionModule briefSummary: Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery.The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients.The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mastectomy, outcomesModule primaryOutcomes measure: Disease-free survival, primaryOutcomes measure: Axillary recurrence rate, secondaryOutcomes measure: Overall survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Ferrol, status: RECRUITING, city: Ferrol, state: A Coruña, zip: 15402, country: Spain, contacts name: EULALIA VIVES, role: CONTACT, email: [email protected], contacts name: EULALIA VIVES, role: PRINCIPAL_INVESTIGATOR, contacts name: MANUEL DÍAZ, role: SUB_INVESTIGATOR, geoPoint lat: 43.4896, lon: -8.21942, locations facility: Hospital Universitario Santiago de Compostela, status: RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: MARÍA EFIGENIA ARIAS, role: CONTACT, email: [email protected], contacts name: MARÍA EFIGENIA ARIAS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Hospital Universitario Vigo, status: RECRUITING, city: Vigo, state: Pontevedra, zip: 36214, country: Spain, contacts name: GONZALO DE CASTRO, role: CONTACT, email: [email protected], contacts name: GONZALO DE CASTRO, role: PRINCIPAL_INVESTIGATOR, contacts name: GEORGINA FREIRÍA, role: SUB_INVESTIGATOR, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Hospital Universitario A Coruña, status: RECRUITING, city: A Coruña, zip: 15006, country: Spain, contacts name: ALBERTO BOUZÓN, role: CONTACT, phone: +34690103810, email: [email protected], contacts name: BENIGNO ACEA, role: CONTACT, phone: +34650482409, email: [email protected], contacts name: MARÍA ALEJANDRA GARCÍA, role: SUB_INVESTIGATOR, contacts name: ALBERTO BOUZÓN, role: PRINCIPAL_INVESTIGATOR, contacts name: BENIGNO ACEA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Universitario Lugo, status: RECRUITING, city: Lugo, zip: 27003, country: Spain, contacts name: LAURA MUÍÑOS, role: CONTACT, email: laura.muiñ[email protected], contacts name: LAURA MUÍÑOS, role: PRINCIPAL_INVESTIGATOR, contacts name: PATRICIA VÁZQUEZ, role: SUB_INVESTIGATOR, geoPoint lat: 43.00992, lon: -7.55602, locations facility: Hospital Universitario Ourense, status: RECRUITING, city: Orense, zip: 32005, country: Spain, contacts name: MANUEL GARCÍA, role: CONTACT, email: [email protected], contacts name: MANUEL GARCÍA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.33669, lon: -7.86407, locations facility: Hospital Universitario Pontevedra, status: RECRUITING, city: Pontevedra, zip: 36071, country: Spain, contacts name: MARÍA TERESA FERNÁNDEZ, role: CONTACT, email: [email protected], contacts name: MARÍA TERESA FERNÁNDEZ, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.431, lon: -8.64435, hasResults: False |
protocolSection identificationModule nctId: NCT06378281, orgStudyIdInfo id: CRSK-3_221381, briefTitle: Testing a New Method to Improve Informed Consent in Prison Research, acronym: Spark BATIR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Stéphanie Baggio, class: OTHER, collaborators name: University of Bern, collaborators name: Leiden University, collaborators name: School of Health Sciences Fribourg, collaborators name: University Hospital, Geneva, descriptionModule briefSummary: Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified "teach-to-goal" informed consent process compared to standard procedures. Conducted within a larger study on psychiatric outcomes, it aims to enhance ethical practices for vulnerable populations., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Modified teach-to-goal informed consent, outcomesModule primaryOutcomes measure: Understanding of the informed consent (binary), secondaryOutcomes measure: Understanding of the informed consent (continuous), secondaryOutcomes measure: Evaluation of the informed consent, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Geneva University Hospitals, city: Geneva, zip: 1211, country: Switzerland, contacts name: Stéphanie Baggio, Prof., role: CONTACT, phone: +41316846774, email: [email protected], geoPoint lat: 46.20222, lon: 6.14569, hasResults: False |
protocolSection identificationModule nctId: NCT06378268, orgStudyIdInfo id: 05/24/DD-BVMD, briefTitle: PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study), acronym: ProGanOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Mỹ Đức Hospital, class: OTHER, descriptionModule briefSummary: This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam.This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists., conditionsModule conditions: Progestins Primed Ovarian Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 626, type: ESTIMATED, armsInterventionsModule interventions name: Dydrogesterone 10 mg, interventions name: Cetrorelix 0.25 mg, outcomesModule primaryOutcomes measure: Ongoing pregnancy, secondaryOutcomes measure: The incidence of premature LH surge, secondaryOutcomes measure: The incidence of premature progesterone elevation, secondaryOutcomes measure: Number of oocytes retrieved, secondaryOutcomes measure: Number of mature oocytes, secondaryOutcomes measure: Number of day 3 embryos, secondaryOutcomes measure: Number of day 5 embryos, secondaryOutcomes measure: Number of good quality day 3 embryos, secondaryOutcomes measure: Number of good quality day 5 embryos, secondaryOutcomes measure: Number of frozen embryos, secondaryOutcomes measure: Incidence of Ovarian hyperstimulation syndrome, secondaryOutcomes measure: Positive ß-hCG test, secondaryOutcomes measure: Clinical pregnancy, secondaryOutcomes measure: Ectopic pregnancy, secondaryOutcomes measure: Early miscarriage <12 weeks, secondaryOutcomes measure: Late miscariage 12-< 22 weeks, secondaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Gestational age at birth, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Birth weight, secondaryOutcomes measure: Very low birth weight, secondaryOutcomes measure: Low birth weight, secondaryOutcomes measure: High birth weight, secondaryOutcomes measure: Very high birth weight, secondaryOutcomes measure: Preterm birth, secondaryOutcomes measure: Gestational diabetes mellitus, secondaryOutcomes measure: Hypertensive disorders of pregnancy, secondaryOutcomes measure: Maternal mortality, secondaryOutcomes measure: Major congenital abnormalities, secondaryOutcomes measure: NICU admission, secondaryOutcomes measure: Reason for NICU admission, secondaryOutcomes measure: Neonatal mortality, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: My Duc Hospital, status: RECRUITING, city: Ho Chi Minh City, zip: 70000, country: Vietnam, contacts name: Tuong M Ho, MD, role: CONTACT, phone: +84 90 3633377, email: [email protected], geoPoint lat: 10.82302, lon: 106.62965, hasResults: False |
protocolSection identificationModule nctId: NCT06378255, orgStudyIdInfo id: PKUSSNCT-23A04, secondaryIdInfos id: PKUSSIRB-202393160, type: OTHER, domain: Ethics Committee of PKUSH of Stomatology, secondaryIdInfos id: Z221100007422088, type: OTHER_GRANT, domain: The SFP for clinical CDTT in capital, briefTitle: Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Peking University Hospital of Stomatology, class: OTHER, descriptionModule briefSummary: Evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy., conditionsModule conditions: Dentin Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Polycation-based new dentinal desensitizer, interventions name: GLUMA desensitizer, outcomesModule primaryOutcomes measure: Improvement of dentin sensitivity induced by probe pressure stimulation, secondaryOutcomes measure: Improvement of dentin sensitivity induced by air temperature stimulation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University School and Hospital of Stomatology, status: RECRUITING, city: Beijing, state: Beijing, zip: 100081, country: China, contacts name: Qianqian Wang, role: CONTACT, phone: +86-10-62173403, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06378242, orgStudyIdInfo id: RC48-C029, briefTitle: To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2029-03-15, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: RemeGen Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2, conditionsModule conditions: High-risk Non-muscle Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Disitamab Vedotin for injection, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicity(DLT) (Phase I), primaryOutcomes measure: Incidence of Adverse event (Phase I), primaryOutcomes measure: Recommended Phase II Dose(RP2D), primaryOutcomes measure: Maximum Tolerated Dosage(MTD), secondaryOutcomes measure: Disease-free survival (DFS) rates, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Disitamab Vedotin anti-drug antibody (ADA), secondaryOutcomes measure: PK of enfortumab vedotin: Maximum concentration (Cmax), secondaryOutcomes measure: PK of enfortumab vedotin: Trough concentration (Ctrough), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital,SunYat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: Tianxin Lin, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Hunan Cancer hospital, city: Changsha, state: Hunan, country: China, contacts name: Shusuan Jiang, M.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The first affiliated hospital with nanjing medical universtity, city: Nanjing, state: Jiangsu, country: China, contacts name: qiang Lv, M.D, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Shandong Cancer hospital & Institute, city: Jinan, state: Shangdong, country: China, contacts name: Jiasheng Bian, M.D, role: CONTACT, contacts name: Yuping Sun, role: SUB_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: The first affiliated hospital withXi'an Jiao Tong Universtity, city: Xi'an, state: Shanxi, country: China, contacts name: Lei Li, M.D, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06378229, orgStudyIdInfo id: ONZ-2023-0157, secondaryIdInfos id: 2022-501857-35-00, type: CTIS, briefTitle: Psilocybin for Hospitalized Patients With Treatment-resistant Depression, acronym: PSIHOS-D, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, collaborators name: Filament Health, descriptionModule briefSummary: The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression., conditionsModule conditions: Treatment Resistant Depression, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open label feasibility study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, outcomesModule primaryOutcomes measure: Incidence and type of Treatment-Emergent Adverse Events, primaryOutcomes measure: Columbia-Suicide Severity Rating Scale (C-SSRS), secondaryOutcomes measure: Recruitment and retention rates., secondaryOutcomes measure: Qualitative data from the semi-structured interviews with the subjects and their partners., otherOutcomes measure: Montgomery Asberg Depression Rating Scale (MADRS), otherOutcomes measure: Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR), otherOutcomes measure: State-Trait Anxiety Inventory (STAI), otherOutcomes measure: World Health Organization Quality of Life Inventory-Brief subscale (WHOQOL-BREF), otherOutcomes measure: Maudsley 3-item Visual Analogue Scale (M3VAS), otherOutcomes measure: Subjective Emotional Health Visual Analogue Scale (SEHVAS), otherOutcomes measure: revised Dyadic Adjustment Scale (RDAS), otherOutcomes measure: Zarit Burden Interview - Short Form (Zarit-12 Burden Scale), otherOutcomes measure: Client Experiencing Scale (EXP), otherOutcomes measure: Mystical Experience Questionnaire (MEQ), otherOutcomes measure: Working Alliance Inventory - Short Revised (WAI-SR), otherOutcomes measure: Semi-structured interviews., otherOutcomes measure: EEG: sensor level analysis (power) and source level analysis (functional connectivity through amplitude envelope correlation), both in resting state and during an emotional paradigm., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ghent University Hospital, status: RECRUITING, city: Gent, state: Oost-Vlaanderen, zip: 9000, country: Belgium, contacts name: Cisse Geleyn, dr., role: CONTACT, phone: +3293328742, email: [email protected], contacts name: Gilbert Lemmens, prof. dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06378216, orgStudyIdInfo id: MEDEA 975, briefTitle: Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe], acronym: MDCJ-NeuBeRe, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-15, primaryCompletionDateStruct date: 2024-03-18, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: The rationale of the study is to collect structured data in the neuropsychological, clinical neuroradiologic and neurorehabilitation fields in children/young people affected by congenital and juvenile myotonic dystrophy. Children affected by the congenital form (CDM1) present important brain alterations present since birth while, on the contrary, patients with the adult form of DM1 often present a degenerative, slowly progressive neurocognitive picture. Promising therapies that aim to correct the molecular mechanism underlying the symptoms of adult forms of DM1 are under development, but their potential role at the level of the nervous system and in particular in forms of CDM1 (which appears to be a distinct disorder of neuronal development) is also to be clarified.To this end, a better definition of neurocognitive profiles and their evolution is essential for the purposes of evaluating the effectiveness of experimental therapies., conditionsModule conditions: Myotonic Dystrophy 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: neurocognitive evaluations, outcomesModule primaryOutcomes measure: Motor function evaluation by Muscular Impairment Rating Scale, primaryOutcomes measure: cognitive evaluation by Wechsler Intelligence scale, primaryOutcomes measure: cognitive evaluation by Raven Matrices, primaryOutcomes measure: cognitive evaluation by Continous Performance Test 3, primaryOutcomes measure: cognitive evaluation by Trail Making Test A-B, primaryOutcomes measure: cognitive evaluation by Digit Span and CORSI Test, primaryOutcomes measure: cognitive evaluation by Rey Figure test, secondaryOutcomes measure: clinical evaluation by Epworth Sleepiness Scale, secondaryOutcomes measure: cognitive evaluation by Wisconsin Card Sorting Test, secondaryOutcomes measure: cognitive evaluation by Tower of London test, secondaryOutcomes measure: cognitive and behavioral evaluation by Minnesota Multiphasic Personality Inventory, secondaryOutcomes measure: cognitive and behavioral evaluation by Vineland Adaptive Behavior Scales, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Maria Grazia D'Angelo, status: RECRUITING, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Maria Grazia D'Angelo, role: CONTACT, phone: +39031 877870, email: [email protected], geoPoint lat: 45.80075, lon: 9.29, hasResults: False |
protocolSection identificationModule nctId: NCT06378203, orgStudyIdInfo id: MEDEA 1013, briefTitle: Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI], acronym: RIMUDI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: Until twenty years ago physical exercise in muscular dystrophies was considered harmful to the muscle cells, inducing an acceleration of cell necrosis. In fact, it is now certain and validated that an active lifestyle and the practice of controlled and regular physical activity are to be considered therapeutic in neuromuscular pathologies with the aim of optimizing muscular and cardio-respiratory function and preventing atrophy In particular, it seems that the optimal care is extensive and can be carried out in a safe and controlled manner even at home.It is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance., conditionsModule conditions: Muscular Dystrophies, conditions: Limb Girdle Muscular Dystrophy, conditions: Facio-Scapulo-Humeral Dystrophy, conditions: Becker Muscular Dystrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Each patient will carry out a series of evaluation and training sessions (15 sessions) with a physiotherapist for the drafting of a personalized treatment plan which will subsequently be carried out "independently" at domicile.The home therapeutic proposal will include the use of the tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) which allows to perform personalized games at home, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA), outcomesModule primaryOutcomes measure: 6 minute walk test (6MWT), primaryOutcomes measure: Motor Function Measure scale (MFM), primaryOutcomes measure: Performance of Upper Limb (PUL), primaryOutcomes measure: Time up and go (TUG), secondaryOutcomes measure: Modification of fatigue and quality of life scales from T0 to T6, secondaryOutcomes measure: Short Form 36 (SF36), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Institute IRCCS Eugenio Medea, status: RECRUITING, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, contacts name: Maria G D'Angelo, MD, role: CONTACT, phone: 031877111, phoneExt: +39, email: [email protected], geoPoint lat: 45.80075, lon: 9.29, hasResults: False |
protocolSection identificationModule nctId: NCT06378190, orgStudyIdInfo id: TranspoCART19, briefTitle: Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology, acronym: TranspoCART19, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Biomédica de Salamanca, class: OTHER, collaborators name: Spanish Clinical Research Network - SCReN, collaborators name: Fundación Canaria de Investigación Sanitaria, collaborators name: Fundación para la Investigación Biomédica del Hospital 12 de Octubre, descriptionModule briefSummary: The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months., conditionsModule conditions: Refractory B-Cell Lymphoma, conditions: B-cell Lymphoma Recurrent, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Phase I/II, pilot, open, national, prospective, multicentre, non-randomised, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: CAR-T cells therapy, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD), primaryOutcomes measure: Efficiency, secondaryOutcomes measure: Procedure-related mortality (PRM), secondaryOutcomes measure: Toxicity assessment, secondaryOutcomes measure: Response (overall and complete), secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Perceived general well-being, otherOutcomes measure: Molecular and cell biology exploratory objectives: Response dynamics, otherOutcomes measure: Molecular and cell biology exploratory objectives: Response dynamics, otherOutcomes measure: Molecular and cell biology exploratory objectives: Response dynamics, otherOutcomes measure: Molecular and cell biology exploratory objectives: In vivo survival of TranspoCART19 cells in peripheral blood, otherOutcomes measure: Molecular and cell biology exploratory objectives: Analysis of molecular markers which are possibly related to the tumor response to TranspoCART19 cells, otherOutcomes measure: Molecular and cell biology exploratory objectives: Evaluation of serum biomarkers of toxicity induced by TranspoCART19 cells (cytokine release syndrome and neurotoxicity), otherOutcomes measure: Molecular and cell biology exploratory objectives: Epigenetic studies on mononuclear bone marrow cells., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut Català d'Oncologia Hospital, status: NOT_YET_RECRUITING, city: Hospitalet de Llobregat, state: Barcelona, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: Alberto Musetti, role: CONTACT, geoPoint lat: 41.35967, lon: 2.10028, locations facility: Virgen de la Arrixaca University Hospital, status: NOT_YET_RECRUITING, city: El Palmar, state: Mur, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: Joaquín Gómez-Espuch, role: CONTACT, geoPoint lat: 37.93939, lon: -1.16095, locations facility: Clínica Universidad de Navarra, status: RECRUITING, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: Carlos Grande, role: CONTACT, geoPoint lat: 42.81687, lon: -1.64323, locations facility: University Hospital of Navarra, status: NOT_YET_RECRUITING, city: Pamplona, state: Navarra, country: Spain, contacts name: Esperanza López-Franco, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: María Carmen Mateos-Rodríguez, role: CONTACT, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Hospital Clínic, status: NOT_YET_RECRUITING, city: Barcelona, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: Valentín Ortiz-Maldonado, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Fundación Jiménez Díaz Hospital, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Esperanza López-Franco, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: Javier Cornago-Navascués, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Salamanca University Health Care Complex, status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: Lucía López-Corral, PhD, role: CONTACT, geoPoint lat: 40.96882, lon: -5.66388, locations facility: Virgen del Rocio Hospital, status: NOT_YET_RECRUITING, city: Sevilla, country: Spain, contacts name: Esperanza López-Franco, PhD, role: CONTACT, phone: 923291200, phoneExt: 55779, email: [email protected], contacts name: José Antonio Pérez-Simón, role: CONTACT, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False |
protocolSection identificationModule nctId: NCT06378177, orgStudyIdInfo id: LVGN6051-0402-HNSCC, briefTitle: A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2027-10-31, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Lyvgen Biopharma Holdings Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This is a multicenter, open-labeled, single-arm Phase 2 clinical study.This study comprises two parts. Part 1 (Safety Run-in Phase) is designed to confirm the dose of combination therapy in Part 2., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: LVGN6051 Monoclonal Antibody Injection, interventions name: toripalimab Injection, interventions name: Paclitaxel injection, outcomesModule primaryOutcomes measure: to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels ), primaryOutcomes measure: to determine objective response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Cancer Hospital, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Jin Gao, role: CONTACT, phone: +86 15395005376, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Yan Sun, role: CONTACT, phone: +86 13671370026, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tongren Hospital Affiliated to Capital Medical University, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Shurong Zhang, role: CONTACT, phone: +86 13501085646, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Fujian cancer hospital, city: Fuzhou, state: Fujian, zip: 350014, country: China, contacts name: Sufang Qiu, role: CONTACT, phone: +86 13609589163, email: [email protected], geoPoint lat: 26.06139, lon: 119.30611, locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Xiaoming Huang, role: CONTACT, phone: +86 13602808820, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: Guangxi Medical University Cancer Hospital, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Song Qu, role: CONTACT, phone: +86 13607887386, email: [email protected], geoPoint lat: 22.81667, lon: 108.31667, locations facility: Henan cancer hospital, city: Zhengzhou, state: Henan, zip: 450008, country: China, contacts name: Hui Wu, role: CONTACT, phone: +86 13503716710, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Kunyu Yang, role: CONTACT, phone: +86 13995595360, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Guangyuan Hu, role: CONTACT, phone: +86 13886000095, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, locations facility: Xiangya Hospital Central South University, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Liangfang Shen, role: CONTACT, phone: +86 13975805137, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Second Xiangya Hospital, Central South University, city: Changsha, state: Hunan, zip: 410011, country: China, contacts name: Ping Liu, role: CONTACT, phone: +86 15084987287, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Yaqian Han, role: CONTACT, phone: +86 18673176667, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Jinguan Lin, role: CONTACT, phone: +86 13307318568, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, locations facility: Liaoning cancer hospital, city: Shenyang, state: Liaoning, zip: 110042, country: China, contacts name: Xia Li, role: CONTACT, phone: +86 189 0091 7377, email: [email protected], geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shanghai Oriental Hospital, city: Shanghai, state: Shanghai, zip: 200123, country: China, contacts name: Ye Guo, role: CONTACT, phone: +86 13501678472, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Lei Liu, role: CONTACT, phone: +86 18980606231, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, locations facility: Zhejiang Cancer Hospital, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Meiyu Fang, role: CONTACT, phone: +86 13750851650, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06378164, orgStudyIdInfo id: P0041406, briefTitle: The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: Chinese University of Hong Kong, collaborators name: Neuroscience Research Australia, collaborators name: The University of New South Wales, descriptionModule briefSummary: To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers., conditionsModule conditions: Older Adults With a History of Falls, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Active Control, outcomesModule primaryOutcomes measure: Choice Stepping Reaction Times, primaryOutcomes measure: Spring Scale Test, secondaryOutcomes measure: Mini Balance Evaluation System Test, secondaryOutcomes measure: Motor Control Test, secondaryOutcomes measure: Falls Efficacy Scale - International, secondaryOutcomes measure: Trail-Making Test, secondaryOutcomes measure: Programme Adherence, secondaryOutcomes measure: Prospective Falls, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Freddy Man Hin LAM, PhD, role: CONTACT, phone: 27666720, email: [email protected], contacts name: Freddy Man Hin LAM, role: CONTACT, contacts name: Freddy Man Hin LAM, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06378151, orgStudyIdInfo id: 2023P002243, briefTitle: Time-limited Trials in the Emergency Department, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department., conditionsModule conditions: Emergencies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Clinician-level randomization, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TLT training, outcomesModule primaryOutcomes measure: Time to complete TLT conversations, primaryOutcomes measure: Patient-reported acceptability of TLT conversations, secondaryOutcomes measure: Intervention fidelity, secondaryOutcomes measure: Clinician-reported feasibility, secondaryOutcomes measure: Clinician-reported satisfaction, secondaryOutcomes measure: EHR documentation by inpatient clinicians, secondaryOutcomes measure: Heard and understood, secondaryOutcomes measure: Patient-reported end-of-life quality of communication, secondaryOutcomes measure: Decisional regret scale, secondaryOutcomes measure: The number of days to the first family meeting in ICU, secondaryOutcomes measure: ICU length of stay (LOS), secondaryOutcomes measure: Hospital LOS, secondaryOutcomes measure: The number of family meetings, secondaryOutcomes measure: ICU procedures (e.g., CPR, pressors, etc.), secondaryOutcomes measure: ICU mortality, secondaryOutcomes measure: Patterns of hospital disposition, secondaryOutcomes measure: Rate of hospice utilization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06378138, orgStudyIdInfo id: ICP-CL-01203, briefTitle: ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2030-11-25, completionDateStruct date: 2031-07-25, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Beijing InnoCare Pharma Tech Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, conditionsModule conditions: Hematologic Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 226, type: ESTIMATED, armsInterventionsModule interventions name: ICP-248, interventions name: Orelabrutinib, outcomesModule primaryOutcomes measure: Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria, primaryOutcomes measure: Changes from baseline in pulse., primaryOutcomes measure: Changes from baseline in blood pressure., primaryOutcomes measure: Changes from baseline in ECG QRS interval., primaryOutcomes measure: Changes from baseline in ECG QT interval., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Anhui Medical University, city: Hefei, state: Anhui, zip: 230022, country: China, contacts name: Jian Ge, role: CONTACT, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Hongmei Jing, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Affiliated Hospital of Chongqing Medical University, city: Chongqing, state: Chongqing, zip: 400016, country: China, contacts name: Xiaoqiong Tang, role: CONTACT, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University, city: Chongqing, state: Chongqing, zip: 400037, country: China, contacts name: Xixi Xiang, role: CONTACT, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Fujian Medical University Union Hospital, city: Fuzhou, state: Fujian, zip: 350001, country: China, contacts name: Zhenshu Xu, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The First Affiliated Hospital of Xiamen University, city: Xiamen, state: Fujian, zip: 361003, country: China, contacts name: Bing Xu, role: CONTACT, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510055, country: China, contacts name: Yang Liang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Fourth Hospital of Hebei Medical University, city: Shijiazhuang, state: Hebei, zip: 050010, country: China, contacts name: Lihong Liu, role: CONTACT, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Nanyang City Center Hospital, city: Nanyang, state: Henan, zip: 473005, country: China, contacts name: Chao Li, role: CONTACT, geoPoint lat: 32.99472, lon: 112.53278, locations facility: Henan Provincial People's Hospital, city: Zhengzhou, state: Henan, zip: 463599, country: China, contacts name: Zunmin Zhu, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Henan Cancer Hospital, city: Zhenzhou, state: Henan, zip: 450003, country: China, contacts name: Keshu Zhou, role: CONTACT, geoPoint lat: 32.28034, lon: 119.16999, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430011, country: China, contacts name: Xiaoxi Zhou, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Union Hospital Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Guohui Cui, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Second Xiangya Hospital, Central South University, city: Changsha, state: Hunan, zip: 410012, country: China, contacts name: Hongling Peng, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Fang Zhou, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Jiangsu Province Hospital, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: Wei Xu, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First Affiliated Hospital of Nanchang University, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Fei Li, role: CONTACT, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Bethune First Hospital of Jilin University, city: Changchun, state: Jilin, zip: 130061, country: China, contacts name: Ou Bai, role: CONTACT, geoPoint lat: 43.88, lon: 125.32278, locations facility: The Second Hospital of Dalian Medical University, city: Dalian, state: Liaoning, zip: 116023, country: China, contacts name: Xiuhua Sun, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: Shengjing Hospital affiliated to China Medical University, city: Shenyang, state: Liaoning, zip: Liaoning, country: China, contacts name: Aijun Liao, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shandong Cancer Hospital, city: Jinan, state: Shandong, zip: 250117, country: China, contacts name: Ji Ma, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Linyi City Cancer Hospital, city: Linyi, state: Shandong, zip: 276002, country: China, contacts name: Meifang Zheng, role: CONTACT, geoPoint lat: 35.06306, lon: 118.34278, locations facility: Huashan Hospital, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Tong Chen, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, city: Xi'an, state: Shanxi, zip: 710004, country: China, contacts name: Jianli Wang, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Sichuan Provincial People's Hospital, city: Chengdu, state: Sichuan, zip: 610072, country: China, contacts name: Xiaobing Huang, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Yibin Second People's Hospital, city: Yibin, state: Sichuan, zip: 644002, country: China, contacts name: Shihua Huang, role: CONTACT, geoPoint lat: 28.76667, lon: 104.62383, locations facility: Tianjin Medical University Cancer Institute and Hospital, city: Tianjin, state: Tianjin, zip: 300181, country: China, contacts name: Lihua Qiu, role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The Affiliated Cancer Hospital of Xinjiang Medical University, city: Urumqi, state: Xinjiang Uygur Autonomous Region, zip: 830000, country: China, contacts name: Shujuan Wen, role: CONTACT, geoPoint lat: 43.80096, lon: 87.60046, locations facility: The First Affiliated Hospital of Kunming Medical University, city: Kunming, state: Yunnan, zip: 650032, country: China, contacts name: Mingxia Shi, role: CONTACT, geoPoint lat: 25.03889, lon: 102.71833, locations facility: The First Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Wenjuan Yu, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06378125, orgStudyIdInfo id: CIR-NA I, briefTitle: Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital Schleswig-Holstein, class: OTHER, descriptionModule briefSummary: A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes., conditionsModule conditions: Safety Issues, conditions: Pharmacokinetic, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Double (Participant, Investigator), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD), interventions name: immediate-release nicotinic acid (SAD), interventions name: Placebo controlled-ileal-release nicotinic acid (SAD/MAD), interventions name: Placebo immediate-release nicotinic acid (SAD), outcomesModule primaryOutcomes measure: Treatment-Emergent Adverse Events [Safety and Tolerability], primaryOutcomes measure: Treatment-Emergent Serious Adverse Events [Safety and Tolerability], primaryOutcomes measure: Haemoglobin, primaryOutcomes measure: White blood cells, primaryOutcomes measure: Blood creatinine, primaryOutcomes measure: Blood urea, primaryOutcomes measure: Blood uric acid, primaryOutcomes measure: Glomerular filtration rate, primaryOutcomes measure: Blood ALT, primaryOutcomes measure: Blood AST, primaryOutcomes measure: Blood GGT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Schleswig-Holstein, Campus Kiel, status: RECRUITING, city: Kiel, state: Schleswig-Holstein, zip: 24105, country: Germany, contacts name: Corinna Geisler, PhD, role: CONTACT, phone: +4943150022243, email: [email protected], geoPoint lat: 54.32133, lon: 10.13489, hasResults: False |
protocolSection identificationModule nctId: NCT06378112, orgStudyIdInfo id: 2734/CEIH/2022, briefTitle: Extraction Socket Augmentation. A Clinical Study, acronym: GTO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-20, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Universidad de Granada, class: OTHER, descriptionModule briefSummary: Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition "extraction socket augmentation" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested.The null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation)., conditionsModule conditions: Edentulous Alveolar Ridge With Labial Resorption, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: * Group 1 (test group): Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.* Group 2 (control): Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: GTO®, outcomesModule primaryOutcomes measure: Dimensional bone changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dental School, status: RECRUITING, city: Granada, zip: E18071, country: Spain, contacts name: Manuel Toledano, Professor, role: CONTACT, email: [email protected], contacts name: Raquel Osorio, role: CONTACT, email: [email protected], contacts name: Manuel Toledano, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: Raquel Osorio, Professor, role: SUB_INVESTIGATOR, contacts name: Cristina Vallecillo, PhD, role: SUB_INVESTIGATOR, contacts name: Marta Vallecillo-Rivas, PhD, role: SUB_INVESTIGATOR, contacts name: Manuel Toledano-Osorio, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 37.18817, lon: -3.60667, hasResults: False |
protocolSection identificationModule nctId: NCT06378099, orgStudyIdInfo id: InFaPro, briefTitle: Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments, acronym: InFaPro, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universidad de Antioquia, class: OTHER, collaborators name: Farmacias Pasteur, descriptionModule briefSummary: Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols., conditionsModule conditions: Community Pharmacy Services, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: An exploratory clinical trial with a baseline reference period of parallel groups will be conducted. The study will take place over a period of 10 months, during which 5 MA will be analyzed, and for each of them, patients will be followed up on days 3 to 5, and 7 to 10 post-care (intervention). Drugstores and drugstores/pharmacies (groups) will be randomized in a 1:1 ratio to enroll in the intervention group or the control group., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Blinding of the participants and the pharmacists involved in the care is not possible due to the nature of the intervention., enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Patient guided and followed by the pharmacist, outcomesModule primaryOutcomes measure: Resolution time of the MA and the frequency of referral to a physician., secondaryOutcomes measure: Characterization of the population visiting drugstore or drugstore/pharmacy, secondaryOutcomes measure: Identification of the presence and classification of the MA, secondaryOutcomes measure: Need to acquire an OTC medication to treat the MA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06378086, orgStudyIdInfo id: TEO-PAS-2302, briefTitle: RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Teoxane SA, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.At screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded.Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant.Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.Subjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted.Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2.If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary., conditionsModule conditions: Pain, conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Split-face design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: RHA® Redensity with new anesthetic agent, interventions name: RHA® Redensity with lidocaine, outcomesModule primaryOutcomes measure: Non-inferiority of RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in terms of reducing pain during device injection into the upper perioral rhytids., secondaryOutcomes measure: Difference between RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in term of reducing pain at 15, 30, 45 and 60 minutes post-injection in each side of the mouth., eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: United States, New York, city: New York, state: New York, zip: 10028, country: United States, contacts role: CONTACT, phone: 212-472-2900, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06378073, orgStudyIdInfo id: DPT/Batch-Fall19/557, briefTitle: Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Superior University, class: OTHER, descriptionModule briefSummary: "A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS", conditionsModule conditions: Surgery-Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 189, type: ACTUAL, armsInterventionsModule interventions name: Incentive Spirometer, interventions name: Numeric Pain Rating Scale, outcomesModule primaryOutcomes measure: Incentive Spirometer, primaryOutcomes measure: Incentive Spirometer, eligibilityModule sex: ALL, minimumAge: 48 Years, maximumAge: 88 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azra Naheed Medical College, Superior University, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, locations facility: Bahria Hospital, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, locations facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, locations facility: The University of Lahore Teaching Hospital, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, locations facility: Punjab Institute of Cardiology Hospital, city: Lahore, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06378060, orgStudyIdInfo id: KM04, briefTitle: Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Hematology department of the 920th hospital, class: OTHER, descriptionModule briefSummary: The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia., conditionsModule conditions: Severe Aplastic Anemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Modified transplantation system, outcomesModule primaryOutcomes measure: overall survival (OS), primaryOutcomes measure: Acute graft-versus-host disease incidence, secondaryOutcomes measure: Transplantation-related motality, secondaryOutcomes measure: Chronic graft-versus-host disease incidence, secondaryOutcomes measure: incidence of Intensive fungal disease, secondaryOutcomes measure: EB virus reactivation rate, secondaryOutcomes measure: CMV reactivation rate, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, status: RECRUITING, city: Kunming, state: Yunnan, zip: 650000, country: China, contacts name: Wang PI sanbin, Doctor, role: CONTACT, phone: 0871-64774206, email: [email protected], geoPoint lat: 25.03889, lon: 102.71833, hasResults: False |
protocolSection identificationModule nctId: NCT06378047, orgStudyIdInfo id: MCC-22325, briefTitle: Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, collaborators name: Angiodynamics, Inc., descriptionModule briefSummary: This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy (A-SMART)., conditionsModule conditions: Pancreatic Cancer, conditions: Locally Advanced Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: Irreversible Electroporation, outcomesModule primaryOutcomes measure: Safety and Tolerability, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Alicia Chin, role: CONTACT, phone: 813-745-4673, email: [email protected], contacts name: Victoria Kryliouk, role: CONTACT, email: [email protected], contacts name: Mokenge Malafa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mohammed Al-Jumayli, MD, role: SUB_INVESTIGATOR, contacts name: Junsung Choi, MD, role: SUB_INVESTIGATOR, contacts name: James Costello, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Aamir Dam, MD, role: SUB_INVESTIGATOR, contacts name: Jason Denbo, MD, role: SUB_INVESTIGATOR, contacts name: Sophie Dessureault, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Martine Extermann, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Jessica Frakes, MD, role: SUB_INVESTIGATOR, contacts name: Pamela Hodul, MD, role: SUB_INVESTIGATOR, contacts name: Sarah Hoffe, MD, role: SUB_INVESTIGATOR, contacts name: Dae Won Kim, MD, role: SUB_INVESTIGATOR, contacts name: Richard Kim, MD, role: SUB_INVESTIGATOR, contacts name: Bela Kis, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Allan Lima Pereira, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Shaffer Mok, MD, role: SUB_INVESTIGATOR, contacts name: Russell Palm, MD, role: SUB_INVESTIGATOR, contacts name: Jose Pimiento, MD, role: SUB_INVESTIGATOR, contacts name: Paulo Rodriguez, PhD, role: SUB_INVESTIGATOR, contacts name: Christine Sam, MD, role: SUB_INVESTIGATOR, contacts name: Andrew Sinnamon, MD, role: SUB_INVESTIGATOR, contacts name: Amalia Stefanou, MD, role: SUB_INVESTIGATOR, contacts name: Jonathan Strosberg, MD, role: SUB_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False |
protocolSection identificationModule nctId: NCT06378034, orgStudyIdInfo id: 2023-A01926-39, briefTitle: Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Ingredia S.A., class: INDUSTRY, descriptionModule briefSummary: The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia., conditionsModule conditions: Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Lactium, interventions name: Placebo, outcomesModule primaryOutcomes measure: Sleep efficiency, secondaryOutcomes measure: Sleep diary, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: PSQI, secondaryOutcomes measure: Sleep quality by cctigraphy, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 55 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06378021, orgStudyIdInfo id: Calcium chloride in CABG, briefTitle: Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Helwan University, class: OTHER, descriptionModule briefSummary: This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation, conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Calcium Chloride, interventions name: Sodium Chloride 0.9% Inj, outcomesModule primaryOutcomes measure: Change in number of patients who developed Atrial fibrillation, secondaryOutcomes measure: Change in length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ain shams university, status: RECRUITING, city: Cairo, state: Abassia Cairo, zip: 02, country: Egypt, contacts name: Mohamed A Gamal, Ass prof, role: CONTACT, phone: 010080827060, phoneExt: 02, contacts name: Abdelhameed I Ebid, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06378008, orgStudyIdInfo id: 300100, briefTitle: A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-09-13, completionDateStruct date: 2024-09-13, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: HALEON, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste., conditionsModule conditions: Dentin Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 234, type: ESTIMATED, armsInterventionsModule interventions name: CSPS toothpaste, interventions name: Regular fluoride toothpaste (Crest Cavity Protection), outcomesModule primaryOutcomes measure: Change from Baseline in Schiff Sensitivity Score at Day 56, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Day 56, secondaryOutcomes measure: Change from Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Days 3, 7, 14 and 28, secondaryOutcomes measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: All Sum Research, status: RECRUITING, city: Mississauga, state: Ontario, zip: L5N 6J2, country: Canada, contacts name: C R Goyal, Dr, role: CONTACT, geoPoint lat: 43.5789, lon: -79.6583, hasResults: False |
protocolSection identificationModule nctId: NCT06377995, orgStudyIdInfo id: OST1_013, briefTitle: Effectiveness of an Intervention Plan Aimed at the Diaphragm in Chronic Non-specific Neck Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Escola Superior de Tecnologia da Saúde do Porto, class: OTHER, descriptionModule briefSummary: The aim of this study is to analyse the effectiveness of an intervention plan targeting the diaphragm, namely stretching technique, neuromuscular diaphragm and phrenic centre inhibition, in the treatment of chronic non-specific neck pain., conditionsModule conditions: Chronic Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Placebo technique, interventions name: Diaphragm protocol, outcomesModule primaryOutcomes measure: Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan, primaryOutcomes measure: Changes in range of motion after applying the diaphragm targeted protocol, secondaryOutcomes measure: Changes in pain level one week after the intervention, secondaryOutcomes measure: Changes in range of motion one week later, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Escola Superior de Saúde do Porto, city: Porto, zip: 4200-072, country: Portugal, contacts name: Natália MO Campelo, PhD, role: CONTACT, phone: +35122 206 1000, email: [email protected], contacts name: Natália MO Campelo, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False |
protocolSection identificationModule nctId: NCT06377982, orgStudyIdInfo id: SCCP001, briefTitle: Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: StemCyte Taiwan Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy, conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: hUCB, outcomesModule primaryOutcomes measure: safety-TEAE, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06377969, orgStudyIdInfo id: 75269, briefTitle: Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord., conditionsModule conditions: Chronic Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot prospective single arm interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation, outcomesModule primaryOutcomes measure: Change in Pain Intensity, secondaryOutcomes measure: Change in Disability, secondaryOutcomes measure: Patient Global Impression Change, secondaryOutcomes measure: Change in Quality of Life, secondaryOutcomes measure: Change in Pain Catastrophizing Scale, secondaryOutcomes measure: Change in sleep quality, secondaryOutcomes measure: Change in Social Functioning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377956, orgStudyIdInfo id: XRGao, briefTitle: The Associations Between Gut Length, Gut Microbiota and Food Assimilation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, class: OTHER, descriptionModule briefSummary: The purpose of this observational study is to explore the correlation between human gut length and food absorption rates. This will include characterization of gut length, total food intake energy, fecal calories, urinary calories, body composition, food intake behavior, genetics and gut microbiota in the small intestine. Researchers expect to recruit up to 100 healthy volunteers., conditionsModule conditions: Gut Length, conditions: Food Assimilation Efficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Observation without intervention, outcomesModule primaryOutcomes measure: Gut length, primaryOutcomes measure: Energy intake, primaryOutcomes measure: Fecal calorie, primaryOutcomes measure: Urine calorie, primaryOutcomes measure: Weight, primaryOutcomes measure: Height, primaryOutcomes measure: Waist circumferences, primaryOutcomes measure: Hip circumferences, primaryOutcomes measure: Bone mass, primaryOutcomes measure: Fat mass, primaryOutcomes measure: Fat free mass, primaryOutcomes measure: Blood pressure, primaryOutcomes measure: Heart rate, primaryOutcomes measure: Resting energy expenditure, primaryOutcomes measure: Thermic effect of food, primaryOutcomes measure: Body shape, primaryOutcomes measure: Microbiome, primaryOutcomes measure: Metabolites, primaryOutcomes measure: Gut transit time, primaryOutcomes measure: Food macronutrient content, primaryOutcomes measure: Feces macronutrient content, primaryOutcomes measure: Total daily water volume, primaryOutcomes measure: Total daily urine volume, primaryOutcomes measure: Physical activity, primaryOutcomes measure: Bristol Stool Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shenzhen Institute of Advanced Technology, city: Shenzhen, state: Guangdong, zip: 518055, country: China, contacts name: John R Speakman, PhD, role: CONTACT, phone: 13466654659, email: [email protected], geoPoint lat: 22.54554, lon: 114.0683, hasResults: False |
protocolSection identificationModule nctId: NCT06377943, orgStudyIdInfo id: SIAT-IRB-240415-H0718, briefTitle: The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, class: OTHER, descriptionModule briefSummary: This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism. Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity., conditionsModule conditions: Thyroid, conditions: Physical Activities, conditions: Resting Energy Expenditure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Body weight, primaryOutcomes measure: Height, primaryOutcomes measure: Waist and Hip circumferences, primaryOutcomes measure: Fat mass, primaryOutcomes measure: Far free mass, primaryOutcomes measure: Bone mass, primaryOutcomes measure: Resting Metabolism, primaryOutcomes measure: Physical activity, primaryOutcomes measure: Thyroid hormone, secondaryOutcomes measure: Total energy expenditure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377930, orgStudyIdInfo id: RAP-219-FOS-201, briefTitle: Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Rapport Therapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy., conditionsModule conditions: Focal Onset Seizures, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: RAP-219, outcomesModule primaryOutcomes measure: Efficacy in reducing frequency of RNS-recorded long episodes in participants with FOS, secondaryOutcomes measure: Measurement of estimated electrographic seizure frequency from available RNS-recorded episodes, secondaryOutcomes measure: Measurement of Clinical Seizure Frequency, secondaryOutcomes measure: Change in seizure severity, secondaryOutcomes measure: Global Impression of Change, secondaryOutcomes measure: Pharmacokinetic parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377917, orgStudyIdInfo id: 2304-BRG-057-JF, briefTitle: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing, acronym: IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Reproductive Medicine Associates of New Jersey, class: OTHER, descriptionModule briefSummary: This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility., conditionsModule conditions: Infertility, 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: 75, type: ESTIMATED, armsInterventionsModule interventions name: Laser Assisted Hatching, outcomesModule primaryOutcomes measure: Blastulation Rate, secondaryOutcomes measure: Embryo morphologic grade, secondaryOutcomes measure: Timing of blastulation, secondaryOutcomes measure: Aneuploidy rate, secondaryOutcomes measure: Positive pregnancy rate, secondaryOutcomes measure: Sustained implantation rate, secondaryOutcomes measure: Pregnancy loss rate, secondaryOutcomes measure: Live birth rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 42 Years, stdAges: ADULT, contactsLocationsModule locations facility: Reproductive Medicine Associates of New Jersey, city: Marlton, state: New Jersey, zip: 08053, country: United States, contacts name: Christine V Whitehead, MS, BSN, RN, role: CONTACT, phone: 973-656-2841, email: [email protected], contacts name: Caroline Zuckerman, BS, RN, role: CONTACT, phone: 19736562841, email: [email protected], contacts name: Jason Fransiak, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kevin Lambrese, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.89122, lon: -74.92183, hasResults: False |
protocolSection identificationModule nctId: NCT06377904, orgStudyIdInfo id: 2023-A02125-40, briefTitle: Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics)), acronym: AGING HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Gérond'if, class: OTHER, descriptionModule briefSummary: This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure., conditionsModule conditions: Patients Hospitalized in Geriatrics for Heart Failure, conditions: Patients Aged 75 and Over, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 810, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure, secondaryOutcomes measure: Factors associated with patients hospitalization or rehospitalization, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377891, orgStudyIdInfo id: TDK-2024-13563, briefTitle: The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, collaborators name: Atatürk University, descriptionModule briefSummary: Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman. While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth. The most important situation that will cause pain during birth is fear. So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth. Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression. While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression. It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety. Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment. In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience. With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience. This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression., conditionsModule conditions: Fear of Childbirth, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Emotional Resilience training, outcomesModule primaryOutcomes measure: The effect of emotional resilience on fear of birth and depression in primiparous pregnant women., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayburt State Hospital, city: Bayburt, zip: 69000, country: Turkey, geoPoint lat: 40.25631, lon: 40.22289, hasResults: False |
protocolSection identificationModule nctId: NCT06377878, orgStudyIdInfo id: Pro00008369, briefTitle: The Preeclampsia Registry, acronym: TPR, statusModule overallStatus: RECRUITING, startDateStruct date: 2013-09-01, primaryCompletionDateStruct date: 2040-05, completionDateStruct date: 2040-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Preeclampsia Foundation, class: OTHER, descriptionModule briefSummary: The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves., conditionsModule conditions: Preeclampsia, conditions: Eclampsia, conditions: HELLP Syndrome, conditions: Toxemia, conditions: Hypertensive Disorder of Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 20000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records, eligibilityModule sex: ALL, minimumAge: 13 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Preeclampsia Foundation, status: RECRUITING, city: Melbourne, state: Florida, zip: 32940, country: United States, contacts name: VeeAnn Argyle, role: CONTACT, phone: 321-421-6957, email: [email protected], contacts name: Eleni Z Tsigas, BA, role: PRINCIPAL_INVESTIGATOR, contacts name: Hilary Gammill, MD, role: SUB_INVESTIGATOR, contacts name: James Roberts, MD, role: SUB_INVESTIGATOR, geoPoint lat: 28.08363, lon: -80.60811, hasResults: False |
protocolSection identificationModule nctId: NCT06377865, orgStudyIdInfo id: endocrine dis & B thalassemia, briefTitle: Thyroid Function, HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: to evaluate thyroid function ,HbA1C,\&lipid profile in thalassemic patient to correlate thyroid function, Hba1c, lipid profile e ferritin level in thalassemic patient, conditionsModule conditions: B Thalassemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377852, orgStudyIdInfo id: Pro00075309, briefTitle: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-28, primaryCompletionDateStruct date: 2028-08-31, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: American Society of Clinical Oncology, class: OTHER, collaborators name: Patient-Centered Outcomes Research Institute, descriptionModule briefSummary: The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with MBC (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.The primary objective of the CDK Study is to compare TTD on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (AI or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing)., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 500 patients will be enrolled, 250 per arm (Arm 1 being indicated dose, Arm 2 being titrated dose)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Palbociclib, interventions name: Ribociclib, outcomesModule primaryOutcomes measure: Time to Treatment Discontinuation (TTD), secondaryOutcomes measure: Toxicity (grade 3-4 AEs), secondaryOutcomes measure: Event-Free survival (EFS), secondaryOutcomes measure: Quality of life assessed by patient reported outcomes, secondaryOutcomes measure: Time to dose reduction and escalation, secondaryOutcomes measure: Reason for not escalating, secondaryOutcomes measure: Treatment received (missed doses, cumulative dose, etc.), secondaryOutcomes measure: Healthcare utilization (ED visits, hospital admissions, etc.), secondaryOutcomes measure: Body Mass Index, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377839, orgStudyIdInfo id: N-20230048, briefTitle: Pain After Removal of Mandibular Third Molars With or Without Advanced Platelet-rich Fibrin, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2024-04-17, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Aalborg University Hospital, class: OTHER, collaborators name: Aalborg University, descriptionModule briefSummary: Pain is the most common complication following surgical removal of an impacted mandibular third molar. Several risk factors may increase the intensity and duration of pain following removal of mandibular third molars. Acute postoperative pain can transcript into postoperative chronic pain without an explainable reason or a specific risk factor. The use of advanced platelet-rich fibrin in the extraction socket following surgical removal of mandibular third molar have diminished the intensity and duration of acute postoperative pain and facilitated improved wound healing. The objective of the present study is therefore to identified specific risk factors and predictors for developing postoperative chronic pain following surgical removal of mandibular third molars with or without advanced platelet-rich fibrin applied in the extraction socket using epigenetic modulation., conditionsModule conditions: Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Advanced platelet-rich fibrin in the ekstraction socket, outcomesModule primaryOutcomes measure: Assessment of postoperative pain by using Visual Analoque scale, secondaryOutcomes measure: Assessment of quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oral and Maxillofacial surgery, Aalborg University Hospital, status: RECRUITING, city: Aalborg, state: Nordjylland, zip: 9000, country: Denmark, contacts name: Thomas Starch-Jensen, Professor, role: CONTACT, phone: +45 23266370, email: [email protected], geoPoint lat: 57.048, lon: 9.9187, hasResults: False |
protocolSection identificationModule nctId: NCT06377826, orgStudyIdInfo id: RCRAHS-ISB/REC/MS-PT/01813, briefTitle: Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data., conditionsModule conditions: Comparison of Aerobic Exercise and Resistance Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: aerobic exercises, interventions name: resistance training, interventions name: medication, outcomesModule primaryOutcomes measure: 6 Minute Walk Test, primaryOutcomes measure: The Beck Depression Inventory Scale, primaryOutcomes measure: SF- 36 SF-36, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Abbottabad medical complex, status: RECRUITING, city: Abbottābād, state: Khyber Pakhtunkhwa, zip: 21300, country: Pakistan, contacts name: saira jahan, MS, role: CONTACT, phone: 031591289095, email: [email protected], contacts name: Usama Iqbal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.1463, lon: 73.21168, hasResults: False |
protocolSection identificationModule nctId: NCT06377813, orgStudyIdInfo id: REC/RCR& AHS/23/01100/Maryam, briefTitle: Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Patients With Knee Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The goal of this \[type of study: Randomized control trial\] is to \[ see the effects of Combined Mode Kinetic Chain Exercises along with or without core stability exercises on pain, range of motion and disability \] in \[ in patients with Knee Osteoarthritis\].The main question it aims to answer is:Wether core stability exercises is effective if performed along with Combined chain kinetic exercises to improves the condition of Knee Osteoarthritis? Group A will receive Core Stability Exercises along with Combined Chain Kinetic Exercises and Group B will receive combined Chain Kinetic Exercises., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Assignment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Mode-Kinetic Chain Exercise With Core Stability Exercises, interventions name: Mode-Kinetic Chain Exercise, outcomesModule primaryOutcomes measure: Numeric pain rating scale, primaryOutcomes measure: Kellgren and Lawrence system for classification of Osteoarthritis, primaryOutcomes measure: Knee Injury and Osteoarthritic outcome score (KOOS), primaryOutcomes measure: Goniometer, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Riphah International University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: Muhammad Sanaullah, MS, role: CONTACT, phone: 03224819253, email: [email protected], contacts name: Maryam Maqsood, DPT, role: CONTACT, phone: 03314815652, email: [email protected], geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06377800, orgStudyIdInfo id: REC 01801 Kainat Fatima, briefTitle: Effects Of Navicular Mobilization In Patients With Planter Fasciitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. Ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition, conditionsModule conditions: Plantar Fascitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: navicular mobilization along conventional therapy., interventions name: conventional therapy, outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale, primaryOutcomes measure: (Foot Function Index), primaryOutcomes measure: Navicular drop test, primaryOutcomes measure: Foot print analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: DHQ Hospital, city: Faisalābad, state: Punjab, country: Pakistan, contacts name: Maria Khalid, MSOMPT, role: CONTACT, phone: 03315369768, email: [email protected], contacts name: Kainat Fatima, MSOMPT*, role: CONTACT, contacts name: Kainat Fatima, MSOMPT*, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.41554, lon: 73.08969, hasResults: False |
protocolSection identificationModule nctId: NCT06377787, orgStudyIdInfo id: REC 01732 Aneeqa Zaheer, briefTitle: Effects of ELDOA in Patients With Cervicogenic Headache, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The aim of our study is to determine the effect of ELDOA in relieving pain, improving ROM and functional disability in patients with cervicogenic headache. This study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. Moreover, it would add to the society as no literature is available on the effect of ELDOA technique in the management of Cervicogenic headache., conditionsModule conditions: Cervicogenic Headache, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: ELDOA and conventional therapy, interventions name: conventional therapy, outcomesModule primaryOutcomes measure: (Numeric Pain Rating Scale)., primaryOutcomes measure: NDI (U) (Neck Disability Index), primaryOutcomes measure: Inclinometer, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alkhidmat Raazi Hospital CBR Town, city: Islamabad, state: Punjab, zip: 46000, country: Pakistan, contacts name: Maria Khalid, MSOMPT, role: CONTACT, phone: 03315369768, email: [email protected], contacts name: Aneeqa Zaheer, MSOMPT*, role: CONTACT, contacts name: Aneeqa Zaheer, MSOMPT*, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.72148, lon: 73.04329, hasResults: False |
protocolSection identificationModule nctId: NCT06377774, orgStudyIdInfo id: NFEC-2024-096, briefTitle: To Optimize Therapeutic Procedures of DPMAS in ACLF Patients: a Prospective, Sigle Arm and Multicenter Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients., conditionsModule conditions: Acute-On-Chronic Liver Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: No intervention in this study, outcomesModule primaryOutcomes measure: 28-day transplantation-free mortality, primaryOutcomes measure: The disease progression rate, secondaryOutcomes measure: the 90-day transplantation-free mortality, secondaryOutcomes measure: the disease progression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377761, orgStudyIdInfo id: BF-2022-121, briefTitle: Study on Heart Failure With Preserved Ejection Fraction With Qishen Granules, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Guangdong Provincial Hospital of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Random parallel grouping, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Qishen Granules, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90, secondaryOutcomes measure: Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90, secondaryOutcomes measure: Changes in E/e' ratio compared to baseline on day 90, secondaryOutcomes measure: Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90, secondaryOutcomes measure: Changes in Left ventricular mass index (LVMI) compared to baseline on day 90, secondaryOutcomes measure: Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90, secondaryOutcomes measure: Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90, secondaryOutcomes measure: Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90, secondaryOutcomes measure: Changes in blood urea compared to baseline on day 90, secondaryOutcomes measure: Changes in blood creatinine compared to baseline on day 90, otherOutcomes measure: Changes in Aspartate aminotransferase(AST) compared to baseline on day 90, otherOutcomes measure: Changes in Alanine aminotransferase(ALT) compared to baseline on day 90, otherOutcomes measure: Number of participants with treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial Hospital of Chinese Medicine, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Lei Wang, M.D, role: CONTACT, phone: 8620-81887233-32801, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: WangLei, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Lei Wang, doctorate, role: CONTACT, phone: +8613724078381, email: [email protected], contacts name: Shuai Mao, doctorate, role: CONTACT, phone: 86-20-81887233-32801, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06377748, orgStudyIdInfo id: 2023/02, briefTitle: The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Istanbul Medeniyet University, class: OTHER, descriptionModule briefSummary: This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants., conditionsModule conditions: Procedural Pain, conditions: Pain, Acute, conditions: Nursing Caries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be assigned to experimental and control groups using block randomization method. Birth weight (2500-3000 g, 3001-3500 g, 3501 g and above), gender (male and female) and mode of delivery (vaginal and cesarean section) variables will be used for block randomization., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Using the block randomization technique, participants will be divided into 4 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B, C and D using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding).Parents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind.Research data will be entered into the computer database by coding the group name as A, B, C and D, and statistical analysis will be performed using this coding (statistician blinding)., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Facilitated tucking position, interventions name: ShotBlocker, interventions name: Combined facilitated tucking and ShotBlocker, outcomesModule primaryOutcomes measure: Neonatal Infant Pain Scale, secondaryOutcomes measure: Crying time during the procedure, secondaryOutcomes measure: Procedure time, eligibilityModule sex: ALL, minimumAge: 38 Weeks, maximumAge: 42 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Istanbul Medeniyet University, city: Istanbul, state: Kadıköy, zip: 34720, country: Turkey, contacts name: Aynur Aytekin Özdemir, PhD, role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06377735, orgStudyIdInfo id: CHEST-001, briefTitle: BAI-BACE for Advanced Lung Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma., conditionsModule conditions: Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI) procedure was performed as follows: Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, paclitaxel (300 mg) was infused slowly at least 30 min. BAI (bronchial arterial infusion) chemotherapy was followed by BACE (Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with cis-platinum (30 mg) were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: BAI-BACE, outcomesModule primaryOutcomes measure: Progression-Free-Survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Qunfang Zhou, MD, role: CONTACT, phone: 8619868000115, email: [email protected], contacts name: Feng Duan, MD, role: CONTACT, phone: 8613910984586, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06377722, orgStudyIdInfo id: CABOPRE, briefTitle: Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer, statusModule overallStatus: TERMINATED, startDateStruct date: 2018-11-01, primaryCompletionDateStruct date: 2022-08-09, completionDateStruct date: 2022-08-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Fundacion Oncosur, class: NETWORK, descriptionModule briefSummary: Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC)., conditionsModule conditions: Renal Cell Carcinoma Metastatic, conditions: Renal Cell Carcinoma Stage IV, conditions: Renal Cell Carcinoma Stage III, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Cabozantinib, outcomesModule primaryOutcomes measure: Radiological response rate prior to cytoreductive nephrectomy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Central de Asturias, city: Oviedo, state: Asturias, country: Spain, geoPoint lat: 43.36029, lon: -5.84476, locations facility: Institut Català d'Oncologia. Idibell, city: L'Hospitalet de Llobregat, state: Barcelona, country: Spain, geoPoint lat: 41.35967, lon: 2.10028, locations facility: Hospital Universitario de Valdecilla, city: Santander, state: Cantabria, country: Spain, geoPoint lat: 43.46472, lon: -3.80444, locations facility: Hospital Univeristario 12 de Octubre, city: Madrid, zip: 28041, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Centro Oncológico Clara Campal - HM CIOCC, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario La Paz, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Ramón y Cajal, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Severo Ochoa, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06377709, orgStudyIdInfo id: 24CP001, briefTitle: A Mixed-methods Acceptability Study of ProACTive™ to Help Burns Patients Adjust to Changes to Appearance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nottingham University Hospitals NHS Trust, class: OTHER, descriptionModule briefSummary: This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy (ACT) based intervention called ProACTive™, aimed at supporting burns patients' adjustment to a changed appearance and preventing distress, is acceptable. This will be measured by descriptive data, questionnaire data and semi-structured interviews.Preliminary data on the potential clinical effectiveness of the intervention will also be gathered. This will be measured by scores on standardised questionnaires., conditionsModule conditions: Burn Injuries, conditions: Burns, conditions: Emotional Distress, conditions: Adjustment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: ProACTive™, outcomesModule primaryOutcomes measure: Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A), secondaryOutcomes measure: Positive and Negative Affect Schedule (PANAS-GEN), secondaryOutcomes measure: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT), secondaryOutcomes measure: Self-Compassion Scale - Short Form (SCS-SF), secondaryOutcomes measure: Helpful Aspects of Therapy Form (HAT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377696, orgStudyIdInfo id: MC230713, secondaryIdInfos id: NCI-2024-02980, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: MC230713, type: OTHER, domain: Mayo Clinic in Rochester, secondaryIdInfos id: 23-005512, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline., conditionsModule conditions: Malignant Brain Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Best Practice, interventions name: Medical Device Usage and Evaluation, interventions name: Metformin, interventions name: Neurocognitive Assessment, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility), secondaryOutcomes measure: Overall completion rates and compliance (Feasibility), secondaryOutcomes measure: Overall satisfaction, secondaryOutcomes measure: Adherence (Feasibility), secondaryOutcomes measure: Neurocognitive scores, secondaryOutcomes measure: Incidence of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Ugur T. Sener, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06377683, orgStudyIdInfo id: XMYY-2023KY122, briefTitle: Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. While PSMA is expressed at low levels in normal prostate, this expression increased by 100-1000-fold in PC, which makes it a favorable target for therapy. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients., conditionsModule conditions: Metastatic Castration-resistant Prostate Cancer, mCRPC, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: classic 3+3 dose escalation, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: 177Lu-Dansyl-PSMA radioligand therapy, outcomesModule primaryOutcomes measure: Incidence of treatment-related adverse events (safety and tolerability), primaryOutcomes measure: To determine the maximum tolerated dose (MTD), secondaryOutcomes measure: Dosimetry, eligibilityModule sex: MALE, minimumAge: 21 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, MD, PhD, 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: NCT06377670, orgStudyIdInfo id: 38RC24.0012, briefTitle: Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-05-06, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication, conditionsModule conditions: Wassel IV Thumb Duplication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Wassel IV Thumb Duplication Surgery, outcomesModule primaryOutcomes measure: Functional and Aesthetic Outcomes, secondaryOutcomes measure: Comparison of Surgical Techniques, secondaryOutcomes measure: Efficacy of Skin Flap Types, secondaryOutcomes measure: Immobilization Method Analysis, secondaryOutcomes measure: Preoperative Angle Decision Model, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377657, orgStudyIdInfo id: DONT4GET, briefTitle: Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-15, primaryCompletionDateStruct date: 2023-06-21, completionDateStruct date: 2024-02-19, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Nis, class: OTHER, descriptionModule briefSummary: Diabetes is a prevalent metabolic disease that leads to increased blood sugar levels due to insulin shortage or resistance. Type 2 diabetes is often linked to obesity, which can increase insulin resistance. Meteorin-like protein (METRNL) is a new secreted protein that affects insulin sensitivity and has been found to be negatively related to serum glucose levels in people with diabetes.Oxidative stress in diabetics can stimulate the production of inflammatory mediators, increasing the activity of the antioxidant system. Aloe vera, a widely used plant, has been used for treating diabetes, wound healing, tumors, and inflammatory bowel disease. It has anti-inflammatory, antioxidant, neuroprotective, antidepressant, and memory-enhancing effects.Exercise can improve diabetic patients' conditions by increasing the expression of GLUT4 protein and skeletal muscle. High-intensity interval training has been shown to increase the expression of the METORIN gene in human subjects and decrease MDA in type 2 diabetic patients. However, no studies have examined the simultaneous effect of exercise and Aloe vera on diabetes indicators.The present study aims to investigate the response of METRNL and some oxidative and antioxidant plasma indicators to high-intensity interval training and Aloe vera supplementation in type 2 diabetic men. The findings indicate that exercise and consumption of plants with anti-inflammatory and antioxidant properties can be effective in modulating the pathological effects of diabetes and increasing insulin sensitivity., conditionsModule conditions: Diabetes Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The participants were blinded for the supplementation., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ACTUAL, armsInterventionsModule interventions name: Exercise, interventions name: Aloe vera, outcomesModule primaryOutcomes measure: METRNL - Meteorin Like, Glial Cell Differentiation Regulator, secondaryOutcomes measure: Glutathione peroxidase (GPx), secondaryOutcomes measure: Serum superoxide dismutase (SOD), secondaryOutcomes measure: Total antioxidant blood capacity (TAD), secondaryOutcomes measure: Plasma malondialdehyde (MDA), eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran, city: Amol, country: Iran, Islamic Republic of, geoPoint lat: 36.46961, lon: 52.35072, hasResults: False |
protocolSection identificationModule nctId: NCT06377644, orgStudyIdInfo id: DPT/Batch-Fall19/560, briefTitle: Comparing the Efficacy of KT vs DN With Conventional Treatment for Improving QOL and Alleviating Pain in Frozen Shoulder, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Superior University, class: OTHER, descriptionModule briefSummary: "Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy., conditionsModule conditions: Frozen Shoulder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Kinesio taping, interventions name: Dry Needling, outcomesModule primaryOutcomes measure: VAS, primaryOutcomes measure: SPADI, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pain away Physical Therapy, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06377631, orgStudyIdInfo id: FATHIS+, briefTitle: Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity, acronym: FATHIS+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fundació Eurecat, class: OTHER, collaborators name: Centre de Diagnosi per la Imatge, collaborators name: Instituto de Investigación Biomédica de Girona (IDIBGI), collaborators name: Laboratorio de Referencia de Cataluña, descriptionModule briefSummary: This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity., conditionsModule conditions: Visceral Obesity, conditions: Non-alcoholic Fatty Liver, conditions: Postmenopausal, 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: 50, type: ESTIMATED, armsInterventionsModule interventions name: Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Visceral Adiposity, secondaryOutcomes measure: Height (cm), secondaryOutcomes measure: Age, secondaryOutcomes measure: Ethnicity, secondaryOutcomes measure: Change in Body Weight (kg), secondaryOutcomes measure: Change in Body Mass Index (BMI) (Kg/m^2), secondaryOutcomes measure: Change in Neck circumference (cm), secondaryOutcomes measure: Change in Arm circumference (cm), secondaryOutcomes measure: Change in Waist circumference (cm), secondaryOutcomes measure: Change in Hip circumference (cm), secondaryOutcomes measure: Change in Conicity Index, secondaryOutcomes measure: Change in Waist-to-Hip ratio, secondaryOutcomes measure: Change in Lipid Accumulation Product (LAP), secondaryOutcomes measure: Change in Systolic Blood Pressure (mm Hg), secondaryOutcomes measure: Change in Diastolic Blood Pressure (mm Hg), secondaryOutcomes measure: Change in heart rate (bpm), secondaryOutcomes measure: Change in serum glucose levels (mg/dL), secondaryOutcomes measure: Change in serum total cholesterol (mg/dL), secondaryOutcomes measure: Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL), secondaryOutcomes measure: Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL), secondaryOutcomes measure: Change in serum triglycerides (TG, mg/dL), secondaryOutcomes measure: Change in serum alanine aminotransferase (ALT, U/L), secondaryOutcomes measure: Change in serum aspartate aminotransferase (AST, U/L), secondaryOutcomes measure: Change in serum gamma glutamyl transferase (GGT, U/L), secondaryOutcomes measure: Change in serum insulin levels (mU/L), secondaryOutcomes measure: Change in serum leptin levels (pg/mL), secondaryOutcomes measure: Change in serum adiponectin levels (ng/mL), secondaryOutcomes measure: Change in Adiponectin/Leptin ratio (numerical ratio), secondaryOutcomes measure: Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL), secondaryOutcomes measure: Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL), secondaryOutcomes measure: Change in plasma Interleukin 6 (IL-6) levels (pg/mL), secondaryOutcomes measure: Change in plasma Interleukin 10 (IL-10) levels (pg/mL), secondaryOutcomes measure: Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL), secondaryOutcomes measure: Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL), secondaryOutcomes measure: Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L), secondaryOutcomes measure: Change in serum C-Reactive protein levels (mg/L), secondaryOutcomes measure: Change in Histidine levels in blood (umol/L), secondaryOutcomes measure: Change in Acylcarnitine levels in blood (umol/L), secondaryOutcomes measure: Change in 17-beta-estradiol (E2) levels in blood (pg/mL), secondaryOutcomes measure: Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL), secondaryOutcomes measure: Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR), secondaryOutcomes measure: Change in Fatty Liver Index (FLI), secondaryOutcomes measure: Change in Triglyceride glucose index (TyG), secondaryOutcomes measure: Change in Plasma atherogenic index, secondaryOutcomes measure: Change in lipidomic profile, secondaryOutcomes measure: Change in intestinal microbiota composition, secondaryOutcomes measure: Change in the expression of lipid-metabolism genes in PBMC, secondaryOutcomes measure: Change in Dietary habits, secondaryOutcomes measure: Change in Physical activity, secondaryOutcomes measure: Concomitant medication, secondaryOutcomes measure: Consumption of dietary supplements, secondaryOutcomes measure: Change in the Supraclavicular skin temperature, secondaryOutcomes measure: Change in postmenopausal symptoms, secondaryOutcomes measure: Adverse events, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anna Crescenti, city: Reus, state: Catalonia. Spain, zip: 43204, country: Spain, contacts name: Anna Crescenti, PhD, role: CONTACT, phone: 977770958, email: [email protected], geoPoint lat: 41.15612, lon: 1.10687, hasResults: False |
protocolSection identificationModule nctId: NCT06377618, orgStudyIdInfo id: DPT/Batch-Fall19/556, briefTitle: Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Superior University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women., conditionsModule conditions: Menopausal, conditions: Pain, Low Back, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Resistance Training and Core Strengthening Exercises Group, interventions name: Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Oswestry Disability Index (ODI), eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azra Naheed Medical College, Superior University, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06377605, orgStudyIdInfo id: MD-15-2024, briefTitle: The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Amany Ahmed Eissa, class: OTHER, descriptionModule briefSummary: The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. \[1\] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing \[2\].Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential \[14\].Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia \[3\].ESPB is effective, easy to perform, and can be performed in a short time. \[4\] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery \[5\]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. \[15\] Few studies examined the use of ESPB in bariatric surgery \[3,6,7\], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient.So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries., conditionsModule conditions: Erector Spinae Plane Block, conditions: Super Obese Patients, conditions: Bariatric Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial- single blinded, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: ESPB, interventions name: local anaesthetic infiltration, interventions name: midazolam and lidocaine, interventions name: Bupivacain, outcomesModule primaryOutcomes measure: Total opioid consumption, secondaryOutcomes measure: VAS score during first 24 hour postoperative, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kasr Al Ainy Hospitals, status: RECRUITING, city: Cairo, country: Egypt, contacts name: amany ahmea eissa, lecturer, role: CONTACT, phone: 01001807207, email: [email protected], contacts name: marwa saeed zayed, ass. professor, role: CONTACT, phone: 01003347560, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06377592, orgStudyIdInfo id: G22396, briefTitle: Development and Accuracy Evaluation of Gram Staining Analysis AI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-10, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: GramEye, class: INDUSTRY, descriptionModule briefSummary: The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI, conditionsModule conditions: Bacterial Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 18000, type: ESTIMATED, armsInterventionsModule interventions name: Sample collection without intervention, outcomesModule primaryOutcomes measure: Advanced level of blood culture Gram stain analysis AI accuracy, primaryOutcomes measure: Ordinary level of blood culture Gram stain analysis AI accuracy, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Osaka University Hospital, status: RECRUITING, city: Suita, state: Osaka, zip: 5650871, country: Japan, contacts name: Go Yamamoto, role: CONTACT, geoPoint lat: 34.76143, lon: 135.51567, hasResults: False |
protocolSection identificationModule nctId: NCT06377579, orgStudyIdInfo id: FILObsLAM_IVOOBS, briefTitle: OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: French Innovative Leukemia Organisation, class: OTHER, collaborators name: Acute Leukemia French Association, descriptionModule briefSummary: Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosisIvosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML (DiNardo et al. 2018) and in front line settings (Montesinos et al. 2022). In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment.In this multicentric retrospective study, we aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Our results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML., conditionsModule conditions: AML, Adult, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: characterize the Overall survival (OS) in the both cohort : 1st line and Relapsed/Refractory (R/R), secondaryOutcomes measure: characterize the composite response rate (CRc) at any time during follow-up, for the both cohort : 1st line and Relapsed/Refractory (R/R), secondaryOutcomes measure: characterize the Event Free Survival (EFS) in both cohorts : 1st line and Relapsed/Refractory (R/R), secondaryOutcomes measure: characterize the incidence and relatedness of serious adverse events (SAE), for patients treated by Ivosidenib, for both cohorts : 1st line and Relapsed/Refractory (R/R), secondaryOutcomes measure: describe the management of treatment by Ivosidenib in both cohorts : 1st line and Relapsed/Refractory (R/R), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amiens CHU, city: Amiens, country: France, geoPoint lat: 49.9, lon: 2.3, locations facility: Angers CHU, city: Angers, country: France, geoPoint lat: 47.46667, lon: -0.55, locations facility: Bayonne CH, city: Bayonne, country: France, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Besançon CHU, city: Besançon, country: France, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Estaing, city: Clermont-Ferrand, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Créteil CHU HENRI MONDOR, city: Créteil, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Grenoble CHU, city: Grenoble, country: France, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Le Mans CH, city: Le Mans, country: France, geoPoint lat: 48.0, lon: 0.2, locations facility: Lyon sud CHU, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Marseille IPC, city: Marseille, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Meaux CH de l'Est francilien, city: Meaux, country: France, geoPoint lat: 48.96014, lon: 2.87885, locations facility: Montpellier - Chu Saint Eloi, city: Montpellier, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Nantes CHU, city: Nantes, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Nice CHU, city: Nice, country: France, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Orléans CHU, city: Orléans, zip: 45000, country: France, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Paris Saint Louis, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bordeaux CHU, city: Pessac, country: France, geoPoint lat: 44.81011, lon: -0.64129, locations facility: ICANS - Institut de cancérologie de strasbourg europe, city: Strasbourg, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Toulouse - IUCT Oncopole - Service d'Hématologie, city: Toulouse, country: France, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False |
protocolSection identificationModule nctId: NCT06377566, orgStudyIdInfo id: 24-039, briefTitle: A Study of BV-AVD in People With Bulky Hodgkin Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, collaborators name: Seagen Inc., descriptionModule briefSummary: The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease.BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer., conditionsModule conditions: Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a multicenter, investigator-initiated, single-arm phase II trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 71, type: ESTIMATED, armsInterventionsModule interventions name: Brentuximab vedotin, interventions name: Doxorubicin, interventions name: Vinblastine, interventions name: Dacarbazine, interventions name: Pembrolizumab, interventions name: Gemcitabine, interventions name: Vinorelbine, interventions name: FDG-PET/CT scan, outcomesModule primaryOutcomes measure: progression-free survival, secondaryOutcomes measure: overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Craig Moskowitz, MD, role: CONTACT, phone: 305-243-5302, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (All Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (All Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (All Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (All Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Robert Stuver, MD, role: CONTACT, phone: 646-608-4308, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False |
protocolSection identificationModule nctId: NCT06377553, orgStudyIdInfo id: 2023P000955, briefTitle: PET/MRI for Evaluation of Endometriosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2026-05-03, completionDateStruct date: 2026-05-03, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare \[68Ga\]CBP8 or \[18F\]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging., conditionsModule conditions: Endometriosis, conditions: Endometrioma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Radiotracer Injection, interventions name: Imaging, interventions name: Rectal Ultrasound Gel Injection, outcomesModule primaryOutcomes measure: Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection, primaryOutcomes measure: Diagnostic Performance of PET/MRI vs. Conventional Imaging, secondaryOutcomes measure: Impact of [18F]-FAPI-74 and [68Ga]CBP8 PET/MRI on Diagnosis and Management in Endometriosis, secondaryOutcomes measure: Correlation of Pre-Treatment PET Uptake and Post-Treatment Response in Endometriosis, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Onforio Catalano, MD, Ph.D, role: CONTACT, phone: 617-724-4030, email: [email protected], contacts name: Diandrea Galloway, role: CONTACT, phone: 617-643-1407, email: [email protected], geoPoint lat: 42.37787, lon: -71.062, hasResults: False |
protocolSection identificationModule nctId: NCT06377540, orgStudyIdInfo id: 2022LS174, briefTitle: MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Masonic Cancer Center, University of Minnesota, class: OTHER, descriptionModule briefSummary: This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant., conditionsModule conditions: Autologous Stem Cell Transplant, conditions: Classic Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: Autologous stem cell transplant, interventions name: Carmustine, interventions name: Etoposide, interventions name: Cytarabine, interventions name: Melphalan, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Non-relapse mortality (NRM), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Rate of Complete Metabolic Response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377527, orgStudyIdInfo id: 2023-0945, secondaryIdInfos id: NCI-2024-03342, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2035-12-28, completionDateStruct date: 2037-12-28, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma., conditionsModule conditions: Mesonephric-like Adenocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Tumor Registry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Jeffrey How, MD, role: CONTACT, contacts name: Jeffrey How, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06377514, orgStudyIdInfo id: PCOL109PHNG, briefTitle: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Johnson & Johnson Surgical Vision, Inc., class: INDUSTRY, descriptionModule briefSummary: Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial., conditionsModule conditions: Cataracts, 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: 250, type: ESTIMATED, armsInterventionsModule interventions name: Test IOL Model DEN00V, interventions name: Control IOL Model DCB00, outcomesModule primaryOutcomes measure: Monocular photopic DCIVA (first eyes) at 66 cm, primaryOutcomes measure: Monocular Depth of Focus, primaryOutcomes measure: Monocular Photopic BCDVA at 4m, primaryOutcomes measure: Monocular Photopic DCVA at 100 cm, secondaryOutcomes measure: Monocular photopic DCNVA at 40 cm (first eyes), eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377501, orgStudyIdInfo id: 804687, briefTitle: Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-07, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention., conditionsModule conditions: Chronic Lymphocytic Leukemia Stage A(0), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Whole-food, plant-based diet, outcomesModule primaryOutcomes measure: Adherence to the Dietary Intervention, primaryOutcomes measure: Satisfaction with the Dietary Intervention, primaryOutcomes measure: Cooking Class Adherence, primaryOutcomes measure: Recruitment, primaryOutcomes measure: Retention, secondaryOutcomes measure: White blood cell count, secondaryOutcomes measure: Absolute lymphocyte count, secondaryOutcomes measure: Anthropometric Measures (height, weight, body mass index), secondaryOutcomes measure: Anthropometric Measures (waist circumference), secondaryOutcomes measure: Biomarkers of cardiometabolic health (complete metabolic panel), secondaryOutcomes measure: Biomarkers of cardiometabolic health (hemoglobin A1c), secondaryOutcomes measure: Biomarkers of cardiometabolic health (cholesterol and triglycerides), secondaryOutcomes measure: Concentration of vitamin B12, secondaryOutcomes measure: Concentration of vitamin B9, secondaryOutcomes measure: Concentration of iron, secondaryOutcomes measure: Concentration of ferritin, secondaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UC San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92093, country: United States, contacts name: Ariel Portera, DO, role: CONTACT, phone: 858-249-6896, email: [email protected], geoPoint lat: 32.71533, lon: -117.15726, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-02-23, uploadDate: 2024-04-17T18:09, filename: ICF_000.pdf, size: 514422, hasResults: False |
protocolSection identificationModule nctId: NCT06377488, orgStudyIdInfo id: CR-6542, briefTitle: Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-24, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Johnson & Johnson Vision Care, Inc., class: INDUSTRY, descriptionModule briefSummary: This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity., conditionsModule conditions: Visual Acuity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 155, type: ESTIMATED, armsInterventionsModule interventions name: JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter, outcomesModule primaryOutcomes measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m, primaryOutcomes measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm, primaryOutcomes measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at near distance 40cm, primaryOutcomes measure: Subjective Vision CLUE Scores, primaryOutcomes measure: Rotational Stability, primaryOutcomes measure: Absolute Rotation Error, primaryOutcomes measure: Incidence of Unacceptable Lens Fit, primaryOutcomes measure: Slit Lamp Findings, secondaryOutcomes measure: Subjective Handling Scores, secondaryOutcomes measure: Subjective Comfort Scores, secondaryOutcomes measure: Subjective Vision Scores, secondaryOutcomes measure: Lens Fit Success, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. James Weber & Associates, PA - City Square Blvd, city: Jacksonville, state: Florida, zip: 32218, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Stam & Associates Eye Care, city: Jacksonville, state: Florida, zip: 32256, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Omega Vision Center, city: Longwood, state: Florida, zip: 32779, country: United States, geoPoint lat: 28.70305, lon: -81.3384, locations facility: Maitland Vision Center - North Orlando Ave, city: Maitland, state: Florida, zip: 32751, country: United States, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Mid-State Eye, city: Clinton, state: Illinois, zip: 61727, country: United States, geoPoint lat: 40.15365, lon: -88.96453, locations facility: Kannarr Eye Care, city: Pittsburg, state: Kansas, zip: 66762, country: United States, geoPoint lat: 37.41088, lon: -94.70496, locations facility: Birmingham Vision Care, city: Bloomfield Hills, state: Michigan, zip: 48301, country: United States, geoPoint lat: 42.58364, lon: -83.24549, locations facility: Center for Ophthalmic and Vision Research/Eye Associates of New York, city: Manhattan, state: New York, zip: 10022, country: United States, geoPoint lat: 40.78343, lon: -73.96625, locations facility: Sacco Eye Group, city: Vestal, state: New York, zip: 13850, country: United States, geoPoint lat: 42.08507, lon: -76.05381, locations facility: ProCare Vision Centers, city: Granville, state: Ohio, zip: 43023, country: United States, geoPoint lat: 40.06812, lon: -82.5196, locations facility: Luxe Vision and Optical, city: Powell, state: Ohio, zip: 43065, country: United States, geoPoint lat: 40.15784, lon: -83.07519, locations facility: Dr. David W. Ferris & Associates, city: Warwick, state: Rhode Island, zip: 02888, country: United States, geoPoint lat: 41.7001, lon: -71.41617, locations facility: Optometry Group, LLC, city: Memphis, state: Tennessee, zip: 38111, country: United States, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Tyler Eye Associates, city: Tyler, state: Texas, zip: 75703, country: United States, geoPoint lat: 32.35126, lon: -95.30106, locations facility: New River Vision Care, city: Oak Hill, state: West Virginia, zip: 25901, country: United States, geoPoint lat: 37.97233, lon: -81.14871, hasResults: False |
protocolSection identificationModule nctId: NCT06377475, orgStudyIdInfo id: 2024-00148, secondaryIdInfos id: 2024-00148, type: REGISTRY, domain: EKNZ, briefTitle: Fabrication and Insertion of Michigan Splints by Dental Students, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Juliana Marotti Großhausen, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the potential effects of different jaw relation determination (KRB) techniques on the fabrication of Michigan splints, in particular by comparing conventional methods with a wax plate and the use of an anterior jig. All materials and methods for the fabrication of the Michigan splint are already part of the curriculum of the Clinic for Dental Prosthodontics for first-year Master-students. Therefore, we intend to conduct a retrospective study (for the 2023 cohort) and a prospective analysis of the data (for the 2024 and 2025 cohorts). Questionnaires, models and intraoral scans will be used to evaluate the efficacy and precision of the different KRB methods as well as the fabrication process of the Michigan splint., conditionsModule conditions: Impression Technic, Dental, conditions: Jaw Relationship, conditions: Bruxism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 73, type: ESTIMATED, armsInterventionsModule interventions name: Jaw relation, interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Wax vs JIG Registration, secondaryOutcomes measure: Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZB, city: Basel, zip: 4058, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06377462, orgStudyIdInfo id: VEXAS-Registry, briefTitle: Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Technische Universität Dresden, class: OTHER, collaborators name: Bristol-Myers Squibb, collaborators name: University Hospital Munich, descriptionModule briefSummary: The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers, conditionsModule conditions: VEXAS Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Collection of epidemiological data on VEXAS, primaryOutcomes measure: Collection and monitoring of initial disease manifestations, primaryOutcomes measure: Documentation of the treatment approaches and therapy sequences, primaryOutcomes measure: Analysis of clinical-relevant clinical endpoints, secondaryOutcomes measure: Describe disease cluster, secondaryOutcomes measure: Laboratory diagnostics, secondaryOutcomes measure: Correlation clinical endpoints with treatment approaches, secondaryOutcomes measure: Quality of life data (QoL), fatigue questionnaire (Facit-F), secondaryOutcomes measure: Accompanying translational research, secondaryOutcomes measure: Collection of Biospecimens, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Carl Gustav Carus, status: RECRUITING, city: Dresden, zip: 01307, country: Germany, contacts name: Katja Sockel, Dr. med., role: CONTACT, geoPoint lat: 51.05089, lon: 13.73832, hasResults: False |
protocolSection identificationModule nctId: NCT06377449, orgStudyIdInfo id: UIL-CSP-18052023, briefTitle: Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Saint Petersburg State University, Russia, class: OTHER, descriptionModule briefSummary: The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are:* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients., conditionsModule conditions: Ischemic Heart Disease, conditions: Aortic Stenosis, Severe, conditions: Aortic Insufficiency, conditions: Mitral Stenosis, conditions: Mitral Insufficiency, conditions: Mitral Stenosis With Insufficiency, conditions: Tricuspid Insufficiency, conditions: Ascending Aortic Aneurysm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 186, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound examination of the lungs, outcomesModule primaryOutcomes measure: The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination, secondaryOutcomes measure: Postoperative pulmonary complications, secondaryOutcomes measure: Cumulative dosage of diuretics, secondaryOutcomes measure: Number of nights at home after hospital discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Saint Petersburg State University Clinic, city: Saint Petersburg, zip: 190020, country: Russian Federation, contacts name: Sergei M Efremov, MD, PhD, role: CONTACT, phone: +79137946090, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, hasResults: False |
protocolSection identificationModule nctId: NCT06377436, orgStudyIdInfo id: PRAISE, briefTitle: Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme, acronym: PRAISE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Milan, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to implement a personalized training program to prevent functional decline in frail subjects but not yet disable. The purpose of the project is to test the training in a subject at particularly high risk of entering the disabled condition. A total of 80 frail subjects, divide the participants into two groups "Divida Senso Group" (experimental group) and "Standard of care Group" (Control group) will be recruited.The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program., conditionsModule conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Experimental training, outcomesModule primaryOutcomes measure: Changes in the Functional decline, primaryOutcomes measure: Intrinsic Capacity (IC), primaryOutcomes measure: Intreaction between IC and cardiac autonomic control (CAC), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gabriella CERRI, status: RECRUITING, city: Milano, zip: 20100, country: Italy, contacts name: Gabriella GC CERRI, Full Professor, role: CONTACT, phone: +393402527675, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06377423, orgStudyIdInfo id: A54678775, briefTitle: Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-10, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Prince Sattam Bin Abdulaziz University, class: OTHER, descriptionModule briefSummary: Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years., conditionsModule conditions: Dental Leakage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 28, type: ACTUAL, armsInterventionsModule interventions name: Direct technique, interventions name: Indirect technique, outcomesModule primaryOutcomes measure: Percentage % of patients with marginal staining, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ali Elkaffas, city: Al Kharj, country: Saudi Arabia, geoPoint lat: 24.15541, lon: 47.33457, hasResults: False |
protocolSection identificationModule nctId: NCT06377410, orgStudyIdInfo id: FF-2023-433, briefTitle: Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients, acronym: SyProNAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: National University of Malaysia, class: OTHER, descriptionModule briefSummary: As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency ., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Syrup Prospan, interventions name: N-Acetylcysteine, outcomesModule primaryOutcomes measure: To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact., secondaryOutcomes measure: to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life., secondaryOutcomes measure: to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry, secondaryOutcomes measure: to determine change of Forced Vital Capacity in litres/minute using spirometry, secondaryOutcomes measure: to determine adverse effects of Syrup Prospan (in %), secondaryOutcomes measure: to determine adverse effects of N-Acetylcysteine (in %), secondaryOutcomes measure: To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied), eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University of Malaysia, city: Cheras, state: Kuala Lumpur, zip: 56000, country: Malaysia, contacts name: Mohamed Faisal Abdul Hamid, MBBS (IIUM), role: CONTACT, phone: 0391455555, email: [email protected], geoPoint lat: 3.05, lon: 101.76667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-02-01, uploadDate: 2024-04-08T19:34, filename: Prot_SAP_ICF_000.pdf, size: 1474657, hasResults: False |
protocolSection identificationModule nctId: NCT06377397, orgStudyIdInfo id: IIRPIG-2023-0000070, briefTitle: Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates, acronym: SAUNA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2028-04-14, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Indian Council of Medical Research, class: OTHER_GOV, collaborators name: Lady Hardinge Medical College, collaborators name: King George's Medical University, collaborators name: Indira Gandhi Institute of Child Health, collaborators name: Institute of Obstetrics and Gynecology, collaborators name: Government Medical College, Chandigarh, collaborators name: Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, collaborators name: Government Medical College, Aurangabad, collaborators name: King Edward Memorial Hospital, Mumbai, descriptionModule briefSummary: Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.The goal of this research study is to find out:1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes")., conditionsModule conditions: Sepsis, conditions: PROM, Preterm (Pregnancy), conditions: Early-Onset Neonatal Sepsis, conditions: Preterm Premature Rupture of Membrane, conditions: Preterm Birth, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Neonates will be randomized to 1 of the following groups:1. Group 1: Intervention group (Selective antibiotic group)2. Group 2: Comparison group (Universal antibiotic group), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Project staff, nurses and resident doctors looking after the neonate will not be blinded. The assessment of the primary outcome will be performed by a blinded adjudicator, who is not involved in the recruitment and monitoring of subjects. A part of the case report form (CRF) containing relevant details of all episodes of sickness in the 1st week of life will be detached from the main form and will be sent to the blinded adjudicator. This part will be linked to the main form only by a unique identification number. No patient identifiers or allocation group will be mentioned on the part sent to the blinded adjudicator., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Antibiotics, outcomesModule primaryOutcomes measure: Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization, primaryOutcomes measure: Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization, secondaryOutcomes measure: All-cause Mortality within 1st 7 days after randomization, secondaryOutcomes measure: Blood culture-positive sepsis of any severity within 1st 7 days after randomization, secondaryOutcomes measure: Episode of severe sepsis within 1st 7 days after randomization, secondaryOutcomes measure: Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization, secondaryOutcomes measure: Individual components of composite outcome within 1st 72 hours after randomization, secondaryOutcomes measure: Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay, secondaryOutcomes measure: Individual components of composite outcome during hospital stay, secondaryOutcomes measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay, secondaryOutcomes measure: Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization, secondaryOutcomes measure: Individual components of composite outcome during 1st 30 days, secondaryOutcomes measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria, secondaryOutcomes measure: Sepsis-related mortality within 1st 72 hours after randomization, secondaryOutcomes measure: Sepsis-related mortality within 7 day after randomization, secondaryOutcomes measure: Sepsis-related mortality during hospital stay after randomization, secondaryOutcomes measure: Sepsis-related mortality during 1st 30 days after randomization, secondaryOutcomes measure: Clinical sepsis within 1st 72 hours after randomization, secondaryOutcomes measure: Clinical sepsis within 7 days after randomization, secondaryOutcomes measure: Clinical sepsis during hospital stay, secondaryOutcomes measure: Clinical sepsis within 1st 30 days after randomization, secondaryOutcomes measure: Episode of Probable EONS within 72 hours after randomization, secondaryOutcomes measure: Episode of Probable EONS within 7 days after randomization, secondaryOutcomes measure: Episode of asymptomatic proven EONS within 72 hours after randomization, secondaryOutcomes measure: Need for sepsis workup during 1st 72 hours after randomization, secondaryOutcomes measure: Need for sepsis workup during 1st 7 days after randomization, secondaryOutcomes measure: Need for sepsis workup during 1st 30 days after randomization, secondaryOutcomes measure: Need for sepsis workup during hospital stay, secondaryOutcomes measure: Cumulative duration of antibiotic therapy during 1st 7 days after randomization, secondaryOutcomes measure: Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization, secondaryOutcomes measure: Cumulative duration of antibiotic therapy during hospital stay, secondaryOutcomes measure: Duration of hospitalization, secondaryOutcomes measure: Episodes of healthcare associated infection during hospital stay., secondaryOutcomes measure: Adverse effects until day 30 after randomization, secondaryOutcomes measure: Serious adverse effects until day 30 after randomization, eligibilityModule sex: ALL, minimumAge: 0 Hours, maximumAge: 4 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Post Graduate Institute of Medical Education and Research (PGIMER), city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-04-02, uploadDate: 2024-04-02T01:02, filename: Prot_SAP_000.pdf, size: 213987, hasResults: False |
protocolSection identificationModule nctId: NCT06377384, orgStudyIdInfo id: DHP-33-FLIGHT, briefTitle: FLIGHT Study for Childhood Chronic Illness, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-20, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Documenting Hope Project, class: OTHER, descriptionModule briefSummary: The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study., conditionsModule conditions: Chronic Illnesses, Multiple, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: FLIGHT Intervention, outcomesModule primaryOutcomes measure: Total Load Index (TLI), secondaryOutcomes measure: Child Health Inventory for Resilience and Prevention (CHIRP), secondaryOutcomes measure: Children's Sleep Habits Questionnaire (CSHQ), secondaryOutcomes measure: Vineland Adaptive Behavior Scale, secondaryOutcomes measure: Sensory Profile 2, secondaryOutcomes measure: Quick Environmental Exposure and Sensitivity Inventory (QEESI), secondaryOutcomes measure: Hayward Environmental Illness Severity Scale, secondaryOutcomes measure: Parenting Stress Index, 4th edition (PSI-4), secondaryOutcomes measure: Beck Anxiety Inventory (BAI), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Epidemic Answers, status: RECRUITING, city: Windsor, state: Connecticut, zip: 06095, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 833-935-5543, email: [email protected], geoPoint lat: 41.8526, lon: -72.6437, hasResults: False |
protocolSection identificationModule nctId: NCT06377371, orgStudyIdInfo id: 23-03025815, briefTitle: Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, collaborators name: Curium US LLC, descriptionModule briefSummary: The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device., conditionsModule conditions: Meningioma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Brain Imaging with [Cu64]DOTATATE, interventions name: Radio-guided Surgery With Neoprobe Utilization, outcomesModule primaryOutcomes measure: Preoperative [Cu64]DOTATATE PET SUV, primaryOutcomes measure: 1st Post-operative [Cu64]DOTATATE PET SUV, primaryOutcomes measure: 2nd Post-operative [Cu64]DOTATATE PET SUV, primaryOutcomes measure: MRI Size Measurements, primaryOutcomes measure: GTR vs STR Assessment, primaryOutcomes measure: MRI Progression Assessment, primaryOutcomes measure: Target Lesion Neoprobe Count, primaryOutcomes measure: Subtotal Neoprobe Count, primaryOutcomes measure: Reference Background Neoprobe Count, secondaryOutcomes measure: SSTR2 expression, secondaryOutcomes measure: WHO grade, secondaryOutcomes measure: Ki67 Proliferation Index, secondaryOutcomes measure: ER/PR expression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: New York-Presbyterian/Weill Cornell Medical Center, city: New York, state: New York, zip: 10021, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06377358, orgStudyIdInfo id: CEEAH CA31, briefTitle: Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-09, primaryCompletionDateStruct date: 2022-07-25, completionDateStruct date: 2023-06-22, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: CAPENERGY MEDICAL, SL, class: INDUSTRY, collaborators name: University of Malaga, collaborators name: Alfonso X El Sabio University, descriptionModule briefSummary: The Scope of this study is to assess the visceral and subcutaneous fat loss in patients having Tecar (Radiofrequency) Therapy and its effects on other anthropometric variables, adipokines and inflammation.20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes of Capacitive and Resistive manual electrodes will be applied to the abdomen, simultaneously, 20 minutes of Lymphatic Drainage placing one active plate in the foot and the other in the lumbo-dorsal area. Patients will be informed that they will only feel comfortable warmth. Five sessions will be applied from Monday to Friday resting Saturday and Sunday, for 2 weeks. Total 10 sessions.Subcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured.Metabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein).Results will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between the medians will be assessed using the Student's t-test for paired samples and independent samples., conditionsModule conditions: Obesity, Visceral, conditions: Obesity; Endocrine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Tecar Theraty was applied to 20 obese patients in order to assess the effect on the body fat loss, serum adipocytokines and imflammation. It was an interventional study in one group of patients. No controls. No masking., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Tecar Therapy, outcomesModule primaryOutcomes measure: Visceral fat loss (cm3), primaryOutcomes measure: Visceral fat loss (g), primaryOutcomes measure: Subcutaneous fat loss (cm3), primaryOutcomes measure: Subcutaneous fat loss (g), primaryOutcomes measure: Tumor Necrosis Factor alfa, primaryOutcomes measure: Interleukin 6 levels, primaryOutcomes measure: C reactive Protein levels, primaryOutcomes measure: Leptin levels, primaryOutcomes measure: Adiponectin levels, primaryOutcomes measure: Resistin levels, primaryOutcomes measure: Total cholesterol changes, primaryOutcomes measure: Total triglycerides changes, primaryOutcomes measure: LDL Cholesterol changes, primaryOutcomes measure: HDL Cholesterol changes, primaryOutcomes measure: Glucose, secondaryOutcomes measure: Body Mass Index loss, secondaryOutcomes measure: Waist to Hip Index loss, secondaryOutcomes measure: Skinfold Thickness (cm), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inneo Terapia Despi, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-02-01, uploadDate: 2024-03-21T05:39, filename: Prot_SAP_000.pdf, size: 597014, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-02-01, uploadDate: 2024-04-11T07:17, filename: ICF_001.pdf, size: 543945, hasResults: False |
protocolSection identificationModule nctId: NCT06377345, orgStudyIdInfo id: 202312-00011, briefTitle: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: SingHealth Polyclinics, class: OTHER, descriptionModule briefSummary: Aim: To evaluate the use of AeviceMD Monitoring System (AeviceMD) asthma in reducing acute exacerbation.Methodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will be recruited. The data follow-up period is 3 months. It will also evaluate the usability of the device from both patients' and clinicians' perspective. 180 patients (124 adults, 56 pediatrics) and 120 clinicians will be recruited.Importance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation.Potential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare resources. An exacerbation is an episode of severe shortness of breath, cough, and chest tightening which warrants a visit to a healthcare institution. Through self-monitoring, patients can be empowered to self-manage their asthma, with aid of the asthma action plan which is given to all patients with asthma. AeviceMD can also help provide clinicians with patients' objective lung data. In the primary care setting, care is also fragmented as patients are often followed-up by a different doctor or healthcare providers. Clinicians have no objective data to track patients, and is dependent on patients' self-report and possible recall bias. There is no expected risk with the use of the device., conditionsModule conditions: Asthma, conditions: Asthma Attack, conditions: Asthma in Children, conditions: Asthma Acute, conditions: Asthma Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-group randomized controlled trial (RCT) design will be used. The control group will receive the usual care, and the intervention group will receive the Aevice device on top of usual care. Outcomes will be measured at baseline, week 4, and week 12. This is to evaluate the long-term impacts of the Aevice device. Clinicians who have interacted with participants using Aevice will also be invited to participate in an interview and clinician perception survey. A convenience sampling will be used for the recruitment of clinicians., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcomes assessor will not be aware of the participants' group, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: AeviceMD device, interventions name: Standard care, outcomesModule primaryOutcomes measure: Rescue therapy, primaryOutcomes measure: Dose of oral Prednisolone use, primaryOutcomes measure: Visit to hospital emergency department, primaryOutcomes measure: Hospitalisation, primaryOutcomes measure: Euro Quality of Life 5 dimensions (EQ5D), primaryOutcomes measure: Asthma quality of life questionnaire (AQLQ), primaryOutcomes measure: Pediatric asthma quality of life questionnaire (PAQLQ), secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Usability, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Respiratory rate, secondaryOutcomes measure: Wheeze detection trend, secondaryOutcomes measure: Medication log, secondaryOutcomes measure: Duration of device usage, secondaryOutcomes measure: Payment, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377332, orgStudyIdInfo id: X23-0330, briefTitle: Biomarkers of Dementia in Chronic Sleep and Breathing Disorders, acronym: ORACLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Woolcock Institute of Medical Research, class: OTHER, descriptionModule briefSummary: Chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA) and overlap syndrome are associated with obstructions in breathing and disturbed sleep.Chronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding how these diseases may contribute to accelerated brain ageing. This study will comprehensively measure sleep, lung function, cognitive performance and blood-based markers of dementia risk and inflammation. The investigators will use innovative technologies to identify biomarkers of cognitive impairment and dementia risk in people with chronic sleep and breathing disorders. The investigators will also investigate the relationships between disrupted sleep and abnormal breathing and the brain. This research may also inform future early interventions to improve cognition and brain health in chronic sleep and respiratory disease., conditionsModule conditions: COPD, conditions: Overlap Syndrome, conditions: OSA, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: High density electroencephalogram (HdEEG), interventions name: Functional near infrared spectroscopy (fNIRS), interventions name: Magnetic resonance imaging (MRI), interventions name: Blood collection, interventions name: Neuropsychological battery, interventions name: Questionnaires, interventions name: Pulmonary Function Test (PFT), interventions name: Cognitive Assessment, interventions name: Polysomnogram (PSG), outcomesModule primaryOutcomes measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk., primaryOutcomes measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio)., secondaryOutcomes measure: Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep., secondaryOutcomes measure: Brain tissue oxygenation during cognitive tasks and sleep., secondaryOutcomes measure: Hypoxemia as measured by pulse oximetry., secondaryOutcomes measure: Sleep Fragmentation, secondaryOutcomes measure: Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF)., secondaryOutcomes measure: Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT)., secondaryOutcomes measure: Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment., secondaryOutcomes measure: Assessment of speed of processing and executive functioning through the Trail Making Test (TMT)., secondaryOutcomes measure: Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT)., secondaryOutcomes measure: Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT)., secondaryOutcomes measure: Blood levels of fibrinogen., secondaryOutcomes measure: Blood levels of clusterin., secondaryOutcomes measure: Blood levels of 8-isoprostane, secondaryOutcomes measure: Blood levels of C-reactive protein (CRP), secondaryOutcomes measure: Blood levels of erythrocyte sedimentation rate (ESR)., secondaryOutcomes measure: Blood levels of plasma tau., secondaryOutcomes measure: Blood levels of neurofilament light chain (NFL)., secondaryOutcomes measure: Blood levels of Glial fibrillary acidic protein (GFAP)., secondaryOutcomes measure: Blood levels of Apolipoprotein E gene (APOE-4)., secondaryOutcomes measure: Blood levels of interleukin-8 (IL-8)., secondaryOutcomes measure: Blood levels of interleukin-6 (IL-6)., secondaryOutcomes measure: Blood levels of tumor necrosis factor alpha (TNFα)., secondaryOutcomes measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio)., secondaryOutcomes measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk., otherOutcomes measure: Brain structure: cortical thickness and volumetric brain maps, otherOutcomes measure: Brain structure: diffusion-weighted imaging, otherOutcomes measure: Brain function: resting-state BOLD fMRI, otherOutcomes measure: Brain pathology: T1-weighted, T2-weighted, diffusion-weighted imaging, and FLAIR, otherOutcomes measure: Assessment of sensorimotor function and comprehension through the Motor Screening Task (MOT) of CANTAB., otherOutcomes measure: Assessment of processing and psychomotor speed through the Reaction Time (RTI) test of CANTAB., otherOutcomes measure: Assessment of working memory and strategy through the Spatial Working Memory (SWM) test of CANTAB., otherOutcomes measure: Assessment of visual episodic memory through the Paired Associate Learning (PAL) test of CANTAB., otherOutcomes measure: Sleep Spindles During Non-Rapid Eye Movement (NREM) Sleep, otherOutcomes measure: Traditional sleep staging., otherOutcomes measure: Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep., otherOutcomes measure: Obstructive sleep apnoea (OSA) severity metrics, otherOutcomes measure: Lung function as measured by clinical pulmonary function tests (PFT), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Woolcock Institute of Medical Research, status: RECRUITING, city: Sydney, state: New South Wales, zip: 2113, country: Australia, contacts name: Angela D'Rozario, PhD, role: CONTACT, phone: 02 9850 3246, email: [email protected], contacts name: Laura Harris, MScMed, role: CONTACT, phone: 02 9805 3194, email: [email protected], geoPoint lat: -33.86785, lon: 151.20732, hasResults: False |
protocolSection identificationModule nctId: NCT06377319, orgStudyIdInfo id: 101080905, briefTitle: Decision Support System for Diagnosis and Progression of Heart Failure, acronym: STRATIFYHF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Coventry University, class: OTHER, collaborators name: Newcastle University, collaborators name: University of Cambridge, collaborators name: University of Novi Sad, collaborators name: University of Florence, collaborators name: University of Regensburg, collaborators name: Utrecht University, collaborators name: Servicio Madrileño de Salud, Madrid, Spain, descriptionModule briefSummary: Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to support clinical validation of an artificial intelligence (AI)-driven decision support system (DSS) and mobile application for risk prediction, diagnosis, and progression of HF to enhance patients' quality of life and lead to more cost-effective health care., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac Output Response to Stress (CORS) test, outcomesModule primaryOutcomes measure: Diagnostic accuracy of the DSS, secondaryOutcomes measure: Demographic and clinical predictors of risk, diagnosis, and progression of heart failure., eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377306, orgStudyIdInfo id: MC study, briefTitle: Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-05, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Wingate Institute, class: OTHER, collaborators name: Weizmann Institute of Science, collaborators name: Kaplan Medical Center, collaborators name: Ministry of Innovation, Science and Technology of Israel, descriptionModule briefSummary: Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking.The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes.200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC.Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment., conditionsModule conditions: Menstrual Cycle, conditions: Athletes, conditions: Physical Activity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Effect of training loads and sport performance level on health and sport performance, outcomesModule primaryOutcomes measure: Stool Microbiome, primaryOutcomes measure: Serum metabolomics, primaryOutcomes measure: VO2max, primaryOutcomes measure: Countermovement jump, primaryOutcomes measure: Flexibility, primaryOutcomes measure: Grip Strength, primaryOutcomes measure: Lower leg Strength, primaryOutcomes measure: Blood tests, primaryOutcomes measure: Knee valgus, secondaryOutcomes measure: Anthropometric (Height), secondaryOutcomes measure: Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS), secondaryOutcomes measure: Anthropometric (Weight), secondaryOutcomes measure: Percentage body fat (%), otherOutcomes measure: Psychological questionnaire (The Sport Emotion Questionnaire (SEQ), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Wingate Institute, status: RECRUITING, city: Netanya, country: Israel, contacts name: Yotam Shribman, B.Sc, role: CONTACT, phone: +972-54-5723401, email: [email protected], geoPoint lat: 32.33291, lon: 34.85992, hasResults: False |
protocolSection identificationModule nctId: NCT06377293, orgStudyIdInfo id: FEMH-IRB-TSAI2024, briefTitle: Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Far Eastern Memorial Hospital, class: OTHER, descriptionModule briefSummary: In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients., conditionsModule conditions: End-Stage Kidney Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A randomized, active-controlled trial with cross-over design, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Laboratory technicians who assess the study outcomes will be masked, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dialysis-specific therapeutic diet, outcomesModule primaryOutcomes measure: Concentrations of intact fibroblast growth factor 23 (pg/mL), secondaryOutcomes measure: Concentrations of C-terminal fibroblast growth factor 23 (RU/mL), secondaryOutcomes measure: Concentrations of phosphate (mg/dL), secondaryOutcomes measure: Concentrations of calcium (mg/dL), secondaryOutcomes measure: Concentrations of intact parathyroid hormone (pg/mL), secondaryOutcomes measure: Concentrations of bone-specific alkaline phosphatase (μg/L), secondaryOutcomes measure: Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL), secondaryOutcomes measure: Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml), secondaryOutcomes measure: Concentrations of alkaline phosphatase (ALP) (IU/L), secondaryOutcomes measure: Concentrations of free indoxyl sulfate (mg/L), secondaryOutcomes measure: Concentrations of free p-cresol sulfate (mg/L), secondaryOutcomes measure: Concentrations of pre-albumin (g/dL), secondaryOutcomes measure: Concentrations of albumin (g/dL), secondaryOutcomes measure: Concentrations of C-reactive protein (mg/dL), secondaryOutcomes measure: Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells, secondaryOutcomes measure: Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells, secondaryOutcomes measure: Absolute number (per μl blood) of monocytes, secondaryOutcomes measure: Concentrations of fetuin-A (μg/ml), secondaryOutcomes measure: Concentrations of trimethylamine-N-oxide (TMAO) (μM), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377280, orgStudyIdInfo id: NAV-0011, briefTitle: En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Wellspect HealthCare, class: INDUSTRY, descriptionModule briefSummary: This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact., conditionsModule conditions: Bowel Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Navina Mini, outcomesModule primaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Assessment of clinical benefit, secondaryOutcomes measure: Ease of handling, secondaryOutcomes measure: Safety Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skåne University Hospital, status: RECRUITING, city: Malmö, country: Sweden, contacts name: Louis Banka Johnson, MD, role: CONTACT, phone: +4640336557, email: [email protected], contacts name: Sara Strandberg, role: CONTACT, phone: +4640336377, email: [email protected], geoPoint lat: 55.60587, lon: 13.00073, hasResults: False |
protocolSection identificationModule nctId: NCT06377267, orgStudyIdInfo id: ESR-20-21103, briefTitle: Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial), acronym: STROBE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Vall d'Hebron Institute of Oncology, class: OTHER, descriptionModule briefSummary: Background:The study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in homologous recombination deficient (HRD) patients remains inconclusive. Current assays used to estimate HR status do not effectively differentiate between patients who benefit most from PARPi and those who do not, making it inefficient to treat all patients. There is a need for a more accurate HR status testing method to optimize PARPi benefit. This study aims to assess the performance of the VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution.Summary:The study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx HRD Solution. Patients classified as HRD positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone. Treatment will be administered according to approved doses, with follow-up evaluations conducted until RECIST progression., conditionsModule conditions: Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Bevacizumab, interventions name: Olaparib, outcomesModule primaryOutcomes measure: Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution, secondaryOutcomes measure: Performance Assessment of VHIO-CARD-300 Test for HR Status Identification, secondaryOutcomes measure: Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes., secondaryOutcomes measure: Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases, secondaryOutcomes measure: Safety and Tolerability of Olaparib Plus Bevacizumab, secondaryOutcomes measure: To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vall d'Hebron Institute of Oncology, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Ana Oaknin, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06377254, orgStudyIdInfo id: BB/X015173/1, briefTitle: Multi-organ Responses to CHronic Physical Activity and INactivity, acronym: CHAIN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2027-12-17, completionDateStruct date: 2028-10-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Nottingham, class: OTHER, collaborators name: Biotechnology and Biological Sciences Research Council, descriptionModule briefSummary: Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual.Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day.To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised.The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for six months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months.Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;* fitness, muscle strength and function tests,* completion of questionnaires and computer-based brain puzzles* having muscle and fat tissue biopsies and blood samples taken.* The study also involves having MRI scans.This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027., conditionsModule conditions: Sedentary Behavior, conditions: Metabolic Syndrome, conditions: Age-related Cognitive Decline, conditions: Age-Related Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Non-randomised, parallel design lifestyle intervention, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Those undertaking analysis of biological samples and MRI data will be masked as to the group the participant is allocated to., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Decreased Physical Activity, interventions name: Increased Physical activity, outcomesModule primaryOutcomes measure: Change in Cardiorespiratory fitness (VO2 max), secondaryOutcomes measure: Change in Isometric leg strength, secondaryOutcomes measure: Change in time to leg fatigue, secondaryOutcomes measure: Change in incremental area under the curve (iAUC) for blood glucose concentration, secondaryOutcomes measure: Change in iAUC for serum insulin concentration, secondaryOutcomes measure: Change in fasting glucose oxidation rate, secondaryOutcomes measure: Change in 'fed' glucose oxidation rate, secondaryOutcomes measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score, secondaryOutcomes measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score, secondaryOutcomes measure: Change in World Health Organisation Quality of Life (WHOQoL) score, secondaryOutcomes measure: Change in Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: Change in Stroop test; % Accuracy, secondaryOutcomes measure: Change in Stroop test; reaction time, secondaryOutcomes measure: Change in four-choice reaction time test; % Accuracy, secondaryOutcomes measure: Change in four-choice reaction time test; reaction time, secondaryOutcomes measure: Change in card sort test; % Accuracy, secondaryOutcomes measure: Change in card sort test; reaction time, secondaryOutcomes measure: Change in Logical reasoning test; % accuracy, secondaryOutcomes measure: Change in Logical reasoning test; reaction time, secondaryOutcomes measure: Change in serial subtractions test; number of responses in 2 minutes, secondaryOutcomes measure: Change in Corsi blocks test; score, secondaryOutcomes measure: Change in Muscle protein synthesis rate, secondaryOutcomes measure: Change in Muscle protein breakdown rate, secondaryOutcomes measure: Change in whole body fat volumes, secondaryOutcomes measure: Change in liver fat volumes, secondaryOutcomes measure: Change in thigh muscle fat volumes, secondaryOutcomes measure: Change in whole body muscle volumes, secondaryOutcomes measure: Change in muscle phosphocreatine synthesis rate, secondaryOutcomes measure: Change in cerebral volume, secondaryOutcomes measure: Change in cortical thickness, secondaryOutcomes measure: Change in plasma metabolome, otherOutcomes measure: Fasting blood lipid concentration, otherOutcomes measure: Fasting blood lipid concentration, otherOutcomes measure: Fasting blood lipid concentration, otherOutcomes measure: Fasting blood lipid concentration, otherOutcomes measure: Fasting blood lipid concentration, otherOutcomes measure: liver function test: alanine transaminase (ALT), otherOutcomes measure: liver function test: alanine transaminase (ALT), otherOutcomes measure: liver function test: alanine transaminase (ALT), otherOutcomes measure: liver function test: alanine transaminase (ALT), otherOutcomes measure: liver function test: alanine transaminase (ALT), otherOutcomes measure: liver function test: aspartate aminotransferase (AST), otherOutcomes measure: liver function test: aspartate aminotransferase (AST), otherOutcomes measure: liver function test: aspartate aminotransferase (AST), otherOutcomes measure: liver function test: aspartate aminotransferase (AST), otherOutcomes measure: liver function test: aspartate aminotransferase (AST), otherOutcomes measure: liver function test: Bilirubin, otherOutcomes measure: liver function test: Bilirubin, otherOutcomes measure: liver function test: Bilirubin, otherOutcomes measure: liver function test: Bilirubin, otherOutcomes measure: liver function test: Bilirubin, otherOutcomes measure: liver function test: Albumin, otherOutcomes measure: liver function test: Albumin, otherOutcomes measure: liver function test: Albumin, otherOutcomes measure: liver function test: Albumin, otherOutcomes measure: liver function test: Albumin, otherOutcomes measure: liver function test: Gamma glutamyl transferase (GGT), otherOutcomes measure: liver function test: Gamma glutamyl transferase (GGT), otherOutcomes measure: liver function test: Gamma glutamyl transferase (GGT), otherOutcomes measure: liver function test: Gamma glutamyl transferase (GGT), otherOutcomes measure: liver function test: Gamma glutamyl transferase (GGT), otherOutcomes measure: Blood Haemoglobin concentration, otherOutcomes measure: Blood Haemoglobin concentration, otherOutcomes measure: Blood Haemoglobin concentration, otherOutcomes measure: Blood Haemoglobin concentration, otherOutcomes measure: Blood Haemoglobin concentration, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: David Greenfield Human Physiology Unit, status: RECRUITING, city: Nottingham, state: Notts, zip: NG72UH, country: United Kingdom, contacts name: Sara Brown, role: CONTACT, phone: +44(0)115 8230434, email: [email protected], contacts name: Joanne Mallinson, PhD, role: CONTACT, phone: +44(0)1158230434, email: [email protected], contacts name: Paul Greenhaff, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Liz Simpson, PhD, role: SUB_INVESTIGATOR, contacts name: Joanne Mallinson, PhD, role: SUB_INVESTIGATOR, contacts name: Abhishek Sheth, MD, role: SUB_INVESTIGATOR, contacts name: Penny Gowland, PhD, role: SUB_INVESTIGATOR, contacts name: Sue Francis, PhD, role: SUB_INVESTIGATOR, contacts name: Rosemary Nicholls, PhD, role: SUB_INVESTIGATOR, contacts name: Aline Nixon, role: SUB_INVESTIGATOR, contacts name: Sara Brown, role: SUB_INVESTIGATOR, contacts name: Donald Peden, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False |
protocolSection identificationModule nctId: NCT06377241, orgStudyIdInfo id: 2023-1436, secondaryIdInfos id: A536000, type: OTHER, domain: UW Madison, secondaryIdInfos id: SMPH/OPHTHAL&VIS SCI/GEN, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 2/23/2024, type: OTHER, domain: UW Madison, briefTitle: ScentAware and OCT in MCI vs HC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:* Whether the test is as effective and reliable as the standard test* Whether there is a link between the results of the smell test and the structure of the back of the eyeParticipants will:* complete a short questionnaire* have pictures of the inside of their eyes taken* perform two smell tests, conditionsModule conditions: Alzheimer Disease, Early Onset, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: ScentAware, interventions name: UPSIT, outcomesModule primaryOutcomes measure: Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting, primaryOutcomes measure: Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently, primaryOutcomes measure: Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently, secondaryOutcomes measure: Compare baseline ScentAware test scores between cohorts, secondaryOutcomes measure: Compare baseline UPSIT test scores between cohorts, secondaryOutcomes measure: Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness, secondaryOutcomes measure: Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness, secondaryOutcomes measure: Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness, secondaryOutcomes measure: Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Wisconsin, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Amy Remm, role: CONTACT, phone: 608-262-3377, email: [email protected], geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06377228, orgStudyIdInfo id: TAK-007-1001, briefTitle: A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2029-04-23, completionDateStruct date: 2029-04-23, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events).Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007., conditionsModule conditions: Refractory Lupus Nephritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: TAK-007, interventions name: Chemotherapy Agents, outcomesModule primaryOutcomes measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), primaryOutcomes measure: Number of Participants With Dose Limiting Toxicities (DLTs), secondaryOutcomes measure: Cmax: Maximum Observed Plasma Concentration for TAK-007, secondaryOutcomes measure: Tmax: Time to Reach the Cmax for TAK-007, secondaryOutcomes measure: Tlast: Time of Last Measurable Concentration Above the Lower Limit of Quantitation for TAK-007, secondaryOutcomes measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007, secondaryOutcomes measure: Change From Baseline in CD19+ B Cell Counts, secondaryOutcomes measure: Duration of B Cell Depletion, secondaryOutcomes measure: Change From Baseline in Plasma Cytokine Levels, secondaryOutcomes measure: Change From Baseline in Physician's Global Assessment (PGA) Score, secondaryOutcomes measure: Percentage of Participants Achieving a Reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Relative to Baseline, secondaryOutcomes measure: Percentage of Participants Achieving Complete Renal Response (CRR), secondaryOutcomes measure: Time to CRR, secondaryOutcomes measure: Duration of CRR, secondaryOutcomes measure: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS), secondaryOutcomes measure: Time to LLDAS, secondaryOutcomes measure: Duration of LLDAS, secondaryOutcomes measure: Percentage of Participants Meeting the Definition of Remission in SLE (DORIS) Criteria, secondaryOutcomes measure: Time to DORIS Remission, secondaryOutcomes measure: Duration of DORIS Remission, secondaryOutcomes measure: Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels, secondaryOutcomes measure: Change From Baseline in Antinuclear Antibody (ANA) Levels, secondaryOutcomes measure: Change From Baseline in Proteinuria Levels, secondaryOutcomes measure: Change From Baseline in Creatinine Levels, secondaryOutcomes measure: Change From Baseline in eGFR, secondaryOutcomes measure: Change From Baseline in Complement (C3, C4) Levels, secondaryOutcomes measure: Percentage of Participants With Antidrug Antibodies Categorized as Anti-Human Leukocyte Antigen (HLA) and Anti- Chimeric Antigen Receptor (CAR), secondaryOutcomes measure: Percentage of Participants With Replication Competent Retrovirus (RCR) in Blood, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Site Contact, role: CONTACT, phone: 888-229-3065, email: [email protected], contacts name: Jacqueline Madison, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: University of Rochester, city: Rochester, state: New York, zip: 14642, country: United States, contacts name: Site Contact, role: CONTACT, phone: 585-486-0901, email: [email protected], contacts name: Christopher Palma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: UT Health Houston, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Site Contact, role: CONTACT, phone: 713-486-3100, email: [email protected], contacts name: Meera Subash, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06377215, orgStudyIdInfo id: Pro00041729, secondaryIdInfos id: R01DC020514, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DC020514, briefTitle: Understanding Aided Speech Perception in Noise, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, collaborators name: National Institute on Deafness and Other Communication Disorders (NIDCD), descriptionModule briefSummary: The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention., conditionsModule conditions: Hearing Impairment, Sensorineural, conditions: Spatial Perception, conditions: Aging, conditions: Hearing Aids, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 121, type: ESTIMATED, armsInterventionsModule interventions name: Open-source master hearing aid, outcomesModule primaryOutcomes measure: Digit Identification, primaryOutcomes measure: Neural Segregation, secondaryOutcomes measure: Minimum Audible Angle (MAA), secondaryOutcomes measure: Speech Localization Error, secondaryOutcomes measure: Fixed Spatial Release from Masking, otherOutcomes measure: Pure-tone Air Threshold (PTac), otherOutcomes measure: Bone Conduction Threshold (PTbc), otherOutcomes measure: Wideband Tympanometry (Equivalent Ear Canal Volume), otherOutcomes measure: Wideband Tympanometry (Static Peak Pressure), otherOutcomes measure: Wideband Tympanometry (Resonant Frequency), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Erol Ozmeral, Ph.D., role: CONTACT, phone: 813-974-9778, email: [email protected], contacts name: Carrie Secor, Au.D., role: CONTACT, phone: 813-974-4148, email: [email protected], contacts name: Erol Ozmeral, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False |
protocolSection identificationModule nctId: NCT06377202, orgStudyIdInfo id: SynKIR-110 LTFU, briefTitle: Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2038-12-15, completionDateStruct date: 2038-12-15, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Verismo Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin., conditionsModule conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of subjects with treatment related adverse events as assessed by CTCAE v5.0, secondaryOutcomes measure: Number of subjects with persistence of SynKIR-110 modified cells, secondaryOutcomes measure: Number of subjects with potential/suspected RCL, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pennsylvania, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Katie Elkins, role: CONTACT, phone: 215-615-6740, email: [email protected], contacts name: Janos Tanyi, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06377189, orgStudyIdInfo id: 2023-01910, briefTitle: Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study, acronym: PLIMeC-P, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, class: OTHER, collaborators name: Neuchâtel Psychiatry Centre (CNP), collaborators name: University of Lausanne Hospitals, descriptionModule briefSummary: The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care.Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated.The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals.The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P., conditionsModule conditions: Mental Health Issue, conditions: Depression/Anxiety, conditions: Quality of Life, conditions: Psychosomatic Disorders, conditions: Patients Lived Experiences, conditions: Doctor-Patient Relation, conditions: Collaboration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In order to answer the research question of the PLIMeC-P (pilot study), aiming to determine the feasibility and practicability of the main PLIMeC study, in the initial phase, the statistical procedures will be limited to questions of practicability and quality.For the main PLIMeC study we will use a mixed method approach, combining various data collection and analysis methods (qualitative and quantitative). Quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest, and qualitative methods will be used to explore and obtain depth of this understanding. More specifically, the combination of methods will be used for complementarity, using qualitative data to examine how the participants, patients and healthcare providers, experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients. In data analysis, the priority among the two methods will be equal., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings, interventions name: Control Arm - Treatment As Usual (TAU), outcomesModule primaryOutcomes measure: Evaluate the feasibility of the main PLIMeC study, primaryOutcomes measure: Mental health - psychiatric symptoms, primaryOutcomes measure: Mental health - Quality of life, primaryOutcomes measure: Mental health - Self-report questionnaire, secondaryOutcomes measure: The lived experience of the participants, secondaryOutcomes measure: The lived experience of the implicated clinicians, otherOutcomes measure: Healthcare system complexity - Quantitative assessment, otherOutcomes measure: Healthcare system complexity - qualitative assessment, otherOutcomes measure: Access to mental healthcare, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site, city: Lausanne, state: Vaud, zip: 1010, country: Switzerland, geoPoint lat: 46.516, lon: 6.63282, locations facility: Service de psychiatrie de l'adulte nord ouest (SPANO) Département de psychiatrie - CHUV (DP-CHUV), city: Yverdon-les-Bains, state: Vaud, zip: 1400, country: Switzerland, contacts name: Julien Elowe, MD, role: CONTACT, phone: 0041 21 314 54 38, email: [email protected], contacts name: Julien Elowe, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Gerrit Weber, MD, role: SUB_INVESTIGATOR, geoPoint lat: 46.77852, lon: 6.64115, locations facility: Centre Neuchâtelois de Psychiatrie (CNP), city: Neuchâtel, zip: 2000, country: Switzerland, contacts name: Stéphane Saillant, PD, role: CONTACT, phone: 0041 32 755 15 15, email: [email protected], contacts name: Stéphane Saillant, PD, role: PRINCIPAL_INVESTIGATOR, contacts name: Julie Gavin-Ramain, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 46.99179, lon: 6.931, hasResults: False |
protocolSection identificationModule nctId: NCT06377176, orgStudyIdInfo id: NTUNHSEN, briefTitle: Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-16, primaryCompletionDateStruct date: 2021-10-03, completionDateStruct date: 2021-10-03, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: National Taipei University of Nursing and Health Sciences, class: OTHER, descriptionModule briefSummary: Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament., conditionsModule conditions: Postpartum Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 102, type: ACTUAL, armsInterventionsModule interventions name: Massage therapy, outcomesModule primaryOutcomes measure: Depression, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Infant temperament, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Community Health Center, city: Sleman, state: Yogyakarta, zip: 55584, country: Indonesia, geoPoint lat: -7.71556, lon: 110.35556, hasResults: False |
protocolSection identificationModule nctId: NCT06377163, orgStudyIdInfo id: acquired pneumonia in children, briefTitle: Bacterial Pathogens Associated With Community-acquired Pneumonia in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2021-08-31, completionDateStruct date: 2021-08-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, descriptionModule briefSummary: Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate., conditionsModule conditions: Children Pneumonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ACTUAL, outcomesModule primaryOutcomes measure: Complete blood count, primaryOutcomes measure: C-reactive protein (CRP), primaryOutcomes measure: Blood culture and sensitivity on admission, primaryOutcomes measure: Gastric lavage culture or sputum culture on admission, eligibilityModule sex: ALL, minimumAge: 28 Days, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Amira Hussin Mohammed, city: Gamasa, zip: 35712, country: Egypt, geoPoint lat: 31.44112, lon: 31.53675, hasResults: False |
protocolSection identificationModule nctId: NCT06377150, orgStudyIdInfo id: ABCA4-1382022BO2, briefTitle: Stargardt Disease in Childhood, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease., conditionsModule conditions: Stargardt Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 39, type: ACTUAL, outcomesModule primaryOutcomes measure: Best Corrected Visual Acuity (BCVA), primaryOutcomes measure: Visual Field (VF), primaryOutcomes measure: Fundus Photography (FP), primaryOutcomes measure: Fundus Autofluorescence (AF), primaryOutcomes measure: Optical Coherence Tomography (OCT), primaryOutcomes measure: Full-Field Electroretinography (ff-ERG), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Tuebingen, city: Tuebingen, state: Baden-Wuerttemberg, Germany, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False |
protocolSection identificationModule nctId: NCT06377137, orgStudyIdInfo id: University of the Porto, briefTitle: High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2023-04-10, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, descriptionModule briefSummary: Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities. Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction. Small-sided soccer games (SSSG) have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment, which favors long-term adherence.The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention.The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training.A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI\> 85th percentile); (iii) Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to-height ratio ≥ 0.5; (iv) willing to participate in the study regardless of possible group allocation; (v) informed consent given by participant and legal representatives. Exclusion criteria: (i) health condition not compatible with participation in physical exercise; (ii) history of recent musculoskeletal injury hindering exercise participation; (iii) concurrent participation in a structured weight loss or exercise program.Those eligible to participate in the study will be randomly assigned to one of three groups: i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participate in a high-intensity small-sided soccer games training, while the TSG will undergo a technical and tactical skills training program and traditional soccer training. The CG participants will continue with regular school physical education classes without any additional intervention. Before and after the intervention, all participants will be assessed for cardiometabolic and hepatic biochemical markers, physical fitness, anthropometry and body composition, blood pressure, objective daily physical activity and sleep quality, and perceived enjoyment of participation in SSSG and TSG. The primary outcomes of the study will be waist circumference and cardiorespiratory fitness.The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile., conditionsModule conditions: Obesity, Adolescent, conditions: Metabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 51, type: ACTUAL, armsInterventionsModule interventions name: Small-sided soccer games groups (SSSG), interventions name: Traditional soccer training groups (TSG), outcomesModule primaryOutcomes measure: Waist circumference, primaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Variation in fasting blood glucose concentration (mg/dL), secondaryOutcomes measure: Variation in serum insulin concentration (mU/L), secondaryOutcomes measure: Variation in HOMA-IR, secondaryOutcomes measure: Variation in glycosylated hemoglobin concentration (mg/dL), secondaryOutcomes measure: Variation in high-density lipoprotein cholesterol concentration (mg/dL), secondaryOutcomes measure: Variation in low-density lipoprotein cholesterol concentration (mg/dL), secondaryOutcomes measure: Variation in total cholesterol concentration (mg/dL), secondaryOutcomes measure: Variation in blood triglycerides concentration (mg/dL), secondaryOutcomes measure: Variation in blood Alanine aminotransferase concentration (U/L), secondaryOutcomes measure: Variation in blood Aspartate aminotransferase concentration (U/L), secondaryOutcomes measure: Variation in blood Gamma glutamyl transferase concentration (U/L), secondaryOutcomes measure: 6-minute walk test, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Lower limb strength, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Neck circumference, secondaryOutcomes measure: Blood Pressure (mmHg), secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Perceived enjoyment of physical activity, eligibilityModule sex: MALE, minimumAge: 11 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Sport of the University of Porto, city: Porto, zip: 4200-450, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False |
protocolSection identificationModule nctId: NCT06377124, orgStudyIdInfo id: UW21-507, briefTitle: A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Queen Mary Hospital, Hong Kong, collaborators name: The Queen Elizabeth Hospital, collaborators name: United Christian Hospital, descriptionModule briefSummary: Lung cancers patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The current study attempts to explore the efficacy of the Smart Self-Management Support Programme (3S) in improving quality of life of patients using self-management support programme with mobile devices., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The 3S intervention includes an individual session, messaging and phone contact related to lung cancer self-management, and hotline services.The general health information includes an individual session, messaging and phone contact related to general health information, and hotline services., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The outcome assessor was not aware of which groups the patients belonged to., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: 3S intervention, interventions name: GH information, outcomesModule primaryOutcomes measure: Change in health-related quality of life, secondaryOutcomes measure: Change in health-related quality of life, secondaryOutcomes measure: Change in patient activation, secondaryOutcomes measure: Change in general self-efficacy, secondaryOutcomes measure: Change in acceptance of illness, secondaryOutcomes measure: Change in physical activity level, secondaryOutcomes measure: Change in diet habit, secondaryOutcomes measure: Change in smoking and drinking habits, secondaryOutcomes measure: Change in health status, secondaryOutcomes measure: Change in anxiety symptoms of patients, secondaryOutcomes measure: Change in depression symptoms of patients, secondaryOutcomes measure: Change in social and family support, secondaryOutcomes measure: Change in adherence to agreed preset health-related goals, secondaryOutcomes measure: Change in symptom severity, secondaryOutcomes measure: Change in functional exercise capacity, secondaryOutcomes measure: Change in lower limb strength, secondaryOutcomes measure: Change in hand grip strength, secondaryOutcomes measure: Change in flexibility, secondaryOutcomes measure: Change in balance, secondaryOutcomes measure: Change in body composition, secondaryOutcomes measure: Change in objective physical activity level, secondaryOutcomes measure: Change in objective sleep quality, secondaryOutcomes measure: Change in burden of family caregivers (For FCGs), secondaryOutcomes measure: Change in quality of life of family caregivers (For FCGs), secondaryOutcomes measure: Change in anxiety symptoms of family caregivers (For FCGs), secondaryOutcomes measure: Change in depression symptoms of family caregivers (For FCGs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Mary Hospital, city: Hong Kong, country: Hong Kong, contacts name: Agnes YK Lai, PhD, role: CONTACT, phone: 3970-2903, email: [email protected], contacts name: Agnes Yuen Kwan Lai, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06377111, orgStudyIdInfo id: PANTHEON-IO, briefTitle: A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This study is open to patients with a type of cancer called melanoma. Patients can join the study if their tumor cannot be removed by surgery or has spread to other organs, and are planned to receive immunotherapy as treatment for their cancer. This study is looking at whether taking calcium pantothenate supplement (a type of Vitamin B5) can increase its levels in the blood and have an effect in the immune system, when its used in combination with the immunotherapy., conditionsModule conditions: Melanoma (Skin), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: C-PAN, interventions name: Nivolumab, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI., secondaryOutcomes measure: Evaluate the overall response rate (ORR) of the enrolled cohort., secondaryOutcomes measure: Evaluate the progression free survival (PFS) of the enrolled cohort., secondaryOutcomes measure: Incidence of immune-related colitis., secondaryOutcomes measure: Correlation between baseline intestinal microbiome composition to the development of immune-related colitis., secondaryOutcomes measure: Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis., secondaryOutcomes measure: The incidence of treatment-related adverse events., secondaryOutcomes measure: The incidence of treatment-related adverse events, secondaryOutcomes measure: Correlation between change in plasmatic pantothenic acid level between baseline and at first day of ICI, and ORR., otherOutcomes measure: Correlation between change in pantothenic acid plasmatic level in mcMol/L between baseline and first day of ICI, and ORR by RECIST and iRECIST., otherOutcomes measure: Correlation between change in plasmatic pantothenic acid level between baseline and week 9 assessment, and immune profiling., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network- Princess Margaret Cancer Centre, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, contacts name: Minge Xu, role: CONTACT, phone: 416-946-4501, phoneExt: 7754, email: [email protected], contacts name: Samuel Saibil, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06377098, orgStudyIdInfo id: UAB-300010901, secondaryIdInfos id: UAB Dixon Endowed Ch/3102800, type: OTHER_GRANT, domain: UAB Dixon Endowed Chair, briefTitle: Intrapartum Sildenafil in Laboring Mothers, acronym: PRISM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: University Teaching Hospital, Lusaka, Zambia, collaborators name: Egerton University, collaborators name: Cameroon Baptist Convention Health, descriptionModule briefSummary: The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.The main questions it aims to answer are:* What are the fetal heart rate monitoring practices in a low-resource setting?* What are the indications for operative delivery in a low-resource?* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.Participants will:* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor* Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.* Have a neonatal neurological assessment prior to discharge* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone callThe results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia., conditionsModule conditions: Neonatal Asphyxia, conditions: Intrapartum Fetal Distress, conditions: Development, Infant, conditions: Intrapartum Asphyxia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blinded, placebo-controlled, 1:1 parallel allocation, randomized feasibility trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The only person who will be unmasked will be the pharmacist who will dispense the study medication--either sildenafil 50mg or identical placebo, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Sildenafil 50 mg Oral Tablet, interventions name: Placebo Oral Tablet, outcomesModule primaryOutcomes measure: Percentage of perinatal mortality, primaryOutcomes measure: Percentage of operative delivery, primaryOutcomes measure: Indication for operative delivery, secondaryOutcomes measure: Percentage of mothers who received fetal heart rate monitoring, secondaryOutcomes measure: Indication for fetal heart rate monitoring, secondaryOutcomes measure: Apgar Score, secondaryOutcomes measure: Percentage of use of bag and mask ventilation in neonates, secondaryOutcomes measure: Percentage of neonates with neonatal encephalopathy, secondaryOutcomes measure: Percentage of neonates with neonatal encephalopathy, secondaryOutcomes measure: Percentage of neonates with hypoxemia, secondaryOutcomes measure: Percentage of infants with neonatal hypoxic-ischemic encephalopathy, secondaryOutcomes measure: Percentage of neonatal ICU admissions, secondaryOutcomes measure: Percentage of maternal rehospitalization, secondaryOutcomes measure: Percentage of neonatal rehospitalization, secondaryOutcomes measure: Infant/child developmental assessment, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Cameroon Baptist Convention Health Services, city: Douala, country: Cameroon, contacts name: Pius Tih Muffih, PhD, role: CONTACT, phone: 677764781, email: [email protected], contacts name: Rahel Kyeng Mbah, role: CONTACT, phone: 370 371378, email: [email protected], contacts name: Akila Subramaniam, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Pius Tih Miffih, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 4.04827, lon: 9.70428, locations facility: Egerton University/Nakuru County Referral Hospital, city: Nakuru, country: Kenya, contacts name: Amos Otara, MD, role: CONTACT, phone: 254 7222 7470, email: [email protected], contacts name: Elizabeth G Kibaru, MbchB, Mmed, role: CONTACT, phone: 072 942 394, email: [email protected], contacts name: Nora Switchenko, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Amos Otara, MD, role: SUB_INVESTIGATOR, geoPoint lat: -0.28333, lon: 36.06667, locations facility: University Teaching Hospital, city: Lusaka, country: Zambia, contacts name: Elwyn Chomba, MD, role: CONTACT, phone: 0211 254 655, email: [email protected], contacts name: Musaku Mwenechanya, MD, role: CONTACT, phone: +260966722966, email: [email protected], contacts name: Elwyn Chomba, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Musaku Mwenechanya, MD, role: SUB_INVESTIGATOR, geoPoint lat: -15.40669, lon: 28.28713, hasResults: False |
protocolSection identificationModule nctId: NCT06377085, orgStudyIdInfo id: 809325, briefTitle: Repurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Shirley Ryan AbilityLab, class: OTHER, collaborators name: Rady Children's Hospital, San Diego, descriptionModule briefSummary: In this controlled dose-escalation study, we will study the initial safety, biological properties, and potential efficacy of 5-azacytidine (AZA). Our overarching aspiration is for AZA to evolve into an approved pharmacological treatment, fostering muscle growth and enhancing body movement, ultimately contributing to an improved quality of life in children with CP.The main questions this study aims to answer are:1. What is the optimal dose of AZA injection that can be used safely in children with CP?2. Can the optimal safe dose of AZA improve the function of muscle-generating stem cells in children with CP?Each participant will have up to five research visits over the course of the study duration, in which they will participate in: blood draws, pregnancy test(s) (if applicable), medical assessments, and a muscle biopsy during a surgery for muscle contractures.Researchers will compare participants with four different dosages of AZA injections to those with four different dosages of placebo injections. A placebo is a look-alike substance that contains no active drug. They will see if a single injection of AZA at a standard concentration currently approved by the FDA to treat myelodysplastic syndromes, can also safely improve muscle growth and function in children with CP., conditionsModule conditions: Cerebral Palsy, conditions: Contracture, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: For this Phase 1 trial, we will conduct a dose-escalation study in children having CP who receive 5-Azacytidine (AZA) via a single subcutaneous (SQ) injection two weeks before their surgery, already scheduled to release their contractures. We will use a "3 + 3" dose-escalation design where decisions are based on the rate of toxicity at the current dose level independently from prior dose levels. The primary goal of this study is to determine a Maximum Tolerated Dose (MTD), which will be the highest dose level at which less or equal of 33% of patients experience Dose-Limiting Toxicity (DLT)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Placebo for the AZA 10mg/m^2, interventions name: Placebo for the AZA 20mg/m^2, interventions name: Placebo for the AZA 35mg/m^2, interventions name: Placebo for the AZA 75mg/m^2, interventions name: 5-Azacytidine 10mg/m^2, interventions name: 5-Azacytidine 20mg/m^2, interventions name: 5-Azacytidine 35mg/m^2, interventions name: 5-Azacytidine 75mg/m^2, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT)., secondaryOutcomes measure: Satellite Cell Fusion Index., secondaryOutcomes measure: DNA methylation quantification in Satellite Cells and Blood Mononucleated Cells., secondaryOutcomes measure: DNA methylation profiling in Satellite Cells., otherOutcomes measure: Chromatin immunoprecipitation sequencing (ChIP-seq), and assay for transposase-accessible chromatin sequencing (ATAC-seq), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
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