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protocolSection identificationModule nctId: NCT06274333, orgStudyIdInfo id: RC.18.1.2024, briefTitle: Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, collaborators name: Benha University, descriptionModule briefSummary: The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia., conditionsModule conditions: Percutaneous Nephrolithotripsy (PCNL), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine 0.5 mic/kg, interventions name: Tramadol 1mg/kg, interventions name: Paracetamol 10mg/kg, outcomesModule primaryOutcomes measure: The incidence of catheter-related bladder discomfort (CRBD), secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Meperidine requirement, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Surgeon satisfaction, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Neveen Kohaf, status: RECRUITING, city: Cairo, zip: 11865, country: Egypt, contacts name: Neveen Kohaf, Ph.D, role: CONTACT, phone: +201069482380, email: [email protected], contacts name: Hany Bauiomy, M.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed M. Abosakaya, M.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06274320, orgStudyIdInfo id: LRP22002 LIPIKAR UREA 30%, briefTitle: Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cosmetique Active International, class: INDUSTRY, descriptionModule briefSummary: This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment., conditionsModule conditions: Actinic Keratoses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Group A: holistic approach, interventions name: Group B: Tolak® Standard of use, outcomesModule primaryOutcomes measure: Change in lesion response rate, secondaryOutcomes measure: Percentage change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CentroDerm GmbH, city: Wuppertal, country: Germany, geoPoint lat: 51.27027, lon: 7.16755, hasResults: False |
protocolSection identificationModule nctId: NCT06274307, orgStudyIdInfo id: IRB-21-10-4045, briefTitle: Efficacy of Transversus Abdominis Plane Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-22, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Justin Hruska, class: OTHER, descriptionModule briefSummary: This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method., conditionsModule conditions: Anesthesia, Local, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Transversus abdominis plane block, outcomesModule primaryOutcomes measure: Time to perform TAP Block, primaryOutcomes measure: TAP block attempts, primaryOutcomes measure: Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery, primaryOutcomes measure: Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery, primaryOutcomes measure: Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery, primaryOutcomes measure: Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery, primaryOutcomes measure: Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery, primaryOutcomes measure: Postoperative Opioid Consumption, primaryOutcomes measure: Ease of performing TAP Block-anatomical plane visualization, primaryOutcomes measure: Ease of performing TAP Block-performance efficacy, primaryOutcomes measure: Patient satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Detroit Medical Center Detroit Receiving Hospital, status: RECRUITING, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: George M McKelvey, PhD, role: CONTACT, phone: 313-598-6036, email: [email protected], contacts name: Justin Hruska, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.33143, lon: -83.04575, locations facility: Detroit Medical Center, Harper University Hospital, status: RECRUITING, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: George M McKelvey, PhD, role: CONTACT, phone: 313-598-6036, email: [email protected], contacts name: Justin Hruska, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.33143, lon: -83.04575, hasResults: False |
protocolSection identificationModule nctId: NCT06274294, orgStudyIdInfo id: 2023/12, briefTitle: Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC, acronym: PASSPORT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: CMC Ambroise Paré, class: OTHER, collaborators name: Paris IBD Center, collaborators name: Celltrion HealthCare France, descriptionModule briefSummary: The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows:* Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24.* Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: CT-P13, outcomesModule primaryOutcomes measure: Ratio SC/IV, secondaryOutcomes measure: Ctrough at week 24 (non-inferiority), secondaryOutcomes measure: AUC at week 24, secondaryOutcomes measure: Clinical response at week 6 and week 24, secondaryOutcomes measure: IBD disability index at week 6, secondaryOutcomes measure: Fecal calprotectin at week 24, secondaryOutcomes measure: Clinical remission at week 6 and week 24, secondaryOutcomes measure: Presence of antibodies to infliximab at Week 6 and Week 24, secondaryOutcomes measure: Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24), secondaryOutcomes measure: Adverse events, including injection site reactions and hypersensitivity reactions, secondaryOutcomes measure: TSQM collected at Week 6 and Week 24, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274281, orgStudyIdInfo id: TOMs_FMD, briefTitle: Digital Telerehabilitation in Functional Motor Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universita di Verona, class: OTHER, descriptionModule briefSummary: Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized." It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs., conditionsModule conditions: Functional Movement Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is an experimental single-blind randomized-controlled trial (RCT) with 2-parallel arms comparing the effects between the experimental group (EG) and control group (CG). After screening, a simple randomization list will be generated by a physician using an automated randomization system (alloca-tion ratio 1:1) to assign eligible patients to either the EG or the CG. Group allocation will be kept concealed., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The outcome assessor will be blinded to the type of intervention performed by the patient., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Digital Telerehabilitation, interventions name: Usual care, outcomesModule primaryOutcomes measure: number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation, primaryOutcomes measure: Budget issues related to TOMs, primaryOutcomes measure: Time spent to train patients, secondaryOutcomes measure: Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score, secondaryOutcomes measure: Multidimensional Fatigue Inventory Scale (MFI-20) score, secondaryOutcomes measure: Change in the Brief Pain Inventory (BPI) score, secondaryOutcomes measure: Change in the Beck Depression Inventory (BDI-II) score, secondaryOutcomes measure: Change in the Beck Anxiety Inventory (BAI) score, secondaryOutcomes measure: Change in the 12-item Short-Form Health Survey (SF-12) score, secondaryOutcomes measure: The EuroQol-5D (EQ-5D), secondaryOutcomes measure: iMTA Productivity Cost Questionnaire, secondaryOutcomes measure: Change in the Clinical Global Impression (CGI) score, secondaryOutcomes measure: Gait outcome: Gait speed, secondaryOutcomes measure: Gait outcome: Stride length, secondaryOutcomes measure: Gait outcome: Cadence, secondaryOutcomes measure: Balance outcome: CoP trajectory, secondaryOutcomes measure: Balance outcomes: Sway area, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, city: Verona, zip: 37131, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, locations facility: USD Parkinson's Disease and Movement Disorders Unit, city: Verona, zip: 37134, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False |
protocolSection identificationModule nctId: NCT06274268, orgStudyIdInfo id: CHMS23006, briefTitle: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments, acronym: SARC-ONCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Metropole Savoie, class: OTHER, collaborators name: Université Savoie Mont Blanc, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers.The main question it aims to answer is :Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests., conditionsModule conditions: Sarcopenia, conditions: Oncology, conditions: Physical Inactivity, conditions: Toxicity Due to Chemotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective cohort study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Sarcopenia diagnostic test, outcomesModule primaryOutcomes measure: Event-free survival according to sarcopenic statut, secondaryOutcomes measure: Event-free survival according to the link between: 1/ the dose/lean mass ratio and 2/ body composition and the occurrence of adverse events linked to treatment., secondaryOutcomes measure: Progression free-survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response rate at 6 and 12 months, secondaryOutcomes measure: Number of patients classified as sarcopenic by BIA method and CT method., secondaryOutcomes measure: Exploratory: Event-free survival during PACLITAXEL protocol, secondaryOutcomes measure: Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2)., secondaryOutcomes measure: Exploratory: RCB-based objective response rate at 6 and 12 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274255, orgStudyIdInfo id: BalikesirU, briefTitle: Serum Magnesium Level and Pediatric Migraine, acronym: Migraine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Mersin University, class: OTHER, descriptionModule briefSummary: Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded., conditionsModule conditions: Migraine, Magnesium, Pediatric, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Serum Magnesium Level and Pediatric Migraine, secondaryOutcomes measure: Serum Magnesium Level and Pediatric Migraine, eligibilityModule sex: ALL, minimumAge: 72 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hilal Aydın, city: Balıkesir, state: Türkiye, zip: 33343, country: Turkey, contacts name: Hilal Aydın, assoc. Dr., role: CONTACT, phone: +902666121461, email: [email protected], contacts name: Hilal Aydın, assoc. Dr., role: CONTACT, phone: +905072607541, email: [email protected], geoPoint lat: 39.64917, lon: 27.88611, locations facility: Aysen Orman, city: Mersin, state: Türkiye, zip: 33343, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, locations facility: MersinU, city: Mersin, state: Türkiye, zip: 33343, country: Turkey, contacts name: Aysen Orman, role: CONTACT, email: [email protected], contacts name: Aysen Orman, role: CONTACT, phone: 3242410000, phoneExt: 2646, email: [email protected], geoPoint lat: 36.79526, lon: 34.61792, locations facility: Aysen Orman, city: Mersin, state: Türkiye, zip: 38000, country: Turkey, contacts name: Aysen Orman, assoc. Dr., role: CONTACT, phone: +903242410000, phoneExt: +903242410000, email: [email protected], contacts name: Aysen Orman, assoc. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False |
protocolSection identificationModule nctId: NCT06274242, orgStudyIdInfo id: MU-CIRB 2022/300.0711, briefTitle: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2023-07-22, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial., conditionsModule conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 98, type: ACTUAL, armsInterventionsModule interventions name: Haruna, interventions name: Placebo Powder, outcomesModule primaryOutcomes measure: Change in Stool Frequency, primaryOutcomes measure: Change in Fecal Microbiota, secondaryOutcomes measure: Change in Stool consistency, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mahidol University, city: Nakhon Pathom, zip: 73170, country: Thailand, geoPoint lat: 13.8196, lon: 100.04427, hasResults: False |
protocolSection identificationModule nctId: NCT06274229, orgStudyIdInfo id: EA4/252/23, briefTitle: DivAirCity Social Health Survey, acronym: DivAirCitySH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, collaborators name: Universitat Politècnica de València, collaborators name: Universitatea din Bucuresti, collaborators name: University of Aarhus, collaborators name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, collaborators name: European Commission, descriptionModule briefSummary: To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site)., conditionsModule conditions: Psychological Stress, conditions: Psychological Well-Being, conditions: Pollution; Exposure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Air pollution and noise reducing installations, outcomesModule primaryOutcomes measure: WHO-5 Well-being Scale, secondaryOutcomes measure: Kessler K6 psychological distress, secondaryOutcomes measure: ASKU questionnaire, otherOutcomes measure: Questionnaire for General Physiological Health, otherOutcomes measure: Questionnaire about feelings of safety and security at the site, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité -- Universitaetsmedizin Berlin, status: RECRUITING, city: Berlin, zip: 14109, country: Germany, contacts name: Farid I Kandil, PhD, role: CONTACT, phone: +491605631744, email: [email protected], geoPoint lat: 52.52437, lon: 13.41053, hasResults: False |
protocolSection identificationModule nctId: NCT06274216, orgStudyIdInfo id: 4381021ABOS, briefTitle: The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2022-03-30, completionDateStruct date: 2022-04-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Ziauddin University, class: OTHER, descriptionModule briefSummary: Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D, conditionsModule conditions: Osseointegration Failure of Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research commences through a self-administered questionnaire such as age, gender, weight, height, BMI, smoking habits, sun exposure, and employment status.Prior to implant surgery, each participant undergoes a blood test to assess their vitamin D levels.Detailed records are maintained concerning the anatomical position (molar, pre-molar, canine, and incisor) and implant site (maxilla and mandible) for every participant.Group Formation: The participant pool is stratified into two distinct groups - Group A and Group B. This categorization is essential for implementing and comparing different interventions within the study. Group A undergoes a specific intervention wherein they receive a daily oral dose of 5000 IU of vitamin D3 for a duration of 12 weeks. In contrast, Group B receives a placebo.Following the intervention period, the implants are allowed to cure adequately, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks, whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant.The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible).Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Vitamin D3, interventions name: Vitamin E 400, outcomesModule primaryOutcomes measure: Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100), secondaryOutcomes measure: Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Afifa Razi, city: Karachi, state: Sindh, zip: 74700, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False |
protocolSection identificationModule nctId: NCT06274203, orgStudyIdInfo id: 10584-2/5-2023, briefTitle: High Dose Vitamin D Supplementation in Children With Sickle Cell Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL., conditionsModule conditions: Sickle Cell Disease, conditions: Vitamin D Deficiency, conditions: Health Related Quality of Life, conditions: Hand Grip Strength, conditions: Bone Mineral Density, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Vitamin D3, outcomesModule primaryOutcomes measure: Serum 25(OH)D level, secondaryOutcomes measure: Bone mineral density (BMD), secondaryOutcomes measure: Maximum handgrip strength (HGS), secondaryOutcomes measure: Health related quality of life (HRQL), secondaryOutcomes measure: Serum concentrations of C reactive protein (CRP), secondaryOutcomes measure: Serum concentrations of Erythrocyte sedimentation rate (ESR), secondaryOutcomes measure: Safety reporting of any adverse events, secondaryOutcomes measure: Safety measurements of serum Ca, secondaryOutcomes measure: childhood health assessment, secondaryOutcomes measure: Safety measurements of serum 25(OH)D levels, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Zagazig university, city: Zagazig, state: Sharkia, zip: 44519, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False |
protocolSection identificationModule nctId: NCT06274190, orgStudyIdInfo id: S68746, briefTitle: Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary, acronym: Treatable, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, collaborators name: Universitaire Ziekenhuizen KU Leuven, descriptionModule briefSummary: Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms., conditionsModule conditions: Rectal Cancer, conditions: LARS - Low Anterior Resection Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 118, type: ESTIMATED, armsInterventionsModule interventions name: bowel e-diary, outcomesModule primaryOutcomes measure: Selection of items for the newly developed bowel diary, primaryOutcomes measure: Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants, primaryOutcomes measure: The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer, primaryOutcomes measure: The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days, primaryOutcomes measure: Construct validity of the newly developed bowel e-diary, primaryOutcomes measure: Criterion validity of the newly developed bowel e-diary, primaryOutcomes measure: Test-retest reliability of the newly developed bowel e-diary, primaryOutcomes measure: Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274177, orgStudyIdInfo id: BTL-785_CTUS1400, briefTitle: Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-26, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: BTL Industries Ltd., class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment., conditionsModule conditions: Fat Burn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: BTL-785-7, outcomesModule primaryOutcomes measure: Submental fat thickness reduction, secondaryOutcomes measure: Incidence of Treatment-related Adverse Events, secondaryOutcomes measure: Change on the Clinician Reported - Submental Fat Rating Scale score, secondaryOutcomes measure: Satisfaction Assessed by the Satisfaction Questionnaire, secondaryOutcomes measure: Change in the submental-cervical angle, secondaryOutcomes measure: Comfort Assessed by Therapy Comfort Questionnaire, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Precision Skin LLC, city: Davie, state: Florida, zip: 33328, country: United States, geoPoint lat: 26.06287, lon: -80.2331, locations facility: Chicago Cosmetic and Dermatologic Research, city: Chicago, state: Illinois, zip: 60654, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: New Jersey Plastic Surgery (NJPS), city: Montclair, state: New Jersey, zip: 07042, country: United States, geoPoint lat: 40.82593, lon: -74.20903, locations facility: Gentile Facial Plastic and Aesthetic Laser Center, city: Youngstown, state: Ohio, zip: 44512, country: United States, geoPoint lat: 41.09978, lon: -80.64952, hasResults: False |
protocolSection identificationModule nctId: NCT06274164, orgStudyIdInfo id: H-54820 / RAI1, briefTitle: Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Baylor College of Medicine, class: OTHER, collaborators name: Doris Duke Charitable Foundation, descriptionModule briefSummary: Currently, there is no clinically available genetic-based treatment for RAI1 (Retinoic Acid-Induced 1) -related disorders other than symptomatic management and there are no established clinical or molecular biomarkers that could be used as measures for the efficacy of therapy in future treatment studies. Biomarkers are measures of what is happening inside the body, shown by the results of laboratory, imaging or other tests.Biomarkers can help doctors and scientists diagnose diseases and health conditions, monitor responses to treatment and see how a person's disease or health condition changes over time.The goal of this observational and laboratory study is to develop clinical, neurophysiology and molecular biomarkers in RAI1-related disorders. The main question\[s\] it aims to answer are:* to characterize the disease features more precisely and analyze the differentiating and overlapping features of RAI1-related disorders (Smith-Magenis syndrome and Potocki-Lupski Syndrome)* to identify clinical, neurophysiology, and laboratory biomarkers that differentiate RAI1-related disorders one from another.Participants will have to complete:* a clinical examination* a blood draw* a skin biopsy (optional)* a sleep studyResearchers will compare patients' blood to control group's blood for biomarker studies., conditionsModule conditions: RAI1 Gene 17P11.2 Deletion+Duplication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Electroencephalography/Polysomnography (EEG/PSG), interventions name: Skin Biopsy, interventions name: Blood draw, outcomesModule primaryOutcomes measure: Rate of neurological clinical finding, primaryOutcomes measure: Rate of electroencephalogram (EEG) and/or sleep abnormalities, primaryOutcomes measure: Concentration of downstream molecular pathway interactors of RAI1, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Texas Children's Hospital, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Davut Pehlivan, MD, role: CONTACT, phone: 713-798-6970, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06274151, orgStudyIdInfo id: H-22038917, briefTitle: Optimal Treatment of Acute Skeletal Muscle Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Bispebjerg Hospital, class: OTHER, descriptionModule briefSummary: Acute muscle strain injuries occur both during sports, in leisure time activities and during manual occupation and represent a major clinical challenge and has societal economic costs. The recovery time is long and a substantial injury recurrence is observed. Despite current best evidence rehabilitation with early mechanical loading, a significant loss of muscle mass, fatty infiltration and formation of scar tissue is reported.Animal models and human in vitro experiments suggest that inflammation is vital in the early period after an injury, however an inhibition of inflammatory processes is beneficial for healing.We investigate here whether a pharmacological inhibition of inflammatory pathways in the 2nd week following a muscle strain injury will provide a better clinical outcome and an advantageous cellular profile than rehabilitative training alone would., conditionsModule conditions: Muscle Strain, Multiple Sites, conditions: Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Naproxen 500 Mg, interventions name: Rehabilitation, interventions name: Placebo, outcomesModule primaryOutcomes measure: Effect of anti-inflammatory medicine on cellular profile in skeletal muscle, secondaryOutcomes measure: Functional outcome performance, secondaryOutcomes measure: Functional outcome re-injury rate, secondaryOutcomes measure: Functional outcome Patient Related Outcome Measures (PROM), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274138, orgStudyIdInfo id: HAPTONOMY, briefTitle: The Enchanting Symphony of Haptonomy's Impact on Attachment and Spousal Harmony for Women Conceiving Through Infertility Treatment, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Baskent University, class: OTHER, descriptionModule briefSummary: Pregnancies resulting from infertility treatment are considered normal and 'low-risk' in some countries, they often entail significant stress. Prenatal attachment may be experienced differently by parents conceiving through fertility interventions. The rising prevalence of fertility treatments is associated with increased risks such as preterm birth, low birth weight, and perinatal mortality for pregnancies achieved through infertility treatments. Beyond medical implications, post-infertility treatment pregnancies can induce high levels of anxiety and a perception of pregnancy as risky, affecting individuals psychologically. The transition to parenthood after infertility treatment can be psychologically challenging.Healthy prenatal attachment in expectant mothers fosters the development of a healthy role as both mother and father. Maternal bonding is closely tied to a woman's mental health during the prenatal period and her commitment to her baby. Similarly, prenatal bonding with the father sheds light on the emotional connection developing between the father and the unborn child. Active participation in prenatal experiences, such as attending ultrasound appointments or discussing parenting plans, contributes to a stronger sense of attachment for fathers and establishes a positive foundation for future bonding. Supportive partner relationships during pregnancy enhance paternal bonding and emphasize the importance of a collaborative approach to prenatal care for both parents. The prenatal period is critical for fathers to establish an early emotional connection with their unborn children, laying a positive groundwork for postnatal bonding.Various interventions aim to enhance communication between parents and augment prenatal attachment. One such practice is haptonomy-haptotherapy. Haptotherapy focuses on restoring emotional connections, especially with one's own body. It helps individuals recognize their emotional capacities and allows them to experience these capacities through insightful conversations, therapeutic touch, and skill exercises. In the context of pregnancy, haptonomy involves physical contact between the pregnant woman, her partner, and the unborn baby. Advocates of haptonomy believe that this touch-based communication can strengthen the bond between parents and the baby, promote a sense of security, and positively influence the pregnancy experience.Haptonomy is thought to contribute positively to the psychological well-being of women during pregnancy, birth, and the postpartum period, potentially preventing mental health issues and enhancing the health of both mother and baby. It is emphasized that haptonomy is a distinct practice focused on enhancing communication between parents and the baby. Existing literature suggests that haptonomy can increase emotional bonding during the prenatal period and may be effective for parents showing low attachment. Studies indicate that touch communication develops from the second month, involving vibrations for communicating with the fetus, ultimately increasing bonding through haptonomy. Furthermore, haptonomy is reported to enhance both spousal and parental attachment, as demonstrated in a study emphasizing increased attachment for fathers with their partners and children.Despite documented benefits of haptonomy in various patient groups, from cancer patients undergoing chemotherapy to pregnant women and those with chronic pain, limited research exists on haptotherapy for pregnant women. This study aims to investigate the impact of partner-administered haptonomy on prenatal attachment and marital adjustment in pregnant women. Conducted through a randomized controlled experimental design, the study seeks to provide evidence by enhancing prenatal attachments in both mothers and fathers.Research Hypotheses:H0-1: The application of haptonomy by partners has an effect on maternal attachment in pregnant women.H1-1: The application of haptonomy by partners does not have an effect on maternal attachment in pregnant women.H0-2: The application of haptonomy by partners has no effect on paternal attachment in pregnant women.H1-2: The application of haptonomy by partners has an effect on paternal attachment in pregnant women.H0-3: The application of haptonomy by partners has no effect on marital adjustment in pregnant women.H1-3: The application of haptonomy by partners has an effect on marital adjustment in pregnant women., conditionsModule conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: haptonomy, outcomesModule primaryOutcomes measure: Marital adjustment score, primaryOutcomes measure: Prenatal attachment score, primaryOutcomes measure: Father attachment score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Başkent University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06274125, orgStudyIdInfo id: AslıDemircioglu1, briefTitle: Evaluation of Kidney Damage Using NGAL Measurements, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery., conditionsModule conditions: Prostatectomy, conditions: Neutrophil Gelatinase-Associated Lipocalin, conditions: Kidney Function Tests, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Robotic-Assisted Laparoscopic Radical Prostatectomy, outcomesModule primaryOutcomes measure: The main objective of this study is to evaluate whether blood NGAL measurement has superiority over sCr and BUN tests in terms of early diagnosis for assessing kidney function in patients undergoing robotic urologic surgery., secondaryOutcomes measure: The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI., secondaryOutcomes measure: The evaluation of the relationship between intraabdominal pressure and the development of AKI., secondaryOutcomes measure: The relationship between intraoperative mean arterial pressure (MAP) and NGAL (Neutrophil Gelatinase-Associated Lipocalin) values., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, status: RECRUITING, city: Ankara, state: Çankaya, zip: 06530, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06274112, orgStudyIdInfo id: 1K23MH135222, briefTitle: Using TMS to Understand Neural Processes of Social Motivation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2029-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Auburn University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks.Adults in the Auburn/Apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate., conditionsModule conditions: Social Avoidant Behavior, conditions: Major Depressive Disorder, conditions: Social Anxiety Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants will receive each dose of TMS in a counterbalanced order (AB or BA), primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TMS, outcomesModule primaryOutcomes measure: Social motivation, primaryOutcomes measure: Neural circuit function, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06274099, orgStudyIdInfo id: TDK-2023-12649, briefTitle: The Effect of the Care Given to Hemodialysis Patients on Comfort Level and Complaints, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Reva Balci Akpinar, class: OTHER, collaborators name: Atatürk University, descriptionModule briefSummary: Kolcaba's comfort theory is a theory used by nurses to increase the comfort of patients. There are limited studies determining that nursing care provided according to this theory contributes to the increase in patients' comfort levels in various patient groups. This study will be carried out in the hemodialysis center of a public hospital located in the city center of Bingöl. Patients in the intervention group receiving hemodialysis treatment will be given nursing care by the researcher for 12 sessions during the sessions in which the patient receives hemodialysis treatment. In order to provide nursing care, nursing diagnoses suitable for the patient group will be determined in advance and the care the patient needs will be given according to these diagnoses.. If necessary, the researcher will add additional diagnoses to the preliminary diagnosis form and provide care.In this research, the individual nursing care needs of the researcher patient will be determined. Individualized caregiving is unique to this study. Individually provided care is expected to increase patient comfort and satisfaction. Increased comfort will help the patient cope more easily with the disease and hemodialysis treatment symptoms. In addition, the results of individual care provided can guide nurses in their care behaviors. By adding this research to the literature, the groundwork will be laid for studies that will provide individual care to patients. It is expected that the results of this research will guide the planning of the research and the provision of individualized care in all patient groups, especially patients receiving hemodialysis treatment., conditionsModule conditions: Hemodialysis Complication, conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pretest posttest randomized controlled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: nursing care, outcomesModule primaryOutcomes measure: General Comfort Scale, primaryOutcomes measure: Dialysis Symptom Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ataturk University, city: Erzurum, state: Diğerleri, zip: 25200, country: Turkey, contacts name: REVA BALCI AKPINAR, PROF. DR, role: CONTACT, phone: +904422312214, email: [email protected], contacts name: RUKIYE DEMİR DIKMEN, role: SUB_INVESTIGATOR, geoPoint lat: 39.90861, lon: 41.27694, locations facility: Ataturk University, city: Erzurum, state: Diğerleri, zip: 25200, country: Turkey, contacts name: REVA BALCI AKPINAR, PROF. DR, role: CONTACT, phone: +904422312214, email: [email protected], geoPoint lat: 39.90861, lon: 41.27694, hasResults: False |
protocolSection identificationModule nctId: NCT06274086, orgStudyIdInfo id: S2022-2027-0001, briefTitle: Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-06-01, primaryCompletionDateStruct date: 2023-03-31, completionDateStruct date: 2023-03-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Asan Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?Participants will:* Receive the first session CDS for endometrioma* Carry the catheter overnight and be monitored in the patient ward* Receive the second session CDS the next day, conditionsModule conditions: Sclerotherapy, conditions: Endometrioma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Two-session catheter-directed sclerotherapy, outcomesModule primaryOutcomes measure: Recurrence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan Medical Center, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06274073, orgStudyIdInfo id: E2-22-2566, briefTitle: Double-dorsal Versus Single-volar Digital Block, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-12, primaryCompletionDateStruct date: 2023-07-12, completionDateStruct date: 2023-09-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the traditional dorsal double injection digital block with the palmar single injection technique in the suturing of acute traumatic hand finger lacerations in terms of injection pain score (NRS), anesthesia onset time, and success of anesthesia.It is understood that single injection digital block and double injection digital block techniques do not have significant advantages over each other in terms of pain levels and procedure times.However, the need for rescue anesthesia was evaluated to be lower in the single injection digital block technique. This difference is especially due to measurements in the volar region incisions.According to the results of this study, we think that choosing the single injection digital block technique for volar region incisions is a more rational approach, especially in terms of the data of the need for rescue anesthesia., conditionsModule conditions: Laceration of Skin, conditions: Anesthesia, Local, conditions: Pain, conditions: Nerve Block, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two parallel groups (two digital block techniques), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: Dorsal digital block, interventions name: Palmar digital block, outcomesModule primaryOutcomes measure: Anesthesia pain score, secondaryOutcomes measure: Anesthesia onset time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara City Hospital Emergency Medicine Department, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06274060, orgStudyIdInfo id: 135399, secondaryIdInfos id: R01MH121161, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MH121161, secondaryIdInfos id: IRB00012628, type: OTHER, domain: JHSPH IRB, briefTitle: Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins Bloomberg School of Public Health, class: OTHER, collaborators name: TB/HIV Care, collaborators name: Unity Health Toronto, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa., conditionsModule conditions: Pre-exposure Prophylaxis, conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. The design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 304, type: ESTIMATED, armsInterventionsModule interventions name: Case management, interventions name: Food vouchers, interventions name: PrEP support buddy, interventions name: Community-based PrEP pickup points, outcomesModule primaryOutcomes measure: PrEP persistence at 7 months after PrEP initiation, primaryOutcomes measure: PrEP adherence at 7 months after PrEP initiation among all trial participants, secondaryOutcomes measure: PrEP persistence at 1 month after PrEP initiation, secondaryOutcomes measure: PrEP persistence at 4 months after PrEP initiation, secondaryOutcomes measure: PrEP persistence at 13 months after PrEP initiation, secondaryOutcomes measure: PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TB HIV Care, status: RECRUITING, city: Pietermaritzburg, state: KwaZulu Natal, zip: 3200, country: South Africa, contacts name: Chitra Singh, MSocSci, role: CONTACT, phone: +27721516828, email: [email protected], contacts name: Joel Steingo, MBChB, MPH, role: CONTACT, phone: +27833009377, email: [email protected], contacts name: Harry Hausler, MD, PhD, MPH, role: PRINCIPAL_INVESTIGATOR, contacts name: Mfezi Mcingana, BA, role: SUB_INVESTIGATOR, contacts name: Jenny Mcloughlin, RN, role: SUB_INVESTIGATOR, contacts name: Joel Steingo, MBChB, MPH, role: SUB_INVESTIGATOR, geoPoint lat: -29.61679, lon: 30.39278, hasResults: False |
protocolSection identificationModule nctId: NCT06274047, orgStudyIdInfo id: 2023-0409, secondaryIdInfos id: NCI-2024-01553, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Janssen Scientific Affairs, LLC, descriptionModule briefSummary: 1. Personalize treatment for prostate cancer based on how aggressive the disease is and2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy., conditionsModule conditions: Androgen Axis Suppression, conditions: Prostatectomy, conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Apalutamide, interventions name: Androgen Deprivation Therapy, outcomesModule primaryOutcomes measure: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Karen Hoffman, MD, role: CONTACT, phone: 713-563-2339, email: [email protected], contacts name: Karen Hoffman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06274034, orgStudyIdInfo id: 23-006870, secondaryIdInfos id: NCI-2024-01019, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-006870, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors., conditionsModule conditions: Breast Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Electronic Health Record Review, interventions name: Medical Device Usage and Evaluation, interventions name: Meditation Therapy, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Frequency of use of meditation, primaryOutcomes measure: Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband), primaryOutcomes measure: Impact of interactive meditation and sleep support through the Muse-S™ system, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Stacy D. D'Andre, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06274021, orgStudyIdInfo id: UMMC-IRB-2023-125, briefTitle: Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Mississippi Medical Center, class: OTHER, collaborators name: Methodist Rehabilitation Center, collaborators name: The Craig H. Neilsen Foundation, descriptionModule briefSummary: People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future., conditionsModule conditions: Spinal Cord Injuries, conditions: Spinal Cord Injury, conditions: Spinal Cord Injury Cervical, conditions: Spinal Cord Injury Thoracic, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: The participants and assessors are kept unaware of which intervention is being administered. For this, the study drugs are designed to be visually identical for all participants, and the intervention and sham stimulation configuration is set without the assessor being present in the room., enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous spinal stimulation at 100 Hz, interventions name: Transcutaneous spinal stimulation at 50 Hz, interventions name: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen, interventions name: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine, interventions name: Sham transcutaneous spinal stimulation, outcomesModule primaryOutcomes measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves., primaryOutcomes measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude., primaryOutcomes measure: Change from baseline of stretch reflex (SR) response amplitude., primaryOutcomes measure: Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),, primaryOutcomes measure: Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)., secondaryOutcomes measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves., secondaryOutcomes measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude., secondaryOutcomes measure: Change from baseline of stretch reflex (SR) response amplitude., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Rehabilitation Center, city: Jackson, state: Mississippi, zip: 39216, country: United States, contacts name: Dobrivoje S Stokic, MD, DSc, role: CONTACT, phone: 601-364-3314, email: [email protected], geoPoint lat: 32.29876, lon: -90.18481, locations facility: University of Mississippi Medical Center, city: Jackson, state: Mississippi, zip: 39216, country: United States, contacts name: Matthias J Krenn, PhD, role: CONTACT, phone: 601-364-3413, email: [email protected], geoPoint lat: 32.29876, lon: -90.18481, hasResults: False |
protocolSection identificationModule nctId: NCT06274008, orgStudyIdInfo id: 230110, briefTitle: Exparel vs. ACB With Bupivacaine for ACL Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Orange County, class: OTHER, descriptionModule briefSummary: Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear., conditionsModule conditions: ACL Tear, conditions: Opioid Misuse, conditions: Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Exparel, outcomesModule primaryOutcomes measure: At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge, secondaryOutcomes measure: Postoperative pain level of child, secondaryOutcomes measure: Functional disability of child, secondaryOutcomes measure: Parent and child anxiety, secondaryOutcomes measure: Child pain, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: CHOC Children's Hospital, status: RECRUITING, city: Orange, state: California, zip: 92868, country: United States, contacts name: Haydee Cortes, role: CONTACT, phone: 714-456-2837, email: [email protected], contacts name: Kiran Athreya, role: CONTACT, phone: 9493064857, email: [email protected], contacts name: John Schlechter, DO, role: PRINCIPAL_INVESTIGATOR, contacts name: Zeev N. Kain, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.78779, lon: -117.85311, hasResults: False |
protocolSection identificationModule nctId: NCT06273995, orgStudyIdInfo id: H-54233, briefTitle: Telehealth Behavioral Activation for Teens, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2029-03-01, completionDateStruct date: 2029-12-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Baylor College of Medicine, class: OTHER, collaborators name: University of Texas, descriptionModule briefSummary: Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas., conditionsModule conditions: Depression, conditions: Suicide and Self-harm, conditions: Depression in Adolescence, conditions: Depression Mild, conditions: Depression Moderate, conditions: Depression Severe, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group, open-label behavioral activation, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Activation, outcomesModule primaryOutcomes measure: Patient Health Questionnaire 9-modified for adolescents (PHQ-A), primaryOutcomes measure: Behavioral Activation for Depression-Short Form (BAD-SF), primaryOutcomes measure: Dimensional Anhedonia Rating Scale (DARS), secondaryOutcomes measure: Strengths and Difficulties Questionnaire (SDQ), secondaryOutcomes measure: Duke Social Support Index (DSSI), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Baylor College of Medicine, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Eric Storch, Ph.D., role: CONTACT, phone: 713-798-3080, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06273982, orgStudyIdInfo id: 1R01MH131698, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MH131698, briefTitle: Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth, acronym: STEP-UP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2028-05-31, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: San Diego State University, class: OTHER, collaborators name: Kaiser Permanente, collaborators name: OCHIN, Inc., descriptionModule briefSummary: The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective., conditionsModule conditions: Depression, Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression), interventions name: ARC (assisted referral to community care), outcomesModule primaryOutcomes measure: Children's Global Assessment Scale (CGAS), primaryOutcomes measure: Pediatric Anxiety Rating Scale (PARS), primaryOutcomes measure: Children's Depression Rating Scale -- Revised (CDRS-R), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06273969, orgStudyIdInfo id: PK20240105- 001, briefTitle: Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome, acronym: TOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-24, completionDateStruct date: 2024-04-24, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: A.T. Still University of Health Sciences, class: OTHER, descriptionModule briefSummary: The purpose of the study is to develop a protocol to assess blood flow in the upper limb vasculature before and after osteopathic manipulative treatment (OMT) using Pulsed-wave Doppler ultrasonography (US). We will assess the subclavian artery and vein at two locations (above and below the clavicle) and the brachial artery and vein (within the axilla) to determine the reproducibility of the blood flow findings at each location and the impact of OMT on the blood flow. Additionally we will qualitatively assess morphological changes of the brachial plexus before and after OMT with US., conditionsModule conditions: Thoracic Outlet Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Twelve consented male and/or female volunteers between the ages of 18 and 65 with intermittent tingling and/or numbness in one or both hands that has occurred with two weeks of the start date of the study will be evaluated using pulsed-wave doppler ultrasonography (US) and then treated with osteopathic manipulative treatment (OMT).US examination of the thoracic outlet will be performed using a Mindray-6 ultrasound machine and will include 4 views/positions with the subject in a seated position.The following intervention will consist of four osteopathic manipulation techniques (OMT) being performed that target the somatic dysfunctions associated with TOS. These techniques include: 1) Direct Thoracic Inlet Myofascial Release (TIMFR); 2) Direct Muscle Energy for the Scalene Muscles; 3) Direct Muscle Energy for the Pectoralis Muscles; and 4) Supraclavicular Fascial Release., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Osteopathic Manipulative Treatment (OMT), outcomesModule primaryOutcomes measure: Blood flow changes in the upper extremity., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273956, orgStudyIdInfo id: bleeding scores in ItP, briefTitle: Explore the Relationship Between Platelet Count and Bleeding Score in ITP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-10, primaryCompletionDateStruct date: 2025-10-10, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP., conditionsModule conditions: ITP - Immune Thrombocytopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aml Sayed Hamed, status: RECRUITING, city: Assiut, country: Egypt, contacts name: Rania Mohammed Mahmoud Hafez, professor, role: CONTACT, phone: +201000019198, email: [email protected], contacts name: Yousreyia Abdel Rahman Ahmed, professor, role: CONTACT, phone: +201223971307, email: [email protected], geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06273943, orgStudyIdInfo id: ANRS 0410s CABOPrEP, secondaryIdInfos id: 2024-510678-25, type: EUDRACT_NUMBER, briefTitle: Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France., acronym: CABOPrEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: ANRS, Emerging Infectious Diseases, class: OTHER_GOV, descriptionModule briefSummary: The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors., conditionsModule conditions: Prevention, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm)., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 322, type: ESTIMATED, armsInterventionsModule interventions name: Cabotegravir Tablets, for oral use., interventions name: Cabotegravir Extended-Release Injectable Suspension, for intramuscular use., interventions name: Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use, interventions name: Rectal Biopsies, outcomesModule primaryOutcomes measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm., secondaryOutcomes measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm., secondaryOutcomes measure: Number of participants with missing follow-up visits, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen, study discontinuation, lost to follow-up., secondaryOutcomes measure: Number of participants whose last condomless anal sexual intercourse was not covered by PrEP., secondaryOutcomes measure: Number of condomless anal sexual intercourse in the month prior to each study visit., secondaryOutcomes measure: Number of sexual partners in the last 3 months., secondaryOutcomes measure: Mean PrEP satisfaction score based on study arm., secondaryOutcomes measure: Number of participants with syphilis, chlamydiae, and/or gonorrhea infection., secondaryOutcomes measure: Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study., secondaryOutcomes measure: Change from baseline in body weight (kg)., secondaryOutcomes measure: Change from baseline in lipids, secondaryOutcomes measure: Change from baseline in the insulin resistance index (HOMA-IR)., secondaryOutcomes measure: Number and severity of injection site reaction., secondaryOutcomes measure: Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots., secondaryOutcomes measure: Number of participants with new HIV infection., secondaryOutcomes measure: Number of participants who used psychoactive drugs in the last 3 months, secondaryOutcomes measure: Score of quality of life measured by the EuroQol-5D questionnaire, secondaryOutcomes measure: Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D)., secondaryOutcomes measure: Self-esteem score assessed with the Rosenberg scale., secondaryOutcomes measure: Number and nature of uses of community peer support and therapeutic patient education., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Hôtel Dieu, city: Paris, state: Ile De France, zip: 75004, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Lariboisière, city: Paris, state: Ile De France, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Saint Louis, city: Paris, state: Ile De France, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Saint Antoine, city: Paris, state: Ile De France, zip: 75012, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital La Pitié Salpêtrière, city: Paris, state: Ile De France, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Necker, city: Paris, state: Ile De France, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Bichat, city: Paris, state: Ile De France, zip: 75018, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Tenon, city: Paris, state: Ile De France, zip: 75020, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06273930, orgStudyIdInfo id: AFID, briefTitle: Reduction of Dentine Hypersensitivity After Use of Different Dentifrices, acronym: Dentrifices, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Armed Forces Institute of Dentistry, Pakistan, class: OTHER, descriptionModule briefSummary: To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis., conditionsModule conditions: Sensitivity, Tooth, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 87, type: ESTIMATED, armsInterventionsModule interventions name: 5% CALCIUM SODIUM PHOSPHOSILICATE, interventions name: 8% Arginine, outcomesModule primaryOutcomes measure: To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by VAS., primaryOutcomes measure: To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by Schiff scale., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AFID, status: RECRUITING, city: Rawalpindi, country: Pakistan, contacts name: Muhammad J Iqbal, role: CONTACT, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False |
protocolSection identificationModule nctId: NCT06273917, orgStudyIdInfo id: FY23_Pilot2_Dresden, briefTitle: Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia, acronym: IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: National Institute on Aging (NIA), class: NIH, collaborators name: Brown University, descriptionModule briefSummary: Aim 1: To demonstrate the feasibility by determining proportion of completed medication reconciliation, Central Nervous System active Potentially Inappropriate Medication (CNS PIM) use among patients with Alzheimer's Disease and Related Dementias (ADRD) and Mild Cognitive Impairment (MCI) in the emergency department (ED), and communication between ED clinical pharmacists and outpatient prescribers.Aim 2: To demonstrate the feasibility of collecting the primary and secondary outcomes for a subsequent study. The future primary outcome will be reduction in CNS PIMs 90 days after an ED visit. Secondary outcomes will include outpatient follow-up, repeat ED visits, and hospitalizations during the 90 days following an ED visit.Aim 3: To demonstrate the acceptability of the PRIDE intervention to outpatient clinicians using the Acceptability of Intervention Measure and qualitative analysis of responses., conditionsModule conditions: Dementia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: PRIDE, outcomesModule primaryOutcomes measure: Pharmacist communication of deprescribing recommendation, secondaryOutcomes measure: Medication reconciliation, secondaryOutcomes measure: Medication supply of CNS PIMs, secondaryOutcomes measure: Outpatient follow up, secondaryOutcomes measure: Repeat Emergency Department visits, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern Memorial Hospital, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Scott Dresden, Dr., role: CONTACT, phone: 312-926-6494, email: [email protected], contacts name: Anuva Fellner, role: CONTACT, phone: 312-926-8816, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, locations facility: Northwestern Medicine Lake Forest Hospital, city: Lake Forest, state: Illinois, zip: 60045, country: United States, contacts name: Timothy Loftus, role: CONTACT, phone: 312-926-6612, email: [email protected], geoPoint lat: 42.25863, lon: -87.84063, locations facility: Northwestern Medicine Palos Hospital, city: Palos Heights, state: Illinois, zip: 60463, country: United States, contacts name: JiHun Lee, DO, role: CONTACT, phone: 708-923-5811, email: [email protected], geoPoint lat: 41.66809, lon: -87.79644, hasResults: False |
protocolSection identificationModule nctId: NCT06273904, orgStudyIdInfo id: Pro00132631, briefTitle: Modulating Escape Using Focused Ultrasound, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, descriptionModule briefSummary: This is a study to find out if a cutting-edge technology called transcranial focused ultrasound (tFUS) can be used to treat how people with anxiety or related concerns cope with emotional situations. tFUS is a brain stimulation technology that causes temporary changes in the activity of deep brain areas without a need for any surgery or other permanent or invasive procedures.This study is recruiting participants who recently started treatment for anxiety or a related concern to come in for 3 visits at the Medical University of South Carolina. At the first visit, participants will do interviews and surveys asking about anxiety and related concerns, and they do tasks where they respond to emotional pictures while brain activity is measured using magnetic resonance imaging (MRI). At the next two visits, participants again do a task where they see and react to emotional images, and this time the task is done once before and again once after receiving tFUS that either actively causes temporary changes (lasting for about an hour) in a targeted brain area or is not active (no changes elicited). At each tFUS visit, responses are measured with sensors worn on the hand, arms, face, and head (these visits do not involve MRI).Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time., conditionsModule conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Active transcranial focused ultrasound (tFUS), interventions name: Sham transcranial focused ultrasound (tFUS), outcomesModule primaryOutcomes measure: Change in Fear-Potentiated Startle Reflex, secondaryOutcomes measure: Change in speed to initiate avoidance behavior, secondaryOutcomes measure: Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation, secondaryOutcomes measure: Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment, secondaryOutcomes measure: Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks, secondaryOutcomes measure: Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia, secondaryOutcomes measure: Change in Task-Based Heart Rate (Beats per Minute) Changes, secondaryOutcomes measure: Change in Task-Based Galvanic Skin Conductance, secondaryOutcomes measure: Change in State Anxiety During Session, otherOutcomes measure: Task-Related Regional Brain Activation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False |
protocolSection identificationModule nctId: NCT06273891, orgStudyIdInfo id: INOVA-2023-58, briefTitle: Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes, acronym: PRACET, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Inova Fairfax Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM., conditionsModule conditions: Premature Rupture of Membrane, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Erythromycin, interventions name: Azithromycin, outcomesModule primaryOutcomes measure: Latency period, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Inova Fairfax Medical Campus, status: RECRUITING, city: Falls Church, state: Virginia, zip: 22042, country: United States, contacts name: Ellen M Murrin, DO, role: CONTACT, phone: 703-776-6040, email: [email protected], contacts name: Antonio Saad, MD, MBA, role: PRINCIPAL_INVESTIGATOR, contacts name: Ellen M Murrin, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.88233, lon: -77.17109, hasResults: False |
protocolSection identificationModule nctId: NCT06273878, orgStudyIdInfo id: RS1439/20, briefTitle: From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Regina Elena Cancer Institute, class: OTHER, collaborators name: Università degli Studi dell'Insubria, descriptionModule briefSummary: Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients., conditionsModule conditions: Endometrial Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Validate the differential expression of LOX-1 and NALP3 receptors., secondaryOutcomes measure: Characterize phenotypic alterations., secondaryOutcomes measure: Evaluate the predictive and/or prognostic value., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Institute - IFO -, status: RECRUITING, city: Rome, state: RM, zip: 00144, country: Italy, contacts name: Benito Chiofalo, Doctor, role: CONTACT, phone: ND, email: [email protected], contacts name: Valentina Bruno, Doctor, role: CONTACT, phone: ND, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, locations facility: "Regina Elena" National Cancer Institute, status: RECRUITING, city: Rome, zip: 00144, country: Italy, contacts name: Benito Chiofalo, Doctor, role: CONTACT, phone: ND, email: [email protected], contacts name: Valentina Bruno, Doctor, role: CONTACT, phone: ND, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06273865, orgStudyIdInfo id: HEMSTOL77, briefTitle: Version Testing of EnzySystem Version A for Hemophilia A, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, collaborators name: Enzyre B.V., descriptionModule briefSummary: Background of the study:To measure blood clotting, blood is taken from a vein. This blood is processed in the laboratory and then tested. A new device has been developed that requires only a very small volume of blood (5-10 drops of blood) to perform the laboratory tests. The long-term goal is that this device can be used by a doctor or at home to quickly measure blood clotting. In this research we want to compare this new system with the standard methods - measurement in the laboratory - and evaluate whether the correct value is determined.Objective of the study:The primary objective of this study is to demonstrate that the EnzySystem HemA version A can record thrombin generation TG and quantify FVIII activity levels within a time frame of 60 min in fresh whole blood samples of healthy volunteers and patients with hemophilia A in the Enzyre laboratory (for healthy volunteers) and the Radboudumc (for patients with hemophilia A).Study design:This is a cross-sectional observational study. All participants are asked to fill a questionnaire prior to blood collection. The blood of healthy volunteers will be collected in an office of Enzyre BV, the blood of patients will be collected in the Radboudumc. Blood collection, by venepuncture, will be conducted by a Radboudumc research nurse or physician of the research team in both locations. In total, four blood tubes with citrate as anticoagulant will be drawn (a total of around 11 mL).Study population:The study population consists of 20 healthy volunteers: evenly distributed between male and female; ages spread over the range from 20 to 70 years old; recruited by Enzyre via advertisement. 20 Patients: 5 severe hemophilia A; 5 moderate hemophilia A; 10 mild hemophilia A; recruited from the Hemophilia Treatment Center (HTC) Nijmegen-Eindhoven-Maastricht (NEM) (location Radboudumc).Primary study parameters/outcome of the study:Demonstrate that the EnzySystem HemA version A can record TG and quantitative FVIII activity levels within a time frame of 60 min in fresh blood samples of healthy volunteers and patients with hemophilia A.Secondary study parameters/outcome of the study (if applicable):Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy.Outcomes are analysed for equivalence compared to one-stage FVIII assay, FVIII chromogenic assay, thrombin generation via the Nijmegen Hemostasis Assay, and possibly via the Technoclone assay.Is it possible to measure FVIII activity with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;* Precision in the normal range (60-140%): min. 30%* Precision in the low range (3-10%): min. 50%* Limit of Detection range min. 100 % FVIII activity* Limit of Detection low range min. 3 % FVIII activity Is it possible to measure TG with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;* Precision in the normal range (60-140%) of control samples: min. 30%* Precision in patient with hemophilia A: min. 50%* Limit of Detection, high range \> 400 nM thrombin activity* Limit of Detection measured with Plasma, low range \< 50 nM thrombinOther study parameters All samples will also be tested for other hemostasis specific parameters as these parameters may affect a proper measurement of both FVIII activity and Thrombin Generation. The following parameters will be measured in plasma obtained from the whole blood vacutainers. Moreover, left over samples (plasma) will eventually be used to develop other coagulation related parameters.* von Willebrand Factor antigen levels* von Willebrand Factor ristocetin activity levels* Prothrombin Fragment 1+2 levels* ADAMTS13 activity* FVIII antigen levels* blood group, conditionsModule conditions: Hemophilia A, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Several assays, outcomesModule primaryOutcomes measure: Time between venipuncture and EnzySystem assay results, secondaryOutcomes measure: Validity of EnzySystem FVIII activity results, secondaryOutcomes measure: Validity of EnzySystem thrombin generation results, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud university medical center, city: Nijmegen, zip: 6525 GA, country: Netherlands, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False |
protocolSection identificationModule nctId: NCT06273852, orgStudyIdInfo id: PBL-0405-01, briefTitle: A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Pure Biologics S.A., class: INDUSTRY, collaborators name: Presage Biosciences, descriptionModule briefSummary: This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, conditions: Soft Tissue Sarcoma Adult, conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This substudy is not blinded., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: PBA-0405, outcomesModule primaryOutcomes measure: Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH), secondaryOutcomes measure: Number of Patients with Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06273839, orgStudyIdInfo id: B3461114, briefTitle: A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-05-27, completionDateStruct date: 2024-05-27, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking three different forms of tafamidis by mouth., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: Tafamidis 61 mg free acid tablet (Test 1), interventions name: Tafamidis 70 mg free acid tablet (Test 1), interventions name: Tafamidis 61 mg free acid capsule (Reference), outcomesModule primaryOutcomes measure: Area under the concentration-time curve (AUCinf), primaryOutcomes measure: Maximum observed plasma concentration (Cmax), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pfizer Clinical Research Unit - Brussels, city: Brussels, state: Bruxelles-capitale, Région DE, zip: B-1070, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06273826, orgStudyIdInfo id: 01, briefTitle: "Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: National Research Oncology and Transplantology Center, Kazakhstan, class: OTHER, descriptionModule briefSummary: The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan.Main Questions:1. Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.2. Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.3. Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage., conditionsModule conditions: Anastomotic Leak Large Intestine, conditions: Anastomotic Leak Rectum, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: "Colorectal Leakage App", outcomesModule primaryOutcomes measure: Diagnostic effectiveness of "Colorectal Leakage App"., primaryOutcomes measure: Frequency of anastomotic leakage after colorectal surgeries., secondaryOutcomes measure: Mortality within 30 days, secondaryOutcomes measure: Delay in the diagnosis of anastomotic leakage, secondaryOutcomes measure: Duration of hospital stay., secondaryOutcomes measure: Number of days in the ICU., secondaryOutcomes measure: Number of days between surgery and detection of AL., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Research Oncology Center, status: RECRUITING, city: Astana, zip: 010000, country: Kazakhstan, contacts name: Saule Khamzina, MD, role: CONTACT, phone: +77757172961, email: [email protected], geoPoint lat: 51.1801, lon: 71.44598, hasResults: False |
protocolSection identificationModule nctId: NCT06273813, orgStudyIdInfo id: NOV-1776-CL-101, briefTitle: Treatment of Topical Ketorolac Gel in Acute Gouty Flare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Novilla Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up., conditionsModule conditions: Acute Gouty Arthritis, conditions: Acute Pain, conditions: Gout Flare, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: All cohost 1 subjects receive single ketorolac tromethamine injection, followed by escalating doses of ketorolac tromethamine gel Cohort 2 and 3 subjects receive doses of ketorolac tromethamine gel for 5 days, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ketorolac Tromethamine 15 MG/ML, interventions name: Ketorolac Tromethamine, outcomesModule primaryOutcomes measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, primaryOutcomes measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Paratus Clinical,, city: Blacktown, zip: 2148, country: Australia, contacts name: Rahul Rahul, role: CONTACT, phone: +61 1300 742 326, email: [email protected], contacts name: Rahul Rahul, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.76667, lon: 150.91667, locations facility: Linear Clinical Research Ltd, city: Nedlands, zip: 6009, country: Australia, contacts name: Jasmine Williams, role: CONTACT, phone: +61 8 6382 5100, geoPoint lat: -31.98184, lon: 115.8073, hasResults: False |
protocolSection identificationModule nctId: NCT06273800, orgStudyIdInfo id: M23CMC, briefTitle: Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients, acronym: Chemosense, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2035-07-15, completionDateStruct date: 2036-07-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, descriptionModule briefSummary: This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients, conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: collection of serum sample blood at first day of neo adjuvant treatment, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, outcomesModule primaryOutcomes measure: pCR rate, secondaryOutcomes measure: Radiological reduction on tumor size, secondaryOutcomes measure: Pathological reduction on tumor size, secondaryOutcomes measure: Residual cancer burden (RCB), secondaryOutcomes measure: Distant recurrence free interval (DRFI), secondaryOutcomes measure: Recurrence-free interval (RFI), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Antoni van Leeuwenhoek, city: Amsterdam, state: Noord-Holland, zip: 1066CX, country: Netherlands, contacts name: Laura Bornes, PhD, role: CONTACT, contacts name: Veerle Geurts, PhD, role: CONTACT, contacts name: Marleen Kok, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06273787, orgStudyIdInfo id: Mitu, briefTitle: Effect of Diaphragmatic Release in Sleep Quality During Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-03-17, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: MTI University, class: OTHER, descriptionModule briefSummary: Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy., conditionsModule conditions: SLEEP APNEA PREGNANCY, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: diaphragmatic release, outcomesModule primaryOutcomes measure: pittshurgh sleep quality index, secondaryOutcomes measure: diaphragmatic excursion assessment, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: MTI, status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06273774, orgStudyIdInfo id: 8189-020, secondaryIdInfos id: MK-8189-020, type: OTHER, domain: Merck, briefTitle: A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-09-10, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study., conditionsModule conditions: Bipolar I Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: MK-8189, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants Who Experience One or More Adverse Events (AEs), primaryOutcomes measure: Number of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hassman Research Institute Marlton Site ( Site 0006), status: RECRUITING, city: Marlton, state: New Jersey, zip: 08053, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 267-981-8911, geoPoint lat: 39.89122, lon: -74.92183, hasResults: False |
protocolSection identificationModule nctId: NCT06273761, orgStudyIdInfo id: UW 23-550, briefTitle: Evaluation of Medication Management Service, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Hong Kong Jockey Club Charities Trust, collaborators name: Hong Kong Sheng Kung Hui Welfare Council, collaborators name: Hong Kong Young Women's Christian Association, collaborators name: Haven of Hope Hospital, collaborators name: Pok Oi Hospital, collaborators name: St. James Settlement, collaborators name: Aberdeen Kai-fong Welfare Association, collaborators name: Health In Action, collaborators name: Lok Sin Tong Benevolent Society, Kowloon, descriptionModule briefSummary: Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects:* To evaluate the perception and satisfaction of patients on MMS service* To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems* To identify and categorize the types of drug-related problems identified during MMS* To evaluate the cost-effectiveness of implementing MMS in community pharmaciesMMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS., conditionsModule conditions: Medication Adherence, conditions: Medication Safety, conditions: Diabetes Mellitus, Type 2, conditions: Hypertension, conditions: Polypharmacy, conditions: High Risk Medications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 640, type: ESTIMATED, armsInterventionsModule interventions name: Medication Management Service (MMS), outcomesModule primaryOutcomes measure: Medication adherence, secondaryOutcomes measure: Additional health service utilization, secondaryOutcomes measure: Patient perception and satisfaction, secondaryOutcomes measure: Patient perceived sensitivity to medicines, secondaryOutcomes measure: Social impact, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Drug-related problems, secondaryOutcomes measure: Change in costs, secondaryOutcomes measure: Change in effectiveness, secondaryOutcomes measure: Incremental cost effectiveness ratio (ICER), secondaryOutcomes measure: Beliefs in medicines, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Kam Kit Mak, role: CONTACT, phone: 3550 5460, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, locations facility: Health In Action Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Ka Shing Mak, role: CONTACT, phone: 3612 9515, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, locations facility: Hong Kong Sheng Kung Hui Welfare Council Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Sze Yin Lee, role: CONTACT, phone: 2116 0382, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, locations facility: PHARM+ Haven of Hope Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Mei Lun Bruce Tsui, role: CONTACT, phone: 2156 2280, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, locations facility: PHARM+ Pok Oi Hospital Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Kwok leung Li, role: CONTACT, phone: 59506880, email: [email protected], contacts name: Anson Tsz Kin Leung, role: CONTACT, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, locations facility: PHARM+ St. James' Settlement Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Kit Sze Chan, role: CONTACT, phone: 2835 4320, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, locations facility: PHARM+ The Lok Sin Tong Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: William Ho Ching Yuen, role: CONTACT, phone: 21872780, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, locations facility: PHARM+ YWCA Community Pharmacy, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Sui Hong Ho, role: CONTACT, phone: 2511 6020, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06273748, orgStudyIdInfo id: RChildUV, briefTitle: RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-10, primaryCompletionDateStruct date: 2032-02-01, completionDateStruct date: 2032-05-02, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases, conditionsModule conditions: Uveitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 290, type: ESTIMATED, outcomesModule primaryOutcomes measure: Describe a population of paediatric patients with chronic non-infectious uveitis, primaryOutcomes measure: Describe a population of paediatric patients with chronic non-infectious uveitis, primaryOutcomes measure: Identify any differences between the different forms of uveitis in terms of characteristics and outcomes, primaryOutcomes measure: Identify risk factors for a more severe course, primaryOutcomes measure: Frequency achievement of response for each drug according to the definition of response, primaryOutcomes measure: Time to archieve the response after drug initiation, primaryOutcomes measure: Achievement of inactive disease on therapy according to the definition of MIWGUC, primaryOutcomes measure: Time to achieve inactive disease on therapy according to the definition of MIWGUC, primaryOutcomes measure: Presence and percentages of flares on therapy after achievement of remission on therapy, primaryOutcomes measure: Time to the first flare on therapy, primaryOutcomes measure: Time to flare after drug withdrawal, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cincinnati Children's Hospital Medical Center, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45207, country: United States, contacts name: Sheila Angels-Han, role: CONTACT, geoPoint lat: 39.12713, lon: -84.51435, locations facility: - ATTIKON General Hospital, status: RECRUITING, city: Athens, zip: 12462, country: Greece, contacts name: Lampros Fotis, role: CONTACT, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, state: Firenze, country: Italy, contacts name: Gabriele Simonini, role: CONTACT, email: [email protected], geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Spedali Civili di Brescia, status: NOT_YET_RECRUITING, city: Brescia, country: Italy, contacts name: Marco Cattalini, role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: IRCCS materno infantile Burlo Garofolo, status: RECRUITING, city: Trieste, country: Italy, contacts name: Serena Pastore, role: CONTACT, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False |
protocolSection identificationModule nctId: NCT06273735, orgStudyIdInfo id: 2019-PS-33b, secondaryIdInfos id: PV7350, type: OTHER, domain: Martini-Klinik, briefTitle: Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-14, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Martini-Klinik am UKE GmbH, class: OTHER, collaborators name: Universitätsklinikum Hamburg-Eppendorf, descriptionModule briefSummary: The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out., conditionsModule conditions: Myocardial Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Pre- and postoperative determination of troponin as part of the study and 24-month FU survey, outcomesModule primaryOutcomes measure: rate of MINS in standardised open and robot-assisted radical prostatectomy, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Martini-Klinik am UKE GmbH, status: RECRUITING, city: Hamburg, zip: 20246, country: Germany, contacts name: Markus Graefen, Professor, role: CONTACT, phone: +4904741051300, email: [email protected], contacts name: Anke Renter, role: CONTACT, phone: +49407410533115, email: [email protected], geoPoint lat: 53.57532, lon: 10.01534, hasResults: False |
protocolSection identificationModule nctId: NCT06273722, orgStudyIdInfo id: 2024-0059, briefTitle: D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping., conditionsModule conditions: Basal Cell Carcinoma, conditions: Optical Coherence Tomography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 424, type: ESTIMATED, armsInterventionsModule interventions name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner, outcomesModule primaryOutcomes measure: Diagnostic accuracy for BCC detection on D-OCT assessment, secondaryOutcomes measure: Diagnostic accuracy for BCC subtyping on D-OCT assessment, secondaryOutcomes measure: Diagnostic value of vascular structures and patterns, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273709, orgStudyIdInfo id: 2023-3698, briefTitle: Remote Assessment of OCT Scans for BCC Detection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT)., conditionsModule conditions: Basal Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner, outcomesModule primaryOutcomes measure: Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273696, orgStudyIdInfo id: 2019-519, secondaryIdInfos id: NU2GGH001927, type: OTHER_GRANT, domain: Centers for Disease Control and Prevention, briefTitle: Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2019-06-11, completionDateStruct date: 2019-07-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: IntraHealth International, class: OTHER, collaborators name: Ministry of Health, Tanzania, collaborators name: President Office Regional Administration and Local Government, Tanzania, collaborators name: Centers for Disease Control and Prevention, collaborators name: Jhpiego, collaborators name: World Health Organization, descriptionModule briefSummary: The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49)., conditionsModule conditions: Penile Infection, conditions: Penile Haematoma, conditions: Penile Bleeding, conditions: Deformity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 575, type: ACTUAL, armsInterventionsModule interventions name: ShangRing, outcomesModule primaryOutcomes measure: Number of Adverse Events, primaryOutcomes measure: Number of Clients with Adverse Events, primaryOutcomes measure: Descriptions of Adverse Events, secondaryOutcomes measure: Provider Training, secondaryOutcomes measure: Client Follow-up Visit Rate, secondaryOutcomes measure: Client Preference for ShangRing Over Surgical Circumcision, secondaryOutcomes measure: Client Recommendation Rate, secondaryOutcomes measure: Cosmetic Result Acceptability, secondaryOutcomes measure: Client Experience While Performing Routine Activities, secondaryOutcomes measure: Client Discomfort, secondaryOutcomes measure: Provider Ease of Application, secondaryOutcomes measure: Provider Preference, secondaryOutcomes measure: Provider Recommendation, secondaryOutcomes measure: Description of Procedures, secondaryOutcomes measure: Healing rate, eligibilityModule sex: MALE, minimumAge: 13 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kahama District Hospital, city: Shinyanga, country: Tanzania, geoPoint lat: -3.66393, lon: 33.42118, locations facility: Ushetu Health Centre, city: Shinyanga, country: Tanzania, geoPoint lat: -3.66393, lon: 33.42118, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2018-10-22, uploadDate: 2024-02-14T09:36, filename: Prot_000.pdf, size: 2701616, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2018-07-01, uploadDate: 2023-01-18T15:12, filename: ICF_001.pdf, size: 173615, hasResults: False |
protocolSection identificationModule nctId: NCT06273683, orgStudyIdInfo id: INOVA-2023-145, briefTitle: Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Inova Health Care Services, class: OTHER, descriptionModule briefSummary: One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes., conditionsModule conditions: Permanent Sterilization, conditions: Pregnancy Related, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Hand-held bipolar energy instrument, interventions name: Traditional suture ligation, outcomesModule primaryOutcomes measure: Change in Hemoglobin levels on postoperative day one, secondaryOutcomes measure: Completion rate of sterilization, secondaryOutcomes measure: Total procedure estimated blood loss, secondaryOutcomes measure: Adjacent organ damage, secondaryOutcomes measure: Need for blood transfusion, secondaryOutcomes measure: Total operative time, secondaryOutcomes measure: ICU admission, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Hospital readmission postoperatively, secondaryOutcomes measure: Reoperation rates, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Surgical site infection, secondaryOutcomes measure: Cost, eligibilityModule sex: FEMALE, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inova Fairfax Medical campus, status: RECRUITING, city: Falls Church, state: Virginia, zip: 22042, country: United States, contacts name: Jean W Thermolice, MD, role: CONTACT, phone: 703-531-3000, email: [email protected], contacts name: Bianca Nguyen, MD, role: CONTACT, email: [email protected], contacts name: Sofia Girald-Berlingeri, MD, role: SUB_INVESTIGATOR, contacts name: Bianca Nguyen, MD, role: SUB_INVESTIGATOR, contacts name: Catherine Kim, MD, role: SUB_INVESTIGATOR, contacts name: Miranda Newell, MS, role: SUB_INVESTIGATOR, contacts name: Renee Brenner, BS, role: SUB_INVESTIGATOR, geoPoint lat: 38.88233, lon: -77.17109, hasResults: False |
protocolSection identificationModule nctId: NCT06273670, orgStudyIdInfo id: 04-2023-200279, briefTitle: Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP), acronym: KAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic., conditionsModule conditions: Contraception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: screening and data collection, outcomesModule primaryOutcomes measure: Clients' knowledge, secondaryOutcomes measure: Clients' attitude, secondaryOutcomes measure: Clients' practice, secondaryOutcomes measure: Providers' knowledge, secondaryOutcomes measure: Providers' attitude, secondaryOutcomes measure: Providers' practice, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Assiut University, status: RECRUITING, city: Assiut, zip: 71515, country: Egypt, contacts name: mahmoud abdelaleem, Doctorate, role: CONTACT, phone: +201018880201, email: [email protected], geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06273657, orgStudyIdInfo id: Apokus-002, briefTitle: Effects of Medisinstart for Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Apokus AS, class: OTHER, collaborators name: Norwegian Pharmacy Association, descriptionModule briefSummary: Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Medisinstart, outcomesModule primaryOutcomes measure: HbA1c, primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Self-reported adherence, secondaryOutcomes measure: Self-reported adherence, secondaryOutcomes measure: Frequency of medication-related problems, secondaryOutcomes measure: Patients' beliefs about their medicines, secondaryOutcomes measure: Diabetes Self-Management, secondaryOutcomes measure: Diabetes Treatment Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Apotek 1 Andslimoen, status: RECRUITING, city: Bardufoss, zip: 9325, country: Norway, geoPoint lat: 69.06448, lon: 18.51521, locations facility: Apotek 1 Brandbu, status: RECRUITING, city: Brandbu, zip: 2760, country: Norway, geoPoint lat: 60.42214, lon: 10.50428, locations facility: Apotek 1 Brummundal, status: RECRUITING, city: Brumunddal, zip: 2380, country: Norway, geoPoint lat: 60.88095, lon: 10.93948, locations facility: Sykehusapoteket i Drammen, status: RECRUITING, city: Drammen, zip: 3004, country: Norway, geoPoint lat: 59.74389, lon: 10.20449, locations facility: Vitusapotek Gjøvik, status: RECRUITING, city: Gjøvik, zip: 2806, country: Norway, geoPoint lat: 60.79574, lon: 10.69155, locations facility: Vitusapotek Jessheim, status: RECRUITING, city: Jessheim, zip: 2050, country: Norway, geoPoint lat: 60.14151, lon: 11.17515, locations facility: Boots apotek Kløfta, status: RECRUITING, city: Kløfta, zip: 2040, country: Norway, geoPoint lat: 60.07407, lon: 11.13805, locations facility: Vitusapotek Leksvik, status: RECRUITING, city: Leksvik, zip: 7120, country: Norway, geoPoint lat: 63.67274, lon: 10.6232, locations facility: Apotek 1 Lena, status: RECRUITING, city: Lena, zip: 2850, country: Norway, geoPoint lat: 60.67391, lon: 10.81317, locations facility: Boots apotek Loddefjord, status: RECRUITING, city: Loddefjord, zip: 5171, country: Norway, geoPoint lat: 60.36879, lon: 5.22607, locations facility: Sykehusapoteket i Oslo, Aker, status: RECRUITING, city: Oslo, zip: 0586, country: Norway, geoPoint lat: 59.91273, lon: 10.74609, locations facility: Vitusapotek Røa, status: RECRUITING, city: Oslo, zip: 0751, country: Norway, geoPoint lat: 59.91273, lon: 10.74609, locations facility: Ryfylke apotek, status: RECRUITING, city: Rennesøy, zip: 4150, country: Norway, locations facility: Vitusapotek Jekta, status: RECRUITING, city: Tromsø, zip: 9015, country: Norway, geoPoint lat: 69.6489, lon: 18.95508, locations facility: Sykehusapoteket i Trondheim, status: RECRUITING, city: Trondheim, zip: 7030, country: Norway, geoPoint lat: 63.43049, lon: 10.39506, locations facility: Vitusapotek Ulefoss, status: RECRUITING, city: Ulefoss, zip: 3830, country: Norway, geoPoint lat: 59.28245, lon: 9.26548, locations facility: Apotek 1 Veakrossen, status: RECRUITING, city: Veavåg, zip: 4276, country: Norway, locations facility: Vitusapotek Åfjord, status: RECRUITING, city: Åfjord, zip: 7170, country: Norway, geoPoint lat: 63.96113, lon: 10.22408, locations facility: Boots apotek Linnea, status: RECRUITING, city: Øystese, zip: 5610, country: Norway, geoPoint lat: 60.38825, lon: 6.19251, hasResults: False |
protocolSection identificationModule nctId: NCT06273644, orgStudyIdInfo id: HNF1719-24, briefTitle: Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-27, primaryCompletionDateStruct date: 2027-10-31, completionDateStruct date: 2037-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Nordlandssykehuset HF, class: OTHER, collaborators name: University of Oslo, collaborators name: Nord University, collaborators name: UiT The Arctic University of Norway, collaborators name: Norwegian University of Science and Technology, collaborators name: The University of Texas Medical Branch, Galveston, descriptionModule briefSummary: The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates., conditionsModule conditions: Porphyria, Acute Intermittent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study is a crossover study involving 50 individuals with AIP. The study design was chosen to determine whether the treatment has an effect compared to baseline analyses and whether the sequence of treatment has an effect, as well as whether one of the interventions is more effective than the other., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Blinding is attempted by labeling the provided diet plans as A and B. The physician recording outcome variables and the researcher performing statistical analysis are blinded to the given diet., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Carbohydrates, outcomesModule primaryOutcomes measure: Change in Urine Porphobilinogen/creatinine, primaryOutcomes measure: Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements, secondaryOutcomes measure: Number of Hospitalizations,sick leaves, and doctor visits due to AIP, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Plasma Glucose level, secondaryOutcomes measure: Interstitial fluid glucose level, secondaryOutcomes measure: Number of hypoglycemic events, secondaryOutcomes measure: Amino acid profile, secondaryOutcomes measure: Plasma insulin, glucose, c-peptide, secondaryOutcomes measure: HOMA score, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Cytokines in plasma, secondaryOutcomes measure: Intestinal microbiota composition, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Body composition, metabolic age, secondaryOutcomes measure: Mitochondrial oxygen consumption rate, secondaryOutcomes measure: ALAS1mRNA, secondaryOutcomes measure: Urine-ALA/creatinine & urine-porphyrins, secondaryOutcomes measure: Mitochondrial function-related genes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nordland Hospital Trust, status: RECRUITING, city: Bodø, state: Nordland, zip: 8092, country: Norway, contacts name: Elin Storjord, MD PhD, role: CONTACT, phone: +4797072484, email: [email protected], contacts name: Hilde Thunhaug, IC nurse, role: CONTACT, phone: +47 95057864, email: [email protected], contacts name: Elin Storjord, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Amy Dickey, MD, role: SUB_INVESTIGATOR, contacts name: Bjørn Steen Skålhegg, PhD, Prof., role: SUB_INVESTIGATOR, contacts name: Bård O. Karlsen, PhD, role: SUB_INVESTIGATOR, contacts name: Elin Røst, Master, role: SUB_INVESTIGATOR, contacts name: Erik Knutsen, PhD, role: SUB_INVESTIGATOR, contacts name: Hilde Thunhaug, Bachelor, role: SUB_INVESTIGATOR, contacts name: Jonas Aakre Wik, PhD, role: SUB_INVESTIGATOR, contacts name: Andersen Karl, MD, Prof., role: SUB_INVESTIGATOR, contacts name: Pettersen Kristin, Bachelor, role: SUB_INVESTIGATOR, contacts name: Marlene B. Karlsen, Master, role: SUB_INVESTIGATOR, contacts name: Nina Lorentsen, Master, role: SUB_INVESTIGATOR, contacts name: Ole-Lars Brekke, MD,PhD,Prof, role: SUB_INVESTIGATOR, contacts name: Randolf Hardersen, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Rita Laastad, Bachelor, role: SUB_INVESTIGATOR, contacts name: Steinar Daae Johansen, PhD, Dean, role: SUB_INVESTIGATOR, contacts name: Tor Erik Jørgensen, PhD, role: SUB_INVESTIGATOR, contacts name: Vegar Rangul, PhD, role: SUB_INVESTIGATOR, contacts name: Åse Emblem, PhD, role: SUB_INVESTIGATOR, contacts name: Fredrik Ellefsrud, MD, role: SUB_INVESTIGATOR, contacts name: Tor Claudi, MD, role: SUB_INVESTIGATOR, geoPoint lat: 67.28, lon: 14.40501, hasResults: False |
protocolSection identificationModule nctId: NCT06273631, orgStudyIdInfo id: 2022-SR-481, briefTitle: Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Yang Tao, class: OTHER, descriptionModule briefSummary: The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators., conditionsModule conditions: Type 1 Diabetes, conditions: Diet Intervention, conditions: Glucose Control, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: multiple-diverse carbohydrate diet, interventions name: middle carbohydrate diet, outcomesModule primaryOutcomes measure: Change of time in range (TIR), secondaryOutcomes measure: Change of coefficient of variation of blood glucose（CV）, secondaryOutcomes measure: Change of mean amplitude of glycemic excursions（MAGE）, secondaryOutcomes measure: Change in large amplitude of glycemic excursions (LAGE) from baseline, secondaryOutcomes measure: Change in GA（glycosylated albumin）from baseline, secondaryOutcomes measure: Change in HbA1c from baseline, secondaryOutcomes measure: Change in 1,5-anhydroglucitol (1,5-AG) from baseline, secondaryOutcomes measure: Change in time above range(TAR) from baseline, secondaryOutcomes measure: Change in time below range(TBR) from baseline, secondaryOutcomes measure: Change in total insulin dose from baseline, secondaryOutcomes measure: Change in blood lipids from baseline, secondaryOutcomes measure: Change in body weight from baseline, secondaryOutcomes measure: Change in Incidence of hypoglycemic events from baseline, secondaryOutcomes measure: Change in gut microbiota from baseline, secondaryOutcomes measure: Change in metabolomics from baseline, secondaryOutcomes measure: Change in autoimmunity from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273618, orgStudyIdInfo id: iLO-ML-23396, briefTitle: iLookOut Micro-learning to Improve Knowledge Retention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs., conditionsModule conditions: Knowledge, conditions: Attitudes, conditions: Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Early Childhood Professionals (ECPs) will be randomized to 1 of 4 groups, which will differ in terms of when they receive access to Micro-Learning. Non-ECPs will constitute a separate group, which will receive access to Micro-Learning immediately upon completing the Core Training., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12000, type: ESTIMATED, armsInterventionsModule interventions name: Micro-Learning, outcomesModule primaryOutcomes measure: Change in knowledge about child maltreatment and its reporting as assessed by validated iLookOut knowledge test, primaryOutcomes measure: Change in behavior regarding child maltreatment and its reporting as measured by self-report questionnaire, secondaryOutcomes measure: Comparison of early childhood professionals vs. non-early childhood professionals, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Penn State College of Medicine, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, geoPoint lat: 40.28592, lon: -76.65025, hasResults: False |
protocolSection identificationModule nctId: NCT06273605, orgStudyIdInfo id: 102828, briefTitle: The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2025-08-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Murdoch Childrens Research Institute, class: OTHER, descriptionModule briefSummary: The goal of this study is to test the safety and feasibility of a change in management approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg allergy will have egg introduced via a gradual and graded home based approach known as an "egg ladder" supervised by a dietitian. The main questions this study aims to answer are how safe and feasible are home-based dietitian-led "egg ladders" as a treatment pathway to achieve tolerance of egg for newly diagnosed infants with egg allergy., conditionsModule conditions: Food Allergy, conditions: Food Allergy in Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Egg Ladder, outcomesModule primaryOutcomes measure: Number and severity of adverse events related to baked egg ingestion (step 1) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history., primaryOutcomes measure: Number and severity of adverse events related to ingestion of well cooked egg as an ingredient (step 2) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history., primaryOutcomes measure: Number and severity of adverse events related ingestion of well cooked whole egg (step 3) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history., primaryOutcomes measure: Number and severity of adverse events related to ingestion of lightly cooked whole egg (step 4) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history., primaryOutcomes measure: Number and severity of adverse events related to raw egg ingestion (step 5) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history., primaryOutcomes measure: Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis, secondaryOutcomes measure: Change from baseline (diagnosis) in parent reported Quality of Life scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) to study completion (12 months from diagnosis), secondaryOutcomes measure: Change from baseline (diagnosis) in parental anxiety scores measured using the Impairment Measure for Parental Food Allergy - Associated Anxiety and Coping Tool (IMPAACT) to study completion (12 months from diagnosis), secondaryOutcomes measure: Heath care costs, eligibilityModule sex: ALL, minimumAge: 4 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Murdoch Children's Research Institute (MCRI), status: RECRUITING, city: Melbourne, state: Victoria, zip: 3052, country: Australia, contacts name: Vicki McWilliam, PhD, role: CONTACT, phone: 0418588953, email: [email protected], contacts name: Kirsten Perrett, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: -37.814, lon: 144.96332, hasResults: False |
protocolSection identificationModule nctId: NCT06273592, orgStudyIdInfo id: 2023-15558, briefTitle: The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men., acronym: Erection 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, collaborators name: Beyond Meat, descriptionModule briefSummary: The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function., conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized crossover design, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Outcomes assessor will be blinded to randomization group and order of testing., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Animal-based meal, interventions name: Plant-based meat meal, outcomesModule primaryOutcomes measure: Percent of time with ≥70% erection during overnight sleep after 1 meal, secondaryOutcomes measure: Erection events per hour during overnight sleep after 1 meal, secondaryOutcomes measure: Tumescence events per hour during overnight sleep after 1 meal., otherOutcomes measure: Heart rate, otherOutcomes measure: Blood pressure, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 32 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273579, orgStudyIdInfo id: 2010-270, NEU-09-042-Trial 5, briefTitle: Efficiency of Verbal Intelligent Tutor Instruction in Neurosurgical Simulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: McGill University, class: OTHER, descriptionModule briefSummary: At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education.In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of three groups (one control and two experimental). Group 1 (control) will be provided with verbal AI tutor feedback based on the ICEMS error detection. Group 2 will be tutored by a human instructor who will receive ICEMS error data and deliver verbal instruction identical to that which the AI tutor delivers. Group 3 will be tutored by a human instructor who will be provided with ICEMS data but may deliver feedback as they feel is appropriate to correct the error.The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee response to instruction and overall surgical performance. Evaluating trainee responses to AI instructor verbal feedback as compared to feedback from human instructors will allow for further development, testing, and optimization of the ICEMS and other AI tutoring systems., conditionsModule conditions: Surgical Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, maskingDescription: Double (Participant, Expert Instructor)Both study participants and expert instructors are unaware of the intervention (varying the method of delivery of verbal error instruction). Moreover, when rating performance in the realistic scenario using the OSATS, experts are unaware of which group any given trainee is part of., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group - Verbal expert instructor feedback in AI's words, interventions name: Experimental Group - Verbal expert instructor feedback in expert's own words, outcomesModule primaryOutcomes measure: Response to instruction, primaryOutcomes measure: Average Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score, primaryOutcomes measure: Objective Structured Assessment of Technical Skills (OSATS) global rating, secondaryOutcomes measure: Difference in the strength of emotions elicited, secondaryOutcomes measure: Difference in cognitive load, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neurosurgical Simulation and Artificial Intelligence Learning Centre, city: Montréal, state: Quebec, zip: H2X 4B3, country: Canada, contacts name: Rolando F Del Maestro, MD, PhD, role: CONTACT, phone: (519) 708-0346, email: [email protected], contacts name: Bianca Giglio, BSc, role: CONTACT, phone: (514) 802-1608, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06273566, orgStudyIdInfo id: 20230202, briefTitle: French Validation of the AdT-Physio Scale, acronym: Trans-AdT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Pole Sante Grace de Dieu, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 121, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: AdT-Physio scale (Adherence to Treatment of Physiotherapy scale), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PSLA GDD, city: Caen, zip: 14000, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False |
protocolSection identificationModule nctId: NCT06273553, orgStudyIdInfo id: RG002-A1201, briefTitle: A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: RinuaGene Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3)., conditionsModule conditions: Human Papillomavirus Associated Intraepithelial Neoplasia, conditions: Cervical Intraepithelial Neoplasia Grade 2/3, conditions: Human Papillomavirus Type 16 Infection, conditions: Human Papillomavirus Type 18 Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: RG002 injection, outcomesModule primaryOutcomes measure: Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events, primaryOutcomes measure: Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection, primaryOutcomes measure: Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression, secondaryOutcomes measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression, secondaryOutcomes measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with clearance of HPV16/18, secondaryOutcomes measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression and clearance of HPV16/18, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the level of cellular immune response, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the proportion of T lymphocytes, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the expression of cytokines in serum, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the serum levels of anti-HPV16 and anti-HPV18 IgG antibodies., secondaryOutcomes measure: Part A and B: Exposure level of RG002 Injection, measured by mRNA, secondaryOutcomes measure: Part A and B: Exposure level of RG002 Injection, measured by cationic lipids, secondaryOutcomes measure: Part A and B: Anti-drug antibody (ADA) to polyethylene glycol (PEG) of RG002 injection, measured by the serum titer of anti-PEG IgG and anti-PEG IgM, secondaryOutcomes measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression, secondaryOutcomes measure: Part B: Secondary efficacy, measured by proportion of subjects with clearance of HPV16/18, secondaryOutcomes measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression and clearance of HPV16/18, secondaryOutcomes measure: Part B: Safety and tolerability of RG002 Injection, measured by the incidence of adverse events, secondaryOutcomes measure: Part B: Optionally assess the biomarker of RG002 Injection, measured by the level of potential biomarkers and the level of infiltrating T cells and myeloid cells in the lesions., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06273540, orgStudyIdInfo id: STA-P7-C001, briefTitle: Phase1, STP7 Cocaine Drug-Drug Interaction Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Stalicla SA, class: INDUSTRY, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age.The primary objective of this study is to determine if there are clinically meaningful interactions between oral STP7 (mavoglurant) treatment concurrent with 20 and 40 mg i.v. cocaine infusions by measuring adverse events and cardiovascular responses including heart rate, blood pressure, and electrocardiogram (including corrected QT interval).The secondary objectives are:* To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine.* To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day.* To evaluate whether STP7 (mavoglurant) treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS) and Brief Substance Craving Scale (BSCS)., conditionsModule conditions: Cocaine Use Disorder, 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: 20, type: ESTIMATED, armsInterventionsModule interventions name: STP7 (mavoglurant) or Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events., primaryOutcomes measure: Heart Rate response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Heart Rate response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion ., primaryOutcomes measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion., primaryOutcomes measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of cocaine., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7., secondaryOutcomes measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of cocaine., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of STP7., secondaryOutcomes measure: Pharmacokinetics: terminal rate constant of STP7., secondaryOutcomes measure: Pharmacokinetics: half-life of cocaine., secondaryOutcomes measure: Pharmacokinetics: half-life of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: half-life of STP7., secondaryOutcomes measure: Pharmacokinetics: half-life of STP7., secondaryOutcomes measure: Pharmacokinetics: clearance of cocaine., secondaryOutcomes measure: Pharmacokinetics: clearance of benzoylecgonine., secondaryOutcomes measure: Pharmacokinetics: clearance of STP7., secondaryOutcomes measure: Pharmacokinetics: clearance of STP7., secondaryOutcomes measure: Pharmacokinetics: Clearance from plasma after oral administration of cocaine., secondaryOutcomes measure: Pharmacokinetics: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine., secondaryOutcomes measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7., secondaryOutcomes measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7., secondaryOutcomes measure: Visual evaluation of the STP7 on the subjective effects of cocaine at screening, secondaryOutcomes measure: Visual evaluation of the STP7 on the subjective effects of cocaine at baseline and during treatment, secondaryOutcomes measure: Craving evaluation of the STP7 on the subjective effects of cocaine., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Altasciences Clinical Kansas, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66212, country: United States, contacts name: Debra Kelsh, MD, role: CONTACT, geoPoint lat: 38.98223, lon: -94.67079, hasResults: False |
protocolSection identificationModule nctId: NCT06273527, orgStudyIdInfo id: 808681, briefTitle: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment., conditionsModule conditions: Anxiety Disorders, conditions: Depression, conditions: Post Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: COGENT, interventions name: Sham Program, outcomesModule primaryOutcomes measure: Change in cognitive performance, secondaryOutcomes measure: Reading Span Blood Oxygen Level Dependent (BOLD) Response, secondaryOutcomes measure: Neuropsychological Performance, secondaryOutcomes measure: Repetitive Negative Thinking (RNT), otherOutcomes measure: Disability, otherOutcomes measure: Suicide Cognitions, otherOutcomes measure: Mood and Emotions, otherOutcomes measure: Self-reported attention, otherOutcomes measure: Anxiety Symptoms, otherOutcomes measure: Symptoms of Depression, otherOutcomes measure: PTSD Symptoms, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: UC San Diego, city: San Diego, state: California, zip: 92037, country: United States, contacts name: Edith Jimenez, role: CONTACT, phone: 858-822-1470, email: [email protected], contacts name: Nathalie Dugas, role: CONTACT, phone: 858-534-2148, email: [email protected], geoPoint lat: 32.71533, lon: -117.15726, hasResults: False |
protocolSection identificationModule nctId: NCT06273514, orgStudyIdInfo id: TECAR and DN intervention, briefTitle: Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Medical University of Silesia, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.Research hypothesis:Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.Therefore, the objectives of the work were:Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy., conditionsModule conditions: Myofascial Pain Syndrome of Neck, conditions: Myofascial Trigger Point Syndrome, conditions: Myofascial Trigger Point Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: TECAR, interventions name: Dry needling, outcomesModule primaryOutcomes measure: Pain - Pressure pain threshold (PPT), primaryOutcomes measure: Pain - numerical rating scale (NRS), secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Cervical spine range of motion (ROM), eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Medical fit, city: Ruda Śląska, state: Śląsk, zip: 41-717, country: Poland, geoPoint lat: 50.2584, lon: 18.85632, hasResults: False |
protocolSection identificationModule nctId: NCT06273501, orgStudyIdInfo id: D-NR 2022-02876-01, briefTitle: MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer, acronym: POSVUC, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-03-24, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Sahlgrenska University Hospital, Sweden, class: OTHER, descriptionModule briefSummary: The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis., conditionsModule conditions: Vulvar Cancer, conditions: Lymph Node Metastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Magtrace, outcomesModule primaryOutcomes measure: Sentinel lymph node identification, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Obstetrics and gynecology, city: Gothenburg, zip: 41345, country: Sweden, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False |
protocolSection identificationModule nctId: NCT06273488, orgStudyIdInfo id: EXZL20240002, briefTitle: The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-23, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College, class: OTHER, descriptionModule briefSummary: To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA., conditionsModule conditions: Auriculotherapy, conditions: Arthroplasty, Replacement, Knee, conditions: Enhanced Recovery After Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Auriculotherapy, outcomesModule primaryOutcomes measure: Range of motion(ROM), secondaryOutcomes measure: Visual Analogue Pain Scale (VAS), secondaryOutcomes measure: Self-Assessment Survey for Anxiety（SAS）, secondaryOutcomes measure: Acupoint electrical measurement value(AE), secondaryOutcomes measure: Vancouver Scar Assessment Scale（VSS）, secondaryOutcomes measure: Dosage of painkillers, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: HSS knee joint scoring, secondaryOutcomes measure: Thigh circumference(knee joint circumference), secondaryOutcomes measure: Kine siphobia (TSK) score, secondaryOutcomes measure: C-reactive protein (CRP), secondaryOutcomes measure: Erythrocyte Sedimentation Rate(ESR), secondaryOutcomes measure: Postoperative satisfaction, secondaryOutcomes measure: Expenses during hospitalization, secondaryOutcomes measure: Demand rate and satisfaction rate of auricular point diagnosis and treatment, secondaryOutcomes measure: Adverse events related to auricular acupuncture diagnosis and treatment, secondaryOutcomes measure: Affected limb drainage volume, secondaryOutcomes measure: Preoperative Anxiety Scale (PAS-7) score, secondaryOutcomes measure: Total number of pain pump uses (presses), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: qindong Mi, role: CONTACT, phone: 8615871784551, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06273475, orgStudyIdInfo id: OUH RoboRehab, briefTitle: Robot-Assisted Training Versus Standard Training in Ischemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: University of Southern Denmark, collaborators name: Rigshospitalet, Denmark, collaborators name: Herlev and Gentofte Hospital, collaborators name: Stanford University, collaborators name: Sygehus Lillebaelt, collaborators name: Danish Association of the Physically Disabled, descriptionModule briefSummary: The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.The main hypothesis of the study is:Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training., conditionsModule conditions: Stroke, conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentre randomised (1:1) parallel-group intervention study with assessor-blinding., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Data will be analysed by the PhD student blinded towards group allocation. The test leader responsible for RCT outcome assessment will be blinded towards group allocation., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Robot-assisted Training, interventions name: Standard Training, outcomesModule primaryOutcomes measure: Fugl-Meyer Lower Extremity Assessment of Motor Function, secondaryOutcomes measure: Modified Rankin Scale Score (between-group change), secondaryOutcomes measure: Functional Ambulation Category (between-group change), secondaryOutcomes measure: Berg Balance Scale (between-group change), secondaryOutcomes measure: Barthel-100 Index (between-group change), secondaryOutcomes measure: Global Rating of Change (between-group change), secondaryOutcomes measure: International Physical Activity Questionnaire - Short Form (between-group change), secondaryOutcomes measure: Fatigue Severity Scale 7 (between-group change), secondaryOutcomes measure: EQ-5D-5L Quality of Life (between-group change), secondaryOutcomes measure: Hand-grip strength (between-group change), secondaryOutcomes measure: Gait speed (between-group change), otherOutcomes measure: Contractile Muscle Power (between-group change), otherOutcomes measure: Modified Sit-to-Stand Test (between-group change), otherOutcomes measure: Blood Biomarkers (between-group change), otherOutcomes measure: Modified Ashworth Scale (between-group change)., otherOutcomes measure: Oxford Cognitive Screen (between-group change), otherOutcomes measure: Montreal Cognitive Assessment (between-group change), otherOutcomes measure: Major Depression Inventory (between-group change), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet and Herlev Gentofte Hospital, status: NOT_YET_RECRUITING, city: Copenhagen, country: Denmark, contacts name: Jon Skovgaard Jensen, Ph.d.-student, role: CONTACT, email: [email protected], contacts name: Christina Rostrup Kruuse, Professor, MD, PhD, DMSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Odense University Hospital, status: RECRUITING, city: Odense, country: Denmark, contacts name: Jon Skovgaard Jensen, Ph.d.-student, role: CONTACT, email: [email protected], contacts name: Anders Holsgaard-Larsen, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False |
protocolSection identificationModule nctId: NCT06273462, orgStudyIdInfo id: NMCSD.2024.0006, briefTitle: Palmitoylethanolamide for Chronic Inflammatory Pain Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Navy Medical Center San Diego, class: FED, descriptionModule briefSummary: The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective Randomize Double Blind Placebo Controlled study comparing the supplement palmitoylethanolamide (PEA) to a visually identical placebo, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double Blinded, patients will receive visually identical capsules from research pharmacist with study label indicating PEA vs Placebo, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Palmitoylethanolamide 600mg twice a day, interventions name: placebo, outcomesModule primaryOutcomes measure: Pain Level, secondaryOutcomes measure: Pain interference and function, secondaryOutcomes measure: Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Naval Medical Center San Diego, city: San Diego, state: California, zip: 92118, country: United States, contacts name: Naval Medical Center Institutional Review Board, role: CONTACT, phone: 619-532-9927, email: [email protected], contacts name: Brian McLean COL, USA MC, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False |
protocolSection identificationModule nctId: NCT06273449, orgStudyIdInfo id: 385/2023, briefTitle: A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-29, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: National Dental Centre, Singapore, class: OTHER, collaborators name: National Medical Research Council (NMRC), Singapore, descriptionModule briefSummary: Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production., conditionsModule conditions: Partial-edentulism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: 1. Conventional: The Standard of Care (SOC) workflow, which will act as a baseline compared to the other 2 groups.2. Partial digital workflow: Adopts the same teeth profile capture method, where a physical impression of teeth profile is taken from the subject. However, instead of using physical wax pattern on the stone model for design, the stone model is scanned and, on the scan, the design is performed digitally. For fabrication of RPD, instead of using lost wax casting, the digital design is used for additive manufacturing.3. SmartRPD digital workflow Adopts a different teeth profile capture method by using the intraoral scanner to digitally scan and save the subject's teeth profile. From the intraoral scan, a digital model of the subject's teeth profile is created but on the digital model instead, the design of RPD is digitally performed. The digital design is used for additive manufacturing., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 141, type: ESTIMATED, armsInterventionsModule interventions name: Group 3 - 3D Printed Removable Partial Denture, interventions name: Group 2 - 3D Printed Removable Partial Denture, outcomesModule primaryOutcomes measure: Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows, primaryOutcomes measure: Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows, primaryOutcomes measure: Comparison of Fabrication Cost and Time Across Three Workflows, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Dental Centre Singapore, status: RECRUITING, city: Singapore, zip: 168938, country: Singapore, contacts name: Hazel Goh Si Ying, role: CONTACT, phone: 63248754, email: [email protected], contacts name: Zi Ying Phang, role: PRINCIPAL_INVESTIGATOR, contacts name: Khim Hean Teoh, role: SUB_INVESTIGATOR, contacts name: Janice Tan Zhi Hui, role: SUB_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06273436, orgStudyIdInfo id: Pro00130902, briefTitle: Healing, Equity, Advocacy and Respect for Mamas, acronym: HEAR4Mamas, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2028-11-30, completionDateStruct date: 2028-11-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, collaborators name: Patient-Centered Outcomes Research Institute, descriptionModule briefSummary: The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities., conditionsModule conditions: Postpartum Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 2894, type: ESTIMATED, armsInterventionsModule interventions name: H.E.A.R. for Mamas, outcomesModule primaryOutcomes measure: Emergency Department (ED) visits within six weeks postpartum, secondaryOutcomes measure: Patient Reported Outcomes (PROs), otherOutcomes measure: Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making, otherOutcomes measure: Patient Activation, otherOutcomes measure: Shared Decision Making, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273423, orgStudyIdInfo id: OULA for Postpartum Depression, briefTitle: Feasibility Evaluation of a Dance Fitness Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Montana State University, class: OTHER, descriptionModule briefSummary: The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD)., conditionsModule conditions: Postpartum Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: OULA, Mind-body Physical Activity, outcomesModule primaryOutcomes measure: Feasibility and acceptability, secondaryOutcomes measure: Changes in postpartum depression, secondaryOutcomes measure: Changes in postpartum anxiety, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273410, orgStudyIdInfo id: 0453-6/2022, briefTitle: Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-13, primaryCompletionDateStruct date: 2023-11-28, completionDateStruct date: 2023-11-28, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Hams Hamed Abdelrahman, class: OTHER, descriptionModule briefSummary: Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial., conditionsModule conditions: Dental Restoration Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Cention N, interventions name: Cention N + Adhesive, interventions name: Bulk Fill Composite, outcomesModule primaryOutcomes measure: Change in pain sensitivity, primaryOutcomes measure: Change in occurrence of recurrent caries, primaryOutcomes measure: Change in occurrence of marginal stains, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alexandria Faculty of Dentistry, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False |
protocolSection identificationModule nctId: NCT06273397, orgStudyIdInfo id: ACME-AHF, briefTitle: Acetazolamide or Metolazone in Acute Heart Failure, acronym: ACME-AHF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Clinica Alemana de Santiago, class: OTHER, descriptionModule briefSummary: Impact of Acute Heart Failure:According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.Use of Diuretics in Acute Heart Failure:Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.Use of Metolazone and Acetazolamide:Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).Outcomes Measured by Major Studies:Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.Congestion Monitoring:Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.Aim of the study:The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure., conditionsModule conditions: Heart Failure Acute, conditions: Decompensated Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is an Open, Multicenter, Prospective, and Randomized study with three treatment arms. The outcomes to be assessed in the initial phase will be at 4 days post-randomization, followed by evaluation at 90 days after hospital discharge., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Acetazolamide 250 MG, interventions name: Metolazone 2.5 MG, interventions name: Furosemide Injection, outcomesModule primaryOutcomes measure: Treatment success, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Worsening Heart Failure, secondaryOutcomes measure: Cumulative 24-hour Natriuresis, secondaryOutcomes measure: Cumulative weight loss, secondaryOutcomes measure: Subclinical congestion, secondaryOutcomes measure: Change in Hematocrit value, secondaryOutcomes measure: Change in NT-proBNP concentration, secondaryOutcomes measure: Change in CA125 value, otherOutcomes measure: Any adverse event, otherOutcomes measure: Changes in pH value, otherOutcomes measure: Change in plasma electrolyte values, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273384, orgStudyIdInfo id: Si 062/2023, briefTitle: Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding, acronym: CIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:* To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.* To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).* To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT., conditionsModule conditions: Helicobacter Pylori Infection, conditions: Peptic Ulcer Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The efficacy of CIM method for H. pylori detection, secondaryOutcomes measure: The advantages of CIM method for H. pylori detection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine Siriraj Hospital, Mahidol University, city: Bangkok Noi, state: Bangkok, zip: 10700, country: Thailand, geoPoint lat: 13.76266, lon: 100.47798, hasResults: False |
protocolSection identificationModule nctId: NCT06273371, orgStudyIdInfo id: DELISA2023, briefTitle: Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain, acronym: DELISA, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2023-12-21, completionDateStruct date: 2023-12-21, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Lactalis, class: INDUSTRY, descriptionModule briefSummary: Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA., conditionsModule conditions: Cow's Milk Protein Allergy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 61, type: ACTUAL, armsInterventionsModule interventions name: Damira 2000 Infant formula, outcomesModule primaryOutcomes measure: Tolerance, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight for height and BMI, secondaryOutcomes measure: Head circumference, eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Quirónsalud de Córdoba, city: Córdoba, state: Andalucia, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, locations facility: H. Virgen del Rocío, city: Sevilla, state: Andalucia, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: H. Virgen Macarena, city: Sevilla, state: Andalucia, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Instituto Hispalense de pediatría, city: Sevilla, state: Andalucia, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Hospital Materno infantil de Ourense, city: Orense, state: Galicia, country: Spain, geoPoint lat: 42.33669, lon: -7.86407, locations facility: H. Clínico de Santiago, city: Santiago De Compostela, state: Galicia, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Clínica privada Dr. Romera, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Fundación Jiménez Día, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06273358, orgStudyIdInfo id: Study Sleep Quality, briefTitle: Preoperative Sleep Quality and Postoperative Delirium, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2023-12-18, completionDateStruct date: 2024-01-27, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Konya City Hospital, class: OTHER, descriptionModule briefSummary: Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years \[SD\]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean., conditionsModule conditions: PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Sleep quality and delirium index, secondaryOutcomes measure: Preop. and postop. sleep quality index, otherOutcomes measure: Sleep quality and QR 15 score, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasin Tire, city: Konya, state: Meram, zip: 42140, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False |
protocolSection identificationModule nctId: NCT06273345, orgStudyIdInfo id: IOV-PR-1-2022-OLIGOS, briefTitle: OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate, acronym: OLIGOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-23, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Istituto Oncologico Veneto IRCCS, class: OTHER, descriptionModule briefSummary: The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).The above criteria define 'high metastatic volume' disease with the following parameters* ≥ 4 bone metastases, including at least one outside the spine and pelvis* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics., conditionsModule conditions: Oligometastatic Prostate Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Cancer-specific survival, secondaryOutcomes measure: CRPCa development, secondaryOutcomes measure: Radiological progression-free survival, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Complications, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale di Bressanone, status: NOT_YET_RECRUITING, city: Bressanone, state: Bolzano, country: Italy, contacts name: Michael Aigner, MD, role: CONTACT, email: [email protected], contacts name: Michael Aigner, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.71503, lon: 11.65598, locations facility: Casa di Cura Abano Terme, status: RECRUITING, city: Abano Terme, state: Padova, country: Italy, contacts name: Daniele Romagnoli, MD, role: CONTACT, email: [email protected], contacts name: Daniele Romagnoli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.35753, lon: 11.78725, locations facility: Ospedale di Dolo, status: RECRUITING, city: Dolo, state: Venezia, country: Italy, contacts name: Gianna Pace, MD, role: CONTACT, email: [email protected], contacts name: Gianna Pace, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.42528, lon: 12.08429, locations facility: Ospedale di Bassano Del Grappa, status: RECRUITING, city: Bassano Del Grappa, state: Vicenza, country: Italy, contacts name: Antonio Celia, MD, role: CONTACT, email: [email protected], contacts name: Antonio Celia, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.76656, lon: 11.72739, locations facility: Ospedale dell'Angelo - Mestre, status: RECRUITING, city: Mestre, country: Italy, contacts name: Francesco Gerardo Mandato, MD, role: CONTACT, email: [email protected], contacts name: Francesco Gerardo Mandato, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.49167, lon: 12.24538, locations facility: Istituto Oncologico Veneto IRCCS, status: RECRUITING, city: Padova, zip: 35128, country: Italy, contacts name: Angelo Porreca, MD, role: CONTACT, phone: 0423 421321, phoneExt: +39, email: [email protected], contacts name: Gian Luca De Salvo, MD, role: CONTACT, phone: 049 8215710, phoneExt: +39, email: [email protected], contacts name: Angelo Porreca, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienda Ospedale Università Padova, status: NOT_YET_RECRUITING, city: Padova, country: Italy, contacts name: Fabio Zattoni, MD, role: CONTACT, email: [email protected], contacts name: Fabio Zattoni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Ospedale MAter Salutis - Legnago, status: NOT_YET_RECRUITING, city: Padova, country: Italy, contacts name: Pierpaolo Curti, MD, role: CONTACT, phone: 0442 622387, phoneExt: +39, email: [email protected], contacts name: Pierpaolo Curti, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Ospedali Riuniti Padova Sud, status: RECRUITING, city: Padova, country: Italy, contacts name: Nicola Zanovello, MD, role: CONTACT, email: [email protected], contacts name: Nicola Zanovello, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), status: NOT_YET_RECRUITING, city: Trieste, country: Italy, contacts name: Carlo Trombetta, MD, role: CONTACT, email: [email protected], contacts name: Carlo Trombetta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC), status: NOT_YET_RECRUITING, city: Udine, country: Italy, contacts name: Gianluca Giannarini, MD, role: CONTACT, email: [email protected], contacts name: Gianluca Giannarini, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.0693, lon: 13.23715, locations facility: Azienda Ospedaliera Universitaria Integrata - Verona, status: RECRUITING, city: Verona, country: Italy, contacts name: Alessandro Antonelli, MD, role: CONTACT, phone: 0458127702/03, phoneExt: +39, email: [email protected], contacts name: Alessandro Antonelli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False |
protocolSection identificationModule nctId: NCT06273332, orgStudyIdInfo id: AI surgery protocol, briefTitle: Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-02-25, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure., conditionsModule conditions: Registration Accuracy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: AI-assisted registration, interventions name: Point-based registration, outcomesModule primaryOutcomes measure: Registration accuracy, secondaryOutcomes measure: Duration for registration, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Private maxillofacial digital lab, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06273319, orgStudyIdInfo id: 010656, briefTitle: The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy., conditionsModule conditions: Gastric Disease, conditions: Gastric Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 2, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: OXYGEN THERAPY, outcomesModule primaryOutcomes measure: Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inonu universitesi, city: Malatya, zip: 44050, country: Turkey, geoPoint lat: 38.35018, lon: 38.31667, hasResults: False |
protocolSection identificationModule nctId: NCT06273306, orgStudyIdInfo id: HULP.PI-4519, secondaryIdInfos id: PI22/00777, type: OTHER_GRANT, domain: Fondo de investigaciones sanitarias.Instituto de Salud Carlos III, briefTitle: Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC), acronym: IMIDOC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Hospital Universitario La Paz, class: OTHER, descriptionModule briefSummary: The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App., conditionsModule conditions: Telemedicine, conditions: Telehealth, conditions: eHealth, conditions: Rheumatic Diseases, conditions: Arthritis, Rheumatoid, conditions: Spondylarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: IMIDOC, outcomesModule primaryOutcomes measure: To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included, secondaryOutcomes measure: To identify features associated with adherence to follow-up through the MAM., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273293, orgStudyIdInfo id: EPIC35-PROMETEUS, briefTitle: Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-01-20, completionDateStruct date: 2026-01-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fundación EPIC, class: OTHER, descriptionModule briefSummary: the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions.In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI.The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up., conditionsModule conditions: Coronary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Fractional Flow Reserve, outcomesModule primaryOutcomes measure: Agreement between cFFR+NTG and FFR, primaryOutcomes measure: SAFETY: MACE, secondaryOutcomes measure: Agreement between Pd/Pa or dPR and FFR, secondaryOutcomes measure: Cut-off point for cFFR+NTG post-ICP, secondaryOutcomes measure: Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: Cardiovascular death, secondaryOutcomes measure: Acute myocardial infarction of the lesion treated/functionally evaluated, secondaryOutcomes measure: Acute myocardial infarction from any lesion, secondaryOutcomes measure: Need for revascularization of the lesion treated/functionally evaluated, secondaryOutcomes measure: Need for revascularization of any lesion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273280, orgStudyIdInfo id: Z-2023025, briefTitle: Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction., acronym: ReQUAD-HF, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ziekenhuis Oost-Limburg, class: OTHER, collaborators name: King Baudouin Foundation, descriptionModule briefSummary: The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.Participants will be randomized towards control (standard of care, SOC) or intervention group.Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT., conditionsModule conditions: Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 345, type: ESTIMATED, armsInterventionsModule interventions name: SOC, interventions name: Protocolized up-titration, outcomesModule primaryOutcomes measure: Weighed composite score of maximal guideline-directed medical therapy, secondaryOutcomes measure: All-cause mortality and heart failure hospitalizations, secondaryOutcomes measure: Change in NTproBNP, secondaryOutcomes measure: Change in renal function, otherOutcomes measure: All-cause mortality, otherOutcomes measure: Number of patients with heart failure hospitalizations, otherOutcomes measure: Change in prescription rate per GDMT class, otherOutcomes measure: Incidence of predefined safety endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ziekenhuis Oost-Limburg AV, city: Genk, state: Limburg, zip: 3600, country: Belgium, geoPoint lat: 50.965, lon: 5.50082, hasResults: False |
protocolSection identificationModule nctId: NCT06273267, orgStudyIdInfo id: APHP231232, briefTitle: Initiating Pediatric Palliative Care in ACT Group 4, acronym: StartSPP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention., conditionsModule conditions: Encephalopathy, conditions: Cerebral Palsy, conditions: Cerebral Malformation, conditions: Traumatic Head Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Collection of data from the patient's medical file, outcomesModule primaryOutcomes measure: Description of first pediatric palliative care intervention, secondaryOutcomes measure: Description of the patient situation, secondaryOutcomes measure: Timing of pediatric palliative care intervention, eligibilityModule sex: ALL, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Necker-Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Ashley RIDLEY, M.D., role: CONTACT, phone: 1 42 19 27 28, phoneExt: +33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06273254, orgStudyIdInfo id: SCVL-TFZ-1009, briefTitle: A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Viatris Inc., class: INDUSTRY, descriptionModule briefSummary: Primary objective is to is to evaluate the bioequivalence of two formulations, conditionsModule conditions: Bioequivalence Study, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Sacubitril and Valsartan Tablets 49mg/51mg, interventions name: Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg), outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: AUC, secondaryOutcomes measure: tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: λz, secondaryOutcomes measure: AUC0-t/AUC0-∞, secondaryOutcomes measure: residual area, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Medica Innova Co Ltd, city: Bangkok, zip: 10310, country: Thailand, contacts name: Ariya Khunvichai, Ph.D, role: CONTACT, phone: 666 2428 7178, email: [email protected], contacts name: Suvimol Niyomnaitham, Assist. Prof., M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06273241, orgStudyIdInfo id: IPHA-2024-009, briefTitle: Impact of Food Intake on Berberine Kinetics, acronym: BERKI-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University Medicine Greifswald, class: OTHER, descriptionModule briefSummary: The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.24 heathy volunteers with an equal ratio of man and women will be enrolled., conditionsModule conditions: Pharmacokinetic Study in Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This study will be an open label study. Participants will be selected from an existing database of our Institute., enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: food intake, outcomesModule primaryOutcomes measure: Berberine plasma concentration fasted vs fed, secondaryOutcomes measure: Berberine plasma concentrations light vs heavy meal, otherOutcomes measure: Blood glucose concentrations, otherOutcomes measure: Blood insulin concentrations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Medicine Greifswald, Institute of Pharmacology, city: Greifswald, state: Mecklenburg-Vorpommern, zip: 17487, country: Germany, contacts name: Stefan Engeli, Prof., role: CONTACT, phone: +49 3834865633, email: [email protected], contacts name: Christin Jeschke, role: CONTACT, phone: +491746471584, email: [email protected], contacts name: Stefan Engeli, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.09311, lon: 13.38786, hasResults: False |
protocolSection identificationModule nctId: NCT06273228, orgStudyIdInfo id: STUDY00000788, briefTitle: Parenting Young Children in Pediatrics, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Oregon, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician.The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings., conditionsModule conditions: Parenting, conditions: Parent-Child Relations, conditions: Substance Use Disorders, conditions: Stress, conditions: Depression, conditions: Anxiety, conditions: Parenting Self-efficacy, conditions: Pediatrics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Parents will be recruited in pediatric primary care settings and will be assessed at baseline and at a 3-month follow-up. Parents will receive the intervention between baseline and follow-up. Nine parents will be randomly selected for an additional follow-up interview., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Family Check-Up Online, outcomesModule primaryOutcomes measure: change from baseline in parenting skills, primaryOutcomes measure: change from baseline in parenting efficacy, primaryOutcomes measure: change from baseline in parent executive functioning, primaryOutcomes measure: change from baseline in child social-emotional behavior, primaryOutcomes measure: change from baseline in family conflict, primaryOutcomes measure: change from baseline in parental substance use, primaryOutcomes measure: change from baseline in parental depression, primaryOutcomes measure: change from baseline in parental anxiety, primaryOutcomes measure: change from baseline in parental stress, primaryOutcomes measure: change from baseline in parental impact of negative life events, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prevention Science Institute, University of Oregon, status: RECRUITING, city: Eugene, state: Oregon, zip: 97403, country: United States, contacts name: Katherine Hails, PhD, role: CONTACT, phone: 610-457-8627, email: [email protected], contacts name: Elizabeth Stormshak, PhD, role: CONTACT, phone: 541-912-3792, email: [email protected], contacts name: Katherine Hails, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.05207, lon: -123.08675, hasResults: False |
protocolSection identificationModule nctId: NCT06273215, orgStudyIdInfo id: DCTC-IIR202217, briefTitle: Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-05, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: 1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM)., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach., outcomesModule primaryOutcomes measure: Pharmacokinetics of study drug, secondaryOutcomes measure: Concentration of endogenous markers of CYP3A and OATP, secondaryOutcomes measure: Genotype of OATP and BCRP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Yafen Li, role: CONTACT, phone: 18222566785, email: [email protected], contacts name: Dongyang Liu, role: PRINCIPAL_INVESTIGATOR, contacts name: Tianpei Hong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06273202, orgStudyIdInfo id: 6257, briefTitle: Ultrasound Monitoring of Muscle Thickness in Premature Patients, acronym: NeoMassage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.The main questions it aims to answer are:* To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.* Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present., conditionsModule conditions: Prematurity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Infant Massage, outcomesModule primaryOutcomes measure: Quadriceps femuri thickness, primaryOutcomes measure: Quadriceps femuri trophism, secondaryOutcomes measure: To valuate the discomfort/behavioral status of the infant., secondaryOutcomes measure: To valuate the potential effects on spontaneous motility., secondaryOutcomes measure: To evaluate differences in ponderal growth., eligibilityModule sex: ALL, minimumAge: 28 Weeks, maximumAge: 35 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273189, orgStudyIdInfo id: 2017/558, briefTitle: Ultrasonic Bone Scalpel in BSSO, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-15, primaryCompletionDateStruct date: 2020-12-15, completionDateStruct date: 2021-12-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO., conditionsModule conditions: Maxillofacial Abnormalities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double blind, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Conventional, interventions name: Bone Scalpel, outcomesModule primaryOutcomes measure: Cutting Time, primaryOutcomes measure: neurosensory disturbance, secondaryOutcomes measure: The length of the procedure, secondaryOutcomes measure: The splitting time, secondaryOutcomes measure: The pattern of the split, secondaryOutcomes measure: postoperative edema, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selin Çelebi, city: Kayseri, state: Melikgazi, zip: 38039, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06273176, orgStudyIdInfo id: MEC-2020-0812, briefTitle: The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma, acronym: RECMAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Haaglanden Medical Centre, collaborators name: Universitaire Ziekenhuizen KU Leuven, collaborators name: University Hospital Heidelberg, collaborators name: Technical University of Munich, collaborators name: Insel Gruppe AG, University Hospital Bern, collaborators name: Massachusetts General Hospital, collaborators name: University of California, San Francisco, descriptionModule briefSummary: Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM)., conditionsModule conditions: Glioblastoma, IDH-wildtype, conditions: Glioblastoma, conditions: Glioblastoma Multiforme of Brain, conditions: Astrocytoma, Malignant, conditions: Brain Neoplasms, conditions: Brain Neoplasms, Adult, Malignant, conditions: Brain Neoplasms, Adult, conditions: Recurrent Adult Brain Tumor, conditions: Recurrent Glioblastoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Awake mapping under local anesthesia, interventions name: Asleep mapping under general anesthesia, interventions name: Resection under general anesthesia without mapping, outcomesModule primaryOutcomes measure: Residual volume, primaryOutcomes measure: Neurological morbidity at 6 weeks, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Onco-functional outcome (OFO), secondaryOutcomes measure: Serious Adverse Events, secondaryOutcomes measure: Neurological morbidity at 3 months, secondaryOutcomes measure: Neurological morbidity at 6 months, secondaryOutcomes measure: Overall functioning at 6 weeks, secondaryOutcomes measure: Overall functioning at 3 months, secondaryOutcomes measure: Overall functioning at 6 months, secondaryOutcomes measure: Quality of life at 6 weeks (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 3 months (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 6 months (EORTC QLQ C30), secondaryOutcomes measure: Quality of life at 6 weeks (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 3 months (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 6 months (EORTC QLQ BN20), secondaryOutcomes measure: Quality of life at 6 weeks (EQ-5D), secondaryOutcomes measure: Quality of life at 3 months (EQ-5D), secondaryOutcomes measure: Quality of life at 6 months (EQ-5D), eligibilityModule sex: ALL, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Mitchel Berger, MD PhD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Brian Nahed, MD PhD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University Hospital Leuven, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Steven De Vleeschouwer, MD PhD, role: CONTACT, geoPoint lat: 50.87959, lon: 4.70093, locations facility: Universitätsklinikum Heidelberg, status: RECRUITING, city: Heidelberg, country: Germany, contacts name: Christine Jungk, MD PhD, role: CONTACT, contacts name: Sandro Krieg, MD PhD, role: CONTACT, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Technical University Munich, status: NOT_YET_RECRUITING, city: Munich, country: Germany, contacts name: Arthur Wagner, MD, role: CONTACT, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Erasmus Medical Center, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015 GD, country: Netherlands, contacts name: Jasper Gerritsen, MD PhD, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Haaglanden Medical Center, status: RECRUITING, city: The Hague, country: Netherlands, contacts name: Marike Broekman, MD PhD, role: CONTACT, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Inselspital Universitätsspital Bern, status: NOT_YET_RECRUITING, city: Bern, country: Switzerland, contacts name: Philippe Schucht, MD PhD, role: CONTACT, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False |
protocolSection identificationModule nctId: NCT06273163, orgStudyIdInfo id: STU-2023-1168, briefTitle: Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: UT Southwestern Nutrition Obesity Research Center, descriptionModule briefSummary: Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized repeated measures between-subjects design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Medically tailored meals, interventions name: Noom®, interventions name: Usual care, outcomesModule primaryOutcomes measure: Intervention Adherence, primaryOutcomes measure: Intervention Satisfaction, secondaryOutcomes measure: Percent weight loss maintained, secondaryOutcomes measure: Diet quality, otherOutcomes measure: Incremental cost effective ratio (ICER), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UT Southwestern Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Carolyn Haskins, MS, role: CONTACT, email: [email protected], contacts name: Jessica Turcios, BS, role: CONTACT, email: [email protected], contacts name: Kelseanna Hollis-Hansen, PhD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06273150, orgStudyIdInfo id: 142048, briefTitle: Dentatorubral-pallidoluysian Atrophy Natural History and Biomarkers Study, acronym: DRPLA NHBS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University College, London, class: OTHER, collaborators name: University of North Carolina, Chapel Hill, collaborators name: NYU Grossman School of Medicine, descriptionModule briefSummary: DRPLA Natural History and Biomarkers Study (DRPLA NHBS) is a prospective observational study that will lay the foundation for clinical trials in DRPLA. The aims of this project are:* To characterize the natural history of DRPLA in both juvenile- and adult-onset patients and study different modalities of biomarkers in this condition.* To identify genetic factors and biomarkers that could predict disease progression.* To provide a platform to support the design and conduct of clinical trials.This study has three arms:1. Adult Participants: this arm of the study will require participants to be 16 years old or over to participate.2. Pediatric Participants: this arm of the study will require participants to be under 16 years old to participate.3. Remote Participants: patients that cannot or do not wish to travel to one of the study sites can participate in this arm of the study, irrespective of their age.Participants will have an annual visit for three years (baseline visit and two follow-up visits, three visits in total). Subjects who complete the whole protocol will be assessed on two consecutive days to reduce patient burden.This project will allow for a better understanding of DRPLA and its course, and therefore allow for future clinical trials on this condition to be more precisely and effectively conducted., conditionsModule conditions: Dentatorubral-Pallidoluysian Atrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Positive genetic test for pathological expansion in ATN1, outcomesModule primaryOutcomes measure: Scale for the assessment and rating of ataxia (SARA), primaryOutcomes measure: Brain atrophy, primaryOutcomes measure: Neurofilament plasma concentration (NfL), secondaryOutcomes measure: Inventory of non-ataxia signs (INAS), secondaryOutcomes measure: Upper limb function test AIM-S, secondaryOutcomes measure: Redenlab DRPLA specific speech battery, secondaryOutcomes measure: Clinical Assessment of Dysphagia in Neurodegeneration (CADN), secondaryOutcomes measure: Tau plasma concentration, secondaryOutcomes measure: Glial fibrillary acidic protein (GFAP) concentration, secondaryOutcomes measure: Ubiquitin carboxyterminal hydrolase L1 (UCH-L1) concentration, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Grossman School of Medicine, status: RECRUITING, city: New York, state: New York, zip: 10017, country: United States, contacts name: Claire Miller, role: CONTACT, phone: 212-263-4838, email: [email protected], geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599-7025, country: United States, contacts name: Yael Shiloh-Malawsky, role: CONTACT, phone: 919-966-2528, email: [email protected], geoPoint lat: 35.9132, lon: -79.05584, locations facility: University College London, status: RECRUITING, city: London, zip: WC1N 3BG, country: United Kingdom, contacts name: Paola Giunti, role: CONTACT, phone: +44 7899974923, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06273137, orgStudyIdInfo id: 2963, briefTitle: Positive Affect Treatment for Adolescents With Early Life Adversity, acronym: PAT4ELA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-03, primaryCompletionDateStruct date: 2026-02-16, completionDateStruct date: 2026-10-16, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will be randomized 1:1 to either receive PAT upon enrollment or after a waitlist period., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Positive affect treatment, outcomesModule primaryOutcomes measure: Positive affect, secondaryOutcomes measure: depressive symptoms - total, secondaryOutcomes measure: depressive symptoms - anhedonia subscale, secondaryOutcomes measure: Systemic inflammation - C-reactive protein (CRP), secondaryOutcomes measure: Inflammatory gene expression, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of California Irvine, status: RECRUITING, city: Irvine, state: California, zip: 92617, country: United States, contacts name: Kate R Kuhlman, role: CONTACT, phone: 949-824-5574, email: [email protected], geoPoint lat: 33.66946, lon: -117.82311, hasResults: False |
protocolSection identificationModule nctId: NCT06273124, orgStudyIdInfo id: 150-1261-00, briefTitle: Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Tandem Diabetes Care, Inc., class: INDUSTRY, collaborators name: Jaeb Center for Health Research, descriptionModule briefSummary: The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).Participants will be asked to:1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour, conditionsModule conditions: Type1diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: SteadiSet Extended Wear Infusion Set, outcomesModule primaryOutcomes measure: Primary Outcome Measure, primaryOutcomes measure: Primary Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hoag Memorial Hospital Presbyterian, status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: Brittany Dennis, role: CONTACT, phone: 949-764-6896, email: [email protected], contacts name: David Ahn, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Stanford University, status: NOT_YET_RECRUITING, city: Stanford, state: California, zip: 94305, country: United States, contacts name: Rayhan Lal, role: CONTACT, phone: 925-727-1317, email: [email protected], contacts name: Rayhan Lal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.42411, lon: -122.16608, locations facility: Barbara Davis Center, status: NOT_YET_RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Samantha Lange, role: CONTACT, phone: 303-724-7514, email: [email protected], contacts name: Erin Cobry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Endocrine Research Solutions, status: RECRUITING, city: Roswell, state: Georgia, zip: 30076, country: United States, contacts name: Jessica Tapia, role: CONTACT, phone: 678-878-4750, email: [email protected], contacts name: John C Reed, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.02316, lon: -84.36159, locations facility: Rocky Mountain Clinical Research, status: NOT_YET_RECRUITING, city: Idaho Falls, state: Idaho, zip: 83404, country: United States, contacts name: Wyatt Larson, role: CONTACT, phone: 208-525-3736, email: [email protected], contacts name: David Liljenquist, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46658, lon: -112.03414, locations facility: Northwestern University, status: NOT_YET_RECRUITING, city: Evanston, state: Illinois, zip: 60208, country: United States, contacts name: Grazia Aleppo, role: CONTACT, phone: 312-926-5431, email: [email protected], contacts name: Grazia Aleppo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.04114, lon: -87.69006, locations facility: Massachusetts General Hospital, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Amy Sabean, role: CONTACT, phone: 617-726-1729, email: [email protected], contacts name: Melissa Putman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Henry Ford Health System, status: NOT_YET_RECRUITING, city: Detroit, state: Michigan, zip: 48202, country: United States, contacts name: Davida Kruger, role: CONTACT, phone: 313-916-3906, email: [email protected], contacts name: Davida Kruger, NP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.33143, lon: -83.04575, locations facility: International Diabetes Center - HealthPartners Institute, status: NOT_YET_RECRUITING, city: Minneapolis, state: Minnesota, zip: 55416, country: United States, contacts name: Kathryn Leet, RD,LD, CDCES, role: CONTACT, phone: 952-993-9793, email: [email protected], contacts name: Richard Bergenstal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Mayo Clinic, status: NOT_YET_RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Corey Kurek, role: CONTACT, phone: 507-255-0316, email: [email protected], contacts name: Yogish Kudva, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Icahn School of Medicine at Mt. Sinai, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Denisa Tamarez, role: CONTACT, phone: 212-241-9089, email: [email protected], contacts name: Camilla Levister, MS, ANCP-C, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: SUNY Upstate Medical University, status: RECRUITING, city: Syracuse, state: New York, zip: 13210, country: United States, contacts name: Suzan Bzdick, RN, CDCES, role: CONTACT, phone: 315-464-9006, email: [email protected], contacts name: Ruth Weinstock, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.04812, lon: -76.14742, locations facility: Texas Diabetes and Endocrinology, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78731, country: United States, contacts name: Emmanuel Lopez, role: CONTACT, phone: 512-334-3505, email: [email protected], contacts name: Jean Chen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Rainier Clinical Research Center, status: NOT_YET_RECRUITING, city: Renton, state: Washington, zip: 98057, country: United States, contacts name: Tina Mitchell, role: CONTACT, phone: 425-251-1720, email: [email protected], contacts name: Frances Broyles, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.48288, lon: -122.21707, locations facility: University of Washington, status: NOT_YET_RECRUITING, city: Seattle, state: Washington, zip: 98109, country: United States, contacts name: Dori Khakpour, role: CONTACT, phone: 206-945-4965, email: [email protected], contacts name: Irl Hirsch, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06273111, orgStudyIdInfo id: 73840, briefTitle: Topical Simvastatin for Treating Infantile Hemangioma, acronym: TSTIH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Joyce Teng, class: OTHER, collaborators name: Stanford University, descriptionModule briefSummary: This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.The primary objective:To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.The secondary objective:1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS).1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire., conditionsModule conditions: Hemangioma Skin, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: 5% simvastatin ointment, outcomesModule primaryOutcomes measure: Number of Participants with Treatment-Related Adverse Events, secondaryOutcomes measure: Percentage of participants achieved a 50% HAS reduction at week 12 compared to baseline, secondaryOutcomes measure: Percentage of participants achieved a 75% HAS reduction from baseline by the end of the study (week 24) compared to baseline., secondaryOutcomes measure: Percentage of targeted hemangiomas with complete or nearly complete resolution (IGA 0 or 1), defined as a minimal degree of telangiectasia, skin thickening, and no definitive palpable cutaneous texture changes., secondaryOutcomes measure: Percentage of targeted hemangiomas that are stabilized (no noticeable change to baseline) or continue to progress., secondaryOutcomes measure: Percentage of participants with a significant improvement in quality-of-life, defined as > 50% reduction in the IH-QoL questionnaire score from baseline to week 24., eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Stanford University, city: Palo Alto, state: California, zip: 94304, country: United States, contacts name: Ramrada Lekwuttikarn, MD, role: CONTACT, phone: 650-313-8207, email: [email protected], contacts name: Thomas Buschbacher, role: CONTACT, phone: 352-278-7603, email: [email protected], geoPoint lat: 37.44188, lon: -122.14302, hasResults: False |
protocolSection identificationModule nctId: NCT06273098, orgStudyIdInfo id: 73162, briefTitle: School-Based Bladder Health Intervention, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2028-01-01, primaryCompletionDateStruct date: 2033-12-31, completionDateStruct date: 2033-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children., conditionsModule conditions: Urinary Dysfunction, conditions: Lower Urinary Tract Symptoms, conditions: Urinary Tract Infections, conditions: Urinary Tract Infections in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Bladder Health Education, outcomesModule primaryOutcomes measure: Bathroom use, primaryOutcomes measure: Symptom score, primaryOutcomes measure: Urine volume, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Stanford Hospital and Clinics, city: Palo Alto, state: California, zip: 94304, country: United States, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False |
protocolSection identificationModule nctId: NCT06273085, orgStudyIdInfo id: MOD00016877, briefTitle: Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Medstar Health Baltimore, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital., conditionsModule conditions: Heart Failure, conditions: Patient Acceptance of Health Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Patient education, outcomesModule primaryOutcomes measure: Change in GDMT score, secondaryOutcomes measure: Heart Failure hospitalization, secondaryOutcomes measure: cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant, secondaryOutcomes measure: Number of GDMT classes of medications in use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medstar Union Memorial Hospital, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21218, country: United States, contacts name: Ahmad Amin, MD, role: CONTACT, phone: 401-533-0696, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, locations facility: Medstar Harbor Hospital, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21225, country: United States, contacts name: Sumanth Bandaru, MBBS, role: CONTACT, phone: 646-240-5289, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, locations facility: Medstar Franklin Medical Center, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21237, country: United States, contacts name: Anup Agarwal, MD, role: CONTACT, phone: 505-620-7815, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, locations facility: Medstar Good Samaritan Hospital, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21239, country: United States, contacts name: Sumanth Bandaru, MBBS, role: CONTACT, phone: 646-240-5289, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06273072, orgStudyIdInfo id: IRB00409080, secondaryIdInfos id: R34HL166438-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/R34HL166438-01A1, briefTitle: Metformin IN Asthma for Overweight and Obese Individuals (MINA), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Baylor College of Medicine, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), collaborators name: Temple University, descriptionModule briefSummary: This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy., conditionsModule conditions: Asthma, conditions: Asthma Chronic, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Metformin hydrochloride extended-release tablets, interventions name: Visually identical placebo Metformin hydrochloride extended-release tablets, outcomesModule primaryOutcomes measure: Number of completed telemedicine visits, primaryOutcomes measure: Adherence to study drug, primaryOutcomes measure: Retention rate, secondaryOutcomes measure: Asthma control as assessed by the Asthma Control Test (ACT) score, secondaryOutcomes measure: Change in Asthma exacerbations rate, secondaryOutcomes measure: Pre-bronchodilator lung function, secondaryOutcomes measure: Fractional exhaled nitric oxide (FeNO), secondaryOutcomes measure: Airways hyperresponsiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06273059, orgStudyIdInfo id: 22-07-0717, briefTitle: Genomic Study of Young-Onset Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-12, primaryCompletionDateStruct date: 2024-12-12, completionDateStruct date: 2024-12-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: Diabetes Mellitus (DM) has been a major contributor to health burden in Indonesia and currently its burden still continues to rise. This is a result of increasing DM prevalence in the country as well as high rates of chronic complications from DM. Findings in Indonesia show that there is a high proportion of young people with diabetes, and also a high risk of therapeutic failure and complications from DM occurring in the younger population.Young-onset DM has a wide clinical spectrum, including autoimmune DM, polygenic DM, and monogenic DM such as Mature Onset Diabetes of the Young (MODY). Identification and proper diagnosis of young-onset DM spectrum is crucial to treatment outcomes, as certain spectrums, such as some subtypes of MODY, may benefit from cost-efficient alternatives with better outcomes.However, proper diagnosis of young-onset DM in Indonesia is still a great challenge, as currently some examinations, including genetic testing, has not yet been feasibly done in the country. With current advances in genomics, genetic testing may prove to be fundamental in providing optimal and personalized treatment and care for DM patients.This study is a pilot project aimed to initiate genomic research in young-onset DM patients in Indonesia. In the short term, this study aims to identify genetic variants that may be able to increase diagnostic accuracy of the young-onset DM spectrum. In the long term, this study aims to identify new genetic variants of young-onset DM. The study also aims to identify genetic variants associated with risks of chronic complications., conditionsModule conditions: Genomic, conditions: Diabetes Mellitus, conditions: MODY, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The overall objective of this study is to identify and describe genetic variation of young-onset DM in Indonesia., secondaryOutcomes measure: To describe the proportion of MODY in young-onset DM, secondaryOutcomes measure: To describe genetic variation of MODY in Indonesia., secondaryOutcomes measure: To describe genetic variation in young-onset DM with diabetic complications in various systems:, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Cipto Mangunkusumo Hospital, status: RECRUITING, city: Jakarta Pusat, state: DKI Jakarta, zip: 10430, country: Indonesia, contacts role: CONTACT, phone: 1 500 135, geoPoint lat: -6.1818, lon: 106.8223, hasResults: False |
protocolSection identificationModule nctId: NCT06273046, orgStudyIdInfo id: PR(AG)614/2023, briefTitle: Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-04-28, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home., conditionsModule conditions: Fecal Incontinence, conditions: Outlet Dysfunction Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Biofeedback, interventions name: Placebo, outcomesModule primaryOutcomes measure: Fecal incontinence study: Number of anal leaks, primaryOutcomes measure: Dyssinergic defecation study: Number of bowel movements, secondaryOutcomes measure: Incontinence study: Wexner scale, secondaryOutcomes measure: Incontinence study: Quality of life, secondaryOutcomes measure: Incontinence study: anxiety and depression, secondaryOutcomes measure: Incontinence study: Anal sphincter function, secondaryOutcomes measure: Dyssinergic defecation study: sensation of outlet obstructed evacuation, secondaryOutcomes measure: Dyssinergic defecation study: Wexner scale, secondaryOutcomes measure: Dyssinergic defecation study: Quality of life, secondaryOutcomes measure: Dyssinergic defecation study: anxiety and depression, secondaryOutcomes measure: Dyssinergic defecation study: defecatory maneuvers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Vall d'Hebron, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Jordi Serra, MD, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
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