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protocolSection identificationModule nctId: NCT06291246, orgStudyIdInfo id: 23-1823, secondaryIdInfos id: K12TR004416-01, type: NIH, link: https://reporter.nih.gov/quickSearch/K12TR004416-01, briefTitle: Expediting Access to Services for Equity (EASE), acronym: EASE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 3 after their initial diagnosis of autism.The main questions it aims to answer are:* Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?* Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?* Does Family Navigation improve caregiver well-being?Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Family Navigation, interventions name: Educational Materials, outcomesModule primaryOutcomes measure: Time to initiation of autism specific intervention, secondaryOutcomes measure: Caregiver Well-Being Score, secondaryOutcomes measure: Child's Developmental Functioning Score, secondaryOutcomes measure: Child's Adaptive Functioning Score, secondaryOutcomes measure: Appropriateness of Intervention Score, secondaryOutcomes measure: Feasibility of Intervention Score, secondaryOutcomes measure: Acceptability of Intervention Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Carolina Institute for Developmental Disabilities, city: Carrboro, state: North Carolina, zip: 27510, country: United States, geoPoint lat: 35.91014, lon: -79.07529, hasResults: False |
protocolSection identificationModule nctId: NCT06291233, orgStudyIdInfo id: HUM00236812, secondaryIdInfos id: 1R01MH132656-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MH132656-01, briefTitle: A Hybrid Effectiveness-Implementation Randomized Clinical Trial (RCT) of Virtual Interview Training for Autistic Transition-Age Youth, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group)., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Interview Training (VIT), interventions name: Services-as-usual, outcomesModule primaryOutcomes measure: Competitive Employment based on self-report employment surveys, primaryOutcomes measure: Change in Job Interview Skills from Mock Interview Rating Scale (MIRS), primaryOutcomes measure: Change in Job Interview Skills from Measure of Job Interview Skills (MOJO-iSkills), primaryOutcomes measure: Time to Employment, primaryOutcomes measure: Vocational Index Score, primaryOutcomes measure: Vocational Index Score, secondaryOutcomes measure: Change in Interview Anxiety using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA), secondaryOutcomes measure: Change in Interview Motivation, secondaryOutcomes measure: Change in Social Responsiveness using the Social Responsiveness Scale 2nd version (SRS-2), secondaryOutcomes measure: Change in Job Search Behavior using the Job Search Behavior Scale (JSBS), secondaryOutcomes measure: Change in Work Readiness using the Work Readiness Scale (WRS), secondaryOutcomes measure: Change in Work Motivation using the Work Motivation Scale (WMS), secondaryOutcomes measure: Change in Social Cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A), secondaryOutcomes measure: Change in Interview Knowledge, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 26 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The San Diego State University, city: San Diego, state: California, zip: 92182, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Disability Network Wayne County, city: Detroit, state: Michigan, zip: 48235, country: United States, geoPoint lat: 42.33143, lon: -83.04575, locations facility: Lincoln Park, city: Lincoln Park, state: Michigan, zip: 48146, country: United States, geoPoint lat: 42.25059, lon: -83.17854, hasResults: False |
protocolSection identificationModule nctId: NCT06291220, orgStudyIdInfo id: M24-291, secondaryIdInfos id: 2023-507637-19, type: OTHER, domain: EU CT, briefTitle: A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-02, primaryCompletionDateStruct date: 2029-07-21, completionDateStruct date: 2029-07-21, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world.Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 years.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Obinutuzumab, interventions name: ABBV-453, outcomesModule primaryOutcomes measure: Part A and B: Percentage of Participants With Adverse Events (AEs), primaryOutcomes measure: Part A: Maximum Administered Dose (MAD) of ABBV-453, primaryOutcomes measure: Part A: Maximum Tolerated Dose (MTD) of ABBV-453, secondaryOutcomes measure: Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453, secondaryOutcomes measure: Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453, secondaryOutcomes measure: Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453, secondaryOutcomes measure: Part A and B: Overall Response Rate (ORR), secondaryOutcomes measure: Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better, secondaryOutcomes measure: Part A and B: Complete response rate (CRR), secondaryOutcomes measure: Part A and B: Duration of Complete Response (DOCR), secondaryOutcomes measure: Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi, secondaryOutcomes measure: Part A and B: Progression-free survival (PFS), secondaryOutcomes measure: Part A and B: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06291207, orgStudyIdInfo id: AD-224P3, briefTitle: A Study to Evaluate the Efficacy and Safety of AD-224, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Addpharma Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of AD-224, conditionsModule conditions: Hypertension,Essential, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: AD-224A, interventions name: AD-224B, interventions name: AD-224C, interventions name: Placebo of AD-224A, interventions name: Placebo of AD-224B, interventions name: Placebo of AD-224C, outcomesModule primaryOutcomes measure: Change rate of MSSBP, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06291194, orgStudyIdInfo id: 22DE30902, briefTitle: Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: AJU Pharm Co., Ltd., class: INDUSTRY, collaborators name: GL Pharm Tech Corporation, descriptionModule briefSummary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease., conditionsModule conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 396, type: ESTIMATED, armsInterventionsModule interventions name: AJU-S56 5%, interventions name: Placebo Group(Vehicle), outcomesModule primaryOutcomes measure: Total corneal staining score (TCSS), secondaryOutcomes measure: LGCSS, secondaryOutcomes measure: TFBUT, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AJU Pharm Co., Ltd., status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: JUNGMIN LEE, role: CONTACT, phone: +82-02-2630-0700, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06291181, orgStudyIdInfo id: Soh-Med-24-01-05MD, briefTitle: Studying the Distribution of Accessory Gene Regulator (Agr) Quorum Sensing System and the Prevalence of Linezolid and Mupirocin Resistance in Biofilm Producer/Non Producer Staphylococcus Aureus in Sohag University Hospitals, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Staphylococcus aureus is an important pathogen causing a wide spectrum of infections . The organism usually colonizes the skin and mucous of humans and several animal species. Multiple body sites can be colonized in humans, however, the anterior nares of the nose are the most frequent carriage site for S. aureus. Other sites for carriage include the skin, perineum, and pharynx . It has been shown that there is an increased prevalence of staphylococcus infections, which may be attributed to its carriage in anterior nares and hands of health care workers and patients .The pathogenic mechanisms enabling S. aureus to cause serious infections could include: biofilm which protects organisms from host immune response; opsonophagocytosis and antimicrobial agents, thus leading to chronic and persistent infections.Antibiotic resistance associated with S.aureus infections is a great concern for the clinicians to prevent spread of infections. Methicillin was commonly used for these infections before the emergence of MRSA which is developed due to irrational use of antibiotics, prolonged hospital stay, nasal and hand carriage in health care staff. Also vancomycin, linezolid and mupirocin are used in treating infections,as well as decolonization of carriers .Mupirocin act by inhibiting the protein synthesis of bacteria by binding specifically to isoleucyl-tRNAsynthetase enzyme. The irrational use of Mupirocin among patients and its carriage in health care staff has led to the emergence of resistance to this antibiotic. .MupA, plasmid mediated gene, has a great role in mupirocinresistence as it had a supplementary modified isoleucyltRNAsynthetase which leads to the high level resistance to Mupirocin. The mupA gene has the ability to facilitate and disseminate the resistance mechanism in different patterns .Linezolid,thefirstoxazolidinonedrug,waslaunchedin2001andis still displaying excellent in vitro activity against Staphylococcus epidermidis on a global scale,although outbreaks of linezolidresistant S. epidermidis (LRSE) are occasionally reported..Linezolid resistance is mediated by, mutations in the 23S rRNA gene, altering the drug-binding site, and/or the 50S ribosomal proteins L3, L4 and L22, impairing linezolid binding;,Oracquisition of the primarily plasmid-encoded genes cfr, encoding a methyltransferase, or optrA, encoding an ABC transporter, or the cfr homologues cfr(B) and cfr(C).While cfr can mediate the PhLOPSA phenotype (resistance to phenicols, lincosamides,oxazolidinones, pleuromutilins and streptogramin A compounds), optrA confers oxazolidinone and phenicolresistance only..Pathogenecity of S. aureus is regulated by various factors ,one of them is the accessory gene regulatory (agr) system. It consists of 2 divergently transcribed loci (3 kb) controlled by means of 2 promoters P2 and P3. Most of clinical isolates of acute infections have a functional agr system and all, like strains, produce RNAIII in vitro and in vivo.Agr deficiency has been related to increased biofilm formation because RNAIII reduces the expression of surface adhesins and increases the production of capsule, toxins, and proteases. The agr system is supposed to regulate over 70 genes, 23 of which are renowned virulence factors.There are 2 classes of virulence factors regulated by agr. The first class includes virulence factors implicated in attachment to the host and immune evasion, whereas the second class contains genes engaged in the production of exoproteins related to invasion and toxin production . The activation of the agr system switches the bacterium from an adhesive, colonizing commensal into an invasive and aggressive pathogen(Roux A et al; 2009).Major virulence factors in S. aureus, exfoliative toxins (ETs), toxic shock syndrome toxin (TSST-1), and staphylococcal enterotoxins (SEs) are involved in host colonization, invasion of damaged skin and mucus, gastrointestinal infection, and prevarication of host defense mechanisms. Indeed, agr operon including agrA, agrB, agrC, and agrD genes regulate over 70 genes in S. aureus 23 of which control its pathogenicity and invasive infections .Moreover, S. aureus can be stratified into 4 different groups (agr I, agr II, agr III, and agr IV) according to the sequences of agrC (auto inducing peptide) and agrD (cyclic AIP) genes. It is stated that agr types are different in their properties and prevalence in various geographical areas thus, identification of predominant types in each region may well be functional ., conditionsModule conditions: Staphylococcus Aureus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 265, type: ACTUAL, armsInterventionsModule interventions name: antibiotic sensitivity test, outcomesModule primaryOutcomes measure: resistence of staphylococci to mupirocin and linezolid antibiotics, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university Hospital, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06291168, orgStudyIdInfo id: CMT002, briefTitle: Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain, acronym: CTESMYCLBP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: SEFA HAKTAN HATIK, class: OTHER, descriptionModule briefSummary: The aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain., conditionsModule conditions: Low Back Pain, conditions: Spinal Manipulation, conditions: Yoga, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The 60 participants will be divided into three groups. These groups will be randomly divided into three groups as chiropractic manipulation group (n=20), yoga-based exercise group (n=20) and conventional exercise group (control group) (n=20). Exercise programs will be performed under the supervision of a physiotherapist. Chiropractic manipulation will be applied to the lumbar region and sacroiliac joint in the side lying position. Data will be analyzed in SPSS 29.0 IBM program. Kruskal-Wallis H test will be used for difference analysis between groups, Kruskal-Wallis H test will be used for comparisons between groups by taking the differences between measurement times and the significance level will be determined as p\<0.05., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chiropractic Manipulation (HVLA - High Velocity Low Amplitude), interventions name: Yoga-Based Exercise Program, interventions name: Conventional Exercises, outcomesModule primaryOutcomes measure: Numeric Rating Scale (NRS), primaryOutcomes measure: Roland-Morris Disability Questionnaire, primaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), primaryOutcomes measure: Range of Motion (ROM), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06291155, orgStudyIdInfo id: HUM00222335, briefTitle: Renal Mechanism of SGLT2 Inhibition, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: University of Colorado, Denver, collaborators name: Renal Pre-Competitive Consortium (RPC3), descriptionModule briefSummary: The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study:Consent and Screening:* Laboratory tests to determine baseline health* Ultrasound to measure kidney size and ensure presence of 2 functioning kidneysMonth 0:* Study entry kidney MRI (day 0)* Study entry kidney biopsy (within 30 days of MRI)* Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supplyMonth 3:* Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication* Review of systemsMonth 6:* Follow-up kidney MRI* Follow-up kidney biopsyStudy participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs).Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples., conditionsModule conditions: Type 2 Diabetes, conditions: Diabetic Kidney Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an open-label, non-randomized mechanistic trial of an FDA-approved drug, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: SGLT2 inhibitor, outcomesModule primaryOutcomes measure: Glomerular basement membrane (GBM) width and mesangial expansion, secondaryOutcomes measure: Kidney Transcript Changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Chrysta C Lienczewski, BS, role: CONTACT, phone: 734-615-5021, email: [email protected], contacts name: Markus Bitzer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False |
protocolSection identificationModule nctId: NCT06291142, orgStudyIdInfo id: R129030, secondaryIdInfos id: IRAS 315004, type: OTHER, domain: IRAS, briefTitle: Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-22, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Manchester, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, collaborators name: Royal Bolton Hospital NHS Foundation Trust, collaborators name: Alder Hey Children's NHS Foundation Trust, collaborators name: University Hospitals of Morecambe Bay NHS Trust, collaborators name: Stockport NHS Foundation Trust, collaborators name: Medway NHS Foundation Trust, collaborators name: Northern Care Alliance NHS Foundation Trust, collaborators name: Royal Free Hospital NHS Foundation Trust, descriptionModule briefSummary: The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:* Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?* Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report* Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report., conditionsModule conditions: Systemic Sclerosis, conditions: Raynaud Phenomenon, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Observation - Nailfold capillaroscopy, outcomesModule primaryOutcomes measure: Pilot Image Acquisition, secondaryOutcomes measure: Qualitative Feedback, secondaryOutcomes measure: Skin tone sub-study data set, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Care Alliance NHS Foundation Trust, city: Salford, zip: M6 8HD, country: United Kingdom, geoPoint lat: 53.48771, lon: -2.29042, hasResults: False |
protocolSection identificationModule nctId: NCT06291129, orgStudyIdInfo id: CAAE: 61347422.4.0000.5626, briefTitle: Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-10-30, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Universidade Federal Fluminense, class: OTHER, descriptionModule briefSummary: Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test., conditionsModule conditions: Gingivitis, conditions: Periodontal Diseases, conditions: Diabetes, conditions: Diabetes Mellitus, Type 1, conditions: Malocclusion, conditions: Malocclusion in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Periodontal therapy, outcomesModule primaryOutcomes measure: Bleeding on probing, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universidade Federal Fluminense, city: Nova Friburgo, state: Rio De Janeiro, zip: 28625650, country: Brazil, geoPoint lat: -22.28194, lon: -42.53111, hasResults: False |
protocolSection identificationModule nctId: NCT06291116, orgStudyIdInfo id: 2022/0345/HP, briefTitle: Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease, acronym: ETERNAL-PKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2029-05-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2. Patients develop renal cysts with progressive impairment of renal function leading to renal failure. terminal renal failure for 1/3 of them. These patients also present early with high blood pressure and cardiovascular complications, notably intracerebral aneurysms. This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions.Experimental results suggested that stimulation of dopamine receptor type 5 (DR5) could restore the mechanosensitivity of endothelial cells, a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD. through restoration of endothelial NO release upon increased blood flow. Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine, a dopamine agonist administered via transdermal patches for 2 months at a low dose (4 mg/24h).Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels.This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact., conditionsModule conditions: Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: standard care + rotigotine at 4 mg/24h for 24 months., interventions name: standard care for 24 months., outcomesModule primaryOutcomes measure: Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06291103, orgStudyIdInfo id: 2022/0342/HP, briefTitle: Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R), acronym: BELA-M-R, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2031-03-01, completionDateStruct date: 2031-03-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and/or proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, we published a retrospective multicenter study within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI \> 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, we did not observe any effect of standard of care treatment in active sABMR. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. They concluded the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, we propose to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.The monitoring of dnDSA after KT and an indication graft biopsy in case of appearance, even in the absence of graft dysfunction, is not part of a routine clinical practice in all KT centers. This strategy could be a valuable option, in order to begin treatment of ABMR before graft dysfunction occurs, and therefore to improve prognosis associated with phenotype 2 ABMR. Parajuli et al.4 suggested that early diagnosis and treatment of sABMR with SOC, using DSA monitoring may improve outcomes after KT, but this is a retrospective and no-randomized study. This study will be the first prospective randomized study in the context of de novo DSA. We will evaluate a new combination of treatment for ABMR in the context of dnDSA with subclinical lesions and in the same time may help to determine the real incidence of sABMR in KT recipients with subclinical dnDSA. The use of belatacept in the context of sABMR to improve the non-adherence and to decrease the endothelial toxicity had never been evaluated in a prospective way., conditionsModule conditions: Kidney Transplant Rejection, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: Conversion to Belatacep, interventions name: Standard of care treatment (SOC regimen) with Tacrolimus, outcomesModule primaryOutcomes measure: The efficacy of belatacept combined with standard of care, compared to calcineurin inhibitors (CNI) combined with standard of care, among kidney transplant recipients with sABMR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06291090, orgStudyIdInfo id: 22-0789, secondaryIdInfos id: K08DA049905, type: NIH, link: https://reporter.nih.gov/quickSearch/K08DA049905, briefTitle: A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-18, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This intervention will be implemented across 12 hospitals, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: OUD treatment intervention, outcomesModule primaryOutcomes measure: Change in buprenorphine prescribing at hospital discharge, secondaryOutcomes measure: Change in rates of methadone prescribing during hospitalization, otherOutcomes measure: Change in average (mean) COWS score over time, otherOutcomes measure: Change in naloxone prescribing at hospital discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medicl Campus, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Susan L Calcaterra, MD, role: CONTACT, phone: 248-703-5947, email: [email protected], geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06291077, orgStudyIdInfo id: 2021/0391/HP, briefTitle: Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>, acronym: BELAFENDO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2028-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Kidney transplantation is the standard treatment for patients with end-stage renal failure.However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a major cause of premature death in these patients. They play an important role in the occurrence of endothelial dysfunction and increased arterial stiffness by decreasing the synthesis of nitric oxide (NO), promoting intrarenal arterial vasoconstriction and stimulating the production of pro-inflammatory cytokines. leading to the development of hypertension and chronic graft dysfunction.Belatacept, a more recently developed immunosuppressant and co-stimulation signal inhibitor, has shown an anti-rejection effect similar to cyclosporine with a better cardiovascular tolerance profile. Preliminary studies are contradictory on the influence of Belatacept on arterial stiffness. Furthermore, to date, no study has evaluated the impact of Belatacept on vasomotor endothelial function in humans, an indicator of NO bioavailability. The interest of this study is to demonstrate that patients taking Belatacept have an improvement in vascular function compared to patients taking anticalcineurins in order to consider an earlier change in immunosuppressive strategy in the event of vascular damage., conditionsModule conditions: Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Belatacept, interventions name: anticalcineurins, outcomesModule primaryOutcomes measure: Replacement of anticalcineurins with Belatacept in kidney transplant patients allows an improvement in the endothelium-dependent dilation of peripheral conductance arteries, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06291064, orgStudyIdInfo id: IRB23-0678, briefTitle: Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer, acronym: TARMAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2032-06, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis., conditionsModule conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Cyclophosphamide, interventions name: Epirubicin, interventions name: Docetaxel, interventions name: Carboplatin, interventions name: Breast Surgery, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast), primaryOutcomes measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes), primaryOutcomes measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage), secondaryOutcomes measure: Side Effects of the Study Pre-surgery Chemotherapy Regimen, secondaryOutcomes measure: Clinical Response, secondaryOutcomes measure: Progressive Disease, secondaryOutcomes measure: Invasive Disease Free Survival (iDFS), secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06291051, orgStudyIdInfo id: 2021/0382/HP, briefTitle: Evaluation of the Safety of Electrical Spinal Cord Stimulation in Parkinson's Patients Presenting With Painful Camptocormia, acronym: CAMPTOSTIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2028-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Camptocormia is defined by abnormal flexion of the trunk, not fixed, present when standing and walking, resolves when lying down and often complicated by lower back pain. It can be observed in numerous neurological pathologies with a prevalence ranging between 5 and 19% in Parkinson's disease. The physiopathology of camptocormia associated with PD is not completely elucidated, however several mechanisms are discussed, including muscular hypertonia, abdominal muscle dystonia, proprioceptive deficit, iatrogenics linked to dopamine agonists, and focal myopathy. Although its impact is major and greater than the main symptoms of the disease, no specific treatment has been the subject of a marketing authorization request in this indication. Its management remains difficult and usually consists of: adjusting the antiparkinsonian treatment, reducing or even eliminating dopamine agonists, resorting to botulinum toxin injections and rehabilitation, sometimes with the use of a corset. However, the results observed are most often disappointing. The benefit of more invasive techniques, such as deep brain stimulation, classically proposed in advanced forms at the stage of motor complications of PD, is discussed by certain authors. Numerous studies thus suggest that bilateral stimulation of the NST could have a significant but moderate beneficial effect on postural disorders associated with PD, in particular on camptocormia. Likewise, the results of a retrospective study recently conducted in 36 Parkinson's patients discuss the effectiveness of bi-pallidal stimulation. Furthermore, surgical interventions by arthrodesis remain invasive and cause more frequent complications in Parkinson's patients with camptocormia compared to patients with isolated degenerative spinal pathology.Electrical spinal cord stimulation (ESS) is a validated technique in the management of chronic neuropathic pain. Several publications suggest that it could be effective on postural disorders in PD. Thus, authors report the case of a Parkinson's patient afflicted with painful camptocormia refractory to drug treatments and deep brain stimulation who benefited from EMS with a remarkable effect on pain, walking and posture. This observation is corroborated by data collected in 3 Parkinson's patients with camptocormia subjected to EMS with a beneficial effect on painful and motor symptoms. The mechanism of action could be linked to the correction of the proprioceptive deficit via ascending stimulation of the basal ganglia. On the other hand, the effectiveness of repetitive spinal cord magnetic stimulation was evaluated in a study carried out in 37 patients with camptocormia associated with PD., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Electrical spinal cord stimulation, outcomesModule primaryOutcomes measure: Evaluation of the safety of electrical spinal cord stimulation in Parkinson's patients with painful camptocormia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06291038, orgStudyIdInfo id: 2021/0381/HP, briefTitle: Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability, acronym: MISSISIIPI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2029-03-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).Our working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric; prospective; randomized; double blind; interregional, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: double blind, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks, interventions name: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks., outcomesModule primaryOutcomes measure: Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06291025, orgStudyIdInfo id: 2021/0374/HP, briefTitle: Efficacy and Safety of Immunosuppression, Caplacizumab and Plasma Infusion Without Therapeutic Plasma Exchange in Immune-mediated Thrombotic Thrombocytopenic Purpura: Multicentric Non-inferiority Single-arm Study, acronym: PEX-FREE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Immune thrombotic thrombocytopenic purpura (iTTP) is caused by a severe, autoantibody-mediated deficiency of ADAMTS13 leading to an accumulation of ultra-large von Willebrand factor multimers in plasma and finally to microthrombi in blood vessels. The current standard of care of iTTP consists in the triple association of daily plasma exchange (PEX, 60 ml/kg/day), immunosuppressive agents and anti-adhesive treatment (Caplacizumab). Our group recently reported the outcome of 90 patients with iTTP treated with this triple association and when compared to historical patients, the triplet regimen prevented death, refractoriness and exacerbations. Likewise, plasma volumes were reduced by 2 to 3-fold and we could reduce the median number of PEX sessions from 13 to 6. PEX is an invasive and time-consuming procedure, associated with catheter and plasma-related complications ranging from 22% to 30%. Consequently, to alleviate the burden of care in iTTP, using a regimen without PEX would represent a major and topical goal. Attempts to treat patients with plasma infusion (PI) without PEX were previously reported and provided evidence that large volumes of PI (20-30 ml/kg/day) improved the initial outcome of iTTP. However, fluid overload occurred in most cases after 5-7 days, limiting the feasibility of this strategy. Nevertheless, the recent availability of caplacizumab opens the perspective of treating patients with plasma for a shorter period. Recently, strategies without PEX have been carried out in Jehovah's Witnesses with iTTP \[5\]. Impressively, improvement was rapid and comparable to those provided with a standard PEX-based treatment. Additionally, a treatment combining caplacizumab and immunosuppression only was successfully performed in six iTTP patients with severe neurologic and/or cardiac involvement. The rapid and durable improvement provides evidence that a regimen without plasma seems feasible. However, we consider that robust data are still lacking to completely remove plasmatherapy from iTTP management. Based on these statements, we wish here to address the efficacy and safety of a PEX-free regimen, combining PI only (15 ml/kg/day), corticosteroids/rituximab, and caplacizumab., conditionsModule conditions: Thrombotic Microangiopathies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This trial is prospective, non-comparative, non-inferiority, single-arm, multicentric, national., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 131, type: ESTIMATED, armsInterventionsModule interventions name: PEX-FREE, outcomesModule primaryOutcomes measure: To evaluate the efficacy of a PEX-FREE regimen in adults with iTTP as assessed by the proportion of participants day-30 post-plasma therapy death, refractoriness, exacerbation or an ADAMTS13 activity < 20%., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06291012, orgStudyIdInfo id: RECHMPL22_0399, secondaryIdInfos id: 2024-512236-30-00, type: REGISTRY, domain: EUCT Number, briefTitle: Stopping Pneumonia Antibiotherapy Regimen Early, acronym: SPARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: Direction Générale de l'Offre de Soins, descriptionModule briefSummary: The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days., conditionsModule conditions: Community-acquired Pneumonia, conditions: Child, Only, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The randomization will be carried out by minimization with stratification on the investigating center and age (\< 1 year and ≥ 1 year), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Quick response: Amoxicillin for 3 days, interventions name: Delayed response: Amoxicillin for 5 days, interventions name: Quick response: Amoxicillin for 5 days, interventions name: Delayed response: Amoxicillin for 7 days, outcomesModule primaryOutcomes measure: Therapeutic failure rate D7, secondaryOutcomes measure: Therapeutic failure rate on D30, secondaryOutcomes measure: Adverse effects, secondaryOutcomes measure: Compliance, secondaryOutcomes measure: Duration of antibiotic therapy, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: CHU de Montpellier, city: Montpellier, zip: 34295, country: France, contacts name: Sarah DUTRON, MD, role: CONTACT, contacts name: Sarah DUTRON, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eric JEZIORSKI, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False |
protocolSection identificationModule nctId: NCT06290999, orgStudyIdInfo id: CHUBX 2023/80, briefTitle: Study of Multifrequential Impedancemetry in Pulsatile Tinnitus, acronym: MADMAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus., conditionsModule conditions: Pulsatile Tinnitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: multifrequential admittancemetry, outcomesModule primaryOutcomes measure: Multifrequency admittancemetry, secondaryOutcomes measure: compression maneuvers, secondaryOutcomes measure: Evaluation of the effect of interventional radiology, secondaryOutcomes measure: success of radiointerventional treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bordeaux University Hospital, city: Bordeaux, zip: 33000, country: France, contacts name: Balthazar CROC, role: CONTACT, email: [email protected], contacts name: Valérie FRANCO-VIDAL, Pr, role: CONTACT, phone: 0556795609, email: [email protected], geoPoint lat: 44.84044, lon: -0.5805, hasResults: False |
protocolSection identificationModule nctId: NCT06290986, orgStudyIdInfo id: Pyrocardan® RCT, briefTitle: Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-26, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Herlev and Gentofte Hospital, class: OTHER, descriptionModule briefSummary: This is a randomized controlled trial comparing the Pyrocardan® implant (intervention group) with the standard ligament reconstruction and tendon interposition (LRTI) (control group). All Danish citizens with osteoarthritis of the thumb carpometacarpal joint referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be considered for participation in the trial. The following exclude from participation in the study: Below 40 years of age; cognitive or linguistic impairment; osteoarthritis of other carpal bones; previous surgery in the carpometacarpal joint; patients with rheumatoid arthritis. A total of 64 patients will be included. The primary outcome is the patient reported outcomes questionnaire; Quick-DASH. The secondary outcomes are patient-reported outcomes, functional outcomes, radiographic outcomes, readmission, complications, revisions. The patients are examined before surgery and 3, 6, 12 and 24 months after the operation. The patients are also contacted after 5 and 10 years., conditionsModule conditions: CMC-1 Osteoarthritis, conditions: Trapeziometacarpal Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Pyrocardan® implant, interventions name: Ligament reconstruction and tendon interposition (LRTI), outcomesModule primaryOutcomes measure: Patient-reported outcome: QuickDASH, secondaryOutcomes measure: Patient-reported outcome, secondaryOutcomes measure: Strength measurements, secondaryOutcomes measure: Radiographs, secondaryOutcomes measure: Return to occupation, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Herlev and Gentofte Hospital, status: RECRUITING, city: Hellerup, zip: 2900, country: Denmark, contacts name: Jens Jørgsholm, MD, role: CONTACT, phone: +4551339705, email: [email protected], contacts name: Rasmus Wejnold Jørgensen, MD, PhD, role: CONTACT, phone: +4538673315, email: [email protected], geoPoint lat: 55.73204, lon: 12.57093, hasResults: False |
protocolSection identificationModule nctId: NCT06290973, orgStudyIdInfo id: PI-23-3017, briefTitle: Quality of Life and Health Perception After Surgery of Varicose Veins, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-11-14, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Hospital Clínico Universitario de Valladolid, class: OTHER, descriptionModule briefSummary: The aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score VCSS and QoL scores SF12 as general health questionary and Veines QoL/Sym as disease specific questionary., conditionsModule conditions: Quality of Life, conditions: Varicose Veins, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: surgery of varicose veins, outcomesModule primaryOutcomes measure: changes in qol questionarie SF-12 after surgery of varicose veins, primaryOutcomes measure: changes in qol questionarie Veines QoL/Sym after surgery of, secondaryOutcomes measure: changes in VCSS after surgery of varicose veins, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital CLínico Universitario de Valladolid, city: Valladolid, country: Spain, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False |
protocolSection identificationModule nctId: NCT06290947, orgStudyIdInfo id: BFR-AE-DT2-2023-01, secondaryIdInfos id: IRB 2022/C/20/N, type: OTHER_GRANT, domain: AAUP, briefTitle: BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes, acronym: BRAID, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-06, primaryCompletionDateStruct date: 2023-12-20, completionDateStruct date: 2024-01-08, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Arab American University (Palestine), class: OTHER, descriptionModule briefSummary: This clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D).The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in individuals with Type 2 Diabetes (T2D).Whether Blood-Flow Restriction Walk Training (BFRw) enhances aerobic capacity in individuals with Type 2 Diabetes (T2D).Participants in the study are divided into two groups. One group undergoes Blood-Flow Restriction Walk Training (BFRw), and the other serves as a control. Both groups attend three treadmill walking sessions weekly for eight weeks. The BFRw group has a restriction cuff placed around both thighs during their sessions, while the control group participates in the walking sessions without any blood flow restriction.Hemoglobin A1c (HbA1c) levels and maximal oxygen consumption (VO2 max) are monitored as indicators of insulin sensitivity and aerobic capacity, respectively., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study employs a randomized controlled trial model with a parallel assignment to evaluate the efficacy of Blood-Flow Restriction Walk Training compared to a control condition. Participants are randomly allocated into two groups: one receiving the intervention (BFR walk training) and the other serving as a control (usual walk training). This design allows for the direct comparison of outcomes between the intervention and control groups over the study period., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: None (Open Label), enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: BFR Cuffs for Intervention Group, interventions name: Standard Walking Training Program, outcomesModule primaryOutcomes measure: Improvement in Insulin Sensitivity, primaryOutcomes measure: Improvement in Aerobic Capacity, secondaryOutcomes measure: Change in Body Mass Index (BMI), eligibilityModule sex: MALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arab American University - Palestine, city: Jenin, zip: P.O Box 24, country: Palestinian Territory, occupied, geoPoint lat: 32.45943, lon: 35.30086, hasResults: False |
protocolSection identificationModule nctId: NCT06290934, orgStudyIdInfo id: GS-US-409-5704, secondaryIdInfos id: 2023-508304-38, type: OTHER, domain: European Medicines Agency, briefTitle: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis, acronym: SWIFT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Gilead Sciences, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).The primary objectives of this study are:Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12, conditionsModule conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 423, type: ESTIMATED, armsInterventionsModule interventions name: GS-1427, interventions name: Ustekinumab, interventions name: Placebo-to-match GS-1427, outcomesModule primaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Clinical Response at Week 24, secondaryOutcomes measure: Parts 1 and 2: Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths., secondaryOutcomes measure: Parts 1 and 2: Incidence of Treatment-emergent Lab Abnormalities, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Remission at Week 12, secondaryOutcomes measure: Part 1: Proportion of Participants Achieving Clinical Remission at Week 52, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Clinical Remission at Week 24, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Partial Modified Mayo Score Remission at Week 52, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 24, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Mucosal Healing at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Mucosal Healing at Week 24, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Endoscopic Improvement at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Endoscopic Improvement at Week 24, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Om Research LLC, status: RECRUITING, city: Camarillo, state: California, zip: 93010, country: United States, geoPoint lat: 34.21639, lon: -119.0376, locations facility: VVCRD Research, status: RECRUITING, city: Garden Grove, state: California, zip: 92845, country: United States, geoPoint lat: 33.77391, lon: -117.94145, locations facility: Om Research LLC, status: RECRUITING, city: Lancaster, state: California, zip: 93534, country: United States, geoPoint lat: 34.69804, lon: -118.13674, locations facility: United Medical Doctors, status: RECRUITING, city: Murrieta, state: California, zip: 92563, country: United States, geoPoint lat: 33.55391, lon: -117.21392, locations facility: Encore Medical Research. LLC, status: RECRUITING, city: Hollywood, state: Florida, zip: 33021, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Encore Medical Research of Weston, LLC, status: RECRUITING, city: Weston, state: Florida, zip: 33331, country: United States, geoPoint lat: 26.10037, lon: -80.39977, locations facility: Clinical Research Institute of Michigan, LLC., status: RECRUITING, city: Chesterfield, state: Michigan, zip: 48047, country: United States, geoPoint lat: 42.66281, lon: -82.84242, locations facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center., status: RECRUITING, city: Wyoming, state: Michigan, zip: 49519, country: United States, geoPoint lat: 42.91336, lon: -85.70531, locations facility: Quality Medical Research, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37211, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Southwest Clinical Trials, status: RECRUITING, city: Houston, state: Texas, zip: 77074, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Southern Star Research Institute, LLC., status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Tyler Research Institute, LLC., status: RECRUITING, city: Tyler, state: Texas, zip: 75701, country: United States, geoPoint lat: 32.35126, lon: -95.30106, hasResults: False |
protocolSection identificationModule nctId: NCT06290921, orgStudyIdInfo id: 3472, briefTitle: Ovulation Triggering 2 vs 3 Follicles, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Clinique Ovo, class: INDUSTRY, descriptionModule briefSummary: Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists. Although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one IVF cycle. Traditionally, IVF cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (IUI) due to the low pregnancy rates associated with these cycles. The minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. This retrospective quality control study aims to compare pregnancy rates in IVF cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles., conditionsModule conditions: Infertility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Ovulation triggering, outcomesModule primaryOutcomes measure: Clinical Pregnancy Rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 42 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinique Ovo, city: Montréal, state: Quebec, zip: H4P 2S4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06290908, orgStudyIdInfo id: TF2018-001-01, briefTitle: RPE-P/TLIF for Lumbar Spinal Stenosis With Instability, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-09-04, primaryCompletionDateStruct date: 2022-04-30, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Wen-xi Sun, class: OTHER, collaborators name: Guangdong Provincial Hospital of Traditional Chinese Medicine, descriptionModule briefSummary: Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films., conditionsModule conditions: Spinal Stenosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: RPE-P/TLIF, outcomesModule primaryOutcomes measure: Pain visual analog scale (VAS), secondaryOutcomes measure: Oswestry disability index (ODI), secondaryOutcomes measure: MacNab criteria, secondaryOutcomes measure: intervertebral space height, secondaryOutcomes measure: lumbar physiological curvature, secondaryOutcomes measure: fusion rate, secondaryOutcomes measure: pedicle screw accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial Hospital of Traditional Chinese Medicine, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06290895, orgStudyIdInfo id: 3465, briefTitle: Artificial Oocyte Activation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-19, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Clinique Ovo, class: INDUSTRY, descriptionModule briefSummary: Studies reported that calcium signal deficiency or insufficiency during oocyte activation are related with embryo arrest and blastocyst quality. The utilization of Artificial Oocyte Activation (AOA) is safe and does not increase birth defects, cognition, language and motor skills. AOA is the first line of treatment in patients with globozoospermia (round headed spermatozoa). Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists and comprises about 10-15% of patients undergoing controlled ovarian hyperstimulation. The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. The European Society of Human and REproduction (ESHRE) recommends AOA in cases with failed fertilization/ low fertilization., conditionsModule conditions: Infertility, conditions: Ovarian Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: women having had a second IVF cycle with AOA, outcomesModule primaryOutcomes measure: Blastocyst rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 42 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinique Ovo, city: Montréal, state: Quebec, zip: H4P 2S4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06290882, orgStudyIdInfo id: ERMA trial, briefTitle: Endoscopic Versus Robotic Myotomy for Treatment of Achalasia, acronym: ERMA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Germans Trias i Pujol Hospital, class: OTHER, descriptionModule briefSummary: Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of the esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms of this pathology. Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world. In recent years, a large amount of data examining the effectiveness of POEM have appeared, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90%. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment of these patients. According to these data, it seems that the two procedures offer the same clinical results in the medium term. On the other hand, in recent years, there has been a growing expansion of the application of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as an alternative minimally invasive approach to traditional laparoscopy with a lower complication rate. Based on the evidence, POEM and RHM could have comparable results in short term, but there is no clear certainty about the results in medium-long term. Likewise, there is a lack of studies that confirm postoperative reflux results in both procedures.The purpose of the study is to evaluate the clinical and quality of life results of the RHM and compare them with the results of POEM in treatment of achalasia., conditionsModule conditions: Achalasia Cardia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ACTUAL, armsInterventionsModule interventions name: Robotic Heller Myotomy, interventions name: Peroral Endoscopic Myotomy, outcomesModule primaryOutcomes measure: Eckhard symptom scores, secondaryOutcomes measure: GERD-Q score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elisenda Garsot Savall, city: Badalona, state: Barcelona, zip: 08016, country: Spain, geoPoint lat: 41.45004, lon: 2.24741, hasResults: False |
protocolSection identificationModule nctId: NCT06290869, orgStudyIdInfo id: STUDY00006070, briefTitle: Tobacco Education and Lung Health Study (TEAL), acronym: TEAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Georgetown University, class: OTHER, descriptionModule briefSummary: Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1188, type: ESTIMATED, armsInterventionsModule interventions name: Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention, interventions name: E-Referral to the Tobacco Quitline, outcomesModule primaryOutcomes measure: Biochemically verified smoking abstinence- MHS vs. QL-E arms, primaryOutcomes measure: Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care, secondaryOutcomes measure: self-reported smoking status, secondaryOutcomes measure: cigarettes per day, secondaryOutcomes measure: readiness to quit, secondaryOutcomes measure: Patient reach and patient engagement, secondaryOutcomes measure: Costs per arm from the health system perspective, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Georgetown University Medical Center, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20007, country: United States, contacts name: Kathryn L Taylor, PhD, role: CONTACT, phone: 202-215-9402, email: [email protected], geoPoint lat: 38.89511, lon: -77.03637, hasResults: False |
protocolSection identificationModule nctId: NCT06290856, orgStudyIdInfo id: 651397, briefTitle: Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, descriptionModule briefSummary: Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making., conditionsModule conditions: Metastatic Colorectal Cancer, conditions: Pancreas Adenocarcinoma, conditions: Cholangiocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Multiplex PCR-test for circulating tumor DNA, outcomesModule primaryOutcomes measure: Clinical validity of ctDNA tests, secondaryOutcomes measure: Resources needed for ctDNA assays in routine diagnostics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo university Hospital, status: RECRUITING, city: Oslo, country: Norway, contacts name: Ragnhild Nome, MD, PhD, role: CONTACT, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False |
protocolSection identificationModule nctId: NCT06290843, orgStudyIdInfo id: AWFiS/2024_1_PE, briefTitle: Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Gdansk University of Physical Education and Sport, class: OTHER, descriptionModule briefSummary: The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group., conditionsModule conditions: Idiopathic Scoliosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Schroth method, outcomesModule primaryOutcomes measure: Analysis of body balance on the AMTI force platform, primaryOutcomes measure: Analysis of body balance on the AMTI force platform, primaryOutcomes measure: Analysis of body balance on the AMTI force platform, primaryOutcomes measure: Analysis of body balance on the AMTI force platform, primaryOutcomes measure: Photographic analysis of body posture, primaryOutcomes measure: Analysis of x-ray in the frontal plane, primaryOutcomes measure: Analysis of x-ray in the frontal plane, primaryOutcomes measure: Analysis of x-ray in the frontal plane, primaryOutcomes measure: Analysis of x-ray in the frontal plane, primaryOutcomes measure: Analysis of x-ray in the sagittal plane, primaryOutcomes measure: Analysis of x-ray in the sagittal plane, eligibilityModule sex: FEMALE, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Gdansk University of Physical Education and Sport, city: Gdańsk, state: Pomorskie, zip: 80-336, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, hasResults: False |
protocolSection identificationModule nctId: NCT06290830, orgStudyIdInfo id: OMUŞükranBaşgöl01, briefTitle: Abdominal Massage and Kegel Exercises on Constipation and Quality of Life in Female Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data., conditionsModule conditions: Functional Constipation, conditions: Constipation, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Abdominal massage group, interventions name: Kegel Exercises group, interventions name: Both abdominal massage and kegel exercises to gether, outcomesModule primaryOutcomes measure: Constipation severity change, primaryOutcomes measure: Quality of Life change, primaryOutcomes measure: Bristol stool form score change, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290817, orgStudyIdInfo id: 2023-0724, briefTitle: Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2026-03-20, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, collaborators name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, collaborators name: Huizhou Municipal Central Hospital, collaborators name: Ningbo Medical Center Lihuili Hospital, collaborators name: Affiliated Hospital of Jiaxing University, collaborators name: The Second Affiliated Hospital of Jiaxing University, descriptionModule briefSummary: This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen., conditionsModule conditions: Diffuse Large B-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Orelabrutinib combined with R-CDOP regimen, outcomesModule primaryOutcomes measure: 2-year central nervous system relapse rate, secondaryOutcomes measure: Complete Response Rate, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: 2-year Overall survival (OS) rate, secondaryOutcomes measure: 1-year Overall survival (OS) rate, secondaryOutcomes measure: 2-year progression-free survival (PFS) rate, secondaryOutcomes measure: 1-year progression-free survival (PFS) rate, secondaryOutcomes measure: Occurrence of hematologic adverse events and non-hematologic adverse events according to CTCAE V4.03, otherOutcomes measure: Occurrence of adverse events and serious adverse events according to CTCAE V4.03, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, status: RECRUITING, city: Zhejiang, state: Zhejiang, country: China, contacts name: Wenbin Qian, role: CONTACT, contacts name: Xibin Xiao, role: SUB_INVESTIGATOR, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, country: China, contacts name: Lihong Shou, role: CONTACT, phone: 13362216921, email: [email protected], geoPoint lat: 30.8703, lon: 120.0933, locations facility: Affiliated hospital of Jiaxing University, the First Hospital of Jiaxing, status: RECRUITING, city: Jiaxing, country: China, contacts name: Hui Zeng, role: CONTACT, phone: 13957330440, email: [email protected], geoPoint lat: 30.7522, lon: 120.75, locations facility: Affiliated hospital of Jiaxing University, the Second Hospital of Jiaxing, status: RECRUITING, city: Jiaxing, country: China, contacts name: Beili Hu, role: CONTACT, phone: 0573-82080930, email: [email protected], geoPoint lat: 30.7522, lon: 120.75, locations facility: Ningbo Medical Center LiHuili Hospital, status: RECRUITING, city: Ningbo, country: China, contacts name: Jing Le, role: CONTACT, phone: 13566511755, email: [email protected], geoPoint lat: 29.87819, lon: 121.54945, locations facility: Taizhou Hospital of Zhejiang, status: RECRUITING, city: Taizhou, country: China, contacts name: Yiqun Guo, role: CONTACT, phone: 13515861286, email: [email protected], geoPoint lat: 32.49069, lon: 119.90812, hasResults: False |
protocolSection identificationModule nctId: NCT06290804, orgStudyIdInfo id: drezgiyucel0000000193593877, briefTitle: Assessing Sustainable Behaviors and Health Impacts of Climate Change, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, descriptionModule briefSummary: The relationship between climate change, sustainability and child health is complex and important. These three concepts are interacting factors and have significant impacts on children's health. Sustainability measures are vital to protect child health by mitigating the impacts of climate change. At the same time, children's education and awareness is an important factor that will contribute to future generations living in a sustainable world. As a society, tackling climate change and striving for a sustainable future is crucial to ensure that children live healthy and safe lives. The aim of this study is to evaluate the effectiveness of the education program and educational videos to be applied to children in terms of environmentally sustainable behaviors and awareness of the health effects of climate change in 60-72-month-old children studying in Eskişehir Odunpazarı Municipality Day Care Center and Nurseries. In addition, in this study, it was aimed to measure the level of global climate change awareness of parents and to evaluate the relationship with children's environmentally sustainable behaviors., conditionsModule conditions: Climate Change, conditions: Child Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: education, outcomesModule primaryOutcomes measure: increasing sustainable behaviors, primaryOutcomes measure: raising awareness of the health impacts of climate change, primaryOutcomes measure: raising awareness of global climate change, eligibilityModule sex: ALL, minimumAge: 60 Months, maximumAge: 72 Months, stdAges: CHILD, contactsLocationsModule locations facility: Ezgi Yücel, city: Odunpazarı, state: Eskişehir, zip: 553 723 43 57, country: Turkey, geoPoint lat: 39.76821, lon: 30.53538, hasResults: False |
protocolSection identificationModule nctId: NCT06290791, orgStudyIdInfo id: K2020214, briefTitle: Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery?, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-31, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis., conditionsModule conditions: Drain Tube Influence the Postoperative Epidural Haematoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 89, type: ACTUAL, armsInterventionsModule interventions name: two level lumbar decompression with BESS procedure received one drain., interventions name: two level lumbar decompression with BESS procedure received two drain., outcomesModule primaryOutcomes measure: the cross-sectional area of POSEH, secondaryOutcomes measure: the volume of drain output, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhonglin Zhong, city: Yiwu, state: Zhejiang, zip: 322000, country: China, geoPoint lat: 29.31506, lon: 120.07676, hasResults: False |
protocolSection identificationModule nctId: NCT06290778, orgStudyIdInfo id: Baylor IRB #023-445, briefTitle: Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees, acronym: PEER UP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Baylor Research Institute, class: OTHER, collaborators name: University of Pittsburgh, collaborators name: Boston University, collaborators name: Texas A&M University, descriptionModule briefSummary: The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?* Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?Participants will:* Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.* Complete a questionnaire and clinical interview prior to the workshop.* Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms., conditionsModule conditions: PTSD, conditions: Alcohol Use Disorder, conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Brief Unified Protocol, interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: PTSD Symptoms, secondaryOutcomes measure: Alcohol Use Disorder symptoms, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Functional Impairment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290765, orgStudyIdInfo id: A23-401, briefTitle: Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera, acronym: PV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: PharmaEssentia, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks)., conditionsModule conditions: Polycythemia Vera, conditions: Myeloproliferative Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Ropeginterferon alfa-2b, interventions name: Phlebotomy, outcomesModule primaryOutcomes measure: The proportion of patients with treatment response evaluated. Treatment response is defined as the maintenance of the median HCT values <45% over time, without progression of disease, and no need of any extra-protocol cytoreductive drugs., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290752, orgStudyIdInfo id: KY-2024-030, briefTitle: Determining the Learning Curve for Ultrasound-guided Caudal Epidural Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: mastering ultrasound-guided sacral canal block entails traversing a multifaceted learning curve characterized by anatomical intricacies, technical challenges, and patient variability. Through systematic education, deliberate practice, and clinical experience, clinicians can ascend this learning curve and harness the full potential of this innovative technique in pain management. As the landscape of regional anesthesia continues to evolve, a commitment to ongoing learning and proficiency attainment is paramount for delivering safe, effective, and patient-centered care., conditionsModule conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: PROSPECTIVE, enrollmentInfo count: 6, type: ESTIMATED, outcomesModule primaryOutcomes measure: operation time, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dongmei Ma, status: RECRUITING, city: Yiwu, state: Zhejiang, zip: 322000, country: China, contacts name: Zhu Xinqiang, role: CONTACT, phone: +8657989935052, geoPoint lat: 29.31506, lon: 120.07676, hasResults: False |
protocolSection identificationModule nctId: NCT06290739, orgStudyIdInfo id: JHuang886, briefTitle: A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-03-07, completionDateStruct date: 2024-03-27, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, conditions: Machine Learning, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: lymph nodes dissection, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: fengmin Luo, Doctor, role: CONTACT, phone: +86 028-85582944, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06290726, orgStudyIdInfo id: 202001927B0, briefTitle: Long-term Outcomes of Living Donor Liver Transplantations With Anti-HBc (+) Grafts in Pediatric Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2002-02, primaryCompletionDateStruct date: 2016-02, completionDateStruct date: 2024-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare in anti-HBc (+) grafts/ anti-HBc (-) grafts. The main question it aims to answer is the long-term efficacy of active vaccination and graft/patient outcomes of anti-HBc (+) grafts have yet to be comprehensively investigated. Researchers will compare anti-HBc (+) grafts/ anti-HBc (-) to see if it would affect the long-term survival., conditionsModule conditions: Living Donor Liver Transplantations With Anti-HBc (+) Grafts, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 204, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Long-term survival in pediatric recipients of living donor liver transplantations with anti-HBc (+) grafts, eligibilityModule sex: ALL, minimumAge: 4 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06290713, orgStudyIdInfo id: IRB202301491, secondaryIdInfos id: 1R21AR079755-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21AR079755-01, secondaryIdInfos id: PRO00050023, type: OTHER, domain: UFIRST, briefTitle: Vasodilator and Exercise Study for DMD (VASO-REx), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, collaborators name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), descriptionModule briefSummary: Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment., conditionsModule conditions: Duchenne Muscular Dystrophy, conditions: Duchenne Disease, conditions: Muscular Dystrophy, conditions: Muscular Dystrophy in Children, conditions: Vasodilation, conditions: Exercise, conditions: DMD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are assigned to receive interventions based on their completion and results of Aim 1 (responsiveness to study drug). If participants are found to be Tadalafil-responsive after one dose, they will be included in Aim 2 of the study and will be asked to participate in the double-blinded, randomized, placebo-controlled longitudinal medication \& exercise 6-month study program., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Tadalafil, interventions name: Placebo, interventions name: Exercise Training, outcomesModule primaryOutcomes measure: Vascular responsiveness after muscle contraction to a single dose of tadalafil., primaryOutcomes measure: Cycling time to fatigue, secondaryOutcomes measure: Quadriceps muscle Fat Fraction, secondaryOutcomes measure: Metabolic recovery, secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Peak aerobic capacity (VO2max), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Minute Ventilation (VE), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Ventilatory Equivalent for Oxygen (VE/VO2), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Gas Exchange Threshold (GET), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Workload at Anaerobic Threshold (W at AT), secondaryOutcomes measure: The 100-meter timed test (100m), secondaryOutcomes measure: the North Star Ambulatory Assessment (NSAA), secondaryOutcomes measure: The 4-stair climb, secondaryOutcomes measure: The Physical activity questionnaire (PAQ-C), secondaryOutcomes measure: Pulmonary function testing - vital capacity (FVC), secondaryOutcomes measure: Pulmonary function testing - forced expiratory volume in 1 second (FEV1), secondaryOutcomes measure: Neurology Quality of Life (NeuroQoL) pediatric lower extremity function, secondaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS) pediatric fatigue, secondaryOutcomes measure: PROMIS parent proxy for physical activity, secondaryOutcomes measure: PROMIS pediatric physical activity, secondaryOutcomes measure: Physical Activity Monitoring - Daily Step Rate, secondaryOutcomes measure: Physical Activity Monitoring - Time in Low-Level Activity, secondaryOutcomes measure: Physical Activity Monitoring - Time in Moderate-Level Activity, secondaryOutcomes measure: Physical Activity Monitoring - Time in High-Level Activity, eligibilityModule sex: MALE, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290700, orgStudyIdInfo id: MCBU_2880, briefTitle: Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life., conditionsModule conditions: Life Quality, conditions: Functional Status, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 126, type: ACTUAL, armsInterventionsModule interventions name: Neonatal Care education, outcomesModule primaryOutcomes measure: severity of maternal function by Barkin Index of Maternal Functioning, secondaryOutcomes measure: Maternal Postpartum Quality of Life Instrument, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yonca ÇIÇEK OKUYAN, city: Manisa, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, hasResults: False |
protocolSection identificationModule nctId: NCT06290687, orgStudyIdInfo id: CASE5824, briefTitle: Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-01-29, completionDateStruct date: 2027-01-29, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy., conditionsModule conditions: Malignant Neoplasm of Bladder, conditions: Muscle Invasive Bladder Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a single-center, prospective, phase II trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Neoadjuvant Chemotherapy, interventions name: Partial cystectomy with Extended pelvic lymph node dissection, interventions name: Adjuvant systemic therapy, outcomesModule primaryOutcomes measure: Recurrence-Free Survival (RFS), secondaryOutcomes measure: Presence of Post-operative Complications, secondaryOutcomes measure: Median Bladder RFS, secondaryOutcomes measure: Median Muscle-Invasive Bladder RFS, secondaryOutcomes measure: Median Bladder-Intact Survival, secondaryOutcomes measure: Median Cancer-Specific Survival, secondaryOutcomes measure: Changes in Genitourinary-specific HRQoL, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Nima Almassi, MD, role: CONTACT, phone: 216-444-1825, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, hasResults: False |
protocolSection identificationModule nctId: NCT06290674, orgStudyIdInfo id: P.T.REC/012/004043, briefTitle: Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-11, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Adly A Adam, class: OTHER, descriptionModule briefSummary: Almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. Postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. Therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women., conditionsModule conditions: Obesity, Abdominal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Clinical randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double masking (Investigator and Participant), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Extracorporeal Shockwave therapy, interventions name: Balanced low-calorie diet, outcomesModule primaryOutcomes measure: Waist/ hip ratio, primaryOutcomes measure: Skin fold caliper, secondaryOutcomes measure: Lipid profile, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Helwan General Hospital, city: Cairo, state: Helwan, Cairo Governate, zip: 02, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06290661, orgStudyIdInfo id: UHCT-IEC-SOP-016-03-01, briefTitle: Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Postherpetic Neuralgia., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, collaborators name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, collaborators name: The Second People's Hospital of GuangDong Province, collaborators name: Xiamen Hospital of Traditional Chinese Medicine, descriptionModule briefSummary: The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia. The main questions it aims to answer are:1. The efficacy of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia2. The safety of percutaneous peripheral nerve stimulation in patients with postherpetic neuralgia Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with postherpetic neuralgia., conditionsModule conditions: Neuropathic Pain, conditions: Postherpetic Neuralgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Active electrostimulation, interventions name: Placebo electrostimulation, outcomesModule primaryOutcomes measure: Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period, primaryOutcomes measure: Visual simulation assessment scale collects pain scores after peripheral electrode placement, secondaryOutcomes measure: Proportion of subjects whose pain relief more than 30%, secondaryOutcomes measure: Proportion of subjects of ideal pain state, secondaryOutcomes measure: Sleep-related assessment after electrostimulation, secondaryOutcomes measure: Change of life quality after electrostimulation, secondaryOutcomes measure: Analgesic medications, secondaryOutcomes measure: Stability of external assistant devices, secondaryOutcomes measure: Questionnaire survey equipment satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Union Hospital, Tongji medical college, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Dong Yang, PHD, role: CONTACT, phone: 13871230491, phoneExt: 86, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06290648, orgStudyIdInfo id: 22-0868, secondaryIdInfos id: 5R34MH130555, type: NIH, link: https://reporter.nih.gov/quickSearch/5R34MH130555, briefTitle: Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings, acronym: FNP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question\[s\] it aims to answer are:1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure).2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records., conditionsModule conditions: Mental Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Forging New Paths, outcomesModule primaryOutcomes measure: Change in Levels of Aggression Score from Baseline to Month 3, primaryOutcomes measure: Change in Levels of Aggression Score From Baseline to Month 6, primaryOutcomes measure: Community Tenure, secondaryOutcomes measure: Change in Overall Criminal Attitudes Score, secondaryOutcomes measure: Change in Overall Impulsivity Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Amy Wilson, PhD, role: CONTACT, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06290635, orgStudyIdInfo id: Pro00119668, briefTitle: Edmonton Dyspnea Inventory- Validation Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-11-11, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, descriptionModule briefSummary: Breathlessness is a common problem for many patients with Interstitial lung disease (ILD). ILD is a group of lung diseases that cause inflammation (swelling) and scarring in the lung tissue where gas exchange (oxygen and carbon dioxide) occurs. Unfortunately, there is no cure for these conditions and as a result many patients decline over time with worsening breathlessness. This limits their ability to live a good life. Clinicians do not often recognize, assess, or treat breathlessness appropriately. Breathlessness, being a subjective experience, cannot be fully understood through objective measurements such as lung function tests, the arterial blood gas test etc. The objective and subjective measures of breathlessness are frequently disconnected. Clinicians who often rely on these types of objective tests do not directly enquire into its nature and severity of breathlessness from patients themselves. As a result, they remain unaware of this disabling symptom and the extent of its impact on patients. While there are many tools to measure breathlessness, they are not consistently used in routine care or have impacted care in a meaningful way. Many such tools are also complex with intricate response systems with possibility of errors and user fatigue. As a result, easy to use tools like modified MRC or MRC are frequently used even though they do not assess severity of breathlessness. No tool has been effective at helping clinicians identify the problem and prescribe appropriate treatments. This results in needless suffering for patients and their families and prevents them from receiving timely and appropriate therapies. Investigators propose to test an easy-to-use tool that combines the subjective and objective aspects of breathlessness. Investigators hope that the tool will help clinicians quickly identify the patient's breathlessness severity and provide them with an algorithm of what to do next. The tool was developed by clinicians with +15 years of experience in ILD and dyspnea. Early analysis already suggests the tool is useful to patients and helps improve care., conditionsModule conditions: ILD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Breathlessness Assessment Tool, outcomesModule primaryOutcomes measure: Validate Edmonton Dyspnea Inventory (EDI; formerly known as multidimensional dyspnea scale-MDDS), secondaryOutcomes measure: To perform time-motion observation of care providers or patients using the scale, secondaryOutcomes measure: Calculate MCID for Edmonton Dyspnea Inventory, secondaryOutcomes measure: Feasibility of Questionnaire, secondaryOutcomes measure: To assess day-to-day variability in dyspnea scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaye Edmonton Clinic, city: Edmonton, state: Alberta, zip: T6G 2G3, country: Canada, geoPoint lat: 53.55014, lon: -113.46871, locations facility: Aarhus University, city: Aarhus, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Bristol ILD Service; North Bristol NHS Trust, city: Bristol, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, hasResults: False |
protocolSection identificationModule nctId: NCT06290622, orgStudyIdInfo id: IRB300012414 (UAB23136), briefTitle: PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses., conditionsModule conditions: Diffuse Large B Cell Lymphoma, conditions: Lymphoma, B-Cell, conditions: Lymphoma, Follicular, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Retifanlimab, INCAGN02385, INCAGN02390, outcomesModule primaryOutcomes measure: Identify the optimal biological dose (OBD) for Retifanlimab in combination with INCAGN02385 and INCAGN02390 in relapsed/refractory DLBCL., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Margaret Thomas, role: CONTACT, email: [email protected], contacts name: Mayur Narkhede, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Amitkumar Mehta, MD, role: SUB_INVESTIGATOR, contacts name: Lauren Shea, MD, role: SUB_INVESTIGATOR, contacts name: Gaurav Goyal, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06290609, orgStudyIdInfo id: 72799, briefTitle: Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study., conditionsModule conditions: Spasticity, Muscle, conditions: Spinal Cord Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A single group of participants who will receive active treatment with the experimental stimulation device will be studied., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Vibrotactile Coordinated Reset, outcomesModule primaryOutcomes measure: Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, city: Stanford, state: California, zip: 94305, country: United States, contacts name: Peter Tass, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False |
protocolSection identificationModule nctId: NCT06290596, orgStudyIdInfo id: MSR/AZAST/AIP029/21/222/8/2023, briefTitle: Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions., conditionsModule conditions: Uterine Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 387, type: ESTIMATED, armsInterventionsModule interventions name: Vasopressin, interventions name: Tranexamic acid, interventions name: Saline, outcomesModule primaryOutcomes measure: blood loss, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06290583, orgStudyIdInfo id: Prilocaine in cesarean section, briefTitle: Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: South Valley University, class: OTHER, descriptionModule briefSummary: one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes., conditionsModule conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, 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: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine, interventions name: Prilocaine, outcomesModule primaryOutcomes measure: Maternal arterial blood pressure, secondaryOutcomes measure: Evaluation of duration of motor block, secondaryOutcomes measure: Total dose of ephedrine, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290570, orgStudyIdInfo id: 23-007685, briefTitle: A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's Heart, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices., conditionsModule conditions: Hypertrophic Cardiomyopathy, conditions: Athlete Heart, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: 12-Lead ECG, interventions name: Apple Smart Watch Single Lead ECG, interventions name: AliveCor KardiaMobile 6-Lead ECG, outcomesModule primaryOutcomes measure: Distribution of AI-ECG probabilities in HCM, primaryOutcomes measure: Comparative diagnostic performance between tracings obtained from different devices, secondaryOutcomes measure: Distribution of AI-ECG probabilities in Athlete's Heart, secondaryOutcomes measure: Correlation with false negative AI ECG result, 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: Heart Rhythm Services Research Team, role: CONTACT, phone: 507-255-0774, contacts name: Konstantinos Siontis, MD, role: CONTACT, phone: (507) 255-1051, email: [email protected], contacts name: Konstantinos Siontis, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06290557, orgStudyIdInfo id: 2023-507737-17-00, briefTitle: First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133, acronym: HY-133, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: In this clinical trial we will test a new approach for decolonization of S. aureus.As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned., conditionsModule conditions: Staphylococcus Aureus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: HY_133, interventions name: Placebo, outcomesModule primaryOutcomes measure: ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290544, orgStudyIdInfo id: CCM 1552, briefTitle: Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus (CARDT1), acronym: CARDT1, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-29, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Centro Cardiologico Monzino, class: OTHER, descriptionModule briefSummary: This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Standard of care plus additional examinations, outcomesModule primaryOutcomes measure: Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines., primaryOutcomes measure: Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE)., primaryOutcomes measure: Prevalence of cardiovascular disease in type 1 diabetes patients, secondaryOutcomes measure: Prevalence of diabetic retinopathy, secondaryOutcomes measure: Prevalence of diabetic nephropathy, secondaryOutcomes measure: Prevalence of diabetic neuropathy, secondaryOutcomes measure: CT-derived calcium score, secondaryOutcomes measure: Carotid intima-media thickness, secondaryOutcomes measure: Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method), secondaryOutcomes measure: Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ), secondaryOutcomes measure: Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS), secondaryOutcomes measure: Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires., secondaryOutcomes measure: Stratify type 1 patient cohort by lipid profile, secondaryOutcomes measure: Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Centro Cardiologico Monzino, status: RECRUITING, city: Milan, zip: 20138, country: Italy, contacts name: Stefano Genovese, MD, role: CONTACT, phone: 0258002327, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico di Monza, status: NOT_YET_RECRUITING, city: Monza, zip: 20900, country: Italy, contacts name: Gianluca Perseghin, MD, role: CONTACT, phone: +390392810430, email: [email protected], geoPoint lat: 45.58005, lon: 9.27246, hasResults: False |
protocolSection identificationModule nctId: NCT06290531, orgStudyIdInfo id: CEBD-CU-2023-11-12, briefTitle: Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-16, primaryCompletionDateStruct date: 2023-09-28, completionDateStruct date: 2023-09-28, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients., conditionsModule conditions: Dental Caries in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study., enrollmentInfo count: 96, type: ACTUAL, armsInterventionsModule interventions name: Buzzy device (cold and vibration), interventions name: Buzzy device (vibration only), interventions name: precooling, interventions name: Flavored Benzocaine topical anesthetic gel 20%, outcomesModule primaryOutcomes measure: Patient reported pain during needle injection, secondaryOutcomes measure: Child behaviour during needle injection, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Child and parent satisfaction, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, city: Cairo, zip: 11559, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06290518, orgStudyIdInfo id: PROBIFERT P051, briefTitle: Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2023-05-03, completionDateStruct date: 2024-01-29, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Biosearch S.A., class: INDUSTRY, collaborators name: Hospital San Carlos, Madrid, collaborators name: Universidad Complutense de Madrid, descriptionModule briefSummary: The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation., conditionsModule conditions: Infertility Unexplained, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment Volunteers are classified into 2 groups. All women in the probiotic group consume (oral route) a daily capsule with \~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin). All women in the placebo group consume (oral route) a daily capsule with \~50 mg of maltodextrin., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Ligilactobacillus salivarius CECT5713, interventions name: Placebo, outcomesModule primaryOutcomes measure: Successful pregnancies, secondaryOutcomes measure: Modification of the vaginal microbiota, secondaryOutcomes measure: Vaginal immunomodulation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biosearch S.A.U., city: Granada, zip: 18004, country: Spain, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Hospital Clínico San Carlos, city: Madrid, zip: 28040, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Universidad Complutense de Madrid, city: Madrid, zip: 28040, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06290505, orgStudyIdInfo id: PALEO, briefTitle: A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study, acronym: PALEO, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-08, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Australasian Gastro-Intestinal Trials Group, class: NETWORK, descriptionModule briefSummary: The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised)., conditionsModule conditions: Oesophageal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Durvalumab, outcomesModule primaryOutcomes measure: Progression free survival rate is the proportion of patients alive and progression free (the cancer has not worsened) assessed by CT Scan and clinical review., secondaryOutcomes measure: Duration of dysphagia relief, secondaryOutcomes measure: Nutritional status, secondaryOutcomes measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-C30, secondaryOutcomes measure: Quality of life change using the - European organisation for the research and treatment of cancer quality of life questionnaire QLQ-OES18, secondaryOutcomes measure: Response rate in metastatic lesions, secondaryOutcomes measure: Physician graded toxicity, secondaryOutcomes measure: SAE Rate, secondaryOutcomes measure: Overall survival., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Border Medical Oncology, status: RECRUITING, city: Albury, state: New South Wales, zip: 2640, country: Australia, contacts name: Jacqui McBurnie, role: CONTACT, email: [email protected], geoPoint lat: -36.07482, lon: 146.92401, locations facility: Calvary Mater Newcastle, status: RECRUITING, city: Newcastle, state: New South Wales, zip: 2298, country: Australia, contacts name: Kim Adler, role: CONTACT, email: [email protected], geoPoint lat: -32.92715, lon: 151.77647, locations facility: Royal Brisbane and Women's Hospital, status: RECRUITING, city: Herston, state: Queensland, zip: 4029, country: Australia, contacts name: Jacqui Keller, role: CONTACT, email: [email protected], geoPoint lat: -27.44453, lon: 153.01852, locations facility: Flinders Medical Centre, status: RECRUITING, city: Bedford Park, state: South Australia, country: Australia, contacts name: Aleksandra Kuruni, Dr, role: CONTACT, email: [email protected], geoPoint lat: -35.03333, lon: 138.56667, locations facility: St Vincent's Hospital, status: RECRUITING, city: Fitzroy, state: Victoria, zip: 3065, country: Australia, contacts name: Nadia Ranieri, role: CONTACT, email: [email protected], geoPoint lat: -37.79839, lon: 144.97833, locations facility: Peter MacCallum Cancer Centre, status: RECRUITING, city: Melbourne, state: Victoria, zip: 3000, country: Australia, contacts name: Shandelle Norman, role: CONTACT, email: [email protected], geoPoint lat: -37.814, lon: 144.96332, locations facility: Sir Charles Gairdner Hospital, status: RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Aylin Yahya, role: CONTACT, email: [email protected], geoPoint lat: -31.98184, lon: 115.8073, locations facility: Auckland Hospital, status: RECRUITING, city: Grafton, state: Auckland, zip: 1023, country: New Zealand, contacts name: Sophie Goodger, role: CONTACT, email: [email protected], geoPoint lat: -36.86029, lon: 174.76566, hasResults: False |
protocolSection identificationModule nctId: NCT06290492, orgStudyIdInfo id: AHMU-tDCS-insomnia, briefTitle: Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: WANG KAI, class: OTHER, descriptionModule briefSummary: To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients., conditionsModule conditions: Chronic Insomnia, conditions: Transcranial Direct Current Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: transcranial direct current stimulation, interventions name: sham transcranial direct current stimulation, outcomesModule primaryOutcomes measure: subjective sleep quality assessed by the PSQI, primaryOutcomes measure: subjective sleep quality assessed by the ISI, primaryOutcomes measure: daytime sleepiness assessed by the FFS, primaryOutcomes measure: daytime sleepiness assessed by the ESS, primaryOutcomes measure: objective sleep quality assessed by the PSG, secondaryOutcomes measure: emotional symptoms assessed by the HAMA, secondaryOutcomes measure: emotional symptoms assessed by the HAMD, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Medical University, status: RECRUITING, city: Hefei, state: Anhui, country: China, contacts name: Kai Wang, PhD, role: CONTACT, phone: +86-0551-62923704, email: [email protected], contacts name: Chengjuan Xie, role: CONTACT, phone: +8615656989777, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06290479, orgStudyIdInfo id: 20358, briefTitle: A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: air up GmbH, class: INDUSTRY, collaborators name: Citruslabs, descriptionModule briefSummary: A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks., conditionsModule conditions: Water Intake, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator), primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: Masking: Triple (Participant, Care Provider, Investigator), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Air Up® Peach Pod, interventions name: Air Up® Orangeade Pod, outcomesModule primaryOutcomes measure: Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale, secondaryOutcomes measure: Blood Biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Citruslabs, status: RECRUITING, city: Santa Monica, state: California, zip: 90404, country: United States, contacts name: Patrick Renner, MSc, role: CONTACT, email: [email protected], geoPoint lat: 34.01945, lon: -118.49119, hasResults: False |
protocolSection identificationModule nctId: NCT06290466, orgStudyIdInfo id: FCN-437c-CP-004, briefTitle: Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-11, primaryCompletionDateStruct date: 2023-02-08, completionDateStruct date: 2023-02-08, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Ahon Pharmaceutical Co., Ltd., class: OTHER, descriptionModule briefSummary: This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Low dose group, interventions name: High dose group, outcomesModule primaryOutcomes measure: ΔΔQTcF, secondaryOutcomes measure: adverse events, secondaryOutcomes measure: Physical examination, secondaryOutcomes measure: Axillary temperature, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: pulse, secondaryOutcomes measure: Ecg monitoring and electrocardiogram, secondaryOutcomes measure: laboratory examination, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100191, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06290453, orgStudyIdInfo id: AOGR, briefTitle: The Regulatory Role of miRNA 27 Follistatin Like Protein-1 Gene in Multiple Scelerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination of the central nervous system. Young women between the ages of 20 and 40 are primarily targeted by this disabling disorder. Till now there are no sufficient mechanisms to explain the pathophysiology of multiple sclerosis., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: micro RNA 27- FLP1 gene expression, interventions name: The Expanded Disability Status Scale (EDSS), interventions name: Electrophysiological assessment:, interventions name: MRI examination MRI brain:, outcomesModule primaryOutcomes measure: • To measure the levels of miR-27 expression and its target gene (FSTL1) in progressive MS and relapsing-remitting multiple sclerosis (RRMS) patients., secondaryOutcomes measure: To correlate the levels of expression of miR-27 expression and its target gene (FSTL1) relative to the severity of symptoms of MD patients., eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290440, orgStudyIdInfo id: 28/NDGD-HDDD, briefTitle: MEdication Counselling Models for Outpatient oRal antIcoaguLation, acronym: MEMORIAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Gia Dinh People Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants., conditionsModule conditions: Anticoagulants; Circulating, Hemorrhagic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Telepharmacy-led counselling, interventions name: Pharmacist-led counselling, outcomesModule primaryOutcomes measure: Medication adherence, secondaryOutcomes measure: Knowledge of oral anticoagulants, secondaryOutcomes measure: All-cause hospitalisation, secondaryOutcomes measure: VTE-related hospitalisation, secondaryOutcomes measure: Bleeding-related hospitalisation, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: VTE-related mortality, secondaryOutcomes measure: Bleeding-related mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290427, orgStudyIdInfo id: COMPAR-K, briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K), acronym: COMPAR-K, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Universitaria Integrata Verona, class: OTHER, descriptionModule briefSummary: The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using three currently available platforms:* DaVinci®;* Hugo®;* Versius®.The questions it aims to answer are:Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?Participants will be invited to join one of these three experimental group:1. surgery with the DaVinci platform;2. surgery with the Hugo platform;3. surgery with the Versius platform., conditionsModule conditions: Renal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: DaVinci RAPN, interventions name: Hugo RAS RAPN, interventions name: Versius® RAPN, outcomesModule primaryOutcomes measure: Number of participants with postoperative complications, primaryOutcomes measure: Number of participants with moderate to major postoperative complications, primaryOutcomes measure: Number of participants with major postoperative complications, secondaryOutcomes measure: Overall duration of the surgery, secondaryOutcomes measure: Number of intraoperative complications, secondaryOutcomes measure: Type of intraoperative complications, secondaryOutcomes measure: Number of intraoperative technical malfunctions, secondaryOutcomes measure: Type of intraoperative technical malfunctions, secondaryOutcomes measure: Estimated Blood Loss, secondaryOutcomes measure: Postoperative hospitalization, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Positive Surgical Margins, secondaryOutcomes measure: Serum Creatinine dosage for renal function assessment, secondaryOutcomes measure: Estimated Glomerular Filtration Rate for renal function assessment, secondaryOutcomes measure: Time taken for platform related timings, secondaryOutcomes measure: Procedure-related costs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Urology Unit, AOUI Verona, status: RECRUITING, city: Verona, state: VR, zip: 37126, country: Italy, contacts name: Alessandro AA Antonelli, MD, role: CONTACT, phone: +39 0458127701, email: [email protected], contacts name: Unità Ricerca Clinica, role: CONTACT, phone: +39 0458122844, email: [email protected], geoPoint lat: 45.4299, lon: 10.98444, hasResults: False |
protocolSection identificationModule nctId: NCT06290414, orgStudyIdInfo id: FDASU-Rec IM 112318, briefTitle: The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated., conditionsModule conditions: Periodontal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: infrared thermal camera, outcomesModule primaryOutcomes measure: Determine the agreement of thermographic images for diagnosis of periodontal diseases, secondaryOutcomes measure: The temperature ranges for healthy periodontium, gingivitis and periodontitis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of dentistry Ain Shams University, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Shrouk N. Elboray, BDS, role: CONTACT, phone: +201065433857, email: [email protected], contacts name: Mahetab M. AbdalWahab, lecturer, role: CONTACT, phone: +201115554490, email: [email protected], contacts name: Ola M. Ezzatt, professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06290401, orgStudyIdInfo id: 2023-0671, briefTitle: A Socio-ecological Approach for Improving Self-management in Adolescents With SCD, acronym: SC-Thrive, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-01-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Medical Center, Cincinnati, class: OTHER, collaborators name: Nemours Children's Health System, collaborators name: Emory University, collaborators name: Children's Hospital of Philadelphia, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.The main question\[s\]it aims to answer are:* Does SCThrive improve patient activation?* Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?* Are any improvements maintained 3 months after treatment?Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits., conditionsModule conditions: Anemia, Sickle Cell, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be allocated to SCThrive or SCHealthED (uniform standard care) using a randomized block design for age group (13-17 years of age or 18-21 years of age) with a predefined block size of 4., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator and Outcomes assessors will not know the condition to which participants have been randomized., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 310, type: ESTIMATED, armsInterventionsModule interventions name: SCThrive, interventions name: SCHealthED, outcomesModule primaryOutcomes measure: Patient Activation, secondaryOutcomes measure: Self-Management Behaviors, secondaryOutcomes measure: Daily Functioning, secondaryOutcomes measure: Emergency Room (ER) Visits, secondaryOutcomes measure: Self-Management Skills, secondaryOutcomes measure: Health-related quality of life, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290388, orgStudyIdInfo id: 23ME-01473-CLIN-001, briefTitle: Study of 23ME-01473 in Patients With Advanced Solid Malignancies, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: 23andMe, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: 23ME-01473, outcomesModule primaryOutcomes measure: Phase 1:Incidence and severity of dose-limiting toxicities (DLTs), primaryOutcomes measure: Phase 1: Incidence and severity of adverse events (AEs), primaryOutcomes measure: Phase 1 Incidence and severity of serious adverse events (SAEs), primaryOutcomes measure: ORR based on investigator assessment against RECIST 1.1 criteria, secondaryOutcomes measure: Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473, secondaryOutcomes measure: Phase 1: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473, secondaryOutcomes measure: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473, secondaryOutcomes measure: Last measurable serum concentration (Clast) following a single dose of 23ME-01473, secondaryOutcomes measure: Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473, secondaryOutcomes measure: Terminal half-life (T1/2) following a single dose of 23ME-01473, secondaryOutcomes measure: Maximum serum concentration (Cmax) following multiple doses of 23ME-01473, secondaryOutcomes measure: Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473, secondaryOutcomes measure: Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473, secondaryOutcomes measure: Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473, secondaryOutcomes measure: Terminal half-life (T1/2) following multiple doses of 23ME-01473, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: START Center for Cancer Care, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False |
protocolSection identificationModule nctId: NCT06290375, orgStudyIdInfo id: HSK21542-T-202, briefTitle: A Study of HSK21542 in a Peritoneal Dialysis Pruritus Population., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-03-08, completionDateStruct date: 2025-04-11, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Xizang Haisco Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a two- stage study. Stage I is a multicenter, open-label trial；Stage II was a multi-center, randomized, double-blind, placebo-controlled trial. About 250 maintenance peritoneal dialysis patients with moderate or above pruritus are planned to be enrolled., conditionsModule conditions: Pruritus, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: HSK21542 tablet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of subjects with an improvement of ≥ 4points from baseline in the weekly average of the daily Worst Itch Numeric Rating Scale (WI-NRS) after 12 weeks of treatment., secondaryOutcomes measure: Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment., secondaryOutcomes measure: Change from baseline in subjects' quality of life (evaluated using the 5-D itch scale) after 12 weeks of treatment., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06290362, orgStudyIdInfo id: EgeTrial4, briefTitle: Exploring Digitalized Interventions for Stress and Problem Solving, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-16, primaryCompletionDateStruct date: 2021-07-30, completionDateStruct date: 2021-11-28, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: Excessive and prolonged stress can have detrimental effects on both psychological and physiological health, compromising overall well-being and functioning. This study examines the impact of telepsychiatric group consultation using Instagram as an unexplored online social media platform on stress levels and problem-solving skills among young adults., conditionsModule conditions: Stress, conditions: Problem-solving, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: The current 8-week randomized, single-blind factorial trial was conducted with a control group and one intervention group. Over eight weeks, participants received cognitive behavioral-based intervention through online sessions. Pre-/post-test and follow-up assessments employed., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Cognitive Behavioural Theory-based group consultation, outcomesModule primaryOutcomes measure: Perceived Stress Scale (first evaluation with posttest), primaryOutcomes measure: Problem Solving Inventory (first evaluation with posttest), primaryOutcomes measure: Perceived Stress Scale (second evaluation with follow up), primaryOutcomes measure: Problem Solving Inventory (second evaluation with follow up), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ege University, city: İzmir, zip: 35100, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False |
protocolSection identificationModule nctId: NCT06290349, orgStudyIdInfo id: DA5221_DM_III, briefTitle: Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Dong-A ST Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: DA5221-T1, interventions name: DA5221-T2, interventions name: Placebo, interventions name: DA5221-B1, interventions name: DA5221-B2, outcomesModule primaryOutcomes measure: Change from the baseline in HbA1c (%) after 24 weeks, secondaryOutcomes measure: Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks, secondaryOutcomes measure: Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks, secondaryOutcomes measure: Change from the baseline in weight after 24 weeks, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Severance Hospital, Yonsei University college of Medicine, city: Seoul, country: Korea, Republic of, contacts name: Cha Bong Soo, Ph.D, role: CONTACT, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06290336, orgStudyIdInfo id: PROTEKT, briefTitle: Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement, acronym: PROTEKT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Linkoeping University, class: OTHER_GOV, collaborators name: Region Östergötland, collaborators name: Region Jönköping County, descriptionModule briefSummary: The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.The main questions it aims to answer are:* Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?* Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?* Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?* Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?Participants will be randomized stratified by age (≤ 67 years, \> 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-center randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessor blinded to group allocation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Pre-operative exercise therapy and education, interventions name: Standardized pre-operative information session, outcomesModule primaryOutcomes measure: Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery, primaryOutcomes measure: Patient satisfaction at 1 year after surgery, primaryOutcomes measure: Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery, primaryOutcomes measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery, primaryOutcomes measure: Change in active knee range of motion from baseline to 6 weeks after surgery, primaryOutcomes measure: Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery, secondaryOutcomes measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery, secondaryOutcomes measure: Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery, secondaryOutcomes measure: Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery, secondaryOutcomes measure: Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: : Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery, secondaryOutcomes measure: Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Linkoping University, status: RECRUITING, city: Linkoping, state: Ostergotland, zip: 58183, country: Sweden, contacts name: Joanna Kvist, Professor, role: CONTACT, phone: +46 (0) 13 284664, email: [email protected], contacts name: Joanna Kvist, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False |
protocolSection identificationModule nctId: NCT06290323, orgStudyIdInfo id: 11/05/2022-9/VIII, briefTitle: Effects of Quadratus Lumborum Block on Lower Urinary System Symptoms, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Muğla Sıtkı Koçman University, class: OTHER, descriptionModule briefSummary: The most common reason for applying to a hospital in the postoperative period due to the double J stent inserted during operations of the uteroscopic lithotripsy is reflected pain (T11-L2). The posterior approximation QL block (QL-P) is known to extend more easily to the thoracic paravertebral cavity or thoracolumbar plane, creating analgesia from T 7' to L 1'. The effects of double J catheter in patients are followed by 'Ureteral Stent Symptom Scoring Survey'. QL-P for postoperative analgesia after URS operations Our primary hypothesis in this prospective, randomized, controlled study is that the symptoms of the sub-urinary system associated with the DJS of the QL-P block will decrease. Our secondary hypotheses in the study are to investigate the effects of the unilateral QL-P block, made under ultrasound guidance, on pain scores that occur after ureteroscopic lithotripsy operations due to unilateral ureteral stones made under spinal anesthesia., conditionsModule conditions: Lower Urinary Tract Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with double J catheter inserted into ureteroscopic lithotripsy surgeries due to urethral stones, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The researcher evaluating the survey does not know which group the patients are., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: Quadratus lumborum block, interventions name: Placebo, outcomesModule primaryOutcomes measure: Quadratus posterior block, secondaryOutcomes measure: Pain Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mugla Sitki Kocman Training and Research Hospital, city: Mugla, zip: 48000, country: Turkey, geoPoint lat: 37.21807, lon: 28.3665, hasResults: False |
protocolSection identificationModule nctId: NCT06290310, orgStudyIdInfo id: PAVELA, briefTitle: Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography, acronym: PAVELA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged, class: OTHER_GOV, collaborators name: Hochschule Furtwangen University, collaborators name: Budapest University of Technology and Economics, collaborators name: Szeged University, descriptionModule briefSummary: Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony., conditionsModule conditions: Acute Lung Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: EIT, interventions name: patient-ventilator asynchrony assessment, outcomesModule primaryOutcomes measure: distribution, secondaryOutcomes measure: connecting asysnchrony cycles with electric impedance tomography measurements, secondaryOutcomes measure: identifying unic electric impedance tomography signs of asynchrony, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kiskunhalas Semmelweis Hopsital the Teaching Hospital of the University of Szeged, city: Kiskunhalas, zip: 6400, country: Hungary, contacts name: András Lovas, M.D. Ph.D., role: CONTACT, phone: 003677522000, phoneExt: 2045, email: [email protected], geoPoint lat: 46.43402, lon: 19.48479, hasResults: False |
protocolSection identificationModule nctId: NCT06290297, orgStudyIdInfo id: Progetti di Rete (RIN-IDEA), briefTitle: Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities (Tablet Project), statusModule overallStatus: RECRUITING, startDateStruct date: 2020-09-30, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, collaborators name: Fondazione Don Carlo Gnocchi Onlus, collaborators name: IRCCS Eugenio Medea, collaborators name: Oasi Research Institute-IRCCS, collaborators name: Ospedale Pediatrico Bambin Gesù, collaborators name: IRCCS San Raffaele Roma, collaborators name: IRCCS National Neurological Institute "C. Mondino" Foundation, collaborators name: IRCCS Centro Neurolesi "Bonino-Pulejo", collaborators name: Istituto Giannina Gaslini, collaborators name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, collaborators name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, collaborators name: IRCCS Ospedale San Raffaele, collaborators name: IRCCS Istituto delle Scienze Neurologiche di Bologna, descriptionModule briefSummary: The development and application of new technologies to support functional assessment and rehabilitation pathways for neurodevelopmental disabilities allow the evaluation and enhancement of cognitive, motor, and speech abilities within a more playful and motivating context. In fact telerehabilitation programs foster access to rehabilitative services and permit the delivery of a wide range of neuropsychological, motor, speech and communication interventions, even for patients unable to frequently attend a clinical institution (distance from the hospital, parental work employment, etc.), by overcoming geographic barriers. In this scenario, new technologies guarantee significant time- and cost-saving, shortening hospitalization and delivering the rehabilitative process at home, in a more ecological context (American Telemedicine Association, 2017) therefore enforcing the generalization of the achieved competences. Another great advantage provided by using innovative technologies in clinical practice to foster therapies tailored to patient's needs concerns both the possibility of collecting comprehensive and accurate quantitative data, thus supporting a better intervention monitoring, and of offering multi domain activities, also integrating peripheral devices (i.e. sensors). Using innovative technologies in clinical practice also give the possibility to propose neuropsychological and motor activities in a playful and motivating context, thus enhancing participation and enjoyment, especially for the pediatric population, while maintaining high levels of efficiency. Such telerehabilitation pathways allow to increase dosage and intensity of the intervention and ensure caregivers' involvement in the rehabilitation process. This multicenter study aims to assess the feasibility of using technological systems, primarily validated in the adult population, in children with congenital and acquired disabilities by administering ad-hoc questionnaires., conditionsModule conditions: Neurodevelopmental Cognitive, Motor and Speech-language Disabilities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Telerehabilitation VRRS, outcomesModule primaryOutcomes measure: Scores of One shot feasibility questionnaire (5-point likert scale), primaryOutcomes measure: Tele-rehabilitation feasibility measures: Adherence to the study, primaryOutcomes measure: Tele-rehabilitation feasibility measures: Adherence to the training, primaryOutcomes measure: Tele-rehabilitation feasibility measures: Number of dropouts, primaryOutcomes measure: Tele-rehabilitation feasibility measures: Number of sessions completed in the target time, primaryOutcomes measure: Tele-rehabilitation feasibility measures: Technical problems encountered that prevent the program from running, primaryOutcomes measure: Scores of training feasibility questionnaire (5-point likert scale), secondaryOutcomes measure: Changes in the Sustained attention subtest of Leiter 3, secondaryOutcomes measure: Changes in the visual attention subtest (CP) of Italian battery for ADHD (BIA), secondaryOutcomes measure: Changes in the Conners' Parent Rating Scale - Brief version, secondaryOutcomes measure: Changes in the Visuo-motor precision subtest of NEPSY II, secondaryOutcomes measure: Changes in the Developmental Test Of Visuo-Motor Integration (VMI), secondaryOutcomes measure: Changes in the digit span forwards and backward subtests of BVN both for children aged 5-11 and for children aged 12-18, secondaryOutcomes measure: Changes in the Corsi Block Tapping test subtest of BVS-Corsi, secondaryOutcomes measure: Changes in the Behaviour Rating inventory of executive function (BRIEF 2/P ) for parents, secondaryOutcomes measure: Changes in the route finding subtest of NEPSY II, secondaryOutcomes measure: Changes in the arrow subtest of NEPSY II, secondaryOutcomes measure: Changes in the Gross Motor Function Measure 88 (GMFM-88), secondaryOutcomes measure: Changes in the Assisting Hand Assessment (AHA), secondaryOutcomes measure: Changes in Both Hand Assessment (BoHA), secondaryOutcomes measure: Changes in the Melbourne Assessment of Unilateral Upper Limb Function o Melbourne Assessment 2 (MUUL o MA2), secondaryOutcomes measure: Changes in the Abilhand Kids, secondaryOutcomes measure: Changes in the Box and Block test (BBT), secondaryOutcomes measure: Changes in the Movement Disorders - Childhood Rating Scale 4-18 revised (MD-CRS 4-18 R), secondaryOutcomes measure: Changes in the 6 minutes walk test (6MWT), secondaryOutcomes measure: Changes in the Functional Reach Test (FRT), secondaryOutcomes measure: Changes in the Pediatric Berg Balance Scale (PBS), secondaryOutcomes measure: Changes in the Timed up and go (TUG), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Stella Maris, status: RECRUITING, city: Pisa, state: PI, zip: 56128, country: Italy, contacts name: Giuseppina Sgandurra, MD, PhD, role: CONTACT, phone: 050 886233/224, phoneExt: +39, email: [email protected], geoPoint lat: 43.70853, lon: 10.4036, hasResults: False |
protocolSection identificationModule nctId: NCT06290284, orgStudyIdInfo id: 6322, briefTitle: Comparison Between Mini-midline and the Peripheral Intravenous Catheter, acronym: INSERT/2022, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2023-11-17, completionDateStruct date: 2023-12-28, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.The main questions it aims to answer are:* Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;* Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms., conditionsModule conditions: Vascular Access Devices, conditions: Venous Puncture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The statistician will be provided an anonymized dataset., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 294, type: ACTUAL, armsInterventionsModule interventions name: Long Peripheral Catheter, interventions name: Peripheral Intra-Venous Catheter, outcomesModule primaryOutcomes measure: Difference in proportion, secondaryOutcomes measure: Adverse events associated with use of LPC and PIVC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, city: Milan, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06290271, orgStudyIdInfo id: CISTAR, briefTitle: Arterial Wall Shear Stress After Intracranial Artery Recanalization, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Chonbuk National University Hospital, class: OTHER, collaborators name: Seoul National University Hospital, collaborators name: Chungnam National University Hospital, collaborators name: Asan Medical Center, collaborators name: Chonnam National University Hospital, collaborators name: Korea University Ansan Hospital, collaborators name: SMG-SNU Boramae Medical Center, descriptionModule briefSummary: There has been consistent research on the cerebral blood flow features in ischemic stroke patients with acute occlusion of major intracranial arteries. However, studies analyzing the overall features of the major intracranial artery blood flow in the periods of pre and post-recanalization are still lacking. Time-of-flight magnetic resonance angiography (TOF-MRA) is extensively utilized to evaluate the intracranial arteries. The arterial signal intensity from MRA-TOF varies across subjects and arterial subtypes, leading to the development of the Signal Intensity Gradient (SIG) concept. SIG has demonstrated a strong correlation with Computational Fluid Dynamics (CFD), a known method for reflecting wall shear stress. SIG could be associated with the pathophysiology of wall shear stress. We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG., conditionsModule conditions: Intracranial Artery Occlusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Intracranial artery flow pattern, outcomesModule primaryOutcomes measure: Neurological Severity at discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Korea University Ansan Hospital, status: NOT_YET_RECRUITING, city: Ansan, state: Gyeonggi-do, zip: 15355, country: Korea, Republic of, contacts name: Sang-Heon Lee, Prof., role: CONTACT, email: [email protected], geoPoint lat: 37.32361, lon: 126.82194, locations facility: Jeonbuk National University Hospital, status: NOT_YET_RECRUITING, city: Jeonju, state: Jeollabuk Do, zip: 54907, country: Korea, Republic of, contacts name: Hyo Sung Kwak, Prof., role: CONTACT, email: [email protected], geoPoint lat: 35.82194, lon: 127.14889, locations facility: Chungnam National University Hospital, status: RECRUITING, city: Daejeon, zip: 35015, country: Korea, Republic of, contacts name: Hee Jung Song, Prof., role: CONTACT, email: [email protected], geoPoint lat: 36.32139, lon: 127.41972, locations facility: Chonnam National University Hospital, status: RECRUITING, city: Gwangju, zip: 61469, country: Korea, Republic of, contacts name: Man-Seok Park, Prof., role: CONTACT, email: [email protected], geoPoint lat: 35.15472, lon: 126.91556, locations facility: Seoul National University Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, contacts name: Keun-Hwa Jung, Prof., role: CONTACT, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, locations facility: Asan Medical Center, status: RECRUITING, city: Seoul, zip: 05505, country: Korea, Republic of, contacts name: Beom-Jun Kim, Prof., role: CONTACT, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, locations facility: SMG-SNU Boramae Medical Center, status: NOT_YET_RECRUITING, city: Seoul, zip: 07061, country: Korea, Republic of, contacts name: Yong-Seok Lee, Prof., role: CONTACT, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, locations facility: Ulsan University Hospital, status: RECRUITING, city: Ulsan, zip: 44033, country: Korea, Republic of, contacts name: Chan-Hyuk Lee, Prof., role: CONTACT, email: [email protected], geoPoint lat: 35.53722, lon: 129.31667, hasResults: False |
protocolSection identificationModule nctId: NCT06290258, orgStudyIdInfo id: 202202143A0, briefTitle: Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis., conditionsModule conditions: Autism Spectrum Disorder, conditions: Gastrointestinal Diseases, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Fecal microbiota transplantation, outcomesModule primaryOutcomes measure: Changes of gastrointestinal symptoms of patients with ASD after FMT, primaryOutcomes measure: Changes of autistic symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of the diversity of intestinal microbiota of patients with ASD after FMT, secondaryOutcomes measure: Changes of cytokine levels of patients with ASD after FMT, secondaryOutcomes measure: Changes of repetitive behavior symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of autistic behavior symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of emotion and behavior symptoms of patients with ASD after FMT, secondaryOutcomes measure: Changes of inattention and hyperactivity of patients with ASD after FMT, secondaryOutcomes measure: Changes of quality of life of patients with ASD after FMT, otherOutcomes measure: Changes of objective sleep of patients with ASD after FMT by actigraphy recording, otherOutcomes measure: Changes of subjective sleep of patients with ASD after FMT, otherOutcomes measure: Changes of intelligence of patients with ASD after FMT, otherOutcomes measure: Changes of attention and impulse control of patients with ASD after FMT, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Wei-Chih Chin, city: Taoyuan city, zip: 333423, country: Taiwan, contacts name: Wei-Chih Chin, role: CONTACT, phone: +886 3 3281200, phoneExt: 3836, email: [email protected], geoPoint lat: 24.95233, lon: 121.20193, hasResults: False |
protocolSection identificationModule nctId: NCT06290245, orgStudyIdInfo id: P.T.REC/012/005045, briefTitle: PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life., conditionsModule conditions: Pulmonary Disease, Chronic Obstructive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: PEP Buddy, interventions name: aerobic exercise, outcomesModule primaryOutcomes measure: dyspnea, secondaryOutcomes measure: pulmonary function, secondaryOutcomes measure: exercise capacity, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Health-related quality of life (HRQoL), eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, status: RECRUITING, city: Giza, state: Dokki, zip: 11432, country: Egypt, contacts name: Ebtesam N Nagy, role: CONTACT, phone: +201278141946, email: [email protected], geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06290232, orgStudyIdInfo id: IRB-P00044498, briefTitle: Fetoscopic Laser Photocoagulation in Management of Vasa Previa, acronym: FLUMEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Vasa previa is a pregnancy complication that happens when blood vessels from the fetus grow over the entrance to the womb. In a VP pregnancy, natural vaginal birth is deadly for the baby in more than half of cases due to the bursting of VP vessels and severe blood loss. Currently, VP patients are recommended to be closely monitored and often hospitalized once they reach the third trimester of pregnancy. An early delivery by C-section would typically be performed in order to avoid breaking the exposed fetal vessels.Fetoscopic laser photocoagulation is a minimally invasive surgery in the womb to remove or correct abnormal blood vessels and tissues. In the FLP procedure, the surgeon uses a fetoscope (a tiny telescope) and a laser device to seal off unprotected vessels. While this surgery has been used to treat other pregnancy conditions, it has not yet been proven to be safe and/or effective for the treatment of vasa previa. This treatment aims to eliminate the VP, and, if successful, may have the potential to minimize the risk of bleeding, thereby enabling patients to avoid long hospitalization before delivery. This procedure may enable VP patients to have a vaginal delivery instead of C-section., conditionsModule conditions: Vasa Previa, conditions: Pregnancy Complications, conditions: Maternal; Procedure, conditions: In Utero Procedure Affecting Fetus or Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Fetoscopic Laser Photocoagulation, outcomesModule primaryOutcomes measure: Mode of delivery, primaryOutcomes measure: Gestational age at delivery, primaryOutcomes measure: Successful visualization and mapping of vasa previa, primaryOutcomes measure: The rate of successful coagulation of the vasa previa - intraoperative imaging, primaryOutcomes measure: The rate of successful coagulation of the vasa previa - postoperative imaging, primaryOutcomes measure: The rate of successful coagulation of the vasa previa - pathology, primaryOutcomes measure: Placental function, secondaryOutcomes measure: GA at hospital admission, secondaryOutcomes measure: Duration of hospital stay, secondaryOutcomes measure: Cause for hospital admission, secondaryOutcomes measure: The rate of spontaneous preterm labor, secondaryOutcomes measure: The rate of preterm premature rupture of membranes (PPROM), secondaryOutcomes measure: The rate of placental abruption, secondaryOutcomes measure: The rate of chorioamnionitis, secondaryOutcomes measure: The rate of chorioamniotic separation, secondaryOutcomes measure: Interval from procedure to delivery, secondaryOutcomes measure: The rate of fetal growth restriction, secondaryOutcomes measure: Fetal brain structure, secondaryOutcomes measure: The rate of NICU admission, secondaryOutcomes measure: NICU length of stay, secondaryOutcomes measure: Short term neonatal morbidity, secondaryOutcomes measure: Neonatal survival, secondaryOutcomes measure: Maternal mental health score, secondaryOutcomes measure: Postnatal examination of the placenta, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06290219, orgStudyIdInfo id: CF23509A, briefTitle: The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction, acronym: PRP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Taichung Veterans General Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia., conditionsModule conditions: Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis), conditions: Effect of Drug, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: platelet-rich plasma combined with hyaluronic acid, interventions name: Zinc Gluconate 10 MG Oral Tablet, interventions name: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil, outcomesModule primaryOutcomes measure: phenyl ethyl alcohol odor detection threshold test, primaryOutcomes measure: traditional Chinese version of University of Pennsylvania Smell Identification Test (TC-UPSIT), secondaryOutcomes measure: Visual Analogue Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taichung Veterans General Hospital, city: Taichung, zip: 40705, country: Taiwan, contacts name: Rong-San Jiang, MD, PhD, role: CONTACT, phone: 800-555-5555, phoneExt: 4088, email: [email protected], contacts name: Kai-Li Liang, MD, role: CONTACT, phone: +886423592525, phoneExt: 82620, email: [email protected], contacts name: Rong-San Jiang, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False |
protocolSection identificationModule nctId: NCT06290206, orgStudyIdInfo id: UU_IRB_00161649, secondaryIdInfos id: 1R01CA279973-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01CA279973-01, secondaryIdInfos id: DSS_10065815, type: OTHER, domain: University of Utah, Document Summary Sheet (DSS) Number, briefTitle: PREVENT HPV-Related Cancers, acronym: PREVENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, collaborators name: Kaiser Permanente, collaborators name: University of Arizona, collaborators name: Sea Mar Community Health Centers, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. The proposed study includes the following: (1) boot camp translation to tailor messaging based on patient and provider input; (2) PREVENT randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention; and (3) qualitative interviews with parents/caregivers, providers, and other healthcare team members and development of best practices, implementation guides and dissemination of findings for other clinics to implement the program on a broader scale. At the end of the trial, personal interviews with parents/caregivers, clinical staff, and providers will be conducted to understand reactions to the program and persistent barriers to initiating and completing HPV vaccination., conditionsModule conditions: Vaccine Hesitancy, conditions: HPV Vaccination, conditions: Vaccine; Uptake, conditions: Vaccination; Series Completion, conditions: Vaccine Refusal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The investigators will use intervention mapping (IM) to plan each intervention step. The investigators will apply IM to develop and test HPV vaccination reminders for parents/caregivers (P/C). Bootcamp Translation (BCT) will engage diverse stakeholders using an iterative schedule of meetings. The BCT process will define the format and content of vaccination messages.Intervention: The investigators propose a 3-arm RCT to compare rates of completing the next step in the HPV vaccination series at six months and completing the HPV vaccination series at 13 months between Auto, Auto-Plus, and UC arms. P/C of children/adolescents (C/A) who have not completed the series will be randomized 1:1:1 to study arms. Participants will be assessed for eligibility and enrolled, with a total participant time in the study of 13 months, for a total of 25 months of enrollment, participation, and follow-up., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Clinic analysts will create a real-time list of patients due for an initial HPV vaccine dose. P/C of remaining C/A patients will be individually randomized to either Auto or Auto-Plus intervention or usual care (UC) in a 1:1:1 ratio. The PREVENT study will only target one child/adolescent per parent/caregiver (siblings will be excluded from intervention assessments). The investigators will use automated codes to manage interventions so that eligible patients get initial HPV vaccines on time and P/C are prompted to repeat vaccination, as recommended. The investigators will select a cohort of approximately 1,038 P/C patients from the 4 clinics, randomized to intervention arms (UC, Auto, and Auto-Plus). Intervention activities largely mimic clinic processes, and clinicians and participants will be unaware of which intervention study arm the P/C has been assigned., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 519, type: ESTIMATED, armsInterventionsModule interventions name: PREVENT, outcomesModule primaryOutcomes measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion), primaryOutcomes measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion, secondaryOutcomes measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion), secondaryOutcomes measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sea Mar Community Health Centers, city: Seattle, state: Washington, zip: 98108, country: United States, contacts name: PREVENT Sea Mar CHC, Study Medical Coordinator, MsPH, MS, role: CONTACT, phone: 206-764-5504, email: [email protected], contacts name: PREVENT Research Assistant, role: CONTACT, phone: 801-587-4565, email: [email protected], contacts name: Amanda Petrik, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06290193, orgStudyIdInfo id: 23-392, briefTitle: Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2029-02-23, completionDateStruct date: 2029-02-23, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution/ANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive surgery., conditionsModule conditions: Ovarian Cancer, conditions: Fallopian Tube Carcinoma, conditions: Ovarian Carcinoma, conditions: Peritoneal Carcinoma, conditions: Ovarian Cancer Stage IIIC, conditions: Fallopian Tube Cancer Stage IIIC, conditions: Ovarian Cancer Stage IV, conditions: Fallopian Tube Cancer Stage IV, conditions: Fallopian Tube Cancer, conditions: Peritoneal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Acute Normovolemic Hemodilution/ANH, outcomesModule primaryOutcomes measure: Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Dennis Chi, MD, role: CONTACT, phone: 212-639-5016, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited protocol activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Dennis Chi, MD, role: CONTACT, phone: 212-639-5016, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited protocol activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Dennis Chi, MD, role: CONTACT, phone: 212-639-5016, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Dennis Chi, MD, role: CONTACT, phone: 212-639-5016, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Limited protocol activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Dennis Chi, MD, role: CONTACT, phone: 212-639-5016, 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: Dennis Chi, MD, role: CONTACT, phone: 212-639-5016, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Dennis Chi, MD, role: CONTACT, phone: 212-639-5016, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False |
protocolSection identificationModule nctId: NCT06290180, orgStudyIdInfo id: 13632, secondaryIdInfos id: 1S06GM146095, type: NIH, link: https://reporter.nih.gov/quickSearch/1S06GM146095, briefTitle: Healing Lodge First Face Training Evaluation Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Cambridge Health Alliance, class: OTHER, collaborators name: National Institute of General Medical Sciences (NIGMS), descriptionModule briefSummary: The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the help they need. All Healing Lodge staff are being asked to complete First Face training.To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations., conditionsModule conditions: Addiction, conditions: Depression/Anxiety, conditions: Trauma, Psychological, conditions: Self-harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pre/post/3-month follow-up model, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: First Face for Mental Heatlh, outcomesModule primaryOutcomes measure: Attitudes Towards Serious Mental Illness - Adolescent Version, primaryOutcomes measure: First Face knowledge assessment, primaryOutcomes measure: Perceived Competence to Respond, secondaryOutcomes measure: Satisfaction with Training, secondaryOutcomes measure: Use of First Face learnings in professional/personal life, secondaryOutcomes measure: Intended Use of First Face learnings in professional/personal life, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Healing Lodge of the Seven Nations, city: Spokane Valley, state: Washington, zip: 99212, country: United States, contacts name: Melinda Bowman, EdD, role: CONTACT, phone: 509-795-8342, email: [email protected], contacts name: Michelle Zuckerman, EdD, role: CONTACT, phone: 509-533-6910, email: [email protected], contacts name: Melinda Bowman, EdD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.67323, lon: -117.23937, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-02-21, uploadDate: 2024-02-21T11:51, filename: SAP_000.pdf, size: 52477, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-28, uploadDate: 2024-02-28T13:20, filename: ICF_001.pdf, size: 251558, hasResults: False |
protocolSection identificationModule nctId: NCT06290167, orgStudyIdInfo id: 30M201, briefTitle: A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab, acronym: DUAL-Rehab, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-03, primaryCompletionDateStruct date: 2026-04-10, completionDateStruct date: 2026-04-10, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The main objective of this project is two-fold1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments., conditionsModule conditions: Cognitive Decline, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: 360° media, interventions name: Treatment As Usual (TAU), interventions name: In hospital sessions, interventions name: at home sessions, interventions name: Mild Cognitive Impairment, interventions name: Subjective Memory Complain, outcomesModule primaryOutcomes measure: Cognitive functions, primaryOutcomes measure: Motor functions, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milan, state: MI, zip: 20149, country: Italy, contacts name: Elisa Pedroli, PsyD, role: CONTACT, phone: 02 61911 2707, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06290154, orgStudyIdInfo id: RG2024-022-02, briefTitle: Factors Associated With Posttransplant Cardiac Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant., conditionsModule conditions: Cardiovascular Diseases, conditions: Liver Transplantation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: a composite outcome of new cardiovascular disease after liver transplantation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06290141, orgStudyIdInfo id: EFC18156, secondaryIdInfos id: U1111-1295-3363, type: REGISTRY, domain: ICTRP, secondaryIdInfos id: 2023-508338-33, type: REGISTRY, domain: CTIS, briefTitle: A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), acronym: VITALIZE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-11-05, completionDateStruct date: 2027-05-19, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up., conditionsModule conditions: Chronic Inflammatory Demyelinating Polyneuropathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Part A is a double-blind treatment period and Part B is an open-label period., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: riliprubart, interventions name: Placebo, interventions name: riliprubart, interventions name: Placebo, interventions name: IVIg, interventions name: Placebo, interventions name: IVIg premedication, outcomesModule primaryOutcomes measure: Percentage of participants experiencing a response, primaryOutcomes measure: Percentage of participants randomized to riliprubart who responded during the double-blind period and had a lasting response during the open-label period, secondaryOutcomes measure: Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score, secondaryOutcomes measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score, secondaryOutcomes measure: Change from baseline in grip strength (kilopascals, dominant hand), secondaryOutcomes measure: Change from baseline in Medical Research Council Sum Score (MRC-SS), secondaryOutcomes measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), secondaryOutcomes measure: Percentage of participants experiencing a relapse, secondaryOutcomes measure: Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L), secondaryOutcomes measure: Number of participants with TEAEs, including SAEs and AESIs, secondaryOutcomes measure: Number of participants with treatment-emergent ADA in participants treated with riliprubart, secondaryOutcomes measure: Number of participants with TEAEs, including SAEs and AESIs, secondaryOutcomes measure: Percentage of participants randomized to riliprubart experiencing a relapse, secondaryOutcomes measure: Percentage of participants randomized to IVIg continuation experiencing a relapse, secondaryOutcomes measure: Number of participants and titer of anti-drug antibodies (ADA), secondaryOutcomes measure: Change from baseline in I-RODS, secondaryOutcomes measure: Change from baseline in adjusted INCAT score, secondaryOutcomes measure: Change from baseline in grip strength (kilopascals; dominant hand), secondaryOutcomes measure: Change from baseline in MRC-SS, secondaryOutcomes measure: Change from baseline in RT-FSS, secondaryOutcomes measure: Change from baseline in EQ-5D-5L score, secondaryOutcomes measure: Percentage of participants randomized to riliprubart who experience a response during the open-label period without prior response in the double-blind period (delayed response), secondaryOutcomes measure: Percentage of participants randomized to IVIg continuation who experience a response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290128, orgStudyIdInfo id: EFC17236, secondaryIdInfos id: U1111-1295-5755, type: REGISTRY, domain: ICTRP, secondaryIdInfos id: 2023-506503-26, type: REGISTRY, domain: CTIS, briefTitle: A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work, acronym: MOBILIZE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2026-02-03, completionDateStruct date: 2027-10-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up., conditionsModule conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy, conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a double-blind treatment in part A and open-label treatment in Part B., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Riliprubart, interventions name: Placebo, interventions name: Riliprubart, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of participants refractory to standard of care (SOC) experiencing a response, primaryOutcomes measure: Percentage of participants randomized to riliprubart with lasting response, primaryOutcomes measure: Percentage of participants randomized to placebo who experience a response, primaryOutcomes measure: Percentage of participants randomized to riliprubart who experience a response, secondaryOutcomes measure: Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score, secondaryOutcomes measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score, secondaryOutcomes measure: Change from baseline in grip strength (kilopascals; dominant hand), secondaryOutcomes measure: Change from baseline in Medical Research Council Sum Score (MRCSS), secondaryOutcomes measure: Percentage of participants refractory to immunoglobulins experiencing a response, secondaryOutcomes measure: Change from baseline in the EuroQol 5 Dimension, 5Level Health Scale (EQ5D5L), secondaryOutcomes measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS), secondaryOutcomes measure: Number of participants with treatmentemergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs), secondaryOutcomes measure: Incidence and titer of anti-riliprubart antibodies (ADA), secondaryOutcomes measure: Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), secondaryOutcomes measure: Incidence and titer of anti-riliprubart antibodies, secondaryOutcomes measure: Change from baseline in I RODS score, secondaryOutcomes measure: Change from baseline in adjusted INCAT score, secondaryOutcomes measure: Change from baseline in grip strength (kilopascals; dominant hand), secondaryOutcomes measure: Change from baseline in MRC-SS, secondaryOutcomes measure: Change from baseline in EQ-5D-5L score, secondaryOutcomes measure: Change from baseline in RT-FSS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alabama Neurology Associates Site Number : 8400019, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35209, country: United States, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06290115, orgStudyIdInfo id: 202301, briefTitle: Adolescents' Non-suicidal Behavior and Perception of Parents' Negative Emotional Expression and Family Communication, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The starting point of this project is to study young people and adolescents, aiming to explore the correlation between non-suicidal behavior of young people and adolescents and the negative emotional expression of their parents and family communication. The purpose of this project is to investigate the non-suicidal self-injury behavior of teenagers aged 15-25 years by issuing questionnaires (sample size: 327 people). In order to find out whether there is any connection between family communication and non-suicidal self-injury behavior of young people and adolescents., conditionsModule conditions: Adolescents, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires set 1, interventions name: Questionnaires set 2, interventions name: Questionnaires set 3, outcomesModule primaryOutcomes measure: Non-suicidal self-injury behavior of young people and adolescents, primaryOutcomes measure: Expression of negative emotions of parents, primaryOutcomes measure: Parent-Adolescent communication scale, secondaryOutcomes measure: Childhood Trauma Questionnaire, secondaryOutcomes measure: Parental Bongding Instrument, secondaryOutcomes measure: The parent-child relationship intimacy scale, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06290102, orgStudyIdInfo id: TV56248-RES-10204, briefTitle: Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-10-02, completionDateStruct date: 2024-11-09, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Teva Branded Pharmaceutical Products R&D, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objectives of this study are:* To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma* To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)* To compare the PK profiles of ABS between the 2 different strengths of TEV-56248The secondary objective is:• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI, conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: TEV-56248, interventions name: Fp MDPI, outcomesModule primaryOutcomes measure: Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp), primaryOutcomes measure: Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS), primaryOutcomes measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp, primaryOutcomes measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS, primaryOutcomes measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp, primaryOutcomes measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS, primaryOutcomes measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp, primaryOutcomes measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS, primaryOutcomes measure: Last Measurable Concentration Above the Quantification Limit (Clast) of Fp, primaryOutcomes measure: Last Measurable Concentration Above the Quantification Limit (Clast) of ABS, primaryOutcomes measure: Time of Last Measurable Concentration (tlast) of Fp, primaryOutcomes measure: Time of Last Measurable Concentration (tlast) of ABS, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs), secondaryOutcomes measure: Number of Participants with Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Teva Investigational Site 12001, status: RECRUITING, city: Boerne, state: Texas, zip: 78006, country: United States, geoPoint lat: 29.79466, lon: -98.73197, hasResults: False |
protocolSection identificationModule nctId: NCT06290089, orgStudyIdInfo id: OEV-131, briefTitle: Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Scandinavian Biopharma AB, class: INDUSTRY, collaborators name: Johns Hopkins Bloomberg School of Public Health, descriptionModule briefSummary: This is an open label study with the aim to estimate the incidence of moderate and severe diarrhea among participants challenged with an enterotoxigenic E. coli (ETEC) strain. This strain is planned to be used in a subsequent challenge study on the efficacy of an oral inactivated ETEC vaccine.The study will be conducted at one site; the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, United States., conditionsModule conditions: ETEC Diarrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Enterotoxigenic E. coli (ETEC) strain, outcomesModule primaryOutcomes measure: The incidence of moderate and severe diarrhea, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Kawsar R. Talaat, MD, role: CONTACT, phone: 410-502-9627, email: [email protected], contacts name: Kawsar R. Talaat, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06290076, orgStudyIdInfo id: IAT-PROACT, briefTitle: A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-09-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials., conditionsModule conditions: Acute Ischemic Stroke, conditions: Endovascular Thrombectomy, conditions: Symptomatic Intracranial Hemorrhage, conditions: Malignant Cerebral Edema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Rate of severe complications, secondaryOutcomes measure: Rate of mRS score of 3-6, secondaryOutcomes measure: Rate of mRS score of 5-6, secondaryOutcomes measure: Rate of symptomatic intracranial hemorrhage, secondaryOutcomes measure: Rate of malignant cerebral edema, secondaryOutcomes measure: Change of NIHSS score, secondaryOutcomes measure: Rate of modified Rankin Scale (mRS) score of 0-2, secondaryOutcomes measure: All-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06290063, orgStudyIdInfo id: 22-08-0138, briefTitle: Cannabidiol and Older Adult Cannabis Users, acronym: QUARTz, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-08-31, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Boulder, class: OTHER, descriptionModule briefSummary: Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market., conditionsModule conditions: Sleep, conditions: Anxiety, conditions: Depression, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 385, type: ESTIMATED, armsInterventionsModule interventions name: fsCBD Cannabidiol, interventions name: bsCBD Cannabidiol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Subjective Motor Function, primaryOutcomes measure: Balance, primaryOutcomes measure: Anxiety, primaryOutcomes measure: Depression, primaryOutcomes measure: Blood Cytokine Levels, primaryOutcomes measure: Depression/Anxiety, primaryOutcomes measure: Drug Effects, primaryOutcomes measure: Inhibitory Control, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Pain Intensity and Interference, primaryOutcomes measure: Cognitive Ability, primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Change in Condition, primaryOutcomes measure: Sleep Disturbance, primaryOutcomes measure: Sleep-Related Impairment, primaryOutcomes measure: Memory, secondaryOutcomes measure: Polypharmacy-Pain Medications, secondaryOutcomes measure: Polypharmacy-Psychiatric Medications, secondaryOutcomes measure: Polypharmacy-Sleep Medications, secondaryOutcomes measure: Strength and Endurance, secondaryOutcomes measure: Sleep Quality, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado at Boulder, city: Boulder, state: Colorado, zip: 80309, country: United States, contacts name: Ellie Sundali, BA, role: CONTACT, email: [email protected], geoPoint lat: 40.01499, lon: -105.27055, hasResults: False |
protocolSection identificationModule nctId: NCT06290050, orgStudyIdInfo id: TAK-279-1006, briefTitle: A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-05-03, completionDateStruct date: 2024-05-16, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide.During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally)., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Midazolam, interventions name: Repaglinide, interventions name: TAK-279, outcomesModule primaryOutcomes measure: Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279, primaryOutcomes measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279, primaryOutcomes measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279, secondaryOutcomes measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, status: RECRUITING, city: Tempe, state: Arizona, zip: 85283, country: United States, contacts name: Study Contact, role: CONTACT, phone: 480-415-7404, email: [email protected], contacts name: Mara Baier, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False |
protocolSection identificationModule nctId: NCT06290037, orgStudyIdInfo id: 2024-01-003, briefTitle: Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result, conditionsModule conditions: Automobile Driving, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: VR Driving Simulator, interventions name: Computerized Neurocognitive Function Test, interventions name: Driver Test Station, interventions name: Short Physical Performance Battery, interventions name: On-road field driving Test, outcomesModule primaryOutcomes measure: Feasibility of VR driving simulator, primaryOutcomes measure: Driving performance in simulator, measured by driving errors, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Ja-Ho Leigh, M.D. Msc., role: CONTACT, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06290024, orgStudyIdInfo id: XH-23-013, briefTitle: A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function, conditionsModule conditions: Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function, outcomesModule primaryOutcomes measure: Visual Analogue Scale/Score（VAS）, primaryOutcomes measure: digital pain grading method (NRS), primaryOutcomes measure: neuropathic pain assessment scale (DN4), primaryOutcomes measure: sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), primaryOutcomes measure: EEG, primaryOutcomes measure: Barrett impulse scale (BIS), primaryOutcomes measure: (Generalized Anxiety Disorder,GAD-7), primaryOutcomes measure: (Patient Health Questionnaire-9, secondaryOutcomes measure: Montreal cognitive assessment scale (MoCA), secondaryOutcomes measure: ocial support assessment scale (SSQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ke Ma, status: RECRUITING, city: Shanghai, state: Yangpu, zip: 200092, country: China, contacts name: Ke NA Ma, PHD, role: CONTACT, phone: 13361879260, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06290011, orgStudyIdInfo id: XH-23-014, briefTitle: A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-11, primaryCompletionDateStruct date: 2024-10-11, completionDateStruct date: 2024-10-11, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain, conditionsModule conditions: Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Pain key group, outcomesModule primaryOutcomes measure: Visual Analogue Scale/Score（VAS）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ke Ma, status: RECRUITING, city: Shanghai, state: Yangpu, zip: 200092, country: China, contacts name: Ke NA Ma, PHD, role: CONTACT, phone: 13361879260, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06289998, orgStudyIdInfo id: RP014-01, briefTitle: Study of Tamibarotene in Patients With ADPKD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-22, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Rege Nephro Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease, conditionsModule conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Tamibarotene, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in TKV from baseline, secondaryOutcomes measure: Changes in TLV from baseline, secondaryOutcomes measure: Changes in eGFR from baseline, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 26 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kurume University Hospital, status: RECRUITING, city: Kurume, state: Fukuoka, zip: 830-0011, country: Japan, geoPoint lat: 33.31667, lon: 130.51667, locations facility: Hokkaido University Hospital, status: RECRUITING, city: Sapporo, state: Hokkaido, zip: 060-8648, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Shonan Kamakura General Hospital, status: RECRUITING, city: Kamakura, state: Kanagawa, zip: 247-8533, country: Japan, geoPoint lat: 35.30889, lon: 139.55028, locations facility: Toranomon Hospital Kajigaya, status: RECRUITING, city: Kawasaki, state: Kanagawa, zip: 213-8587, country: Japan, geoPoint lat: 35.52056, lon: 139.71722, locations facility: Juntendo University School of Medicine Juntendo Hospital, status: RECRUITING, city: Bunkyo-ku, state: Tokyo, zip: 113-8431, country: Japan, geoPoint lat: 35.37517, lon: 139.92991, locations facility: Toranomon Hospital, status: RECRUITING, city: Minato-ku, state: Tokyo, zip: 105-8470, country: Japan, geoPoint lat: 34.2152, lon: 135.1501, locations facility: Tokyo Women's Medical University Hospital, status: RECRUITING, city: Shinjukuku, state: Tokyo, zip: 162-8666, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Kyoto University Hospital, status: RECRUITING, city: Kyoto, zip: 606-8507, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, hasResults: False |
protocolSection identificationModule nctId: NCT06289985, orgStudyIdInfo id: STEP, secondaryIdInfos id: 1OT2NS129366-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1OT2NS129366-01, briefTitle: StrokeNet Thrombectomy Endovascular Platform, acronym: STEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, collaborators name: National Institute of Neurological Disorders and Stroke (NINDS), collaborators name: University of Cincinnati, collaborators name: University of Virginia, collaborators name: Berry Consultants, collaborators name: University of California, Los Angeles, collaborators name: MOUNT SINAI HOSPITAL, collaborators name: The Cooper Health System, collaborators name: University of Pittsburgh Medical Center, collaborators name: Stony Brook University, collaborators name: University at Buffalo, descriptionModule briefSummary: STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO)., conditionsModule conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Endovascular thrombectomy with any FDA-approved category POL or NRY device, interventions name: Medical Management, outcomesModule primaryOutcomes measure: Global disability measured by Modified Rankin Score, otherOutcomes measure: Global disability measured by Modified Rankin Score, otherOutcomes measure: Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS), otherOutcomes measure: Symptomatic intracranial hemorrhage, otherOutcomes measure: Any radiologic intracranial hemorrhage, otherOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289972, orgStudyIdInfo id: HUvbayraktaroglu1, briefTitle: Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02-20, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, descriptionModule briefSummary: The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis., conditionsModule conditions: Cystic Fibrosis, conditions: Parents, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 22, type: ESTIMATED, outcomesModule primaryOutcomes measure: The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C), secondaryOutcomes measure: Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version, secondaryOutcomes measure: Parent Attitude Scale (PAS), secondaryOutcomes measure: Perceived Social Support Scale (PSS), secondaryOutcomes measure: Parent Attitude Scale, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haliç University, status: RECRUITING, city: Istanbul, state: Eyup, zip: 34060, country: Turkey, contacts name: Vildan Bayraktaroglu, PT, MSc, role: CONTACT, phone: (0212) 924 24 44, email: [email protected], contacts name: Seda Saka, PT, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06289959, orgStudyIdInfo id: JD-LC2023006-I01, briefTitle: Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2029-01-01, completionDateStruct date: 2029-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients., conditionsModule conditions: Lymphoma, Large B-Cell, Diffuse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: cfDNA, outcomesModule primaryOutcomes measure: Progression-free survival（PFS）, secondaryOutcomes measure: Sensitivity, and specificity of plasma cfDNA in DLBCL patients, secondaryOutcomes measure: Overall survivals(OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Bingzong Li, Professor, role: CONTACT, phone: 0086-13776054037, email: [email protected], geoPoint lat: 31.30408, lon: 120.59538, hasResults: False |
protocolSection identificationModule nctId: NCT06289946, orgStudyIdInfo id: NitroRadialLHC, briefTitle: Topical Nitro or Placebo Pre-Cath, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Thomas Jefferson University, class: OTHER, descriptionModule briefSummary: Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 256, type: ESTIMATED, armsInterventionsModule interventions name: NitroBid, interventions name: Placebo, outcomesModule primaryOutcomes measure: Crossover rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
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